A phase II pilot randomized controlled trial of an integrated stepped collaborative care intervention for patients...

Patients awaiting kidney transplant carry a high symptom burden which has been associated with waitlist inactivation, mortality, and poorer post-transplant outcomes. However, few studies have tested the effects of symptom management interventions in this population. This Phase II study aimed to (1) test the feasibility and preliminary efficacy of an integrated stepped collaborative care intervention (CARES-Transplant) on patient-reported outcomes and unplanned healthcare utilization, and (2) explore treatment effects on family caregiver outcomes. The study was a randomized controlled trial designed to test the efficacy of CARES-Transplant versus standard of care (SC). Patients completed a battery of questionnaires at baseline and 3-months including the Center for Epidemiological Studies-Depression (CES-D) scale, Brief Pain Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue, and Rand Short Form-36. Caregivers were administered the CES-D, Perceived Stress Scale, and Pittsburgh Sleep Quality Index at baseline and 3-months. Patient unplanned health care utilization was assessed over the course of one-year post-randomization. Nineteen patients (mean age = 65 ± 6 years, 74% male, 90% White) and 8 caregivers (mean age = 61.3 ± 8.1 years, 100% female and white) were randomized. Reductions in pain intensity and interference were observed for CARES (- 0.2) while patients in the SC arm had increases in pain intensity and interference (+ 1.3, ES = 0.30). Similar trends were observed for fatigue (CARES = - 0.4 versus SC = - 7.7, ES = 0.41) and depressive symptoms (CARES = - 2.0 versus SC =  + 2.33, ES = 0.56). Lower rates of transplant-related complications (CARES mean = 1 versus SC = 3), fewer emergency room visits (CARES = 1.0 versus SC = 2.67) and 90-day readmissions (CARES = 0% versus SC = 28.6%) were also observed. A moderate to large effect size was observed for changes on caregiver reported depressive symptoms (CARES =  + 0.5 versus SC =  + 3.3, ES = 0.55) and sleep quality (CARES = - 1.5 versus SC =  + 0.07, ES = 0.34). The findings of this pilot study warrant a Phase III trial to test the efficacy of CARES-Transplant.Clinical trials registration number ClinicalTrials.gov NCT02938351.