Improving transplant readiness in kidney patients: a pilot study

Improving transplant readiness in kidney patients: a pilot study

Sandy Hinton BSN, RN, Nancy Nardelli RN, CCRC, Shelley Long, BS, Lisa Fitzgibbons, PhD, and Morley Herbert, PhD

5/8/2009 9:59:50 AM

Abstract: This study tested the hypothesis that an intensive education program would lead to better educated patients, improving their adherence to pre-transplant guidelines and treatment. These patients should have less anxiety and better outcomes compared to pre-transplant patients that receive standard care.

This pilot project was designed to provide patient-specific education for both patients on the waiting list for a kidney transplant, and for those who are not listed because of patient-driven issues. Discussion with patients prior to and during the project suggested that there is inadequate patient education about what will be a life-altering surgery.

For various reasons, the pilot study enrolled fewer patients than planned, resulting in inadequate statistical power to detect small differences in numerical measurements. The program patients did score better on coping tests, suggesting a learning process and were more active physically, even though as a group, they had higher body mass index (BMI) values. Patient satisfaction was high, with patients reporting that they considered the education program very useful.

Introduction
At many kidney transplant centers, patients on the transplant waiting list are seen annually while they await a donor. At this annual visit, the patients meet with their coordinator and physician who examine them, counsel them and answer any questions they may have. Despite this, many listed patients are really not ready psychologically for a transplant, failing to fully grasp or remember that they may be called in and then sent home without a transplant. Some seem unaware how their life will change after a transplant, that they may miss the support of their "dialysis family," have strong mood swings from medications, and the financial burden from their transplant medications.

Some patients fail to make the waitlist because of patient-driven issues, such as obesity (BMI > 35), noncompliance with treatment and medications, or risky social behaviors such as smoking or drug use. Often these patients are not given the tools to overcome these hurdles. While some change their lifestyle and get listed, many end up in a holding pattern, unable to meet the criteria for committee approval and listing.

Annual visits may not be enough contact for the patients to establish a relationship with the transplant team and to learn all they need to know. While given printed material, many patients fail to read it, may not understand it and likely do not remember it until the next year. Patients who have problems meeting criteria may not get enough encouragement to get past their personal hurdles. The purpose of pre-transplant evaluation is to identify and treat medical problems or psychosocial issues, which could adversely affect the patients post transplant outcome.

This pilot program was designed to demonstrate that an intensive pre-transplant education program could lead to empowered patients that have less anxiety and better outcomes.

The National Kidney Foundation Council of Nephrology Nurses and Technicians provided a research grant for a pilot project entitled "Improving transplant outcomes: A wellness intervention program."

Pilot Program
Goals
The primary aim of the pilot study was to examine patient participation in a 16-week wellness program and its impact on adherence to treatment. The program group attended the 16-week series of classes at the hospital, while the non-program group (controls) only received standard care. Standard care consisted of educational material from the hospital's transplant department covering aspects of transplant care (material routinely given to the patients at their annual transplant visits). For the purpose of this study, members of the control group were mailed copies of all the educational material that the transplant department routinely gives to patients.

Location
The study was carried out at Medical City Dallas Hospital, a 660-bed facility with an active kidney transplant program. In 2006 the program completed 34 kidney (nine living related and 25 cadaveric) transplants and four kidney/pancreas transplants. In 2007, the program completed 31 kidney (nine living related and 22 cadaveric) transplants and one kidney/pancreas transplant.

Preparation of the program
The program and its evaluation was a collaboration between the transplant and research departments at Medical City. A committee, consisting of transplant coordinators, research coordinators, physical therapists, a dietitian, a psychologist, and social workers met regularly to plan the curriculum. The program material was to be delivered using handouts, illustrated lectures, group activities, and personal appearances by successful patients. Ultimately a schedule of weekly classes lasting 16 weeks was drawn up.

Patient enrollment
The patients eligible to participate included those currently on the waitlist, under consideration for the waitlist, and those on hold for the waitlist due to weight/smoking/lifestyle issues. If a participant received a kidney transplant during the period covered by the course, they were allowed to continue with the classes.

The 95 patients on the transplant list were first randomized to either the program or non-program group. We also chose to add the nine patients on hold for transplant to the program group since they were most likely to receive maximum benefit from the classes. All patients received letters explaining the program and then personal telephone calls explaining the goals of the study and possible benefits, helping them decide whether to participate. Family members were welcome to attend along with the patient. With the variety of dialysis schedules, the program was scheduled for Sunday evenings.

The discussions with the potential participants revealed some interesting issues. Some patients said that they did not know they had been put on the list or that they were still on the list. This reinforced our premise that the patients require more contact than just an annual visit. Reasons for not participating included a lack of time, lack of interest, health issues, language problems, and transportation problems (despite our offer to provide free transportation).

In the program group, 23 signed the consent to participate, 15 attended the first class, and 13 completed the program. In the control group, 14 returned their signed consent and 10 completed the study.

Follow-up
At the request of the participants, plans were made to continue classes on a monthly basis after the program terminated. Subjects covered were based on their interests. Among the classes was a session on living donation, which covered the types and advantages of living donation (better genetic match, reduced chance of rejection, and restoration of kidney function immediately). A living donor who had donated a kidney to her son came to talk to the group about her experiences. Further sessions presented information on blood pressure, the definition, and causes of hypertension, how the body controls blood pressure, the kidney's role in blood pressure control, and what happens to blood pressure when the kidney fails.

Subsequently, there was a class on setting goals and sticking with them; explaining that to be successful, the goals must be SMART (specific, measurable, attainable, realistic and time limited). The group then set goals for themselves and discussed how they plan to attain and stick with them.

A final highlight was a talk by a father and son, in which the father had donated a kidney to his son. An unexpected surprise to meet and talk about the donation process was presented to the husband of one participant. He was thinking about donating a kidney but had a lot of fears and unanswered questions. Having the chance to talk to someone who had been through donating a kidney helped him make up his mind and he donated a kidney to his wife.

Test Results
Coping tests
Patients in each group filled out a coping test at the start of the program and at 12 months. Coping tests measure areas of avoidance, intrusion and hyper arousal, with lower scores representing better coping skills. As seen in Figure 1 (below), the two groups had similar scores at the start of the study but in the re-test at 12 months the program group scored better on the coping skills than the non-program group.

Exercise
The number of days the patients reported exercising and the intensity level were recorded and analyzed. While the program group reported more days of exercise (201 81) than the control group (169 107) over the 50-week interval, this did not reach statistical significance (p=0.4) because of small numbers of patients and large variances. In the intensity of exercise analysis (based on an average intensity over each week), there was a much larger percentage reporting moderate levels in the program group (46% or 23/50) versus the non-program group (16% or 8/50), p = 0.005.

Quality of life (SF-12)
This test was given at baseline, three, six and 12 months. Figure 2 (below) shows the results with the program group scoring slightly better on the mental sub-scale at all time points, including the baseline measurement. No trend over time was observed. On the physical sub-scale, the groups were equivalent with no trends observed.

Body Mass Index
BMI was calculated monthly for all patients. It averaged 31.5 7.4 for the program group, and 23.6 4.8 for the control group. The difference did not change over the study period, or from month to month.

Phosphorous and potassium levels
Based on the monthly lab values reported to the study center, we calculated the number of months when either value was above 6 mg/dL. For phosphorous, the program group averaged 3.5 2.6 months when they were above the acceptable level, and the non-program group averaged 4.1 3.8 months (p = 0.6). Control of potassium was much better for the control group, being above the limit 0.2 0.4 months and the control group 1.0 2.3 (p = 0.3).

Interdialytic weight gain
The dialysis centers reported the interdialytic weight gain weekly. Averages were taken for the first and last 10 weeks and compared. The program group averaged 3.2 1.4 kg and the control group 2.5 1.0 kg (p = 0.3) for the first 10 weeks and 3.5 1.4 kg (program) and 2.8 1.8 kg (control) for the last 10 weeks (p = 0.4). No trends were seen in week-to-week means in either group.

Patient satisfaction
As seen in Figure 3 (below) at the end of the classes, a patient satisfaction questionnaire was given to the program group. The highest satisfaction for classes was for the classes regarding diet and transplant information.

Discussion
This pilot project was set up in response to a perceived need to improve patient education for those patients on the waiting list for a kidney transplant, and for those who are unable to be listed for patient-driven issues. Discussion with patients prior to and during the project reinforced our belief that there is inadequate patient education around what will be a life-altering surgery.

For various reasons, the pilot study had to be run with fewer patients than desired and resulted in insufficient statistical power for small differences in numerical measurements. Nonetheless, the program patients did score better on the coping tests, suggesting a learning process. Overall they were more active physically, even though as a group, they had higher BMI values. Anecdotally, the patients found it to be very useful, giving the program very high scores in all areas.

Their interest led to a continuation after the scheduled classes were completed, with continuing good attendance. Feedback from the program committee and the patients has led to the hiring of a full-time dietitian to work with transplant patients. From this, the hospital has developed a Renal Education Series that includes quarterly orientation tours of the hospital, and meetings with members of the transplant team who provide information about their specific roles. Information is provided on post-op care, finances, and changes in lifestyle. The tour is given on two different days to meet the needs of the patients and their dialysis schedules.

The transplant coordinator also has reported that there is a difference between the program and control group participants when called in for transplant, with the program group and their families appearing to be better prepared, less anxious and already comfortable with the staff. As a group, the coordinator felt they participated better in their post-op care, were not overwhelmed with the new medications, and understood the financial issues.

The control group also appeared to have benefited from participation in the study. Regular contact with the research staff resulted in their being more familiar with the transplant program and an improved attitude from a feeling of belonging. The regular contacts between the hospital staff and patients in both programs seemed to have the most significant impact.

We continue to see positive results from the personal connection made between staff and patients. Relationships with chronically ill patients with ESRD continue for a lifetime, whether the patient is on dialysis or transplanted. Both the commitment and education have led to better outcomes.

Education Course Curriculm
Appendix A

Week 1 (Introduction)
The medical director of the Kidney Transplant program for MCDH welcomed the participants to the program. The purpose of the study and what was expected of the participants throughout the course of the study was introduced. Other topics included informed consent, their rights as a research participant, their right to withdraw at any time, and that withdrawing would not affect their transplant status in any way. Participants were asked to sign a release of information to contact their dialysis centers monthly for 12 months. Dialysis centers were asked about patient adherence to dialysis, the patient's interdialytic weight gain, and lab records. Monthly data was collected on each patient's serum phosphorus levels and serum potassium levels. Participant questions were answered and informed consent was obtained.

The study staff was introduced and a long-term kidney transplant patient spoke to the group about her experience. Participants then took the Quality of Life and the Coping tests, and filled out an information sheet on their history of exercise and medication adherence. Participants were given weekly logs to complete to track the duration and intensity of exercise and adherence to medication. Between the two arms of the study, 18 dialysis centers were contacted monthly for the information needed. Cooperation from the dialysis centers was excellent.

Week 2 (Dietitian)
An intensive course was provided on nutrition as it relates to kidney disease and transplant. Conducted by the dietitian working with the transplant program, it covered the topics of consuming appropriate calories, maintaining adequate protein levels, and limiting phosphorus, potassium, sodium, and fluids. An after-transplant diet (restricting calories, simple sugars, fat, and cholesterol) was also discussed, incorporating information on the side effects of transplant medications and food safety. They were given healthy tips for maintaining appropriate body weight and suggestions for maintaining food restrictions when eating out. Participants were asked to fill out a food log once a week for use in future classes as an aid to focus on the educational needs of the participants. Patients were also given a book of prepared recipes and a list of Web sites where they could find more appropriate recipes. The dietitian gave the participants her phone number and email address, inviting the participants to contact her directly with any questions or problems.

Week 3 (Psychologist)
Two classes targeted difficult behavior and were titled, "Yes, you can change." The goals were to describe why people engage in unhealthy behaviors and avoid healthy behaviors, then assess the readiness (motivation) to decrease unhealthy behaviors and identify ways to create behavior change. The pros and cons to changing, how past attempts at change influence your present attempts to change and the possibility of attempting a small change were all discussed. Participants used a work sheet to identify the behavior they wanted to change, the advantages of maintaining this behavior, the reasons why they would like to decrease this behavior, the potential obstacles in decreasing this behavior, what life would be like if they decreased the behavior, the types of triggers (situations, people, thoughts, and feelings), and the alternatives. After identifying the replacement behaviors, they discussed how likely they were to engage in the behavior, the potential pleasure from the behavior, and obstacles to engaging in the behavior. Participants were encouraged to set a goal-the change they wanted to make in the next eight weeks. They wrote down the most important reasons why they wanted to make that change, the steps and plan they would take to make the change, the ways people could help them make the change and the things that might interfere with the change.

Week 4 (Exercise Physiologist)
A discussion of the physiological benefits of exercise was presented. The class covered the five components of an exercise program--warm up, cardiovascular exercise, weight training, stretching, and cool down. They received exercise guidelines, hints to keep cool, symptoms to report, and how to manage their exercise program, including information on area mall walkers.

Week 5 (Transplant Coordinator)
This class covered all the transplant medications used, including immunosuppressive medications, antibiotics, antivirals, antifungals, ulcer prevention, and financial considerations. It incorporated information on how the medications worked, the side effects, and the importance of compliance. Other areas discussed included the number and importance of clinic and lab appointments after transplant, what to expect after transplant, and the lifestyle changes required. They were told the reason to avoid excessive sunlight and the importance of preventing infections when on immunosuppressive medications.

Week 6 (Transplant Coordinator)
This class covered the role of the immune system, identifying the four types of rejection, reviewed the relationship of immunosuppressive medications to the immune system and rejection, related definitions, and immunological testing for transplant. Definitions and explanations were presented for terms patients often hear in transplant (antigen, antibody, ABO, HLA typing, serum cross match between donor and recipient, PRA, inheriting HLA antigens, perfect match, six known antigens, humoral and cellular responses). This class lent itself to visual aids to stress the information: a cookie sheet and "cookies" shaped like people to explain who is a match; rejection is like "Pac Man," munching away at the transplanted kidney with him taking another "munch" every time a dose of medication is missed. The importance of immunosuppression and the participants' role in successful transplantation was emphasized in the class.

Week 7 (Dietitian)
This class on phosphorus was very well received. It covered the metabolism of calcium and phosphorus in the body and how calcium stores are depleted from bone when phosphorus levels are high. Presented with slides of x-rays showing the effects of calcium stores on the body, the participants commented that they "finally got it." They felt that they should have learned this earlier and wondered if it was "too late". While most transplant candidates are tired of hearing about phosphorus, the participants felt that it was the pictures that made it real for them.

Week 8 (Psychologist)
Difficult behavior Part 2. The participants continued their discussion on reaching their goal.

Week 9 (Physical Therapist)
This was a second class on fitness covering the importance of exercise to maintain your balance and range of motion as the body ages. It included demonstrations of exercises designed to accomplish this. They were given printed instructions for the exercises to help with remembering the material.

Week 10 (Psychologist)
There were two classes on stress management. Patients were guided to recognize what the top three stressors in their lives were, what their thoughts were when they stressed and what stress relievers they have tried, and why or why not they have been successful. The group helped each other see what some solutions to the stressors in their life were.

Week 11
No class.

Week 12 (Psychologist)
Stress Management Part 2.

Week 13 (Psychologist)
This class focused on positive thinking, reviewing the research literature examining the relationship between positive thinking and health outcomes. The relationship between thoughts, feelings, and behaviors was presented, with the research findings showing a "faking it until you make it" strategy for improving positive mood. The group participants were asked to generate a list of strategies and behaviors that facilitate a more positive mood, examine which of these strategies and behaviors they can increase in their daily life to improve mood and analyze potential obstacles that prevent them from engaging in behaviors that lead to a more positive mood.

Week 14 (Research Coordinator)
Participants were asked what classes they liked the best and what else they would like to learn about. They said they did not want the class to end and wanted to continue them on a monthly basis. The suggestions for future classes included having the transplant surgeon come and talk about the actual surgery, a speaker from the United Network for Organ Sharing come and explain more about the transplant list, cholesterol, blood pressure, and having more long term transplant patients come and talk. They overwhelmingly liked the phosphorus class the best but said they liked the relationships with the participants in the class and the transplant coordinator and felt so much more comfortable about the transplant process.

Week 15 (Social Worker)
The renal transplant social worker discussed the role of the social worker (Dialysis social worker versus the transplant social worker). Participants were presented information on transplant medication coverage and the role of Medicare, Medicaid, private health insurance, and Texas kidney health care in paying for transplant medications.

Week 16 (Dietitian/Graduation)
In the final class the dietitian presented information on understanding monthly labs and reviewed potassium, phosphorus, albumin, and prealbumin. This was followed by a graduation ceremony and each participant received a certificate (one participant had perfect attendance).

Author bios: The authors work for Medical City Dallas Hospital in Dallas. Grant support for this project was provided by the National Kidney Foundation's Council of Nephrology Nurses and Technicians.

Acknowledgments:
The authors wish to acknowledge the contributions of Christine Brandt RD, LD, Ryan Eason, exercise physiologist, Elizabeth Ransom, MPT, Carolyn Atkins BS, RN, CCTC, Michelle Trajan RD, LD and Lisa Pratka, LMSW to the success of the projects. Their contributions to the planning and carrying out of the program were invaluable. We also wish to thank the National Kidney Foundation's Council of Nephrology Nurses and Technicians for their financial support for this project.

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Figure 1 Coping tests
Figure 2 Quality of life (SF-12)
Figure 3 Patient satisfaction