Two new NIH-funded studies opened at CHOP in 2012. These studies will test novel ways of supporting teenagers who have received solid organ transplants. Both examine potential solutions to a critical problem: the high number of adolescents who don’t take anti-rejection medications as prescribed (called non-adherence), which puts this age group at increased risk for losing function of their transplanted organ.
- TAKE-IT: Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial: A multicenter study called TAKE-IT aims to answer two questions. First, whether simple, practical interventions can improve adherence among adolescent kidney transplant recipients ages 11-19; and second, which factors within the healthcare system are associated with adherence. Susan Furth, MD, MHS is the principal investigator for the CHOP Division of Nephrology contribution to TAKE-IT. Six other centers in the U.S. and Canada will also participate.
- Peers4PATH: Peers for Promoting Adolescent Transplant Health: Peers4PATH will examine how peer mentoring changes rates of adherence and improves quality of life for adolescent transplant recipients ages 14-22. The study will show whether support from another young adult with a chronic illness results in better adherence rates for teens than traditional support from parents and doctors. Sandra Amaral, MD, PhD is the principal investigator for Peers4PATH.
Non-adherence by the numbers
To stay healthy after transplant surgery, organ recipients must adhere to a treatment program that’s been designed specifically for them. Post-transplant treatment requires a combination of immunosuppressants and steroids that must be taken at specific times throughout the day. Immunosuppressants prevent organ rejection. So to ignore the treatment plan is to put the new organ and the life of the transplant recipient at extreme risk.
Adolescent rates of non-adherence are twice as high as younger transplant recipients, and almost 60 percent higher than adults between 24 and 44 years old. Adolescents are also 1.6 to 2.6 times more likely than younger or older recipients to have graft failure. And the frightening reality is that the mortality rate for transplant recipients who lose function of their donated organ is 4.4 times higher than the rate among pediatric recipients who are able to maintain it.
In addition to the medical and quality of life costs associated with non-adherence, studies show there are also substantial economic costs. The median annual cost per patient with graft function is estimated at $8,550, compared with $50,938 following graft failure. Another study estimates that persistent poor adherence is associated with a $12,840 increase in a patient’s 3-year medical costs.
Defining non-adherence can be difficult. No tolerable level of non-adherence has been identified, largely due to the fact that every patient has a different tolerance for missing medications and a different post-transplant treatment plan. For these reasons, adherence is measured on a continuous scale, and patients are not generally categorized as adherent or non-adherent.
Barriers to adherence for teens with transplants
Studies have shown that there are educational, organizational and behavioral barriers to adolescent adherence, each of which will be targeted by the interventions examined in the TAKE-IT and Peers4PATH studies. Specific barriers to adolescent non-adherence include:
- Forgetfulness and distraction
- Poor planning, organization or scheduling
- Difficulty swallowing pills
- Voluntary resistance (trying to be more like everyone else)
Research also suggests that the changes in the immune system that happen during puberty mean adolescents may be inherently at higher risk for graft failure. This makes following the post-transplant treatment plan even more critical for this age group.
About the transplant adherence studies
TAKE-IT will examine two different methods for improving adolescent adherence rates:
- MedMinder. This electronic pill box and medication monitoring system is just a few years old and not widely used. Not only does it serve as an automated reminder to take medications on time and as prescribed, Medminder also has the ability to record whether or not the patient opened the pill box. Medminder notifies the patient (and parent) of a missed dose with a flashing light, alarm sound, text, email or call based on patient preferences. This recording capability will be used to measure adherence.
- Adherence Support Team (AST). Each participant will have an Adherence Support Team (AST) that includes the patient, a parent or guardian, and a facilitator (or Coach) from outside the medical team providing care. The team will identify adherence issues and work to overcome them. The facilitator will call the patient every week after the first intervention, and every month for the next eleven months to ask about any problems with Medminder.
Over a 15-month period, study participants will be assigned to either the control group (using only MedMinder) or the intervention group (using MedMinder and working with an Adherence Support Team). Researchers will measure three primary factors: the proportion of prescribed doses that were consumed between the intervention group and the control group; the percent change in estimated glomerular filtration rate (eGFR, or level of kidney function); and the changes in rates of acute rejection and graft failure. TAKE-IT began enrollment of 45 patients in February 2012, and will run for 5 years.
The Peers4PATH study goes outside the family and healthcare team to create a new approach to supporting teens with organ transplants. It will connect transplant patients with a young adult mentor who has experience managing a chronic disease. To eliminate the struggle between the teenager who wants independence and the parent who wants to be involved, the peer mentor will approach the patient as a friend, not as an authority figure. Most importantly, they’ll act as role models — people who have overcome the same challenges their mentee is facing, and gone on to lead successful, happy and healthy lives.
The peer mentor will communicate with their mentee weekly by phone for one year. The pair can also send text, email and Facebook messages as often as they’d like during the one year they are working together.
Medication adherence will be measured using pharmacy refill data and a questionnaire filled out by patients. Participants’ quality of life will be assessed using another questionnaire, first when the patient enters the study and then again at the end of the study. Peers4PATH began enrollment of 60 patients in March 2012, and will run for 4 years.
Potential changes to post-transplant psychosocial support
Ultimately, the findings of these studies may affect the way transplant recipients are supported during adolescence, and as they transition from pediatric to adult care.