Women's Health Initiative Clinical Trial and Observational Study

The CC environment should be clean, pleasant, and oriented to the comfort of the participant. A quiet waiting room area, an efficient reception and appointment scheduling area, appropriate reading materials and posters, and a clean, organized interview area are important. Pleasant experiences with the CC staff, visit contents, appointment scheduling, and exiting can all encourage the participant to continue in the study. A feedback mechanism for the participants, for example a suggestion box in the waiting area, may be a good idea.

Aspects of convenience and accessibility include:

• telephone access
• CC location
• availability of transportation
• convenient clinic hours

Depending on local circumstances, different approaches may be used. Appointments should be available at times and on days that do not interfere with the participant’s working schedule. All CCs should have at least some appointments available on evenings or weekends, outside of usual working hours. Pre-arranged parking should be available if at all possible. Maps, parking information, and public transportation information should be made available to participants.

Convenience and accessibility should be reviewed at each CC twice a year and obstacles eliminated to the greatest possible degree. Parking fee reimbursements or other travel expenses or arrangements may need to be considered by the CC if retention lags due to transportation problems. You may need to come up with creative solutions to help transportation problems. For example, local churches or other volunteer organizations may be able to help through the use of their van or other vehicles and/or by providing volunteers to drive participants to and from visits.

The length of a CC visit, as well as the time waiting for the visit, may be of vital importance in keeping participants returning for visits over a prolonged period of time. Try to keep total CC visit time on all visits to a minimum, but not be so brief at follow-ups that the travel time and effort seem excessive. It is especially important to keep waiting times to a minimum. If an extended waiting period becomes necessary, do what you can to avoid anxiety and hostility in the participant:

• encourage completing or review of study forms
• explain the situation and give the participant some alternatives from which to choose
• offer the option of seeing another staff member, if possible, or rescheduling if necessary
• have the daily newspaper, magazines, or other reading materials available.

A key element in successfully maintaining long-term participation is the development of a personal relationship between the individual participant and individual members of the staff. Good communication is essential to promoting and maintaining retention in the study. Consistency among staff and clarity of instructions are key to good communication. At all times, the participant should be helped to understand the beneficial nature of participation in the study. Encourage her to ask questions at visits, or to call between visits to clarify questions and problems that may arise. Assure participants that they should not hesitate to bring up any issues of concern.

It is recommended that each CC identify CC staff to serve as retention specialists. This staff member or members will participate in developing local retention strategies, will serve as contacts for Clinical Coordinating Center (CCC) retention activities, and will coordinate management of retention problems at the CC. Retention specialists should identify CC activities to promote retention that can be offered to women in each component of WHI.

Encourage the support and involvement of participants’ family members throughout WHI using the following strategies:

• Invite husbands, partners, or significant others to attend the CC visits, especially the initial visits, as well as special events held during the course of the study. Both retention and adherence are more likely if family members are involved in the process.
• Encourage family members to learn about the study’s purpose and general design, and inform them of the ongoing safety monitoring of participants.
• Encourage family members to notify the CC if the participant becomes ill or happens to be out of town when contact is to be made or a visit scheduled.

Participant membership identification cards are distributed to participants at the time of enrollment (OS) or randomization (CT). The purpose of these cards is to provide a quick identification of the participant’s name and study ID, give the participant easy access to her CC’s telephone number, enhance identification and bonding with WHI, and provide the participant with a card to show her health care provider, if appropriate.

These wallet-sized cards are printed with the WHI logo and CC name and phone number on one side. A label including the participant’s name, participant ID, and ID barcode is placed on the backside of the card at time of enrollment. At the same time, mark the participant’s study component(s) with a permanent ink marker. The label may need to be replaced periodically throughout the study, depending on wear. Membership cards are ordered through the CCC using Form 172 - Supplies Order.

Clinical Centers are encouraged to establish a participant representative to meet periodically with the CC staff. Representatives can provide CC staff with the participant’s perspective on the WHI experience. She may be able to help address barriers to retention by making suggestions, for example, about enhancing the waiting room environment, helping to deliver educational and informational materials, organizing alternative or cooperative transportation, and providing feedback from other participants.

Clinical Centers are encouraged to plan events and activities to promote retention. The frequency of retention events and activities is at the discretion of the Clinical Centers. Clinical Centers are encouraged to consider their own CC’s retention data and resources when considering the frequency of events and activities.

Open house events where all WHI participants are invited to attend are permitted, if study component information is not made apparent. During studywide events, care should be taken to avoid contamination between DM Dietary Change and Comparison groups. Topics for discussion at events and social activities should focus on information not related specifically to one study component or another and should not include discussion of topics relating to WHI interventions (e.g., nutrition) or outcomes. For example, it is okay to present health information such as tips for quitting smoking, but is not okay to present information on ways to prevent heart disease. Discussion of study progress (e.g., number of randomizations to date) is appropriate. Non-health related activities, for example, fashion shows or WHI birthday parties are allowed. During events, express appreciation for participating in the WHI and reinforce the importance of every participant’s continued involvement to the success of the study.

Foods served at CC-wide events should include moderate- or high-fat choices as well as low-fat choices, similar to the acceptable cultural foods of your region. Although low-fat choices should not be stressed, avoid serving “junk” food or foods that send an unhealthy message; given that this a study on women’s health, we don’t want to promote the use of unhealthy foods. Fat content of foods should not be labeled and recipes should not be provided. If a separate meeting is held for Dietary Change participants, then it would be appropriate to serve only low-fat foods and to provide recipes. For DM participants, CCs should focus adherence and retention efforts on Dietary Change group participants rather than on DM Comparison group participants.

The following is an example of a studywide event: A “WHI birthday party” to celebrate the WHI is held. All participants (CT and OS) are invited, and they may bring a spouse or guest. Participants are asked in advance not to identify themselves by group assignment. A large hall is rented as the site for the reception, and a variety of low-fat and “regular-fat” foods are available. In addition, a large number of door prizes, donated by local merchants, are distributed. After a brief overview of WHI recruitment progress, an invited speaker presents a brief talk of interest to participants.

Both CCC and CC staff will address participant health information and concerns in standardized formats. Some suggestions for distribution of health information are the following:

• Create a distribution center or display for free health-related (not diet-related) materials in the waiting area or other convenient, accessible location. Free publications approved by the National Institute of Health (NIH) for WHI distribution (see Section 2.3.2.6 - Other Equipment and Supplies) can be ordered from the NIH by calling 1-800-4-CANCER. Publications not on this list need NIH approval before being distributed to participants. Health materials developed by the CC must be approved by the CCC, following the standard procedures for CC materials review, before distribution at the CC. The display might include copies of the informed consent forms for participants to read again, if interested, or health educational videos for viewing on site or at home.
• Compile a list of all local services and programs for health promotion (e.g., smoking cessation) and for special support groups (e.g., bereavement, cancer). Copy and display this list at the distribution center. Make these referral sheets available for participants at each local site.
• Invite participants to health promotion events that do not interfere with WHI interventions, such as sessions on smoking cessation or administering CPR.

The Post-Randomization Visit Reminder (WHIP 0787) is a WHILMA report generated by CCs that lists, by target date, all women who are due for a given post-randomization follow-up visit during a specified time period. This report should be used with your CC’s system to track and set up participant follow-up contacts.

During the screening and randomization phases, when the CC process is still relatively new to participants, CC staff may contact participants by telephone to remind them of upcoming CC appointments, check to see if they have questions or concerns, and make sure they are properly prepared (e.g., fasting, wearing light clothes).

During follow-up visits, use appointment reminders to prompt participants to come for CC visits and to bring their current medications, study pill bottles, forms, and food records with them. These reminders can be postcards, telephone calls, or letters. To save time, you may want to send a postcard or letter to the participant well before the visit time window, reminding her that she is due for a visit and asking her to call the clinic for an appointment.

During all contacts, use procedures to aid participants in overcoming any reluctance to attend follow-up visits, such as a discussion of transportation reimbursement or daycare facilities, if available. Remind participants at each follow-up visit that they have ready access to study personnel. Specify the days and hours for your CC, as well as after-hour contacts. Encourage participants to call with questions, concerns, or symptoms.

You may want to send a thank you card or postcard following attendance at clinic visits, either screening and/or follow-up visits. Stress the importance of these visits and your appreciation to the participant for taking the time to come into the clinic. Thank you cards can be ordered through the CCC using Form 172 – Supplies Order.

It is important to maintain contact with participants for the full duration of the study to ensure that study results are valid and, at the very least, to ensure that vital status (dead or alive) is known on each participant at the end of the study. The task of maintaining contact with participants will be facilitated by maintaining up-to-date personal information in each participant’s file. Although participants are not required to answer every question on Form 20 - Personal Information, encourage them at a minimum to complete questions on full name including middle initial; address; phone number; the names, addresses and phone numbers of two personal contacts; Social Security Number; and name of health care provider. It is generally preferable to have personal contacts who are younger than the participant, in good general health, and who are not likely to move during the course of the study.

It is important to confirm during follow-up contacts that information on the participant’s name, address, phone number, personal contact information, and health care provider is still current. This information should be reviewed at least once a year with the participant, even if she does not visit the clinic. If any of this information has changed, the participant should update Form 20 - Personal Information, and the participant’s personal information should be updated on the member screen in WHILMA. This will minimize the possibility of participants becoming “lost” at any subsequent stage of the study. Participants should be asked to provide the name of a new personal contact if either of the personal contacts named at the start of the study is no longer suitable to act as a contact person.

When a participant’s address is found to be no longer valid, the undeliverable address should be flagged on the participant’s member screen and activities should be initiated to establish the participant’s new address (see Section 17.2 - Locating “Hard to Find” Participants). Each month, CCs should run two reports to help maintain up-todate and deliverable addresses in WHILMA (see Vol. 5- Data System, Section 9.2 - Reports and Appendix D - WHILMA Reports for information on running these reports):

• WHIP 0611 - Members With an Incomplete Address or Long Name/Address. This report provides a list of all (CT and OS) participants with a problem address (e.g., the address is incomplete or will not fit on a mailing label). Participants with address lines that are too long should be fixed immediately by using address line 2 for the second line of the address, or abbreviating words in the first line so that it stays within the 30 character width limit of the mailing labels. Those that are incomplete should be investigated as soon as possible. If the zip code is missing, try calling the post office or, if that fails, call the participant to obtain the correct address. If you cannot fix the address right away, set the undeliverable address flag on the “Contact Information Screen” in WHILMA. This will prevent mailings, such as OS follow-up mailings or the participant newsletter, from being sent to an undeliverable address. Try to fix incomplete addresses within two weeks of their appearance on the report. Participants will continue to appear on this report until either the address has been fixed or the “undeliverable address” flag has been set.
• WHIP 1211 - Undeliverable Address Report. This report provides a list of all (CT and OS) participants with undeliverable addresses (indicated by the undeliverable address flag) in the CC’s database. The report does not include those with participation status of “no follow-up”, “deceased”, or “lost to follow-up”. Items that may appear on the report are the participant’s name and (undeliverable) address; participant ID; home phone; work phone; a note indicating that the workplace should not be contacted, if applicable; best time to call; phone of other contact; follow-up status; and date the undeliverable address flag was turned on.

  For participants appearing on this report, attempt to correct the address by contacting the participant at home and, if necessary, at work. If these attempts fail, telephone her personal contacts using information listed on the report. If preliminary attempts to contact the participant fail, initiate a formal search to locate the participant (see Section 17.3.1 - Initiating a Search to Locate Participant (Form 23) (Required).

  Undeliverable addresses should be updated as soon as possible, since a participant will not receive any mailings until the address is fixed. The sooner you try to get an address correction, the more likely you will be successful in tracking down the participant. Undeliverable addresses should be corrected within one month of appearing on the report. Participants will continue to appear on this report until the “undeliverable address” flag has been removed or follow-up status changes.

The CCC is responsible for the production and distribution of the annual newsletters, including content, design, layout, graphics, production costs, and coordination of printing through the Government Printing Office. Staff members at the CCC or any of the CCs are welcome to contribute ideas or articles for consideration. The CCC is responsible for keeping CCs informed of deadlines relating to submission of these articles.

The CCC is responsible for the mailing of the annual newsletters to CT and OS participants. Clinical Center-specific return addresses are printed on the newsletters mailed to that CC’s participants.

Newsletters include both project-specific and general, health-related information. Each newsletter includes the following general content areas:

• A column from the WHI Director at the NIH describing the progress and importance of the WHI.
• A section with articles on relevant health topics (not diet related).
• A section describing overall progress on study activities.
• A section with features and interviews of WHI participants.
• A section featuring segments submitted by and about the CCs (optional).

The following guidelines are to be followed for all newsletter submissions:

• Articles should be written at a 6th grade reading level; a slightly higher level may be acceptable for more complex articles, such as science or health articles.
• Original sources for articles, such as articles reporting the results of scientific research, will be carefully consulted for technical accuracy and kept on file at the CCC.
• When quoting an individual, the interviewer must ask the individual for permission to quote him or her. Quotes must be used verbatim, with quotation marks. Quotation marks are not used unless a direct quote is cited.
• If quotations are used from sources such as magazines, journal articles, or books, permission must be obtained from the publisher. This information is cited at the end of the article (for example: used with permission, name of source, date). When contacting a source to obtain permission, be sure to identify yourself as a nonprofit research organization; permission will usually be granted without a fee. When reprinting cartoons, permission must be obtained from the syndicate that represents the cartoonist.

The newsletter staff and Project Directors at the CCC make initial discretionary decisions regarding newsletter content, appropriateness of articles, readability level, layout, and emphasis in coverage. Before final approval by the Project Office and Steering Committee, a draft of the newsletter is sent to the following committees for input and approval: Behavioral, CC Staff Group, Observational Study, and Special Populations.

One purpose of the participant newsletter is to help CCs make sure that they have up-to-date address information for each participant. A mailing label for each participant’s newsletter is generated at the CCC based on the address listed on the Personal Information Screen in WHILMA. When the address on the mailing label is incorrect and the newsletter is not deliverable, the local Post Office will notify the CC. This notification is in the form of a photocopy of the mailing portion of the newsletter, along with address correction information (because newsletters are mailed bulk rate, undeliverable newsletters are neither returned nor forwarded to the new address). The CC is charged for each notification of an undeliverable address ($.50 per address as of 10/95). Update the contact information screen in WHILMA immediately when an address correction notification is received to ensure that future mailings are sent to the correct address and to avoid additional postal charges.

When a CC is notified of an updated address, the CC should try to contact the participant by telephone to make sure that her telephone number is still current. If this contact is made as soon as the CC is notified of the change of address, there may still be a recorded message with the new number, if it has changed. If a new telephone number is obtained, update the Personal Information Screen in WHILMA.

If a participant has a changed address, the Post Office does not forward the newsletter. The CCC will send an extra supply of newsletters annually to each CC. When you are notified of a new address, you may want to put one of the extra newsletters in an envelope and mail it to the participant at her new address; otherwise, she will not get a newsletter that year. Another option is to notify the CCC of the change, and a new newsletter will be sent to the participant from there. Note: you may not mail the newsletters using the “Bulk Rate” permit printed on the newsletters. This is for CCC use only and misuse by CCs can result in the cancellation of the CCC’s mailing permit.

If address correction information is not available (i.e., “forwarding address unknown”), set the undeliverable address flag on the “Contact Information Screen” in WHILMA and initiate procedures to locate the participant. Try to contact the participant and, if necessary, telephone her personal contacts using information listed on Form 20 - Personal Information to get an updated address. If preliminary attempts to contact her fail, initiate a formal search to locate the participant [see Section 17.3.1 - Initiating a Search to Locate Participant (Form 23) (Required)]. Participants with an undeliverable address will appear on the Undeliverable Address Report (WHIP 1200) the next time it is produced (see Section 17.1.4.5 - Maintaining Complete and Deliverable Participant Addresses).

If the Post Office indicates that the participant is deceased, initiate contact with persons listed on Form 20 - Personal Information. If a death is confirmed, update Form 7 - Participation Status, complete Form 120 - Initial Notification of Death, and process according to procedures outlined in Volume 8 - Outcomes.

The CCC produces and delivers to the CCs one retention incentive (e.g., magnet, mug, bookmark, pocket planner) per year for each CT participant and guidelines for distribution at the annual visit. The CCC also provides a retention incentive for OS participant attending their Year 3 annual visit. Selection of annual incentives is subject to approval by the Behavioral, CC Staff Group, and Special Populations Committees.

Each CC may use its own incentives for increasing participant retention. Examples of incentives are small gifts (e.g., t-shirts, bags, certificates of appreciation), educational materials (e.g., non diet-related health brochures), coupons (e.g., free coffee or soft drink from local cafe), or raffle tickets for small prizes (e.g., every participant who comes in for a follow-up visit is entered in a monthly drawing for a small prize). Clinical Centers may purchase incentives, if their budget allows, or obtain donated incentives from outside sources. If incentives are donated from outside sources, it is important that the WHI not appear to endorse a particular company or product. Therefore, a donated incentive cannot include both the WHI logo and the sponsors name or logo, unless a disclaimer of endorsement of the sponsor appears on the incentive.

All participants should receive an annual retention incentive when they come in for their annual visit. It is probably easiest to hand out the incentive at the same time during each visit; use whatever timing works best for you. If a participant does not attend her annual visit, try to mail that year’s incentive to her.

Research shows that incentives can help improve retention when their distribution is accompanied by a positive message. Please take the idea of an incentive seriously. When the incentive is distributed, be sure to stress that this is a token of our appreciation for her time and effort. For example, you may want to say something like:

Intervention retention challenges in HRT and CaD are defined as having either low adherence (less than 80% of study pills) or non-adherence to the intervention’s pill taking regimen. Participants identified as retention challenges require special retention activities to improve adherence (refer to Section 17.2.2.2.1 – Intensive Adherence Program (IAP) for specific procedures).

Clinical Center staff may identify HRT or CaD intervention retention challenges at a clinic visit, telephone contact, mail contact, or through discussion with other CC staff. Retention challenges in HRT and CaD can be identified in at least four ways:

• Participants with a calculated adherence rate of less than 80% at a clinic visit, based on pill weights or pill count estimates. However, if a participant has poor adherence but a concrete, reasonable reason for such poor adherence rate (e.g., loss of the pill bottle, inability to return to the CC to obtain more pills in time, illness), she may not require special retention activities.
• Participants with responses to the adherence questions on Form 10 - HRT Management and Safety or Form 17 - CaD Management and Safety that indicate adherence problems. Both Form 10 and Form 17 contain an item to check if the participant should be referred to the IAP based on the interview.
• Participants who CC staff determine need more assistance with adherence regardless of the adherence rate calculated. Examples of participants who may need special retention activities even though they meet the guidelines for good (>80%) adherence are:
  • - Participants who the CC interviewer feels could benefit from a more systematic approach to adherence discussion. This could occur if the interviewer has limited discussion skills or minimal experience with adherence problems, or sees a situation with multiple or diverse adherence problems.
  • - Participants who express concern about study pill symptoms or impact on health problems.
  • - Participants who anticipate or are going through major changes in their routines, such as illness or death of a family member, extended trip away, etc.

While a participant is not removed from active HRT or CaD intervention status for low adherence, achieving an adherence of rate of at least 80% is desired if the goals of the study are to be met.

Refer to the HRT/CaD Medication Adherence (WHIP 1260) report to identify which HRT/CaD women need special retention activities to improve their adherence. Also refer to 17.2.2.1.3 - Documenting and Tracking Special Activities for HRT/CaD Retention Challenges for a list of other reports and forms that may be useful in identifying which HRT/CaD participants need special activities.

When a participant has been identified as an HRT or CaD retention challenge, initiate the special retention activities outlined in Section 17.2.2.2.1 – Intervention Adherence Program (IAP). To help keep track of special activities, complete Form 24 – Adherence and Retention Worksheet.

Section 7.2.2.2 - Dealing with Non-Adherence, and Tables 17.3 – Reasons for Poor Retention and/or Adherence, 17.4 - Strategies to Retain Full Participation in CT and OS, 17.5 - Strategies for Adherence to CT Intervention, and 17.6 - Examples of Retention Strategies provide interviewers and CPs with additional items for discussion and ideas for improving adherence and retention of HRT/CaD participants. These are methods of identifying participants who have poor adherence before they become non-adheres.

The following forms and reports may be useful in identifying which participants need special retention activities and documenting and tracking activities that have been initiated or completed:

• HRT/CaD Medication Adherence (WHIP 1260) – Use this report to identify which participants require special retention activities due to low adherence levels (i.e., less than 80%).
• Form 10 – HRT Management and Safety – This form is completed at each semi-annual visit to evaluate safety issues related to HRT use. Refusal to complete this form results in a participant’s removal from the intervention. Item 13 on this form indicates that a participant needs to be enrolled in the IAP.
• HRT Management Recontact (WHIP 0616) – This form lists participants who need to be recontacted as indicated on Form 10. The report output indicates whether the needed contact is a one-month safety contact or an IAP contact.
• Form 17 – CaD Management and Safety – This form is completed at each annual visit to evaluate safety issues related to CaD use. Refusal to complete this form results in a participant’s removal from the intervention. Item 11 on this form indicates that a participant needs to be enrolled in the IAP.
• CaD Management Recontact (WHIP 1048) - Use this report to identify which participants should be receiving IAP contacts, as indicated on Form 17.
• IAP Checklist and IAP Participant Call Record - Use these to document IAP activities.
• Form 24 – Adherence and Retention Worksheet - This form can be used to track retention activity, to identify which participants need further adherence/retention assistance, and to indicate when (i.e., date) future contacts should be made.
• Member Adherence and Retention Activity Tracking (WHIP 1238) – This report is used to track which participants have received retention/adherence contacts (based on Form 24 data) and the date to conduct future contacts, as needed. The report can be sorted by member ID or name, retention problem (i.e., in which study component), or date for next contact.

When special adherence and retention strategies have been exhausted and the participant indicates that she is no longer willing to take her study pills and/or complete follow-up safety procedures (HRT and CaD) complete a Form 7 - Participation Status to reflect the change in status. If the participant decides to resume with intervention and/or follow-up activities that had been previously stopped, update Form 7 - Participation Status as appropriate to indicate the current level of participation status (i.e., make sure that the participation status [intervention and/or follow-up status] indicated on Form 7 accurately reflects the level of participation she is currently willing to do).

Try to maintain the highest level of participation that the woman is willing to achieve. Even if she refuses to take her study pills, it is very important to try to keep her on a high level of follow-up status. Contact participants with less than full intervention status at least once a year throughout the study to see if they are willing to resume some or all aspects of their participation (see Section 17.4.5 - Reactivation of Participants with Changes in Participation Status).

Retention challenges for DM Intervention are characterized by difficulty meeting Dietary Change goals and/or difficulty completing Dietary Change sessions. Refer to Section 6.10 (including all subsections) – DM Intervention Participation and Section 6.11 (including all subsections) – Intensive Intervention Protocol (IIP).

The Group Nutritionist uses the Triage System for DM Intervention to set priorities for managing participants having retention challenges. The system categorizes participants into one of four adherence categories where Level 1 reflects high adherence and Level 4 reflects low adherence. Refer to Section 6.10.7 – Triage System for DM Intervention.

Difficulty Meeting Dietary Change Goals

The Group Nutritionist uses high intensity Intensive Intervention Protocol (IIP) procedures with Level 2 and Level 3 participants having difficulty meeting Dietary Change goals. Refer to Section 6.11 – Intensive Intervention Protocol (IIP).

Difficulty Completing Dietary Change Sessions

The Group Nutritionist most often uses low intensity Interrupted DM Intervention Participation procedures with Level 4 participants having difficulty completing Dietary Change sessions. However, the Group Nutritionist may use high intensity IIP procedures with Level 4 participants if CC resources support this level of effort. Refer to Section 6.10.8 – Interrupted DM Intervention Participation Procedures.

The Group Nutritionist documents Intensive Intervention Protocol (IIP) contacts using Form 64 – Individual Data Sheet and progress notes. The Group Nutritionist tracks IIP contacts using the IIP Triage & Tracking (WHIP 0444) report. Refer to the following manual sections: Vol. 2, Section 6.11 (including all subsections) – Intensive Intervention Protocol (IIP), Vol. 3 – Forms, Instructions for Form 64 – Individual Data Sheet, Vol. 5, Section 8.2 – DM Intervention Group Reports and Vol. 5, Appendix D – WHILMA Reports.

The Group Nutritionist documents Interrupted DM Intervention Participation contacts using Form 24 – Adherence and Retention Worksheet and progress notes. The Group Nutritionist tracks Interrupted DM Intervention Participation contacts using the IIP Triage & Tracking (WHIP 0444) and Member Adherence and Retention Activity (WHIP1238) reports. Refer to the following manual sections: Vol. 2, Section 6.10.8 (including all subsections) – Interrupted DM Intervention Participation Procedures, Vol. 3 – Forms, Instructions for Form 24 – Adherence and Retention Worksheet and Vol. 5, Appendix B.3.4 – Adherence and Retention Worksheet.

The Group Nutritionist stops special retention activities if the participant refuses all contact with the Group Nutritionist and other CC nutrition staff. Ideally, a non-nutrition CC staff member with retention responsibilities (e.g., retention specialist or designee) attempts to continue special retention activities when the participant refuses all contact with CC nutrition staff.

If the participant refuses all contact with CC nutrition staff and all special retention activities have failed, refer to Sections 6.10.6.2.1 – Non-Participation and 17.4 – Changes in Participation Status for information about stopping intervention.

Follow-up retention challenges are defined as follows:

• HRT/CaD Follow-up Problems: Follow-up retention challenges in HRT and CaD occur when a participant refuses phone and mail contacts during the follow-up period and/or refuses to come in for follow-up visits to complete the ongoing minimum safety requirements following randomization. Failure to meet minimum safety requirements will result in the participant’s removal from active HRT or CaD intervention (see Section 16.4.2 - Minimum Procedures Required for a CT Participant to Remain in Intervention).
• DM Follow-up Problems: Follow-up retention challenges in DM occur when a participant (intervention or control) refuses phone and mail contacts during the follow-up period and/or refuses to come in for follow-up visits (see Section 16.4.2 - Minimum Procedures Required for a CT Participant to Remain in Intervention).
• OS Follow-up Problems: An OS participant who refuses phone and mail contacts during the follow-up period and/or who refuses to come in for the 3-year annual visit is a retention challenge and requires special retention activities.

When a participant has been identified as a follow-up retention challenge, initiate any special retention activities available to help keep her on full follow-up. See Section 16.4 - Follow Contact Problems for Annual (CT) and Third-Year (OS) Visits for strategies on managing follow-up contact problems for annual (CT) and third-year visits. Refer to Section 16.5.3 - CC Date Collection for Non-Respondents to OS Mailings for procedures on initiating contact with OS participants who have not responded to data collection attempts by mail.

See also Tables 17.3 - Reasons for Poor Retention and/or Adherence, 17.4 - Strategies to Retain Full Participation in CT and OS, and 17.6 - Examples of Retention Strategies for ideas on ways to keep participants on full follow-up.

The following forms and reports may be useful in identifying which participants need special retention activities and documenting and tracking activities that have been initiated or completed:

• Missed Scheduled Visit (WHIP 0799) – This report lists all participants who do not have any encounters for their most previously scheduled visit (as per the Member Visit Schedule Tracking screen).
• OS Enrolled Members Needing Clinic Follow-up (WHIP 1206) – Lists OS participants who have not completed a Form 33 – Medical History Update following the mailed data collection contacts (during Year 1, 5, 7, or 9). These women require CC mail or phone follow-up to obtain a completed Form 33.
• Form 24 – Adherence and Retention Worksheet - This form can be used to track retention activity, to identify which participants need further adherence/retention assistance, and to indicate when (i.e., date) future contacts should be made.
• Member Adherence and Retention Activity Tracking (WHIP 1238) – This report is used to track which participants have received retention/adherence contacts (based on Form 24 data) and the date to conduct future contacts, as needed. The report can be sorted by member ID or name, retention problem (i.e., in which study component), or date for next contact.

Special activities may be discontinued when one of the following occurs:

• The participant agrees to some level of follow-up participation.
• The participant requests no further contact from the CC.

Try to maintain the highest level of participation that the woman is willing to achieve. Even if she refuses to take her study pills, it is very important to try to keep her on a high level of follow-up status. Contact participants with less than full intervention status at least once a year throughout the study to see if they are willing to resume some or all aspects of their participation (see Section 17.4.5 - Reactivation of Participants).

If at the end of special activities, the participant’s follow-up status has changed (e.g., activities have failed and she requests “no-follow-up”), complete Form 7 - Participation Status to indicate the change. See Section 17.4.2 - Changing Follow-up Status for guidelines and procedures on changing follow up status.

If a participant cannot be located, initiate a search to determine her current location (see Section 17.3.1 - Initiating a Search to Locate Participants (Form 23)).

A participant’s vital status is considered to be one of the three following categories: known to be alive, deceased, or lost-to-follow-up.

Deceased is defined as follows:

• Form 120 - Initial Report of Death or Form 124 - Final Report of Death completed.

Known to be Alive is defined as follows:

• Does not meet deceased criteria, and
• For CT participants: at least one of the following has happened:
  • - a Form 33 in the last 18 months, or
  • - a Form 23 in the last 6 months, with Item 4-Search Result, code 1 – “participant has been located” marked.
• For OS participants: at least one of the following has happened:
  • - a Form 33 in the last 24 months, or
  • - a Form 23 in the last 12 months, with Item 4-Search Result, code 1 – “participant has been located” marked.

WHILMA automatically updates the participant’s follow-up status to “lost-to-follow-up” as long as the participant is not “no follow-up” or “absolutely no contact.” Names appear onWHIP 1591under the following circumstances:

• CT – either no Form 33 within 18 months or no Form 23 with “found” box marked within 6 months.
• OS – either no Form 33 within 24 months or no Form 23 with “found” box marked within 12 months..
• “No follow-up” participants, when they meet the CT/OS criteria for “lost” (bullets 1 and 2 above). However, to ensure that participants do not fall off of reports, follow-up status remains “no follow-up.”

Note: Participants with “no follow-up” status are only contacted/searched for annually.

Participants’ names will not appear onWHIP 1591under these circumstances:

• Form 120 – Initial Report of Death and/or Form 124 – Final Report of Death has been data entered.
• Participants with “absolutely no contact” status.

Note: The lack of Form 33 drives the definition of lost-to-follow-up. It is possible a participant has come into the clinic in the last 18 months and completed required clinic forms, excluding Form 33. By definition, this participant will be included on WHIP 1591 – Participants Who Are Lost-to-follow-up and Participants Requesting No Follow-up because outcomes data are missing. For this reason, CCs should make every effort to collect the medical information on Form 33 each time they have a routine contact with a participant.

1. Vital Status Investigation (WHIP 1591)

   The CCC began distributing a new clinic-specific report, WHIP 1591 – Participants Who Are Lost-to-follow-up and Participants Requesting No Follow-up, for main and satellite sites, in January 2000. This report lists all CT and OS participants defined as Lost-to-Follow-Up (as defined in “Definition of Vital Status” above). The report includes the participant’s ID, name, current vital status, last Form 33 received date, last Form 7- Participation Status and 23 – Search to Locate Participant information, and prior follow-up status. For each participant listed on the report, CCs are required to conduct a search to locate the participant.

   WHIP 1591 – Participants Who Are Lost-to-follow-up and Participants Requesting No Follow-up also includes participants in the CT and OS who have a current follow-up status of “no follow-up,” since Vital Status ascertainment needs to periodically occur for these women as well.

2. Conducting a search usingWHIP 1591 – Participants Who Are Lost-to-follow-up and Participants Requesting No Follow-up

   For each participant listed on the WHIP 1591, complete a search to locate the participant. The search to locate participant should include:

   • Review of the participant’s chart, including verification of phone number and retention documentation before making a contact.
   • Review of Vol. 2, Section 17 - Retention, for a comprehensive review of retention strategies.

   In general, use a six-month time period as a guideline for the search duration. For future searches, make every effort to conclude in time for the DSMB database freezes. (Notification of freeze dates are sent by the CCC.) However, do not compromise the search--if the search is on-going, do not close the search out. Continue to search until all sources are exhausted before you complete Form 23 and close out the search.

3. Document search results onForm 23 - Search to Locate Participant.

   Complete the forms based on the search results, as follows:

   1. If participant has been in contact with the clinic in the last 18 months:
      • Document the contact information on Form 23:
        • - Record the date you spoke or had contact with participant in Item 1-Initiation date;
        • - Enter the current date in Item 4 - Date Search Ended.
        • - Complete the rest of the form as appropriate.
   2. If CC is in the process of searching for a participant:
      • Document the contact information on Form 23;
      • Attach documentation of the search to the Form 23;
      • Indicate the date you began the search in Item 2 - Initiation date on Form 23 and continue searching for participant;
      • When the search is complete, record the search results and complete Items 4–6 - Date Search Ended, Search Ended By, and Search Result.
   3. If participant is located (includes a participant who is deceased):
      • Document search on Form 23 - Search to Locate Participant;
      • Complete rest of Form 23. Mark code 1 - “Participant has been located.” in Item 6 - Search Result. If participant is deceased, also complete Form 120 - Initial Report of Death and ask a proxy to complete Form 33, if possible;
      • Update Form 7 to change a participant’s follow-up status by using the “prior status” listed on WHIP 1591 unless a new follow-up status is negotiated directly with the participant.

      Note: If a participant listed on the report completes a Form 33:

      • and you have not initiated a Form 23, you are not required to complete Form 23.
      • if you have initiated a Form 23, you must complete the Form 23 and data enter it to close out the search, regardless of whether or not the participant completed a Form 33.
   4. Participant is not located:
      • Document search on Form 23;
      • Complete rest of Form 23. Mark code 4 - “The participant could not be located” in Item 6-Search Result.
4. Document changes in participant follow-up status on Form 7 - Participation Status, if appropriate.

   For any participant listed on WHIP 1591, you need to update the participant’s follow-up status on Form 7,if:

   • participant completes a Form 33, or
   • you complete a Form 23, marking code 1 – “participant has been located” in Item 6-Search Results.”

   Note: If the participant was previously on “no follow-up,” it is not necessary to change the follow-up status unless she indicates that she wants to change (i.e., resume or increase her study participation).

   For participants who appear on WHIP 1591 who have a follow-up status set to “lost-to-follow-up,” based on the criteria described in B.1 - Vital Status Investigation above:

   • When you find the participant alive (i.e., collect a Form 33 or indicate “participant has been located” on Form 23), you need to change the follow-up status from “lost-to-follow-up” to her prior status listed on WHIP 1591 unless a new follow-up status is negotiated directly with the participant. To do this, complete Form 7, indicating if the participant is on full, partial, custom, or no follow-up.
   • When you find the participant is deceased, do not update her follow-up status on Form 7. Instead complete Form 120 - Initial Notification of Death.
5. Data enter the Form 23, Form 7 and Form 33 before the DSMB database freeze dates, when possible.

“No follow-up” status is used when a CT or OS participant wants no follow-up (no CC visits, no phone and no mail contact), and retention activities have failed. Retention activities must be conducted before changing status to no follow-up. For HRT and CaD participants, WHILMA will automatically set the intervention(s) to which the woman was randomized to “stop.” If she insists on no follow-up, she must stop HRT and CaD study pills (for safety reasons), and study pills should be retrieved (see Section 17.4.4 - Retrieving Study Pills [HRT and CaD]). “No follow-up” status does not impact DM intervention status and DM dietary change participants may continue to attend DM sessions.

Only participants who verbally refuse follow-up should be classified as no follow-up. Failure to participate (i.e., consistent failure to show up for CC visits) should not be used to classify a participant as no follow-up.

Contact the no follow-up participants periodically to see if they are willing to resume contact. When a participant specifically states that she will not tolerate further contacts, change her status to “absolutely no follow-up” and do not attempt further contacts.

Partial follow-up means that the woman is not able or willing to continue one or two of: CC visits, phone and mail contact. If she is unwilling to continue CC visits, she must have retention activities. If she is unable to attend CC visits because she has moved or is seriously ill, retention activities are decided on by the CC. For a woman who has moved near another WHI CC, see Section 17.4.5 - Transfer of Participants Between Clinical Centers. If she has stopped both CC visits and phone contact and she is in the HRT and/or CaD intervention, she must stop HRT and/or CaD study pills (for safety reasons) (see Section 17.4.4 - Retrieving Study Pills [HRT and CaD]). For these women, WHILMA will set “HRT intervention” and/or “CaD intervention” to stop. Otherwise, “partial follow-up” women should be encouraged to stay on intervention. OS women who refuse the year 3 CC visit do not need to be classified as “No CC visits”. Stopping DM intervention sessions only is not included as “No CC visits.”

If a woman can no longer communicate, for example, due to stroke or dementia, she may, if willing, continue in the WHI through a proxy respondent, usually one of her personal contacts. The order of priority for selecting a proxy respondent is: 1) spouse or partner; 2) nearest relative; 3) friend; 4) physician. On Form 7 - Participation Status, indicate “proxy follow-up” and identify the proxy who will be contacted. Participants on proxy follow-up may continue on intervention if the minimum procedures are followed. (See Section 16.4.2 - Minimum Procedures Required for a CT Participant to Remain in Intervention.) Specifically, a participant on HRT or CaD study pills on proxy follow-up must have her proxy approved (see Section 16.7 - Follow-Up by Proxy). If the participant will not remain on intervention, check the appropriate “stop intervention” box(es). Also check any appropriate boxes: no CC visits, no phone calls, and/or no mailings.

Use for special circumstances, such as refusal of specific forms or procedures (e.g., blood draws). Also check any appropriate boxes: no CC visits, no phone calls, and/or no mailings.

This status is used when a participant’s location (i.e., address and/or phone number) cannot be determined and attempts to locate her over at least a six month period have failed (see Section 17.1 - Locating “Hard to Find” Participants and Form 23 - Search to Locate Participant) and she has had no contact with the CC for at least one year. Form 23 must be completed before a participant can be classified as lost to follow-up. When a participant has been classified as lost to follow-up, WHILMA will automatically change the appropriate intervention status to “stop.”

When a woman has died, complete Form 7 - Participation Status and Form 120 - Initial Notification of Death. WHILMA will automatically change the appropriate intervention status to “stop.” See Volume 8, Section 2 - Outcome Identification, Ascertainment, and Documentation for the remaining procedures.

All WHI women, even those currently classified as “no follow-up,” should be periodically contacted so that they may reconsider participation in follow-up activities. “Absolutely no follow-up” means a woman should never again be contacted about participating in follow-up activities. This classification should be reserved for women who are hostile to WHI and unlikely to change. This classification requires PI approval.

Use to indicate/resume full follow-up (mail, phone, and CC visits).

The purpose of reactivation is to:

• Resume CC visits for participants who have previously asked to have no CC visits
• Return participants to their routine follow-up schedules
• Resume some form of follow-up contact for participants who have previously elected to have no follow-up or who have been lost to follow-up
• Resume intervention for eligible participants who previously had stopped intervention (either voluntarily, because of a refusal to complete safety monitoring procedures, or because of an illness event that necessitated stopping intervention)

All randomized participants will be included in the final clinical trial data analysis (“once randomized, always analyzed”). Thus, ensuring that WHI participants stay on their intervention and continue appropriate follow-up contacts is important to maintain and detect potential effects of the intervention. Retention problems may also dilute any true difference between treatment groups. Thus, participants who change their follow-up or intervention status will be allowed, and even encouraged, to return to active participation in the study whenever feasible.

All participants who have stopped their intervention are eligible for reactivation of intervention, except those who were removed from intervention because of specific health conditions or events that necessitate stopping intervention (see Sections 5 - HRT and 7- CaD) or for whom a specific request was made by their personal physician to stop intervention (unless their physician has since allowed their return to the study).

All participants who have less than full follow-up status are eligible for reactivation of activities. Do not contact participants for reactivation if they have elected “no follow-up” until at least one year has passed since their last contact of any kind. You may reactivate these participants, however, if they initiate the process and are otherwise eligible.

When a participant changes her follow-up or intervention status, the CC staff records the reason on Form 7 - Participation Status. Use this information and any other information available from the participant’s file to determine whether it is appropriate to encourage reactivation. For future reference, mark the charts of no-contact participants indicating whether they are eligible for reactivation.

CT participants who want to reactivate and who have elected no follow-up or no intervention for one year or more must come to the CC for a visit (see Section 17.4.5.3.1 - Reactivation from No Follow-Up or Stop Intervention Status). If their change in follow-up or intervention status has been for less than one year, they may be reactivated by phone.

The reactivation visit is designed to follow the flow of regular follow-up visits, if acceptable to the participant. Complete the same forms and procedures as you would for the routine follow-up contact, if possible.

Conduct the contact that is closest to the visit target date. If the reactivation visit date is closest to the semi-annual contact target date, do a semi-annual visit (but use your judgment about whether a semi-annual mail and/or phone contact would be more acceptable to the participant). If the reactivation visit date is closest to the annual visit target date, do an annual visit.