Living donors constitute 46% of all organ transplant donors in the U.S. They are a unique patient population: they are healthy persons who do not require any surgery, yet they undergo major surgery involving removal of critical organ mass in order to help another person. Hence, the protection of living donors'well- being and the prevention of any negative consequences of donation are among the foremost priorities not only in transplantation but in the US healthcare and regulatory communities at large. Although surgical innovations continue to drive down the risks of donor perioperative morbidity, the risk of poor psychosocial outcomes in the months and years after donation remains high: up to 54% of living donors report (a) clinically significant psychological distress (including depression and anxiety), (b) poor perceived physical well-being (including persistent pain and fatigue), and/or (c) strained spousal or other family relationships. No preventive interventions have been mounted or tested for their ability to avert poor psychosocial outcomes in living donors, despite evidence that certain factors consistently predict such outcomes. In particular, residual ambivalence about the prospect of donating-i.e., lingering feelings of hesitation and uncertainty that remain after the prospective donor's pre-donation medical workup and that coexist with his/her intention to donate-has emerged as a critical predictor of poor post-donation psychosocial outcomes. We propose to refine and test the feasibility and efficacy of a brief, nurse-administered intervention representing a novel application of the theoretical framework and principles of motivational interviewing (MI) to address residual ambivalence about proceeding with living donation. We hypothesize that reduction of such ambivalence will prevent poor post-donation psychosocial outcomes in the three areas noted above. In Phase I of the study, we will refine the intervention for prospective living donors, fully manualize it, and train Nurse Interventionists to administer it. In Phase II, we will conduct a randomized controlled trial to test the intervention. We will enroll 106 prospective donors (76 kidney, 30 liver donor candidates) who screen positive for the presence of residual ambivalence about donation, based on an established measure. They will be randomized to the 2-session telephone-based MI intervention or a comparison condition (telephone-based enhanced standard nursing care). Data will be collected to examine the intervention's immediate effects on subjects'pre-donation ambivalence, psychological distress, and satisfaction with their decision about donation. Data will be collected 6 weeks and 3 months post-donation in order to (a) determine whether donors who received the intervention show lower psychological distress, better perceived physical health, and less familial relationship strain than donors in the comparison condition, and (b) examine whether any such post-donation effects are mediated by the intervention's more proximal effects on pre-donation outcome variables.
The protection of living organ donors'well-being and the prevention of any negative consequences of donation are among the foremost priorities not only in transplantation but in the US healthcare and regulatory communities at large. Given evidence that many donors experience poor psychosocial outcomes after donation (including psychological distress, poor perceived physical well-being and strained familial relationships), we propose to refine and test the efficacy of a brief nurse-administered intervention to prevent such outcomes. The proposed study is consistent with NIH programmatic priorities emphasizing health promotion and disease prevention research;initial data on intervention efficacy will be critical in order for us to prepare to undertake a larger multi-site randomized controlled trial.
