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End-stage kidney disease poses a high health and societal burden on US patients and their families, with more than 100 000 patients starting dialysis every year. Although other treatment options are available, more than 90% of patients receive hemodialysis (HD) as their first renal replacement therapy modality. Little is known about factors that are important to chronic kidney disease (CKD) patients and their perspectives at the time they choose a dialysis modality.
The Empowering Patients on Choices for Renal Replacement Therapy (EPOCH-RRT) study aimed to identify patient priorities and gaps in shared decision-making with the support of the large cohort of nationally representative dialysis patients participating in the Dialysis Outcomes and Practice Patterns Study Program, to inform the development of a new web-based patient decision aid (DA) that would provide relevant information about the 2 most widely used dialysis options: in-center HD and peritoneal dialysis (PD).
Aim 1 was a mixed methods approach involving open-ended and closed-ended interview responses from 180 patients. This was followed by aim 2, implementation of a retrospective quantitative survey assessing the dialysis modality decision-making process and impact on the daily lives of 1963 HD and PD patients. We based the interview and survey design and subsequent development of the DA on feedback from a patient advisory panel. In aim 3, we measured the effectiveness of the DA through a randomized controlled study of 140 predialysis CKD patients, including a pre-post assessment.
The EPOCH-RRT study identified independence, flexibility, concerns about looks, and quality and quantity of life as some of the most frequently reported patient priorities.55 The results from our surveys suggest that people who start PD are more often informed, engaged in the decision-making process, and satisfied with their dialysis modality; however, overall, a need for improving patient education, access to peers, and other support was identified. The DA developed in this study was subsequently shown to be effective in increasing knowledge and decreasing decisional conflict.
EPOCH-RRT provided novel information that helps fill the knowledge gap on patients' perspectives on the choice of dialysis modality. A key innovation is the inclusion of patient representatives, caregivers (family members), and patient advocacy organizations as collaborators in all aspects of the study. Priorities, identified by patients and confirmed in a representative sample of US patients receiving HD and PD treatments, guided the development of the DA. The DA, now publicly available at www.choosingdialysis.org, will help empower patients in selecting the appropriate treatment modality that best fits their clinical as well as personal needs and lifestyle—thereby improving satisfaction with modality choice and potentially improving patient outcomes.
Chronic kidney disease (CKD) poses a high health and societal burden on US patients and their families. According to data from the 1999-2004 National Health and Nutrition Examination Survey, 16.8% of the US population aged ≥20 years had CKD, a 15.9% increase compared with 1988-1994.1 Further, the data also indicated that people with diabetes or cardiovascular disease had a greater prevalence of CKD. In 2009, approximately 116 000 patients were diagnosed with kidney failure, and more than 390 000 were on dialysis.2 The mortality rate for patients on dialysis was 199.5 per 1000 patient-years, and the adjusted rate was 6.5 to 7.4 times higher than that of the general population. Hospitalization rates were 1836 admissions per 1000 patient-years, accounting on average for 12 days in the hospital per year per dialysis patient.2 Dialysis patients also present with poor quality of life, higher rates of depression, and other debilitating symptoms, including fatigue, poor sleep quality, and lack of appetite.3-5 Most patients starting dialysis present with multiple chronic conditions, including diabetes, ischemic heart disease, and congestive heart failure.6 In 2005, total Medicare spending for end-stage renal disease (ESRD) was more than $30 billion, representing 6.7% of the entire Medicare budget.2
As kidneys fail, patients face the difficult decision of which treatment is the most appropriate for them. Conservative treatment—medications and dietary restrictions without dialysis—is an option chosen by few patients, usually the elderly with limited life expectancy.7 Patients who receive a kidney transplant have the best outcomes.8,9 However, due to organ shortage, the median waiting time is more than 43 months,10 and only 2% of incident ESRD patients receive a transplant without receiving dialysis first. Thus, the choice between other renal replacement therapy (RRT) options is very relevant, even for patients for whom kidney transplantation may eventually occur.
More than 90% of patients receive hemodialysis (HD) at a dialysis center (“in-center”) as their first RRT modality. During HD sessions, patients are connected to a machine that removes wastes, excess fluid, and electrolytes from the blood; currently, <2% of HD patients perform HD at home.2 Peritoneal dialysis (PD) involves placing fluid in the abdominal cavity, using the peritoneal membrane to filter toxins from the blood. Patients perform PD at home or at work, thus enjoying more freedom and flexibility, along with greater responsibility in their own care. Mortality rates of patients treated with HD and PD are similar, yet PD use in the United States is much lower than that in other countries.11,12
Clinical contraindications may restrict modality choice for some; however, most patients are candidates for both PD and HD. Either modality may be a better fit for a specific patient based on dialysis treatment characteristics and associated impacts on daily life. Thus, the choice between modalities should be based on patient preferences, and it is critical to include and engage patients in the dialysis modality decision.13,14 This is supported by increasing evidence that aligning treatment with patient preferences may improve quality of life and adherence as well as better medical outcomes.3,15-17
Current clinical practice guidelines recommend involving patients and their care partners in the dialysis modality decision-making process.15,18-20 Unfortunately, studies have shown that many do not feel they were given an active choice of modality,13,21,22 despite a desire to be involved in decision-making.13,23 To do so effectively, patients and their care partners must have a comprehensive understanding of differences between dialysis modalities and their impacts on daily life.24,25 However, previous studies have shown many patients feel unprepared and ill-informed about starting dialysis and about different dialysis modalities.22,26 Therefore, dialysis education could not only prepare patients for shared decision-making but could also increase ESRD knowledge and may ultimately lead to better outcomes through more active engagement in care.24,27-30 Shared decision-making (SDM) is the collaborative process involving, at a minimum, the patient and the clinician finding the optimal treatment option for a patient; it is a central concept in patient-centered care.31 Studies on the benefits of SDM are primarily in the context of patient decision aids. Patient decision aids are tools used to facilitate patient decision-making about 2 or more health care options.32 Such tools aim to provide unbiased information to improve patients' understanding of their options, increase participation in the decision-making process, reduce perceived pressure in selecting treatment choice, and mitigate decisional conflict. Increasing patients' clarity on the available options as they relate to their own personal values facilitates greater decision-making self-efficacy—that is, the belief that patients are able to make the right decision for themselves.33 Several studies have shown that decision aids can substantially affect key outcomes, including satisfaction with and confidence in the decision made, and that these outcomes may affect treatment adherence.33-35
Our study comprised 3 specific aims, each described in detail as separate sections in this report. In aim 1, we identified and compared patient-centered outcomes across patient groups by applying qualitative research methods in a large cohort of CKD patients. For aim 2, we leveraged the existing infrastructure of both the Dialysis Outcomes and Practice Patterns Study and the Peritoneal Dialysis Outcomes and Practice Patterns Study to compare patient-centered outcomes between HD and PD. In aim 3, priorities identified by patients in aim 1 and confirmed by surveying patients receiving HD and PD treatments in aim 2 guided the development of a web-based dialysis modality decision aid. We then tested the decision aid using a randomized controlled study of predialysis CKD patients to measure its effect on decision-making outcomes.
This study is registered with clinicaltrials.gov, and study outcomes have been submitted and results have been released (ID NCT02488317). All study procedures were approved by local IRBs (Ethical and Independent Review Services E&I #13016, Henry Ford Health Systems IRB #8144, University of Michigan IRBMED HUM00073058), as appropriate.
A key innovation of our study is the inclusion of patient representatives, care partners (family members), and patient advocacy organizations as collaborators. At the start of the study, with the help of the National Kidney Foundation of Michigan and Nephrologists in southeast Michigan, we recruited 9 patients and family members with experience in kidney disease, kidney transplants, different dialysis modalities, and peer mentoring; we further recruited clinicians (nephrologists and social workers) involved in the dialysis treatment decision process to form our advisory panel. Researchers worked closely with the advisory panel through quarterly in-person meetings in Ann Arbor, Michigan, and teleconferences as well as email correspondence between meetings throughout the entire study. The advisory panel was particularly instrumental in developing study protocol and survey and decision aid content, prioritizing the focus for analyses, and interpreting and disseminating findings. The advisory panel was involved in all 3 aims of the study, as described in the methods for each aim. The National Kidney Foundation and American Association of Kidney Patients were involved in recruitment efforts for aims 1 and 3 (review of the decision aid and dissemination of the website). In this report, we divide the text into separate sections for aim 1, aim 2, and aim 3. Within each section, we subdivide into Methods, Results, and Discussion. The contributions of stakeholders to specific study design decisions appear in the pertinent sections.
The choice between the 2 most frequent treatment options—hemodialysis (HD) and peritoneal dialysis (PD)—is often driven by the patient's clinical conditions and the nephrologist's familiarity with each technique, with little attention paid to individual patient preferences.22,36-39 There is a paucity of literature on patient preferences in the dialysis community. In aim 1 of the Empowering Patients on Choices for Renal Replacement Therapy study, we conducted semi structured interviews of chronic kidney disease (CKD) and end-stage renal disease (ESRD) patients to understand factors important to patients at the time they face the choice of dialysis modality.
We designed three distinct interview protocols for (1) CKD not yet on dialysis (CKD-ND) patients, (2) HD patients, and (3) PD patients based on input from the advisory panel. Protocols used a mixed methods approach comprising open-ended and closed-ended questions, with closed-ended questions including yes/no, categorical, and Likert-type (1-10) scales. Protocols were similar in content and sequence across the 3 patient subgroups, with appropriate differences in probes for each subgroup. Protocols included questions assessing demographics, clinical history, and patients' perception of their health. We developed standardized interview protocols to ensure uniform data collection. The advisory panel members reviewed all protocols to ensure understandable content and language, and they were also involved in prioritizing analysis and interpreting findings.
Inclusion criteria were (1) aged >18 years, and (2) either estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m2 or on dialysis (HD or PD) for at least 3 months. Recruitment and data collection occurred between June and December 2013. We, with the help of some of the advisory panel members, recruited participants both through nationwide social media outreach and locally (Figure 1. Aim 1). The national outreach involved email blasts and postings on Facebook and Twitter in collaboration with the National Kidney Foundation and the American Association of Kidney Patients. We received a high volume of responses primarily through phone messages. Only those we could recontact by phone and who self-identified as CKD-ND, HD, or PD patients were eligible for inclusion in the study. In Michigan, social workers on the study team approached potential participants in person at renal clinics or dialysis units. Participants provided informed consent either verbally before the start of telephone interviews or in person. Participants also received a $25 gift card upon completion of the interview.
Study investigators conducted a 1-day interviewer training session that offered background information about the study, tips and guidelines on conducting qualitative interviews, coaching, and role playing for various scenarios. Between June and December 2013, 2 trained interviewers conducted digitally recorded and transcribed telephone interviews (30-40 minutes) of study participants.
Two independent coders entered interview transcripts into NVivo 10 ([computer program]. QSR International Pty Ltd; 2014), coded the qualitative data, and identified common themes using content analysis. Coders discussed and resolved discrepancies. We collected theme categories in a codebook that included both overarching themes identified before coding and subthemes that emerged directly from patient responses. We identified common themes across all patients as well as within each of the 3 patient subgroups. We further classified yes/no responses on the patients' perceived role in selection of dialysis modality into 4 mutually exclusive categories: (1) “strong yes”—yes response was consistent with an informed or deliberate decision; (2) “weak yes”—yes response, but the transcript indicated medical conditions determined modality choice, or that the patient felt pressure to choose 1 type of dialysis; (3) “no”—no response consistent with not having made the decision; and (4) “combined”—response consistent with making the decision collaboratively with a doctor or a family member.
We calculated standard descriptive statistics (ie, means and frequencies) for quantitative data across patient groups using SAS, version 9.2. To test for differences across patient subgroups, we used chi-square tests of homogeneity for categorical variables and analysis of variance with a Bonferroni correction for multiple comparisons for continuous variables.
Among 302 responders to the national outreach, we interviewed 72 patients (Figure 1. Aim 1). In Michigan, we approached 181 patients and interviewed 109 respondents. The most common reason for not completing the interview was inability to reach the participant to conduct the interview after he or she had provided informed consent. We conducted a total of 181 (72 + 109) interviews, and we included 180 in this analysis; we excluded 1 interview because the participant lived outside of the United States, where clinical practices and education on RRT may be different. While participants represented the 4 major geographic regions, most resided in the Midwest (Michigan). Of participants, 65 had CKD-ND, 77 were on HD, and 38 were on PD. Some had prior dialysis experience.
Patient characteristics (demographics and health status) were markedly different across CKD-ND/dialysis modality groups (Tables 1 and 2. Aim 1). Compared with the US Renal Data System data from 2012, the study sample was younger and included a higher percentage of females and African Americans/Black participants.40 PD participants ranked their health slightly better than did either HD or CKD-ND patients but were also more likely to report that kidney disease limited their daily activities. A higher percentage of CKD-ND patients reported having diabetes and high blood pressure compared with HD and PD patients.
As Figure 2. Aim 1, Panel A shows, overall, the 3 most important factors identified by patients were keeping as much independence as possible (96%), issues related to quality and quantity of life (94%), and flexibility in daily schedule (92%). The 3 factors less often cited as important were concern about appearance (39%), spending time with other patients at the dialysis center (37% of HD patients; not asked of PD patients), and worrying about how dialysis will affect others (36%).
Differences were observed among patient groups, including CKD-ND/dialysis modality (Figure 2. Aim 1, Panel B), age (Panel C), and marital status (Panel D). Going to work or school was important to a larger percentage of PD patients compared with CKD-ND patients and for participants aged 45 to 49 compared with younger (<45) and older (60 and older) patients. Patients in the youngest age group affirmed concern about physical appearance more often compared with patients in the older age groups.
Further analysis revealed several subthemes. For example, different patient subgroups defined “quality and quantity of life” differently. Compared with PD patients, HD patients were more likely to respond with themes about extending life (quantity of life) and less likely to respond with quality of life themes. A common theme was that quantity of life was most important because patients were on dialysis to stay alive; dialysis had negatively affected the quality of their life, but within their limitations they felt they were choosing the best dialysis option. However, PD patients responded that quality of life was very important and that PD allowed them to take part in hobbies and be engaged in activities and maintain a more normal lifestyle. CKD-ND patients responded that quality of life meant being able to maintain a somewhat normal lifestyle (eg, continue with hobbies or household activities) after starting dialysis, but they worried dialysis would negatively impact their quality of life by making them feel tired or run down.
Among 115 participants on dialysis (either HD or PD), more than a third felt that their dialysis modality had not been their choice, 5.2% responded that their modality choice was a combined decision, and 62.6% stated it was their choice (Table 3. Aim 1). However, patients' perceptions of their role were dramatically different between dialysis modalities: 94.7% of PD vs 46.8% of HD patients said the decision was largely their choice. Among patients responding “yes,” a much higher percentage of PD patients were classified as “strong yes” vs “weak yes” (88.9% vs 11.1%) than with HD patients (61.1% vs 38.9%).
Patients responding “no” identified acute medical need or crisis situation and doctor's decision as the primary factors attributed to not having a choice. The “weak yes” themes suggest that medical conditions strongly governed patients' modality decision. Informed choice, fits lifestyle, switched from HD to PD, and investigated options about dialysis were the main themes within the category of patients grouped as “strong yes.”
Patients were asked to explain why they chose HD or PD (Table 4. Aim 1). Patients who chose HD and classified as “weak yes” identified medical condition as a common theme. For PD patients, a common theme was side effects from HD. Among HD patients classified as “strong yes,” themes included fear of infection from pd and having trained medical personnel administer dialysis therapy. PD patient responses classified as “strong yes” were associated with the themes of better quality of life on PD, convenience of home dialysis, and ability to work. Individual themes emerging from choice of dialysis modality were not mutually exclusive, and based on some patient responses, multiple themes emerged.
We took the responses to “Was the dialysis modality largely your choice?” (Table 3. Aim 1) and the corresponding individual themes for the question “What led you to choose HD/PD?” (Table 4. Aim 1) and mapped them to the 2 metathemes (Table 5. Aim 1). The metathemes represent higher-level conceptual categories containing the individual themes.
The 2 metathemes suggest patients primarily considered perceived benefits or perceived risks when making their decision about the type of dialysis. Perceived benefits include maintaining independence, quality of life, continuing daily activities, ability to work, convenience of doing dialysis at home, and making an informed choice about dialysis. Perceived risks or constraints contains themes about medical conditions constraining the decision on modality choice, negative side effects from dialysis, starting dialysis in a crisis situation, fear of infection, and greater comfort having trained medical personnel administering dialysis. In some cases, patient responses resulted in the emergence of multiple themes associated with both metathemes.
Regardless of perceived choice in the dialysis decision, HD patients tended to highlight burden, medical concerns, or limitations of treatment—characteristics associated within the perceived risks or constraints metatheme. In contrast, PD patients highlighted maintaining some semblance of their lifestyle, which we associated with the perceived benefits metatheme.
In this large set of interviews, the top 3 factors identified as most important to patients when choosing a treatment modality were keeping as much independence as possible, quality and quantity of life, and flexibility in daily schedule. Among patients who had started dialysis, almost half of HD patients felt that the HD decision had not been their choice, compared with only 2% of PD patients. Perceived benefits and perceived risks were the major metathemes related to the choice of dialysis modality.
From patient decision-making and dialysis modality choice literature,13,22,26,37,39,41-52 several common themes have emerged, suggesting the importance of patient choice and specific factors that help determine dialysis modality selection.13,39,43,44,46,50,53 Factors identified as most important by participants in this study are consistent with prior findings.39,41,43,44,48,51 As anticipated, different factors were more or less important to specific patient subgroups; for example, fewer older participants (>75 years) reported that flexibility in daily schedule was important.
A sobering and key finding of our study is that approximately one-third of respondents felt that the dialysis modality decision had largely not been their choice. This has been reported in other smaller studies22,51 as well as from a large multi-country study in Europe.49 These findings clearly indicate the need to improve communication strategies between the health care team and patients, so that dialysis modality decision-making is truly shared between patients and providers. The lack of choice was overwhelmingly more common among patients who had started HD (~46%), while only reported by ~2% of PD patients, reflecting a need for greater engagement of HD patients in decision-making and treatment.
Study participants also identified distinct reasons for choosing a specific dialysis modality (eg, PD included better quality of life and convenience of doing dialysis at home, while for HD, reasons included fear of infection and wanting trained medical personnel to deliver treatment). Similar reasons for modality choice have been observed in other studies.26,39 However, factors previously identified in a UK cohort study,46 such as distance to the dialysis center and receipt of verbal and written information, did not emerge in our analyses.
The perceived benefits and perceived risks metathemes that emerged from our analysis highlighted the benefits and the risks patients consider when selecting a modality and provide a framework for clinicians to better understand the patient perspectives. These results suggest patients qualitatively emphasized varying benefits and risk tradeoffs.
A potential limitation to our study is that participants tended to be younger, had higher educational attainment, and included a higher percentage of females and African Americans compared with the US national population for each modality. The selected study sample is in part the result of our recruitment method using social media and being concentrated in a geographic region. Given their willingness and ability to participate in lengthy telephone interviews, participants were potentially healthier and more engaged compared with the general US population of CKD-ND and dialysis patients; however, this may have allowed participants to better articulate their experiences and provide greater detail in their responses. Finally, we were not able to account for whether patients had timely referral to a nephrologist. Our study makes several unique contributions and expands findings of earlier research.
A unique strength and innovation was the collaboration with patients, family members, and other stakeholders throughout the study. This was a new experience for both researchers and the advisory panel and required creative thinking on different styles of collaboration to ensure that study questions and methods were relevant and appropriate for patients and other stakeholders. Ultimately, this resulted in increased knowledge and acquisition of new perspectives for all study team members. To our knowledge, this is the largest series of qualitative interviews conducted in patients with kidney disease. While the large sample size was crucial for analysis, the level of enthusiasm and interest expressed by patients supports the importance of this study's objective: to identify factors important to patients using a rigorous scientific approach. We recruited a more diverse sample of patients throughout the United States compared with prior studies on the US CKD-ND and dialysis population. Finally, interview questions covered a comprehensive set of topics identified in collaboration with the stakeholder advisory panel, thus allowing us to expand beyond prior studies and to assess the reasons patients chose a specific dialysis modality.
In aim 1, we identified independence, flexibility, and both quality and quantity of life as the most frequently reported patient priorities.54 In aim 2, with the guidance of the advisory panel, we developed a survey based on aim 1 interviews, and we administered the survey to the large, nationally representative US cohorts of the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). We designed the survey to compare the dialysis modality decision process among hemodialysis (HD) and peritoneal dialysis (PD) patients by assessing involvement of clinical staff, peers, family, and friends, as well as patients' understanding of dialysis and satisfaction with their modality choice. We also assessed the extent of impact of PD and HD on patients' lives to identify opportunities for patient engagement to improve patient-centered outcomes.
We developed a 39-question survey to assess patients' experiences with the dialysis modality decision and factors that patients had previously identified as important (patient-centered outcomes).54 The advisory panel tested the survey for readability and comprehension and helped review and finalize survey questions.
The survey asked whether the participant was told that he or she had a choice between PD and HD when starting dialysis and to indicate if his or her involvement in this decision was more, less, or just what was desired. The survey proceeded with 3 sets of questions: (1) Patients ranked the degree to which 10 groups of family members, peers, and clinical staff were involved in their dialysis modality decision. (2) Patients rated their level of agreement with 9 statements focused on recollection of their experiences and satisfaction with their dialysis modality decision. Additionally, patients indicated whether the information they had received before starting dialysis was more, less, or just the amount that they had wanted, and whether they and their doctor agreed on the type of dialysis best for them. (3) Patients ranked the degree 16 different factors were affected by dialysis. We designed the survey for both paper and electronic (tablet) formats and provided both English and Spanish versions.
The DOPPS and PDOPPS are ongoing, international prospective cohort studies of dialysis facility practices and patient outcomes for adult HD and PD patients, respectively.55-57 The Empowering Patients on Choices for Renal Replacement Therapy (EPOCH-RRT) survey was administered to patients as an additional patient questionnaire in the DOPPS and PDOPPS studies. All DOPPS and PDOPPS consented patients were eligible for the EPOCH-RRT study. Study coordinators targeted eligible patients between February 2015 and August 2015 to participate in the EPOCH-RRT survey based on patient visit schedules and staff availability (Figure 1. Aim 2). Some patients departed the dialysis facility before study coordinators could approach them with the EPOCH-RRT survey or were unable to participate due to other reasons (eg, cognitive, physical, language, or social impediments); others were approached for participation but unwilling to complete the EPOCH-RRT survey. Facilities were randomly assigned to receive the survey on either paper or tablet platforms.
For questions related to involvement of families and peers in the dialysis modality decision, we treated the responses as continuous outcomes. For outcomes on experiences and satisfaction with the dialysis modality decision, we dichotomized responses into agreement (agree or strongly agree) vs nonagreement (strongly disagree, disagree, or neither agree nor disagree). For outcomes on factors important to patients, we dichotomized responses into a large impact (very much or extremely) vs not large impact (not at all, somewhat, or moderately). We excluded patients who reported not applicable from analyses of each corresponding question and excluded missing responses for each question. For dichotomized outcomes (experiences and satisfaction with the dialysis modality decision and factors important to patients), we used generalized estimating equation (GEE) logistic regression models to compare outcomes between HD and PD patients. We used an exchangeable working covariance matrix to account for patient clustering within facility in GEE models. For continuous outcomes (involvement of families and peers), we used linear mixed regression models to compare dialysis modality, accounting for clustering by including a random intercept for each facility. In all models the primary predictor was dialysis modality and adjusted for age, sex, Black race, years on dialysis, and diabetes. In sensitivity analyses, we added paper or tablet platform used for collecting survey data as an additional adjustment factor and tested for effect modification by platform by including an interaction term between platform and dialysis modality. We conducted all analyses using SAS, Version 9.4 ([computer program]. Cary, NC: SAS Institute Inc.; 2013).
Out of 807 PD and 1683 HD patients approached for participation in the EPOCH-RRT study, 614 (76.1%) PD patients and 1346 (80.0%) HD patients responded to at least 1 question in the survey (Figure 1. Aim 2). Among patients <65 years old, response rates across platform (ie, paper or tablet) were similar among both PD and HD patients; however, patients >65 years who were offered tablets had lower response rates than those offered paper surveys. Thus, we controlled for platform and explored effect modification by platform in sensitivity analyses. The median (interquartile range) number of questions answered was 36 (33-38) among PD patients and 35 (32-37) among HD patients. The amount of missingness for each question ranged from 3% to 7%, with the exception of question 2 about the amount of patient involvement in the dialysis modality decision compared with what the patient wanted. This question was left unanswered by 11% of PD patients and 35% of HD patients. Table 1. Aim 2 displays patient characteristics. Compared with HD patients, PD patients were, on average, younger, had shorter dialysis vintage, and were less likely to be Black and to have diabetes.
PD patients were more frequently (93%) told they had a choice between dialysis modalities than were HD patients (66%). Ten percent of PD patients and 20% of HD patients felt their involvement in the type of dialysis they would start on was either more than or less than they wanted compared with just what they wanted.
Clinical staff members, especially nephrologists, were most frequently involved in the dialysis modality decision overall compared with involvement of family members and friends (Figure 2. Aim 2). Fewer PD patients than HD patients reported at least some involvement of primary care doctors (60% vs 70%) but slightly more involvement of a nephrologist in their dialysis modality decision (94% vs 92%). We observed greater differences in the 2 modalities for lack of involvement of other clinical staff. For example, 40% of HD patients and 22% of PD patients reported no involvement at all of nursing staff in the dialysis decision. More than 35% of all patients reported that they did not know someone on dialysis at the time of their modality decision. Among those who did know a peer on dialysis, more than 50% recalled no peer involvement. More PD patients than HD patients recalled at least some involvement of physician assistants and nursing staff in their dialysis modality decision. Also, more PD patients than HD patients reported at least some involvement of partners/spouses (79% of PD patients, with 55% reporting very much or extremely involved; 70% of HD patients, with 46% reporting very much or extremely involved). For both PD and HD patients, involvement of other family and friends was low to moderate (32% -60%) and mostly similar across dialysis modalities. In adjusted models, PD patients indicated more involvement than HD patients by physician assistants, nursing staff, partner/spouse, and adult child/children.
Overall, HD patients felt less informed and less confident than PD patients at the time of the dialysis modality decision and were less satisfied with their dialysis modality choice (Figure 3. Aim 2). PD patients more often felt that the information received was enough and easy to understand, dialysis choices were explained, advantages and disadvantages of PD and HD were understood, and that they were happy with their dialysis decision compared with HD patients. Almost all PD patients felt their dialysis choices were explained easily and understandable, whereas ~20% of HD patients did not. Additionally, 11% of HD patients regretted their dialysis modality choice, compared with 6% of PD patients (P < .001). While 26% of PD patients reported the information, they had before starting dialysis was not the amount that they wanted but, rather, either more or less than they wanted (9% and 17%, respectively), 36% of HD patients reported they had either more or less information (11% and 25%, respectively; P = .178) than they wanted. Finally, 95% of PD patients and 84% of HD patients reported that they and their doctor agreed on the type of dialysis that was best for them.
For all factors, many patients reported that dialysis had a large impact (range, 17%-46%; Figure 4. Aim 2). HD patients were more affected than PD patients by 15 of 16 factors, although most differences were small. PD patients more often felt that their dialysis modality largely affected self-reliance compared with HD patients. In contrast, HD patients more often felt their dialysis modality had a large effect compared with PD patients on doing what I want in my free time, doing activities I am interested in (hobbies), drinking as much water as I want, eating what I like, and feeling healthy.
For all outcomes, similar results were obtained after adjusting additionally for platform (tablet vs paper). In analyses testing for interactions between modality (PD vs HD) and questionnaire platform (tablet vs paper), we found little effect modification.
Through dissemination of our survey to DOPPS and PDOPPS patients, we found that PD patients were more informed and engaged in dialysis modality decision-making compared with HD patients. This may be expected, given that PD patients undergo intense training coordinated by clinical staff and that this dialysis technique impacts household routine, space needs, and organization (eg, space to store PD supplies). Therefore, those who choose PD may already be more involved in their own care and likely more receptive to the education they receive. Nonetheless, the low involvement of several groups in the dialysis modality decision for both PD and HD patients demonstrates an opportunity to increase family and peer engagement to promote shared decision-making. Such engagement may result in a better fit of the dialysis modality with each patient's life as well as improved experience for their families and other caregivers. Furthermore, the large number of dialysis patients who did not know someone else on dialysis highlights a potentially useful but underutilized resource: Peer mentoring programs have proved to be successful in different clinical conditions,58-61 and anecdotal evidence indicates that existing peer support programs in dialysis are highly valued by patients and their care partners.62,63 By improving awareness of and access to peers, patients new to dialysis may benefit from increased practical information about dialysis, empathy and understanding, advice on coping strategies, and a greater sense of empowerment and agency.63
We found large differences in understanding and satisfaction with current dialysis modality between PD and HD patients. PD patients were much more likely than HD patients to report that they had enough information during the dialysis modality decision, that the information given was easy to understand, and that they understood differences between dialysis modalities. Previous studies have found that deficiencies in knowledge are a barrier to choosing PD and that educational interventions can increase PD use.64-66 Thus, those who choose PD are likely to be patients who have sufficient knowledge about dialysis modalities and willingness to participate in self-care. PD patients also more frequently indicated that they were happy with the modality they chose compared with HD patients. This result may reflect a more deliberate and informed decision-making process among PD patients and/or greater involvement in the dialysis modality decision. Still, more than 20% of PD patients did not know the disadvantages of their modality, and more than 10% did not feel they had easy-to-understand written information. Furthermore, some patients from both PD and HD groups reported not receiving enough information and expressed regret in dialysis modality choice. This finding is consistent with previous research that found anecdotal evidence of dialysis patients who were not satisfied with their dialysis modality decision process.21,22,26 Therefore, opportunities exist to improve CKD education to increase understanding of dialysis modalities and satisfaction with treatment, especially among HD patients.
Patients perceived a moderate to high impact of dialysis on factors previously identified as important to patients in EPOCH-RRT interviews. Particularly, many patients felt their ability to rely on themselves and travel out of town was affected by starting dialysis. Several life-affecting factors were more frequently identified by HD patients than by PD patients, which may be explained by the differences in modalities. For example, clinical characteristics (eg, lack of residual urine output) of HD patients may require more restrictive diets and fluid intake, while technical aspects of HD (eg, intermittent dialysis in a facility setting) often limit the time HD patients have for their own interests. Some HD patients have also reported that dialyzing in a clinical setting and being surrounded by other patients makes them feel less healthy, although this opportunity to interact with other patients in the in-center setting was not always perceived as a negative aspect of HD.13
Overall, the proportion of patients who skipped each question was low, providing some evidence that the survey questions were appropriate and easily interpretable by most dialysis patients. This likely reflected the high engagement of the advisory panel in the development of the survey and the reviews of its questions. There was a higher amount of missingness for 1 question about the amount of the patient's involvement in the dialysis modality decision. The reasons for which 11% of PD patients and 35% of HD patients did not answer this question could include not having preconceived desires about involvement in the dialysis modality decision and/or unwillingness to admit low involvement. Both suggest that more effort should be made to give patients adequate choice and involvement in their dialysis modality decision process.
There are a few limitations of the aim 2 survey worth noting. First, survey questions asked the extent to which patients felt affected by dialysis—without options to indicate whether the effects were positive or negative. Therefore, the interpretation of differences between HD and PD patients must be speculated based on what is known about the different modalities. Second, we administered surveys to both incident and prevalent dialysis patients, so the time between dialysis initiation and survey was variable. Particularly for those who had longer dialysis vintage, recall bias may have affected survey responses related to the dialysis modality decision; however, we have no reason to believe that the recall bias would be different across PD and HD patients, indicating that our comparisons of interest may still have little bias. Third, we did not have information on whether patients in the study had contraindications to either dialysis modality, which also may have affected survey responses. For example, some HD patients may not have been eligible for PD, which limited their exposure to PD information. Still, the fact that HD patients sometimes felt that they did not have enough information about their own modality supports the conclusion that increased access to information on dialysis options is warranted.
Despite these limitations, our study has several strengths and important implications for end-stage renal disease patients, their families, and health care providers. By collaborating with an advisory panel and using analyses from qualitative data collected from patient interviews, our survey was specifically designed to focus on patient-centered outcomes. This approach—consistent with PCORI goals for multi-stakeholder engagement in research—was invaluable for informing the survey content and interpretation of results. We were able to compare factors important to patients in choosing a dialysis modality and living with dialysis treatments. We found that dialysis largely affects patients, which emphasizes the need to optimize the dialysis experience. By comparing the experiences of PD and HD patients, we identified significant differences between dialysis modalities. We found several aspects of the dialysis modality decision that require improvement, including patient education, access to peers, and other support. Increased efforts are needed to encourage multidisciplinary care and to provide resources, such as decision aids for patients facing the choice between dialysis modalities.
Patient decision aids are tools used to facilitate patient decision-making about treatment options. They provide unbiased information to improve patients' understanding of the treatment options, increase participation in the decision-making process, reduce perceived pressure, and mitigate decisional conflict. Patients' increased clarity on available treatment options and their values facilitates greater decision-making self-efficacy, which is one's belief that he or she is able to make the right decision for him- or herself.33-35
In the past few years, several dialysis option decision aids focusing on different aspects of dialysis-related decision-making have been developed, and some are archived by Ottawa Hospital Research Institute and assessed for compliance with International Patient Dialysis Aid Standards (IPDAS) criteria.67-69 While valuable, these decision aids have either been developed outside the United States in other health care contexts or have not been tested for effects on decisional outcomes among patients with CKD in the United States. To address a need for an easily accessible, freely available decision aid based on the experiences of patients with chronic kidney disease (CKD) in the United Sates, in aim 3 of the Empowering Patients on Choices for Renal Replacement Therapy (EPOCH-RRT) study, we developed a web-based decision aid with active collaboration from the advisory panel on content and design. The decision aid is designed to provide support to patients deciding between in-center hemodialysis (HD) and peritoneal dialysis (PD), the 2 most common dialysis treatment options in the United States, informed by results from aims 1 and 2. We then tested the decision aid for efficacy in supporting decision-making among patients with advanced CKD and measured the effect of the decision aid on decision-making outcomes (ie, decision preference, decisional conflict, self-efficacy, and knowledge).
We collaboratively developed the decision aid content based on literature review, the US Renal Data System data,70 and results from aims 1 and 2; further, the advisory panel reviewed and refined the decision aid in an iterative method. Patients and social workers with different dialysis modality experience and who educate CKD patients reviewed the decision aid on several iterations of the refinement process. An additional set of people with no prior exposure to the study nor the decision aid and some with no exposure to kidney disease reviewed the content. We sought additional input from members of a kidney disease patient advocacy organization. We performed formal usability testing using think-aloud methodology by direct observation of 6 patients recruited from the University of Michigan Health System. We recorded reactions to the website and asked participants to describe what they liked or disliked about each page of the decision aid; this feedback further modified its design, structure, and content.
The finalized decision aid contained the following sections: (1) CKD and its progression, information and comparison of PD and HD from the patient perspective, and (3) value clarification exercise to map personal preferences to dialysis modality features. It included information on potential lifestyle changes associated with each option and consequences of changing one's mind after choosing either option. The decision aid integrated quotes from patients collected from interviews in aim 1 and tips for talking with health care professionals collected during the refinement process. Printing options were provided in sections that might be useful when discussing dialysis options with medical staff.
Per IPDAS,32,71 the decision aid addresses all the qualifying criteria—that is, describes kidney disease, explicitly states the dialysis treatment decision between HD and PD, describes these 2 options, and describes positive and negative features of each option and side effects of both.
The following IPDASi v3.0 certification criteria were addressed: balanced information on both HD and PD; each page on the website references the funding source (Patient-Centered Outcomes Research Institute); offers additional resources and information about research used to develop the decision aid; and the year of website publication and terms of use and privacy policy. The website, which will be managed and updated by Arbor Research Collaborative for Health, can be updated whenever new information is available.
The design focused on intuitive navigation and accessibility of information. For the study, we designed the website to collect questionnaire data and walk users through all the steps without skipping ahead. We provided hover-over definitions for commonly used terms throughout the site and logged progress so that users could resume where they left off when unable to complete in a single session.
We recruited advanced CKD adults (eGFR <25 mL/min/1.73 m2) with internet access to test the decision aid from CKD clinics in southeast Michigan; we also conducted national online outreach with the help of the National Kidney Foundation and American Association of Kidney Patients (Figure 1. Aim 3). Each of the 4 recruiters, immediately after obtaining informed consent, provided the participant with a user login ID chosen sequentially from a list generated by the study team. The list of user login IDs provided to each recruiter was ordered to alternate between intervention and control arm user login IDs, but neither the recruiter nor the participant could discern the assignment based on the login ID. This ensured even distribution of intervention and control arm assignments of consented participants.
Once the participant granted informed consent, we provided instructions, login information, links to the test website, and contact information for technical or other support. Participants could access the study website from their own computers or portable devices by following the instructions and using the login credentials provided. Study coordinators could track task completion for each participant who logged into the website. They followed up weekly with consented participants to check on any technical issues and to promote study completion.
Participants in the control arm were required only to complete 1 questionnaire and click the submit button before accessing the decision aid. Participation in the control arm was considered complete once the questionnaire was completed and the submit button was clicked. Participants in this arm were included in the analysis if they answered all questions in the control questionnaire. Participants in the intervention arm were required to click on answers for all the pretest questions and click the submit button in order to proceed to the decision aid. Similarly, participants in the intervention arm were asked to click a button to indicate they had completed review of the decision aid and this would enable them to proceed to the posttest. All participants consented to complete each questionnaire in 1 sitting.
We designed the website to force intervention arm participants to click through sections of the decision aid sequentially and at their leisure. Participants could return to a section at any time, as many times as needed. The last page of the decision aid study website required participants to click a button to proceed to the posttest. We considered intervention arm participants to have completed the study if they answered all questions in the posttest and clicked the submit button.
The questionnaires developed to test the efficacy of the decision aid in promoting shared decision-making included several established and/or validated measures of the following parameters: preference for shared decision-making,72 decisional conflict,73 decision self-efficacy,74 knowledge based on the contents of the decision aid and adapted from Cavanaugh,75 literacy,76 numeracy,77,78 and demographics. The posttest also included the Preparation for Decision Making Scale79 and questions to help assess usability, satisfaction with the decision aid, adequacy, and relevance and quality of content, as well as open-ended questions for positive and negative feedback.
Inclusion criteria were (1) aged >18 years, (2) eGFR <25 mL/min/1.73 m2, (3) internet access through a computer or tablet, and (4) English language fluency. We recruited participants through both nationwide social media outreach and local efforts (Figure 1. Aim 3). The national outreach involved email blasts and postings on Facebook and Twitter in collaboration with the National Kidney Foundation and American Association of Kidney Patients. We received a high volume of responses, primarily through emails and telephone messages. We tracked only those who could be recontacted by telephone and self-identified as CKD, HD, or PD patients and who met all eligibility criteria. Clinic staff reviewed patient visit schedules to identify potential participants meeting clinical criteria. Social workers on the study team approached these patients at the renal clinic for interest in participation. We obtained informed consent either verbally before the start of telephone interviews or in person. Participants received a $25 gift card upon completion or attempted completion of study questionnaires. Local institutional review boards (Ethical and Independent Review Services E&I #13016, Henry Ford Health Systems IRB #8144, University of Michigan IRBMED HUM00073058) approved all study procedures. We considered enrolled participants who did not complete the study as lost to follow-up after 5 unsuccessful attempts to contact them by phone or email. One month before data collection completion, we attempted to contact every patient who had consented but had not completed the study.
We tested for differences between the intervention and control arms using pretest intervention arm responses and control arm responses. We statistically tested differences in demographic composition regarding age, race, sex, education, ethnicity, and numeracy based on t tests, Pearson's chi-square tests, and Fisher exact tests. We compared outcomes between the pretest and posttest within the intervention arm using paired t tests, Wilcoxon signed rank tests, and tests for marginal homogeneity. We compared the intervention posttest with the control arm using unpaired t tests, Wilcoxon rank sum tests, and Pearson's chi-square tests.
We also assessed whether the effects of the decision aid differed across subgroups regarding self-efficacy, decisional conflict, preparation for decision-making, and knowledge of dialysis options. Thus, we tested whether differences between intervention pretest and posttest responses and differences between intervention posttest and control arms differed across age, sex, education level, or race groups. We used generalized estimating equation logistic or linear regression models for these tests by including an interaction term between subgroups and different arms in models.80 Models accounted for the correlations within subjects when comparing pretest and posttest intervention arm responses using an exchangeable correlation structure and sandwich-type estimator for standard errors.
Figure 1. Aim 3 summarized the participant flow. In Michigan, we could not reach all screened patients at the renal clinics; some were ineligible for participation as determined by clinic staff. Several eligible patients could not be contacted either in person or over the phone for consent. Among those who were available and approached, reasons for ineligibility included prior experience of dialysis or patients having started dialysis by the time they were approached for consent. A large number of the patients did not have internet connectivity or access to a computer. Of those patients who declined to participate because they were not interested or were not comfortable providing consent (131), approximately 24% of these patients self-described level of computer literacy (23) or English fluency (8) as not sufficient for study requirements. Other patients were unable to participate because their eyesight was too poor for the study tasks.
We received informed consent from 234 participants. Some consented participants (96) across both control and intervention arms did not start the study, and 78 were not reachable by phone or email (Figure 1. Aim 3). A total of 140 participants logged into the site and started the study. Demographic information was self-reported and collected from participants in the control and pretest questionnaires for the 2 arms, respectively (Table 1. Aim 3). Seven participants in the intervention arm started the study and completed the pretest but did not go on to finish the posttest. The remaining 133 participants started and completed the study. Fifty of the 63 intervention arm participants (79.3%) completed the pretests and posttests within 1 week, with 60% having completed both tests on the same day. Only 5 participants needed more than 1 month to complete both tests.
Patient characteristics in the control and intervention arms had similar demographic composition regarding age, race, sex, education, ethnicity, and numeracy (Table 2. Aim 3). Patients were mostly White, and almost all had graduated high school and considered English as their native language. The Subjective Numeracy Scale is a self-report measure of perceived ability to perform various mathematical tasks.77,78,81 Both arms were similar in terms of overall subjective numeracy as well as ability and preference subscales.
In the control arm and treatment arm, both before and after using the decision aid, patients reported what type of dialysis they might do when starting treatment. Both the control and pretest results suggest that both arms had similar baseline uncertainty on treatment choice: 40% and 47%, respectively. Those in the treatment arm reported a significant decrease to 16% in uncertainty on choice of dialysis type after using the decision aid (Table 3. Aim 3).
We measured decisional conflict scores using the validated Decisional Conflict Scale68 before and after using the decision aid. The decision aid was effective in decreasing the average decisional conflict score by 15 points, from 44 to 29 (Table 3. Aim 3). The average decisional conflict score between the control and pretest responders was not significantly different, with 43 and 44, respectively. We did not observe differences by age, sex, or educational level on decisional conflict scores.
The baseline decisional self-efficacy scores (pretest and controls) were in the higher side of the 0-100 scale (approximately 80). There was no discernable change in this score in the posttest.
The control group, on average, answered 77% of the knowledge questions accurately. After going through the decision aid, the intervention group got 90% of the knowledge questions right. Black patients in the control arm had significantly lower baseline knowledge scores compared with non-Black participants (62.2 vs 78.9, respectively; P = .022). However, Black patients also showed a greater difference in knowledge scores between control and intervention arms (26 points higher in the intervention arm) compared with non-Black participants (12 points). Our study design was not powered for comparing other minority groups. We did not observe differences by age, sex, or educational level on scores.
Greater than 90% of participants in the intervention arm felt that the decision aid helped somewhat to a great deal, both for preparing for dialysis and for follow-up with care providers, with approximately 80% responding “quite a bit” and “a great deal” (Figures 2 and 3. Aim 3).
Only 1 person did not like the website, and 2 people said they would not recommend the decision aid to others. Most participants (92%) felt the decision aid was balanced and not slanted toward HD or PD, 88% trusted the website content, and 89% agreed/strongly agreed the content was relevant to them, with 49% agreeing the decision aid was extremely helpful in understanding dialysis options.
Participants provided open-ended feedback on what they liked about the decision aid and how it might be improved. Overall, participants most frequently cited that the decision aid was informative (65%) and helpful (40%), with 22% providing critical comments and 3% unsure about what they thought of the decision aid. One participant said, “There was a lot of very good information to assist me to make a very serious decision when and if the time comes. I hope I won't need to make the choice, but if necessary, I can make a knowledge-based decision that is best for me. I do appreciate the unbiased information. Thank you!” Another wrote, “I was knowledgeable already on 80% of the information, but it was helpful. Since I am hopefully still years away from needing dialysis, reviewing this info was a little depressing. I hope all treatments improve.”
When asked what they liked about the decision aid, participants often expressed that they found the website easy to navigate and well organized, and they liked the value clarification exercise and the testimonials from patients. One participant said, “I like the 'feel' perspective… the facts of each treatment can be found everywhere, but not often do you see the feelings of the patient put in consideration. I had mixed feelings about which way to go, but this site helped a great deal.”
A few participants (10%) had suggestions for improvements in usability, such as, “Make this available to patients that do not have a computer” and “Maybe add video clips during the decision aid to make it more interesting and captivating. People typically like to view videos on their computers.” Another suggested, “Speak more about the positives in making this decision. Include more testimonials on improving quality of life.”
We received considerable positive feedback regarding ease of readability and comprehensiveness of content, especially the juxtaposition of PD and HD. The most critical feedback was concerns about missing information on dietary restrictions (29%); how patients deal with side effects; RRT options other than PD, HD, and the slow overnight in-center HD option; effects of PD on family members; complications from treatment; and data on demographics and life expectancy. For example, 1 participant asked, “What about home hemo? And what about info about having to change dialysis types if, for instance, your abdominal wall becomes tough and can no longer filter?” Of respondents, 41% didn't have any suggestions for improvement.
Decision aids have demonstrated improved communication between patients and their doctors. A comprehensive review of decision aids suggests that more detailed decision aids are better than simple decision aids in improving knowledge and lowering decisional conflict scores, factors that are related to feeling uninformed and unclear about one's personal values.33 Decision aids have proved to improve knowledge, increase risk perception, decrease decisional conflict, and enhance participation in shared decision-making among the elderly.82 However, few decision aids have been developed specifically for people aged >65 years to characterize important components for this demographic.82 We are aware of a small number of decision aids related to dialysis treatment modality choice and that incorporate value clarification tools: 3 in the United States and some developed outside the United States in other health care contexts.67,68,83,84 The main difference between our choosingdialysis.org decision aid and the others developed in the United States are the use of qualitative interviews and patient-reported data to identify factors important to patients; more detailed information on the 2 main dialysis treatment options; involvement of the advisory panel throughout the study, including the development of the decision aid; the use of quotes and tips from health care professionals reflecting stakeholder perspectives throughout the decision aid; and testing the decision aid with the end-users described in this paper to evaluate the effect of the decision aid on decision-making outcomes.
We developed the content and format of the EPOCH-RRT decision aid for patients deciding on dialysis treatment options in collaboration with an expert advisory panel, and we were guided by decision aid development experts. The advisory panel included patients who had faced this decision and social workers supporting CKD patients in their transition to dialysis. Nephrologists and clinical researchers also reviewed content. Additionally, the EPOCH-RRT decision aid content complements clinical information with the experiences of individuals undergoing dialysis in the form of quotes to share experiences, quotes from their families, and tips from health care professionals to address practical issues. Also included is a value clarification exercise that assists in identifying factors that matter most to the reader or user and how these factors influence which option may best suit him or her. Some participants in our study provided feedback that they found this interactive value clarification tool helpful, but the decision aid literature is uncertain of the benefits of the value clarification exercise to decision-making outcomes.85,86 Users, patients, and family members are encouraged through different print options to leverage the information gained through the decision aid as a tool to inform discussions and increase communication with their health care teams. Involvement of family members has been suggested as beneficial for patients' health outcomes.87
Similar to other decision aids,33 this dialysis treatment choice decision aid improved knowledge and reduced decisional conflict but did not significantly improve decisional self-efficacy. We carried out subgroup analyses for these outcomes between intervention pretest and posttest responses and differences between intervention posttest and control arms to test for differences across age, sex, education level, or race groups. We observed no differences for any outcomes other than the knowledge test, for which Black participants had lower scores before accessing the decision aid but showed greater improvement in knowledge upon accessing the choosingdialysis.org decision aid than did non-Black participants. Racial disparities in choices for RRT are well documented,88-90 and improving knowledge through CKD education has been proposed as 1 solution to overcoming identified barriers, such as patients' awareness of choices and disparities in shared decision-making and improved patient-centered care.87,88,91-93
A recently published randomized controlled study of another web-based decision aid about depression treatment options also showed improvement only in knowledge and decisional conflict outcomes.94 It is possible that multiple factors contribute to decisional self-efficacy, which would require a holistic socioecological approach to move the needle on this indicator.
Our work suggests that this decision aid—a new and effective tool developed through a stakeholder-engaged process—informs and supports CKD patients in making the difficult choice of dialysis modality. The broader implementation of this decision aid would complement current CKD education in clinical practice and could support both care providers and patients in shared decision-making, by facilitating communication about treatment options.
A limitation of this study is that self-selected participants were, on average, healthier, more educated, and younger than the US CKD population.95 Patients with stage IV kidney disease (eGFR <25 mL/min/1.73 m2), the target population for this study, are often dealing with a heavy medication burden and a multitude of physical and mental symptoms related to kidney failure before the start of RRT.96,97 These factors could have negatively contributed to willingness to participate in a research study and are reflected in the low consent rate, resulting in a less generalizable participant cohort. We envisioned a web-based format as the ideal way to quickly disseminate the decision aid to the broadest possible audience; however, lack of internet access and computer literacy limitations challenged recruitment efforts, which also contributed to differences in the composition of participants and the broader CKD population. Further studies are needed to address the multiple social and demographic disadvantages that may impact participation in shared decision-making for those facing the dialysis decision.
Seven participants in the intervention arm did not complete the study. Sensitivity analysis to compare the control and intervention groups, with and without the 7 participants in the intervention arm who did not complete the study, suggests that these departures did not affect our study results. Based on the study design, the time between pretest and posttest questionnaire responses might have resulted in drift in the responses in the intervention arm that would affect results, independent of the decision aid. Sensitivity analysis with and without the 13 participants in the intervention arm who had a gap of more than 7 days between completions of the 2 questionnaires did not change any of the measured outcomes nor the reported statistical differences.
Most participants found the decision aid helpful and would recommend it to others. We incorporated specific feedback from study participants and patient advocacy organizations to further modify the layout and readability of the decision aid. We improved the decision aid accessibility by modifying the language to a grade 10 Flesch-Kincaid readability level using the readability statistics package embedded in Microsoft Word. As the content of the website was finalized, we improved the navigation and architecture to ensure that information would be easily discerned. We improved graphics and layout based on feedback from target users. The advisory panel reviewed and approved the final content and design of the decision aid; it was released to the public at http://choosingdialysis.org/.
The PCORI-funded Empowering Patients on Choices for Renal Replacement Therapy (EPOCH-RRT) study comprised 3 specific aims to result in a public website designed to support patients and family members in making an informed decision between the 2 most common dialysis treatment modalities (ClinicalTrials.gov identifier NCT02488317).
In the first aim, the advisory panel—comprising 9 patients and family members as well as clinicians (nephrologists and social workers)—was involved in study protocol development, prioritization of analyses, and interpretation of findings. Through qualitative interviews we found that a third of patients on dialysis felt that the type of dialysis modality had largely not been their choice. Those who were involved in decision-making qualitatively emphasized varying benefits and risk tradeoffs as contributing to choice of dialysis modality. These initial findings were the foundation for other study aims and the development of the decision aid tool. In the second aim, the advisory panel was involved in reviewing and pretesting the survey and discussing the findings. To assess how each treatment modality affected factors identified in aim 1, we collected patient-reported survey data from patients enrolled in the Dialysis Outcomes and Practice Patterns Study (DOPPS) program studies. The results of this survey highlighted opportunities to improve CKD education to increase understanding of dialysis modalities and satisfaction with treatment, especially among HD patients.
In aim 3, we used data collected in the first 2 aims to guide content development for the choosingdialysis.org decision aid, in collaboration with the advisory panel. Some members helped with recruitment for the study. When tested among predialysis CKD patients, the decision aid was well received and showed improvements in knowledge and decrease in decisional conflict, but it did not affect decision self-efficacy. Based on the findings, the advisory panel was involved in finalizing the design and content of the decision aid, before making it available to the public, and was engaged in supporting its dissemination.
By identifying factors important to patients and incorporating them into the decision aid and providing printout options to enable better communication of patient preferences to their health care providers, care teams will be more aware of patients' conditions, values, and preferences. This could result in better self-management, thereby potentially improving patient health and quality-of-life outcomes.
This work would not have been possible without the contributions of all study participants involved in all 3 aims. Of particular note are the successful collaboration, the active engagement, and the participation of the advisory panel with the research team.
Research reported in this report was [partially] funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (#1109). Further information available at: https://www.pcori.org/research-results/2012/does-online-decision-aid-help-people-advanced-chronic-kidney-disease-choose-between-two-treatment-options
Abbreviations: CKD-ND, chronic kidney disease not on dialysis; HD, hemodialysis; HHD, home HD; ICHD, in-center HD; MW, Midwest; NE, Northeast; PD, peritoneal dialysis; S, South; W, West.
Recruitment and interviews occurred between June and December 2013.
Participants are grouped by geographic regions per US Census Bureau: W, S, NE, and MW; see https://www.census.gov/geo/maps-data/maps/pdfs/reference/us_regdiv.pdf. [link no longer works]
NE = Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont.
MW = Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin.
S = Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, West Virginia.
W = Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, Wyoming.
* Previously on another dialysis modality (HD or PD).
1Only on reported dialysis modality (HD or PD); no previous experience with other modality.
a72 respondents to a national outreach effort that relied on email blasts and postings on Facebook and Twitter incollaboration with the National Kidney Foundation and the American Association of Kidney Patients. Patients wereidentified as CKD-ND, HD, or PD patients, and determined eligible, consented, and interviewed by phone. A highvolume of responses was received, primarily through phone messages, and only those who could be recontactedby phone and self-identified as ESRD patients were tracked.
bInterested participants provided their contact information during the consent process. Three attempts were madeon different days at different times to contact participants by phone for interviews. After 3 unsuccessful attempts,participants were classified as unreachable.
Abbreviations: HD, hemodialysis; PD, peritoneal dialysis.
Note: Patients who reported not applicable (range, 3% for nephrologist to 35% for peer and 47% for adult child/children) were excluded from relevant question.
Abbreviations: HD, hemodialysis; OR, odds ratio; PD, peritoneal dialysis.
Abbreviations: HD, hemodialysis; OR, odds ratio; PD, peritoneal dialysis.
Note: Patients who reported not applicable (range, 1% to 9%) were excluded from relevant question.
| Characteristics | All | CKD-ND | HD | PD | P valuea |
|---|---|---|---|---|---|
| (N = 180) | (n = 65) | (n = 77) | (n = 38) | ||
| Age, mean (SD), y | 57.5 (16.8) | 63.4 (16.2) | 56.1 (16.6) | 50.4 (14.8) | <.001 |
| Female, % | 55.0 | 66.2 | 46.8 | 52.6 | .06 |
| Race/ethnicity, % | .89 | ||||
| Caucasian/White | 54.0 | 53.9 | 51.3 | 60.0 | |
| African American/Black | 39.8 | 40.0 | 43.4 | 31.4 | |
| Asian/Pacific Islander | 2.8 | 1.5 | 2.6 | 5.7 | |
| Hispanic | 1.1 | 1.5 | 1.3 | 0 | |
| Other | 2.3 | 3.1 | 1.3 | 2.9 | |
| Education level, % | .71 | ||||
| High school | 29.4 | 32.3 | 28.6 | 26.3 | |
| Some college | 34.4 | 27.7 | 37.7 | 39.5 | |
| College graduate or above | 36.1 | 40.0 | 33.8 | 34.2 | |
| Lives with others, % | 76.7 | 69.2 | 77.9 | 86.8 | .12 |
| Employment status, % | .004 | ||||
| Employed | 19.0 | 18.8 | 14.3 | 29.0 | |
| Not employed | 38.6 | 23.4 | 50.7 | 31.6 | |
| Retired | 42.5 | 57.8 | 35.1 | 39.5 |
Abbreviations: CKD-ND, chronic kidney disease not yet on dialysis; HD, hemodialysis; PD, peritoneal dialysis.
aP value for difference across modality groups using a chi-square test of homogeneity for categorical variables and analysis of variance with a Bonferroni correction for multiple comparisons for the continuous variables.
| Characteristics | All | CKD-ND | HD | PD | P valuea |
|---|---|---|---|---|---|
| (N = 180) | (n = 65) | (n = 77) | (n = 38) | ||
| Self-rated health,b mean (SD) | 3.2 (1.0) | 3.4 (1.0) | 3.1 (0.9) | 3.0 (0.9) | .07 |
| Recent diagnosis of kidney disease (within past 5 y), % | 38.3 | 47.7 | 33.8 | 31.6 | .16 |
| Respondents reporting daily activities are limited due to kidney disease, % | 66.1 | 49.2 | 71.4 | 84.2 | <.001 |
| Have had a kidney transplant, % | 24.4 | N/A | 20.8 | 31.6 | .20 |
| Of those, how many transplants? | .07 | ||||
| 1 | 64.3 | N/A | 50.0 | 83.3 | |
| >1 | 35.7 | N/A | 50.0 | 16.7 | |
| No. of chronic conditions | .16 | ||||
| Range | 0-6 | 0-6 | 0-6 | 0-6 | |
| 0, % | 6.7 | 9.2 | 6.5 | 2.6 | |
| 1, % | 20.0 | 16.9 | 15.6 | 34.2 | |
| 2, % | 26.1 | 21.5 | 32.5 | 21.1 | |
| 3 or more, % | 47.2 | 52.3 | 45.5 | 42.1 | |
| Chronic conditions, % | |||||
| Diabetes | 40.0 | 49.2 | 40.3 | 23.7 | .04 |
| High blood pressure | 80.6 | 89.2 | 70.1 | 86.8 | .009 |
| Heart disease | 36.1 | 36.9 | 37.7 | 31.6 | .80 |
| Other conditions | 41.7 | 44.6 | 42.9 | 34.2 | .56 |
Abbreviations: CKD-ND, chronic kidney disease not yet on dialysis; HD, hemodialysis; max, maximum; min, minimum; N/A, not applicable; PD, peritoneal dialysis.
aP value for difference across modality groups using a chi-square test of homogeneity for categorical variables and analysis of variance with a Bonferroni correction for multiple comparisons for the continuous variables.
bSelf-rated health score ranges from 1 = excellent to 5 = poor.
| Response, % | Theme | Participant quote |
|---|---|---|
| No: 32.2b HD: 46.8 PD: 2.6 | Crisis situation: Patient was in a crisis situation and his kidneys were failing | “Well, I guess the doctors at the hospital [chose] while I was in with my heart failure episode.” [HD, male, aged 69] |
| Doctor's decision: Doctor made the dialysis decision | “I don't think it was my choice, it was the doctors' choice!” [HD, male, aged 59] | |
| Combined decision: 5.2b HD: 6.5 PD: 2.6 | Joint decision with doctor: Doctor and patient decided together | “I want to say it was the doctor's recommendation … but the choice was mine too So, I did go with the doctor.” [HD, female, aged 57] |
| Yes: 62.6b HD: 46.8 PD: 94.7 Weak yes: 25c HD: 38.9 PD: 11.1 | Medical condition: Patient said it was her choice but she was able to do only 1 type of dialysis because of medical condition(s) | “It was largely my choice. Well, the doctor actually said … because I had the polycystic kidney … that I did not have room in my abdomen to do peritoneal dialysis. So, that wasn't even tried, or discussed.” [HD, female, aged 72] |
| Negative side effects from PD: Switched from PD to HD because of negative side effects | “I thought I would stay on peritoneal until I could get a kidney, but … like I said the sugar was just wreaking havoc with my body So I really didn't have much choice.” [HD, male, aged 69] | |
| Pushed toward HD: HD was default choice; felt pushed toward that modality | “They sent me right to a … guy to do my fistula. Then, about a month later, I went down to a dialysis center and started up.” [HD, male, aged 78] | |
| Strong yes: 75c HD: 61.1 PD: 88.9 | Informed choice: Patient made an informed choice after talking with health provider(s) | “Yeah, when the options were put forward to me … it was my choice. I talked with the doctors.” [HD, female, aged 53] |
| Fits lifestyle: Chose modality that fit best with his circumstances or lifestyle | “It was just more suitable for my lifestyle, my age group, and the active, younger individual. It was best for me.” [PD, male, aged 39] | |
| Switched from HD to PD: Made own decision to switch from HD to PD | “Well, I already had experience with hemodialysis and so I was pretty well set on trying something different … so I started with peritoneal.” [PD, female, aged 37] | |
| Investigated options: Made decision after doing his own research on options | “My mom and I did the research and asked questions … because they were just going to basically ship me straight off to a dialysis clinic like I didn't even know there were other options. No one told us about it [PD] until we brought it up.” [PD, male, aged 31] |
Abbreviations: HD, hemodialysis; PD, peritoneal dialysis.
aAsked only of HD and PD patients on dialysis.
bNo N = 37; combined N = 6; yes N = 72. Responses were classified as “combined” if patient said he or she made the decision together with a doctor or a family member.
cAmong respondents who answered “yes,” weak yes N = 18 and strong yes N = 54. Responses classified as “weak yes” if patient stated that he or she made the decision but medical conditions determined the modality choice, or he or she later admitted being pushed toward 1 type. Convergence was found between “weak yes” and “no” responses.
| Role in dialysis choiceb | HD patients | PD patients | ||
|---|---|---|---|---|
| Theme | Participant quote | Theme | Participant quote | |
| No | Developed infection on PD | “Well I had no choice. What happened was, when I was on the peritoneal … I got a really bad infection and developed a lot of scar tissue … so they tried to put it back in but it wouldn't work so I had to go on hemo.” [female, aged 45] | Negative side effects from HD | “[With] hemodialysis I was feeling so sick. I had all the headaches I didn't have energy to even walk to do anything and I looked so sick on it.” [female, aged 27] |
| HD was default choice | “So, it was more beneficial for me to go on hemo, which was the instant plan I started it the same day as they put the catheter in” [male, aged 45] | |||
| Combined decision | Developed infection on PD | “I got peritonitis and … the surgeon told me that after he removed the second catheter for an infection, he told me my body didn't like the catheter and was rejecting it. So, because I was … frequently with infections, then it would be better for me to not do peritoneal.” [female, aged 57] | Convenience of home dialysis | “If I want to plug in at 3:00 in the morning and be plugged in until late the following day, it doesn't really matter I know it's something I have to do every day. At least I have the flexibility of when I want to do it.” [male, aged 27] |
| Too much time on machine with PD | “It was really my time … doing that every day for 12 hours … was rough.” [male, aged 39] | |||
| PD makes you look like a patient | “I didn't want any tubes hanging out of my belly.” [female, aged 33] | |||
| Weak yes | Medical Condition | “It [PD] was not an option. Because of surgery that I've had, the cancer in my abdomen So, it couldn't be done.” [male, aged 70] | Negative side effects from HD | “The hemo was giving me horrible headaches. The last couple days … it was making me sick. I couldn't tolerate it any longer.” [male, aged 56] |
| Strong yes | Fear of infection from PD | “To me, hemo just seems to be … more clean. Because the peritoneal, you have a lot of chances of getting infections, and I didn't want to do that.” [female, aged 52] | Better quality of life on PD | “I felt like the PD would allow me to have a normal life. Other than the dialysis … I could still go out, do everything.” [female, aged 43] |
| Want trained medical person | “While I'm doing my dialysis, I like the fact that there's someone there … that could help me if something went wrong or something like that. I don't know, I just feel more comfortable … going into the center and having it done there.” [male, aged 37] | Convenience of home dialysis | “Well, just the fact that I can do it at home. The idea of going into a center 3 times a week for 4 or 5 hours just absolutely does not appeal to me.” [male, aged 82] | |
| Ability to work | “The fact that I was still able to work and take care of my family …” [male, aged 48] | |||
Abbreviations: HD, hemodialysis; PD, peritoneal dialysis.
aAsked only of HD and PD patients on dialysis.
bClassified by perceived role in choice of dialysis modality reported in Table 3 (no, combined, weak yes, and strong yes) and dialysis modality selection.
| Dialysis Choice |
|---|
|
Abbreviation: HD, hemodialysis.
aThe table describes overlap of individual themes across different classifications. Patient responses to the question, “Do you feel that the decision to go on HD/PD was largely your choice?” were classified as “strong yes” (rectangle) “weak yes” (triangle) and “no” (diamond). Individual themes (text within the tables) emerged from responses to the question, “What led you to choose HD/PD?” Circles represent the 2 metathemes (perceived benefits and perceived risks or constraints), each containing the individual themes (text within the shapes). The 2 metathemes suggest patients consider both “benefits” and “risks” when making a decision about the type of dialysis.
| Variable | PD (n = 614), %a | HD (n = 1346), %a |
|---|---|---|
| Patient age | ||
| <45 y | 17 | 11 |
| 45-59 y | 29 | 28 |
| 60-74 y | 37 | 38 |
| ≥75 y | 17 | 23 |
| Male | 54 | 57 |
| Race | ||
| White | 70 | 60 |
| Black | 23 | 36 |
| Other | 7 | 5 |
| Years on dialysis | ||
| 0-1.9 | 46 | 32 |
| 2-5.9 | 43 | 45 |
| 6-9.9 | 8 | 15 |
| ≥10 | 4 | 9 |
| Diabetes | 41 | 43 |
Abbreviations: HD, hemodialysis; PD, peritoneal dialysis.
aOne PD patient and 9 HD patients were missing demographic data.
| Section | Intervention | ||
|---|---|---|---|
| Control | Pretest | Posttest | |
| Treatment preference | ✓ | ✓ | ✓ |
| Preference for shared decision-making72 | ✓ | ✓ | ✓ |
| Decisional conflict73 | ✓ | ✓ | ✓ |
| Decisional self-efficacy74 | ✓ | ✓ | ✓ |
| Knowledge75 | ✓ | ✓ | |
| Literacy76 | ✓ | ✓ | |
| Numeracy77,79 | ✓ | ✓ | |
| Demographics | ✓ | ✓ | |
| Preparation for decision-making79 | ✓ | ||
| Relevance, usability, and satisfaction | ✓ | ||
| Open-ended feedback on decision aid | ✓ | ||
| Patient characteristics | Control | Intervention | P value |
|---|---|---|---|
| No. of patients | 70 | 70 | |
| Age, mean (SD), y | 59 (14) | 59 (15) | .9065 |
| Race, % | .8366 | ||
| White | 79 | 74 | |
| Black | 14 | 17 | |
| Other | 7 | 9 | |
| Male, % | 50 | 43 | .3968 |
| Hispanic or Latino/Latina, % | 3 | 3 | 1.0000 |
| High school graduated, % | 94 | 99 | 1.0000 |
| English native language, % | 96 | 91 | .4932 |
| Ability to understand, mean (SD) score | |||
| Reading materialsa | 2.94 (1.25) | 3.67 (1.45) | .3099 |
| SNSb | 3.83 (1.11) | 3.92 (0.99) | .7579 |
| SNS abilityc | 3.88 (1.18) | 3.92 (1.10) | .9761 |
| SNS preferenced | 3.74 (1.26) | 3.93 (1.08) | .4837 |
Abbreviations: SNS, Subjective Numeracy Scale.
aScore of answer choices from all of the time (0) through none of the time (4); higher is better.
bScore for answers not at all good (1) through extremely good (6) of 3 questions: “How good are you at working with fractions?” “How good are you at figuring out how much a shirt will cost if it is 25% off?” “How often do you find numerical information to be useful?”
cScore for answers not at all good (1) through extremely good (6) of 2 questions: “How good are you at working with fractions?” “How good are you at figuring out how much a shirt will cost if it is 25% off?”
dScore for answers not at all good (1) through extremely good (6) of 1 question: “How often do you find numerical information to be useful?”
| Outcome measures | Intervention | Control vs pretest | Pretest vs posttest | Control vs posttest | ||
|---|---|---|---|---|---|---|
| Control | Pretest | Posttest | ||||
| n = 70 | n = 70 | n = 63 | ||||
| % (No.) or mean (SD) | P value | |||||
| Which dialysis type do you think you might choose? | .8203 | <.0001 | .0083 | |||
| Hemodialysis | 22.9 (16) | 22.9 (16) | 42.9 (27) | |||
| Peritoneal dialysis | 31.4 (22) | 25.7 (18) | 36.5 (23) | |||
| Not sure | 40.0 (28) | 47.1 (33) | 15.9 (10) | |||
| Other | 5.7 (4) | 4.3 (3) | 4.8 (3) | |||
| Decisional conflict score (higher = more conflict) | 42.5 (17.1) | 44.3 (16.0) | 29.1 (13.7) | .5149 | <.0001 | <.0001 |
| Decisional self-efficacy score (higher = more confident) | 79.9 (17.6) | 82.2 (18.6) | 82.0 (18.4) | .3642 | .9911 | .3621 |
| Knowledge (higher = more correct answers chosen) | 76.5 (15.3) | 90.3 (11.9) | <.0001 | |||
Subramanian L, Zhao J, Zee J, Tentori F. (2018). Does an Online Decision Aid Help People with Advanced Chronic Kidney Disease Choose between Two Treatment Options? Patient-Centered Outcomes Research Institute (PCORI). https://doi.org/10.25302/10.2018.CER.1109
The [views, statements, opinions] presented in this report are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors or Methodology Committee.
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