Procedures to collect post-donation follow-up data from living donors

Outline

Executive Summary

Introduction

Methodology

Summary of Observations

Recommendations, Strategies and Suggested Activities for Maximizing Donor Follow-up

1. Program “culture” focused on safety and positive donor outcomes
2. Relationship Building
3. Systematic approach to follow-up with quality assurance reviews of efforts’ success
4. Minimizing donor burden

Executive Summary

The OPTN has required living donor programs to submit follow-up data on their donors since 2005. Until recently, the policy did not set specific requirements for what data needed to be completed on the form. That changed in February 2013 when the newly implemented policy (approved at the November 2012 board meeting) defined specific thresholds not only for data submission but for completeness.

Members of the OPTN Living Donor Committee have been developing and improving resources to help living donor programs comply with policy. During two waves of research, multiple programs with a range of living donor follow-up rates were interviewed by committee members. The results of those interviews together with the results of interviews with UNOS living donor auditors yielded the recommendations you’ll find in this recently updated guidance document.

Four categories of best practice factors emerged from the research. Although the strategies vary, all high-performing programs developed and implemented core activities that reflect all four of the following concepts:

• Conviction that follow-up is essential for donor safety and well-being

• Importance of building and maintaining a relationship with each donor

• Use of a systematic approach to follow-up, with ongoing quality assurance activities

• Use of strategies to minimize burden to donors

This document provides strategies and suggestions on how your program can improve care of and collect data from living donors. You will also find information on how the policy has changed, background material, and information on the methodology the committee used to conduct its research.

Introduction

In November 2009, the OPTN Board of Directors charged the Living Donor (LD) Committee with developing and disseminating a resource outlining best practices for the collection and submission of living donor follow-up data. To this end, the LD Committee developed a non-exhaustive set of recommendations to assist transplant programs to improve their protocols for maintaining contact with donors and for the collection and timely submission of accurate and complete Living Donor Follow-up (LDF) data. With the passage of new policy in November 2012 that specifies the minimum percentages of kidney donors for whom living donor transplant programs must report follow-up information, the OPTN Board of Directors requested that the LD Committee revise and update its recommendations in order to further assist transplant programs. The revised and expanded recommendations described herein derive from the LD Committee’s review of actual practices described by programs with high rates of LDF and by programs with lower rates of LDF data collection, as described further below.

Follow-up of living kidney and liver donors is crucial for understanding and minimizing the risks that donors face. Since 2005, OPTN policy has required transplant programs to submit LDF forms on their donors at discharge (or 6 weeks post-donation, whichever is earlier), 6 months, 1 year, and 2 years after donation. Compliance with this data submission policy has been high, i.e., programs submit the LDF forms. However, the forms are often submitted with missing or incomplete data. Living donors may be lost to follow-up or transplant programs may have obtained only partial data on donors at the time of LDF form submission. Under policy 12.8.3, approved in November 2012, living donor kidney transplant programs will be required to meet minimum thresholds for the percentages of donors on whom they submit data at each of the follow-up time points. These thresholds went into effect for kidney donors who donate on February 1, 2013 or later, and the thresholds rise over time, as follows:

 Programs must report LDF data on donor status (alive/deceased) and clinical information on LDF forms for at least:

• 60% of their living kidney donors who donate between February 1, 2013 and December 31, 2013
• 70% of donors who donate between January 1, 2014 and December 31, 2014
• 80% of donors who donate after December 31, 2014

 Programs must report LDF data on donor laboratory data (serum creatinine, urinary protein excretion) on LDF forms for at least:

• 50% of their living kidney donors who donate between February 1, 2013 and December 31, 2013
• 60% of donors who donate between January 1, 2014 and December 31, 2014
• 70% of donors who donate after December 31, 2014

Because many transplant programs have reported rates of complete data on LDF forms that are well below these thresholds for living kidney donors, the LD Committee sought to develop recommendations to assist programs in attaining higher rates of successful follow-up with their living donors.   In addition, because thresholds for the reporting of data from living liver donors may eventually be included in OPTN policy as well, the LD Committee also aimed to develop recommendations that could be helpful to living donor liver programs.

This resource does not specify official policy for clinical practice with respect to the follow-up medical care of living donors and it is not intended to be prescriptive or define a standard of care. It does not carry any monitoring or enforcement implications associated with any OPTN or UNOS policy. It will not be used to determine member compliance with any policy or bylaw. Rather, this resource is intended for transplant programs’ voluntary use. Ideally, it should lead to review, discussion, and the generation of ideas within individual transplant programs as to how best to develop or further tailor their own strategies to promote optimal follow-up of living donors. Transplant programs should consider the recommendations below as suggestions, and consider the extent to which each suggestion may or may not be applicable or feasible given their own institutional setting and operational constraints.

Living donor transplant programs can use this resource as a “toolbox” when developing or modifying protocols for follow-up with their living donors. The toolbox may be useful for LDF data collection specifically as well as for general issues of maintaining contact with donors after donation.

Methodology for generating recommendations

Recommendations were generated based on two waves of data collection, conducted in Fall 2010 – Winter 2011 (Wave 1) and in Fall 2012 – Winter 2013 (Wave 2). Each wave of data collection involved one interview with UNOS transplant program auditors in order to learn about auditors’ observations of factors contributing to programs’ ability to maintain contact with donors and obtain LDF data. The auditors were interviewed as a group and they were asked not to identify specific programs but instead to focus on their general observations. At the time of Wave 1 data collection, UNOS auditors had completed audits with a total of 10 living donor transplant programs. By Wave 2, they had completed audits with a total of 50 programs.

Each wave of data collection also involved interviews with individual transplant programs. For Wave 1, LD Committee members, working the OPTN and UNOS staff, identified and interviewed representatives from transplant programs that had been identified as having high rates of successful follow-up with their living donors. Specifically, LD members interviewed programs that were not only compliant in submitting LDF forms but had rates of complete LDF information on 1 year post-donation donor status (alive/deceased) and 1 year post-donation donor lab values (creatinine for kidney donors, bilirubin for liver donors) in greater than 80% of their donors. A total of 8 transplant programs (6 living kidney donor programs, 2 living liver donor programs) were interviewed. They were selected in order to include both smaller and larger programs (ranging from 5-10 donors per year to 100 per year), and both urban and non-urban programs.

For Wave 2, LD Committee members focused on rates of follow-up at 2 years post-donation because programs are required to follow donors until that time point and it could be more difficult to achieve 2 year follow-up data collection than data collection during the first year. Committee members decided that they should talk not only with representatives of programs with high rates of follow-up but with representatives from programs with lower rates of living donor follow-up. This was important because it would allow the Committee to assess whether practices utilized by high-performing programs truly were linked to successful follow-up or whether some practices were as likely to be used by lower-performing programs and thus were not sufficient to promote high rates of LDF. Thus, the Committee sought to identify programs that were already meeting the new OPTN policy thresholds (i.e., reporting of 2-year post-donation LDF data for donor status on 80% of their donors and reporting of data on laboratory values on 70% of their donors), as well as programs which fell well below these thresholds by reporting status and laboratory data on less than 25% of their donors. A total of 8 high-performing programs (6 living kidney donor programs, 2 living liver donor programs) and 6 lower-performing programs (3 living kidney donor programs, 3 living liver donor programs) were selected. Although LD Committee members knew which programs fell into the high-performing and lower-performing groups, OPTN and UNOS staff did not provide specific rate information to LD Committee members and the specific rate information was not the subject of investigation, as noted below. As in Wave 1, programs were selected to represent a range of program sizes, and programs that were urban vs. not. The Committee sought to include programs varying in these characteristics within both the set of high-performing programs and the lower-performing programs.

For each program assessed in Wave 1 and Wave 2, a single telephone interview was conducted (one call per program). LD Committee members, led by Mary Amanda Dew, Ph.D., conducted the interviews. Committee members who were themselves living donors participated on the telephone calls. One to four individuals from each program (designated by their program directors and administrators as having the greatest knowledge of the follow-up procedures in use by their programs) participated together on the telephone calls. During these open-ended, qualitative interviews, respondents were asked to assist the LD Committee to learn more about procedures used and barriers faced in following living donors. Specifically, respondents were asked to describe the procedures used by the programs for following living donors, what strategies appeared to be most effective, what strategies they had found not to be effective, what barriers and challenges were faced in following living donors, which personnel recorded and submitted data to the OPTN, and any quality assurance or quality improvement activities undertaken with regard to living donor follow-up. Information collected during the interviews was, in many cases, separately corroborated by program directors and/or administrators via email correspondence.

The decision to interview representatives from 8 programs in Wave 1 and 14 programs in Wave 2 (rather than conducting interviews with a smaller or greater number of programs) was based on key principles of qualitative methodology. Namely, an iterative approach was employed such that interviews continued until “saturation” was reached, i.e., no new themes, major follow-up strategies, or barriers to follow-up were described by programs that had not been discussed in earlier interviews.

Summary of Observations About Program Practices

Four categories of “best practice” factors emerged. Thus, although the specific strategies utilized by any given program vary, all high-performing programs had developed and implemented core activities that reflect all four of these "best practice" components:

1. Conviction that follow-up is essential for donor safety and well-being
2. Importance of building and maintaining a relationship with each donor
3. Use of a systematic approach to follow-up, with ongoing quality assurance activities
4. Use of strategies to minimize burden to donors

In the remainder of this document, we list recommendations regarding strategies useful within each of these four components. No single high-performing program employed all of the strategies described. However, they each employed multiple strategies within each of the four components, and they employed a greater total number of strategies within each component than did lower-performing programs. Conversely, lower-performing programs did not simultaneously utilize all four components and, for any component utilized, they employed fewer strategies within it.

In addition, from interviewing both high-performing and lower-performing programs, it became apparent that some of the four components were necessary but not sufficient for ensuring high follow-up, while other components—if absent—greatly reduced the likelihood that high follow-up could be achieved. Thus, the majority of all programs (regardless of rates of follow-up) had sought to develop protocols for follow-up, had attempted to apply the protocols systematically, and had incorporated some strategies for quality assurance. Most programs had also attempted to incorporate at least some strategies to minimize burden for donors, including principally some cost coverage for required follow-up (coverage of lab costs, for example). High-performing programs, however, were more likely to have more extensive quality assurance activities, and they often provided a greater degree of cost coverage to minimize donor burden. But the presence of systematic approaches and strategies to minimize donor burden were not sufficient, because some (but not all) lower performing programs also incorporated some of these features, yet failed to have adequate follow-up. Instead, high-performing programs consistently stood out because they both incorporated these features and uniformly included (a) a major emphasis from program leadership on the value of donor follow-up for monitoring donor safety and well-being, and (b) heightened attention to establishing and maintaining a relationship with each donor. These programs instilled the expectation and need for post-donation follow-up as part of their relationship with the donor and their clinical obligation to the donor.   The expectation for follow-up was framed as important for donors’ well-being rather than described primarily as a program obligation for compliance with national regulations or policy.

With respect to the relationship with the donor, one element that was distinctly prominent among high-performing programs was continuity in terms of contacts: high-performing programs most often utilized a model in which at least one clinician—usually a living donor coordinator—was a consistent point of contact for the donor from the donor’s first interactions with the program through post-donation follow-up. This clinician was involved in the donor’s initial education and evaluation, and then continued to follow the donor post-donation. This clinician either collected the LDF data, or directly oversaw the collection of data by another staff member. This continuity in staffing was an approach that was successfully applied by both smaller and larger programs, i.e., a small program might have only one coordinator, but the large programs that used this model also allowed each individual coordinator to follow his/her set of donors from pre-donation through post-donation. In contrast, less successful approaches to LDF data collection included the use of data personnel (who had no previous connection to the donor) to approach donors for LDF data collection, or the assignment of post-donation clinical personnel with no previous connection to the donor to this task of follow-up.

In sum, the recommendations listed below are based on strategies used by high-performing programs to maintain contact and collect complete and accurate follow-up data from donors. Although no single program employed all of the strategies described, high-performing programs stood out in (1) utilizing multiple strategies in all four of component areas listed below and (2) placing a particularly heavy emphasis on the components related to the idea that donor follow-up was essential for clinical care and related to the key value of forming and maintaining the relationship with each donor. No recommendations are listed unless they were actually employed in one or more high-performing programs.

Recommendations for maximizing donor follow-up

1. Program “culture” focused on safety and positive donor outcomes

Develop and promote a program “culture” or philosophy that (a) emphasizes the importance of donor follow-up in order to ensure donor safety and well-being, and (b) includes the belief that high rates of donor follow-up can be achieved. View donor follow-up as critical for monitoring donor outcomes and well-being, as well as for providing information to future donors on any risks and health consequences of donation. If an increase in program volume/size is an aim, work to actively promote positive donor outcomes so that growth can occur in an atmosphere of safety. The strategies used by high-performing programs that reflected these elements of program philosophy are shown in Recommendation 1.

Strategies embodying a program culture focused on donor safety and well-being

Strategy: Focus on the donor as the patient, separate from the transplant recipient.

Suggested Activities

• If you typically see donors in clinic for LDF data collection and clinical evaluation, consider establishing a dedicated post-donation clinic to see donors after surgery and obtain follow-up information. Separate this activity from recipient follow-up in order to reflect a program philosophy focused on the donor.
• Maintain living donor policy and protocols separately from your general transplant program policies. This separation allows for more complete consideration of issues specific to donors.

Strategy: Develop strong staff commitment to donor follow-up and accountability for collecting complete follow-up data.

Suggested Activities

• Show that expectations regarding complete and accurate follow-up data come from the top down: the program directors and administrators expect both staff and donors to have a strong commitment to follow-up.

Strategy: Involve clinical staff in donor follow-up.

Suggested Activities

• Have clinical staff collect LDF data or oversee nonclinical staff who collect or submit LDF data. This shows that donor follow-up is not only for data collection but for the care of the donor. It also increases the likelihood that information about donor well-being is transmitted to the appropriate clinical staff for any necessary additional follow-up (see also Section 2 [Relationship building] for further strategies related to the value of clinical staff involvement in follow-up).

Strategy: Strive for high follow-up rates: establish specific follow-up target levels. It is not unrealistic to set your target at an even higher percentage of complete donor follow-up than OPTN policy requires. Seek institutional support and understanding of the rationale for follow-up and the need to achieve target levels.

Suggested Activities

• Consider whether it is possible to dedicate certain staff members to providing follow-up care and completing donor LDF forms; these staff members would have little to no responsibility for following or completing forms on transplant recipients.
• When your program’s expectations for complete donor follow-up rates are not met, review and consider revisions to program procedures in order to increase follow-up rates (see Section 3[Systematic approach] for additional details).
• Consider having a program requirement that, if any donor is to be listed as “lost to follow-up on the LDF forms, this entry must be approved by the program coordinator, administrator, or another responsible party (indicating that all options for locating the donor have been exhausted) before the LDF forms are submitted.
• Seek institutional support for achieving targeted follow-up rates. Inclusion of members of the donor program’s medical center administration in Exit Sessions conducted by UNOS auditors at the conclusion of their review of program activities may help institutional officials to understand OPTN requirements for follow-up and better appreciate the resources needed by your program to accomplish the requirements. Cite the “best practices” that have been found effective in high-performing programs in the U.S. in order to justify your requests to institutional officials.

Strategy: Work to ensure that donors understand the need for follow-up and make a commitment to it.

Suggested Activities

• Inform your prospective donors from the very first contact you have with them that follow-up is critically important, and specify the required post-donation follow-up time points. The living donor coordinator should provide this information and it should be reinforced by the other health care professionals that prospective donors see during the course of the education and evaluation process (e.g., surgeon, nephrologist/hepatologist, social worker, independent donor advocate).
• Emphasize to donors that follow-up is not only valuable to them personally, but will also help future donors to understand the potential consequences of donation. Structure donor education to address both donor-specific value and value for the future of donation.
• Emphasize to donors that follow-up is a clinical care activity and not simply a data collection activity. Explain that the follow-up information collected will be important for monitoring their well-being, and that this is a clinical goal of your program. Reiterate the message before and after donation, “we care about you; your health is important to us.”
• Use multiple formats (oral, visual, written) to present information about the follow-up time points and what information will be obtained at each. List the follow-up time points in the informed consent form signed before donation. Remind the donor (both orally and in writing) of the follow-up time points before hospital discharge post surgery.
• In order to increase donors’ own commitment to a healthy lifestyle post-donation, ask donors to acknowledge verbally and in writing that they understand why follow-up is important and what responsibility they have (if any) for costs associated with follow-up evaluation or care. (As noted in Section 4 [Minimizing donor burden], consider whether the program will cover some or all follow-up costs.)
• Ask prospective donors to acknowledge and sign a care plan which includes the name of the PCP who will provide long-term care after donation and acknowledges that they understand the importance of obtaining regular health maintenance care from a PCP. Obtain these signed documents separately from the signed informed consent form and view them as part of the donor education process.
• Ask prospective donors to have a standard physical examination from their PCP close to the time of donors’ pre-donation evaluation. One purpose of this request is to ensure that donors have established a relationship with a PCP so that post-donation follow-up care is more likely.

Strategy: Develop a process to educate the donor’s PCP on the following: the risks of living donation risks, the need for follow-up, time points for required follow-up data collection, recommended tests at follow-up visits, and how often continued follow-up beyond two years is advised. Establish open lines of communication.

Suggested Activities

• After the surgery, send a discharge summary to the donor’s PCP (with the donor’s permission) along with a letter that explains donor needs for long-term health maintenance.
• If the donor will be visiting the PCP rather than the program for any of the LDF data collection during the first two years post-donation, send a letter before each PCP visit (with the donor’s permission) delineating exactly what data will need to be collected and why.
• Inform the donor’s PCP of the results of any additional tests or procedures your program undertakes.

Strategy: Collect donor follow-up data not only in order to comply with OPTN data submission requirements but also to monitor donor health and inform the donor’s regular health care provider.

Suggested Activities

• Establish procedures to review of any abnormal or anomalous findings you obtain during LDF data collection and procedures to obtain additional tests and procedures as needed.
• After a given follow-up assessment, inform donors (by telephone, letter, or email) about the outcomes of any standard tests or additional tests/procedures you recommend.
• During each follow-up contact, let the donor know that they can call the program with their questions and concerns at any time, and not just during the times of scheduled follow-up.

Strategy: Beyond what is required by policy, consider whether your program wants to collect additional donor outcomes data either during the first two years post-donation and/or beyond the first two years.

Suggested Activities

• Decide whether the collection of addition outcomes data would address your program priorities or interests (with approvals of Quality Improvement or Institutional Review Boards as appropriate), or whether collecting such data would reflect a programmatic view that donor follow-up should be for life.
• Consider whether to participate in other local or national work focused on donor outcome issues. Examples of donor outcomes data collection and clinical activities (beyond the data required for LDF forms) include:
  • The administration of surveys designed by program staff to assess donors’ quality of life and general well-being. You could continue administer such surveys beyond 2 years post-donation.
  • The continued annual collection of laboratory and other clinical data values to monitor organ function and donor health beyond 2 years post-donation.
  • Participation in national initiatives to survey donor well-being.

2. Relationship Building

Use a variety of “relationship building” strategies to establish a connection with the donor before donation and to maintain contact with donors post-donation. This will foster not only high rates of clinical follow-up but high rates of collection of required LDF information. Consider employing one or more of the strategies delineated in Table 2 for these purposes.

Strategies for building and maintaining a relationship with donors

Strategy: Utilize staff members dedicated to specific activities with donors.

Suggested Activities

• Utilize a dedicated living donor coordinator or other clinician (e.g., a social worker) who talks with the prospective donor when they first contact the program, sees them during the evaluation process, and who continues to maintain contact with them, including seeing them for post-donation clinic visits. This continuity in the relationship is one of the factors most consistently related to achieving high rates of follow-up.
• If it is not possible for the same donor coordinator (or other dedicated clinician) to follow donors both before and after donation, assign a single post-donation donor coordinator to consistently contact and collect LDF data so that a steady relationship is formed. Ensure that this person meets the donor before the donor is discharged from the hospital after surgery.
• Have the donor coordinator (or other dedicated clinician) serve as the point of contact for all post-donation clinical and follow-up visit scheduling issues. The coordinator/clinician may see the donor for face-to-face follow-up visits at the medical center or contact the donor and the donor’s PCP if the PCP will be collecting the follow-up data.

Strategy: Structure follow-up contacts in order to facilitate continued ability to connect with donors in the future.

Suggested activities

• If your program sees both donors and recipients at the same clinic, schedule donor follow-up visits to coincide with recipient follow-up visits (in situations where donors and recipients know each other). This can build on the relationship between these individuals, and it emphasizes the need to consider each person’s health and well-being.
• Use the LDF data collection clinic visit or any telephone contact not only as an opportunity to obtain the required follow-up information (or arrange for it to be collected) but to further build a relationship with the donor. Use the contact as an opportunity to ask the donor general questions about his/her health and well-being in order to identify any issues or concerns that you may need to address, as well as to solicit comments about aspects of the donation process that might be improved. Provide referrals as needed.
• Utilize a dedicated clinician rather than a non-clinician (e.g., data manager or clerk) to obtain or record follow-up data. Non-clinicians
  • (a) are unlikely to have had any prior relationship with the donor,
  • (b) would not be able to advise the donor regarding any questions that might arise about the follow-up information collected,
  • (c) would not necessarily recognize test values that were abnormal or likely to be in error, and
  • (d) would not be able to respond to questions by donors about their general health, well-being, and concerns. Each of these elements could affect the donor’s willingness to engage in further follow-up with the program. Use of a non-clinician to collect follow-up data may also give donors the impression that they have been “handed-off” by the program now that their donation has taken place.

Strategy: Work actively to build and maintain relationships with donors’ PCPs.

Suggested Activities

• Begin building relationships with PCPs before donation, through an initial contact with follow-up as needed. Fostering this relationship helps to ensure that the PCPs understand the kind of follow-up that donors need and that PCPs (if they are involved in collecting any required follow-up data) understand why the information is required for donor care.
• Give the PCP contact information for your program members in case the PCP has questions about clinical or lab results.

3. Systematic approach to follow-up with quality assurance reviews of efforts’ success

Develop and periodically reassess the effectiveness of a systematic, methodical approach to donor follow-up that incorporates quality assurance and improvement strategies in order to strive for 100% ascertainment of LDF data. Relevant strategies are listed in Recommendation 3. No single approach is necessarily best; the most important principle is to develop procedures that can be followed reliably. It is likely that modifications will be needed over time as programs and/or the patient populations they serve change.

Strategies for systematic follow-up with monitoring of efforts

Strategy: Be clear within the program, and clearly communicate with donors regarding the program’s preferences for the collection of LDF data and donor clinical care.

Suggested Activities

• Consider the following options in light of the program’s overall philosophy for care of donors post-donation: (a) a program preference for the donor to return to the program for face-to-face visits for every LDF time point, (b) a program preference for donors to be followed by their PCPs, (c) a decision to leave the location of follow-up to donor preferences. Clarification of program preferences can guide the implementation of strategies to ensure that LDF time points are not missed.

Strategy: Develop specific plans for collecting LDF data based on the preferences delineated above.

Suggested Activities

• If the goal is for donors to return to the program for some or all visits, develop strategies to maximize the chances that visits will be completed by, for example, scheduling initial visits at the time of hospital discharge post-surgery. At the time of each visit, confirm and/or schedule the next visit. Consider developing a laminated card for the donor’s wallet that lists all visits and their purpose (including lab data to be collected) for the 2 years of follow-up; give the donor this card at the time of hospital discharge.
• If the goal is for donors to be seen for some or all visits beyond the post-surgical check-up by their PCP, make sure that the PCP receives information at the time of the donor’s hospital discharge regarding the required visit schedule, and what information is to be collected and forwarded to the program. (see also Section 1 [Program culture] above).
• If the goal is to support donor preferences for location of follow-up care, coordinate with the donor well ahead of each visit time point regarding whether the donor will return to the program or see their PCP.
• Before donation, discuss with the donor whether and which follow-up donation-related care costs will be covered by the program and for how long post-donation the costs will be covered (see also Section 4 [Minimizing donor burden] below).

Strategy: Develop a range of strategies for maintaining contact, finding and re-contacting donors for routine reminders or other purposes.

Suggested Activities

• Use not only regular mail and telephone contacts, but emails and texts to communicate with donors. Consider emailing orders for lab work or other required tests, with pdf attachments.
• If your program’s medical center allows it, consider calling donors with a cell phone rather than the medical center’s main line because
  • (a) the main line sometimes does not appear on the donor’s phone leading some donors not to answer, and
  • (b) donors who see that there is an incoming call from the medical center may be apprehensive or skeptical about why the center would need to call.
• Use internet search strategies to locate difficult-to-find donors.
• Do not prematurely conclude that a donor cannot be reached. Donors may be out of town or unavailable for extended periods of weeks or more.
• Develop plans for repeated attempts at contact that span at least one month and potentially several months before concluding that donors will not respond. Attempt contact on evenings, weekends, or other times that busy, employed donors may be available.
• Ask the donor before hospital discharge whether there is a family member or close friend who could be contacted in order to locate the donor in the event that donor contact information becomes outdated. Communicate with donors through regular mail, telephone, email and texts.
• Ensure at hospital discharge that the donor has correct contact information for program staff responsible for follow-up care and/or available to address donor concerns and questions. Ask the donor to let them know should the donor’s contact information change.
• Send email reminders before the donor’s scheduled follow-up appointments with either the program or the donor’s PCP, and/or send reminders that the program will be calling the donor to schedule appointments (or ensure the donor schedules them him/herself).
• If the donor misses an appointment unexpectedly, try to reach the donor within 24 hours to reschedule the appointment. This demonstrates your program’s commitment to the donor and the importance of the appointment.
• Routinely review and update contact information from donors each time they are successfully contacted post-donation, including telephone numbers, email addresses, and alternative contact information (e.g., another family member).

Strategy: Develop a tracking and reminder system for follow-up data collection activities.

Suggested Activities

• Use electronic reminders to alert the donor coordinator (or other dedicated clinician) about which donors will need LDF data collected in the near future. Program data management personnel may provide these automated reminders, or the donor coordinator may use electronic resources such as an Outlook calendar or a dashboard available through the electronic medical records system used by the program.
• Use electronic reminders about what LDF forms are due for submission.
• Use electronic reminders to indicate which donors have completed their follow-up visits and now need to be contacted with routine feedback about visit results (e.g., indicating that they are doing well, or indicating that they need additional tests or procedures).
• Use similar electronic reminders to indicate which donors require re-contact to determine whether they completed any ordered tests or procedures.
• Create and maintain an electronic spreadsheet with a complete summary of which donors are due for what types of contact/re-contact or for the completion of follow-up visits or other assessments.
• Designate a day and time of the week or month (depending on program size) to review the complete list of which donors need to be contacted about scheduling, rescheduling, or reminders of follow-up data collection appointments.

Strategy: Develop a system for recording medical information collected during follow-up care and for completing LDF forms.

Suggested Activities

• Design an assessment guide or tool to use to ensure that all required LDF form elements are assessed during a given follow-up visit. Use this tool at clinic visits held by the program or mail it to the PCP before the donor’s scheduled follow-up visits. Consider mailing it directly to the donor as well. Retain it as a source document and enter the information into the donor’s medical chart/electronic medical record by scanning it or dictating a progress note based on it. A progress note template, also containing all of the required LDF elements, may be developed to facilitate note-writing.
• Require that the individual who sees the donor for follow-up or who obtains the follow-up information from the PCP records the information directly into the donor’s medical record, thus providing permanent documentation (as opposed to entering the data only onto LDF forms with no permanent documentation).
• Develop specific procedures to record follow-up information on the LDF forms for required submissions. Decide whether the individual responsible for the collection of follow-up information will also record the information on the forms, or whether a data manager or clerk would extract the information from the medical record.
• If a data manager or clerk extracts information for the LDF forms from the medical record, develop a protocol to train this individual in how to identify the correct data and what steps to take regarding values that appear unusual or out of range. For example, consider whether some or all completed LDF forms require review by the donor coordinator before submission. Scanning a completed template or form (as described above) with LDF elements clearly marked, or using a progress note template to record collected LDF elements in the medical record can help to simplify the data manager’s or clerk’s task of locating the correct follow-up information to be reported.
• Avoid utilizing a system in which a data manager or clerk extracts the LDF information and records it on the forms with no supervision and clinical review by a donor coordinator/clinician dedicated to the collection of follow-up information.

Strategy: Design and implement a protocol for quality assurance/quality improvement (QA/QI) for follow-up visit data and LDF form completion.

Suggested Activities

• Develop a plan for the regular review of a sample of submitted LDF forms, and compare them with donor medical record and other source documents in order to identify discrepancies. Decide how often the reviews should occur (e.g., monthly, quarterly).
• Monitor the extent of missing data on submitted forms and develop a plan to reduce missing data rates.
• Ensure that the individual conducting the QA review is trained in required procedures and can identify unusual or out-of-range data values.
• Develop a plan for regularly reporting results of QA monitoring at program-wide meetings that include program leadership and clinical and data-related staff.
• Investigate whether there is institutional support and resources for conducting QA/QI work.
• Encourage program staff to develop QI initiatives focused on donor outcomes and donor satisfaction. Use results to modify program activities and donor care and follow-up strategies.
• Develop a QA “scorecard” with metrics to monitor program success, including LDF data collection rates. Work toward achieving specific scorecard targets and include scorecard information when reporting on program achievements to hospital senior management.

4. Minimizing donor burden

Develop and implement multiple strategies to minimize any financial or logistical burden to donors related to the collection of follow-up data. Use of strategies such as those listed in Table 4 also gives clear recognition to the donor of their value and of the importance the program places on providing care to them.

Strategies to minimize donor burden for follow-up

Strategy: Develop systematic plans for how LDF data will be collected from donors who cannot or will not return to the program for follow-up (see Section 3 [Systematic approach] above for additional details).

Suggested Activities

• Consider the geographic distribution of donors who cannot or will not to return to the program for follow-up in order to decide whether it would be possible to see donors at satellite clinics connected to the main medical center (e.g., if large proportions of donors reside beyond the main center but near to other locations already served by the health center).
• If the program views PCP follow-up as a more appropriate and less burdensome option than returning to the program for LDF data collection and clinical care (e.g., due to a decision that this approach best fosters continuity of long-term care for the donor), develop a systematic plan for alerting the PCP about what information is needed, and coordinate with the PCP regarding the communication process for reporting clinical and laboratory findings to the program.

Strategy: Consider what steps to adopt to minimize donor burden so that they mesh well with other program decisions about donor requirements.

Suggested Activities

• If the program does not require donors to have their own health insurance but then prefers that donors visit their own PCP for follow-up, donors without insurance may be unable or unwilling to complete PCP visits unless cost coverage from the program is provided for these visits. Consider covering PCP visit costs under these circumstances or instead provide cost coverage to facilitate donors returning to the program for follow-up.
• If donors are expected to return to the program for follow-up, do not expect donors to schedule their follow-up appointments as the follow-up time points approach. Schedule their appointments at the time of hospital discharge after donation surgery and work with them proactively to remind them of appointments and reschedule appointments as needed (see also Section 3 [Systematic approach to follow-up] above).
• Extend donor follow-up clinic hours to weekends to accommodate donors who cannot or will not take time off from work.

Strategy: Consider having the program cover some or all of the dollar costs of required follow-up data collection during the first 2 years post-donation (e.g., costs of medical evaluation at follow-up time points; costs of lab work).

Suggested Activities

• Consider whether cost coverage is possible for follow-up clinic visits completed by program personnel and/or whether cost coverage could extend to PCP visits devoted to follow-up data collection.
• Consider whether cost coverage can be provided for any care required in the event that abnormal findings related to the living donation emerge during follow-up clinic or PCP visits.
• Consider whether cost coverage could be extended to any medications related to living donation prescribed at discharge.
• If cost coverage will be provided for donation-related required lab tests, arrange for bills for lab work to be sent directly to the program, or consider contracting with a national or state-wide facility in advance. Under this approach, requisitions may be sent directly from the program to the lab via email or secure web portals and, after a donor has had the required tests, the results are sent automatically to the program.
• If cost coverage will be provided for follow-up visits conducted by a PCP, notify the donor’s PCP about what is billable and how to bill the program.

Strategy: Develop plans to minimize donor burden in the event that donor circumstances change or if program priorities extend to LDF past the 2 years required by OPTN.

Suggested Activities

• If donors develop financial problems post-donation (including the loss of health insurance or inability to afford copayments), work with them to identify sources of coverage for costs of donor follow-up or consider whether the program can cover the costs.
• Consider whether cost coverage for lab tests or other continued follow-up needs could be extended past the first 2 years of follow-up, and how long the program would cover the costs.
• Provide the donor with access to a financial coordinator both before and after donation who can assist with locating insurance coverage or address financial hardships during follow-up. Emphasize that the goal is to facilitate appropriate care for the donor both before and in the long-term after donation.

In conclusion, the strategies offered in this guidance document represent approaches that high-performing programs have found to contribute to their ability to provide clinical care and collected required follow-up data from their living donors. There may be additional useful strategies that programs use that were not identified through the interviews conducted by the LD Committee. The strategies listed may also be useful to spur thinking about additional approaches that could be tried in order to increase a given program’s success in following and caring for its donors.

The LD Committee thanks the representatives of programs who were interviewed and who graciously discussed their programs’ practices. The Committee welcomes feedback on this guidance document and steps that could be taken in the future to provide additional assistance to living donor transplant programs in their follow-up activities.