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| Fidelity: domains of fidelity |
Completing action plans was described as a box-ticking exercise sometimes Tension between taking a motivational interviewing-informed approach and getting patients to do things they were supposed to do to hit fidelity targets, specifically action plans
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There was evidence that patients received the intervention and that some patients enacted some of the behaviours such as action plans Receipt – both intervention sessions and CFHealthHub were a source of information and education Intervention sessions helped to identify individual barriers and facilitators – also helped people link treatments to aspects of daily routine Preference for different aspects of intervention – mainly the interventionist knowing more about them Enactment – successes in establishing new routine and habits. Using cues and triggers was popular but did not always work
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| Adaptations |
Interventionists adapted timing of visits around patient availability Sometimes wanted patients to have more visits than patients wanted Some did not stick to scripts and tools but adapted them Some interventionists showed the CFHealthHub videos during visits
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| Access to intervention |
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CFHealthHub went down for 5 weeks near the end of the RCT, affecting a subset of patients Four new interventionists recruited
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| Dose |
Some patients were hard to get hold of and may not have had the expected number of visits Interventionists sometimes used the flow chart of visits in a flexible way but generally stuck to the overall flow of intervention visits
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Patients spoke about having to rearrange appointments and so there was longer between sessions than there should have been, or visits were missed No one mentioned that they would have liked more sessions
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| Feasibility |
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| Reach |
Self-selecting sample of people who are happy to be monitored? CF centres had preferences for nebulisers, which influenced reach Some interventionists approached patients who they thought would sign up (at least initially). Some interventionists had patients with learning disabilities who found the written aspects of the intervention difficult. Some interventionists reported hard to reach populations with no fixed abode, nowhere to plug a hub in Better for ‘middle’ adherers – people who are not ill enough to see team regularly but are not high-level adherers with established routine
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Good for some but ‘not for me’ (very low-level baseline adherers) Good for people who are online quite often, for people who need more knowledge; reassurance for high-level adherers
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1581/3510 (45% of eligible) 607/1581 (38% of eligible recruited to RCT) 125 unwilling to change nebuliser (8% of eligible)
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| Mechanisms of action/impact |
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| Acceptability of interventionists |
Relationship with interventionists highly valued. Patients seemed to prefer home visits but not allowed in some RCT sites Creating long-term continuity of care in relationship important Having time to build and maintain relationships Difficulties contacting some patients
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Relationship with interventionists highly valued Patients liked choice of venue for meetings Preferred face-to-face visits than telephone visits but if away from CF centre, telephone visits could also work
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60% found interventionist support very helpful and 7% unhelpful, so a largely acceptable component 287/305 (94%) got first intervention visit. A total of 77% patients found first meeting very helpful. No one not finding it helpful, so a universally acceptable component. But note that only 257 out of 305 people completed this item owing to loss to follow-up For follow-up telephone and facet-to-face visits, 59% and 67%, respectively, found very helpful, again with few finding it unhelpful Helpfulness ratings of interventionists differed by site with three sites having higher levels of dissatisfaction/saying not helpful (24–33%)
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| Acceptability of adherence feedback graphs |
Useful for interventionists and MDT Technical problems, sometimes data different from patient experience Proof of adherence or proof of non-adherence
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Key mechanisms of self-monitoring and self-regulation Patients used this part of the intervention outside visits Liked traffic light aspect Main aspect of CFHealthHub that was looked at or used by PWCF as proof, reward and motivation
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| My toolkit |
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| Action plans/coping plans |
Some people doing actions plans Need to revisit and tweak plans, so not a one-off exercise It is sometimes a box-ticking exercise in terms of completing actions plans Difficult to set them and encourage people to do it themselves Happening informally in that patients do not want to put them down on paper Day and party planner not used independently by patients Interventionists struggled to understand coping plans and use them with patients. Easier when renamed as backup plans and further training from research team
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If action plans do not work at first, some were reluctant to try again, whereas others did try again Difficult to formulate plans on CFHealthHub Some patients found these worked straightaway, whereas others tweaked them to make them work and others just struggled with them
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216 participants with push notifications enabled 227 participants made action plans 118 participants made coping plans 39% very helpful and 20% not helpful
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| Treatment videos |
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Patients understood better how treatments worked even if they already thought they knew Thought they would be good to share with others (e.g. family)
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| ‘Talking head’ videos |
Patients either loved or hated them Some interventionists showed them during visits rather than leaving patients to look at them alone after visits
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| Problem-solving |
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| App | – |
Preferred way to access CFHealthHub Not everything was accessible on the app and tricky to see some aspects of the graphs Could not see times on app but quick and easy
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| Interaction with MDT |
Some difficulties if MDT gave different advice to patients Engagement of MDT varied across RCT sites Concerns that others in MDT would use graphs information in the wrong way
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Key mechanism of action was that others were monitoring, including MDT and interventionists Feeling of not being believed by MDT in the past but objective data could offer proof of adherence Mechanism of praise from MDT for adherence improvement, completing the feedback loop
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| Training in delivering the intervention |
Training was well received. Some gap between training and delivering the intervention. Some issues around the way the intervention is delivered in terms of MI-informed approach. More could have been done around that
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| Value/perceived benefits of intervention |
Reported examples of improvements: reductions in exacerbations, put on weight, doing exercise, family have noticed Only of benefit to some patients? Depends on baseline adherence level. Or is it different benefits for each group? Videos increase knowledge of patients, and family and friends Can change identity of patient to MDT if patient had been known as a low-level adherer but the objective data showed they were a high-level adherer Interventionists found that the approach to communicating with people stimulated reflection on their own practice even if they had had MI training in the past
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Reported examples of improvements: increase in FEV1, less hospital visits, cough stopping Able to show proof to MDT and family that they were doing their treatment High-level adherers already had habit formation, so no improvements there, but could see patterns and check, use monitoring for reassurance Some patients liked routine and habit forming, and others disliked it, so resisted habit forming Appreciated the more in-depth relationships with interventionists – felt they were known better by health-care professionals
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| Unexpected pathways and consequences/safety |
Monitoring objective adherence data was worrying to some patients because they fixated on the data and withdrew owing to felling the pressure to improve If there was no praise from the MDT, patients could be demotivated to increase adherence CTRU monitoring of action plan completion may have contributed to some interventionists setting inappropriate action plans or with patients who were not sufficiently motivated
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| Context |
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| Differences between PWCF |
Baseline adherence rate is very important in terms of how patients use the intervention and benefit from it Adherence can be inconsistent owing to life events Needs to be the right time for someone for them to engage fully with intervention
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Chaotic lives hindered habit formation Low levels of literacy or dyslexia could prohibit writing action plans
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| Usual care in RCT sites |
Usual-care arm feel monitored in the RCT, so may increase their adherence rates so not just receiving usual care Differences between RCT sites in how much adherence and MI communication style was embedded in usual care
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Intervention seen by patients as opportunity for interventionists to get more insight into their lives than usual care – opportunity to discuss more things, and in more depth, as had longer time with interventionists than usually have with MDT Differences between sites in how intervention was delivered (in a clinic or at home) Variation in how integrated the intervention was perceived to be with usual care
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Sites tended not to use MPR to understand adherence during consultations, but this increased over time, and did not use bespoke graphs of I-neb plots, but some used Insight Online. Majority said they used some objective adherence measurement but in an ad hoc way A minority of sites tended to reduce the target prescription and this increased over time (21% then 37% always/often), and tended not to use I-neb data to inform consultations (21% then 25%) Majority asked about adherence and thought adherence support important 63% used MI at baseline and a further five sites used it at follow-up On average, encouraging airway clearance was considered the most important and encouraging exercise was considered the least important
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There did not seem to be a high level of action similar to the intervention at play in usual care Usual care varied by RCT site The intervention appeared to be offering new actions over and above usual care Not much changed in usual care over the time of the RCT If monitoring is an important mechanism then some controls may wrongly believe that the MDT were monitoring them and this could have increased adherence
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| Nebuliser type |
Patients had preferences that influenced participation in RCT and withdrawal from RCT CF centres had preferences for nebulisers, which influenced reach
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Some found the new nebuliser issued in the RCT quicker, quieter, smaller and more effective Others found it harder to use because they had to use it at different times from their old nebuliser and they had to change established systems/habits
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| RCT sites/CF centres |
There are differences between RCT sites in terms of implementation, context, interventionists, who joined the RCT, and engagement from MDT. Differences included whether interventionists could make home visits or had to see patients at a clinic, the organisation of the interventionist’s role, organisation of care (e.g. patient notes), culture of the CF centre, how the CF centre reacted to the CQUIN that paid treatment costs for the intervention, types of nebulisers usually used, drugs prescribed, links to MDT, and interventionist skills/background
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| RCT |
Some usual-care arm patients believed that the interventionist could see their data. Usual-care arm participants feel monitored, so may increase their adherence rates Disappointment in usual-arm participants Motivation questions on RCT questionnaire did not pick up who was not motivated to do treatment. This could be picked up by the interventionist in their first meeting Paperwork and data collection burden The site principal investigator was more involved in the RCT in some sites CTRU monitoring of sites influenced which aspects of the intervention were focused on
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