Project ANCHOR: A Small-Scale Pilot RCT of a Supportive Care Intervention for Caregivers of Patients Awaiting Transplantation

New York University School Of Medicine, New York NY

Investigators

Abstract

SUMMARY Annually, over 800,000 individuals provide unpaid support to patients with end-stage kidney disease (ESKD), such as care coordination, activities of daily living, nursing tasks, and emotional support. Much like caregivers of patients with other life-limiting illnesses, ESKD caregivers experience psychological distress and adverse health outcomes, including cardiovascular disease and poor self-rated health. This is problematic, because lack of adequate caregiver support is associated with poor patient outcomes. One of the largest inflection points for both patients and their caregivers along the treatment continuum for ESKD is listing for kidney transplantation. However, this process is fraught with uncertainty, ranging from timing of organ offers to post- transplant risk of infection and graft failure. To our knowledge, no interventions exist to address the needs of caregivers facing kidney transplantation. To address this gap, my interdisciplinary mentoring team and I have developed an intervention called Project ANCHOR (Addressing the Needs of Caregivers to Help Optimize Resilience), based conceptually on the Windle and Bennett framework for resilience in the context of caregiving and on prior evidence-based interventions. Project ANCHOR employs a telehealth coaching approach to provide supportive care to family caregivers of patients awaiting kidney transplantation, consisting of six weekly sessions and monthly follow-up led by a trained lay coach. Content includes management of kidney disease, skills for coping with stress, ensuring effective social support, improving self-care, and planning for the future. The overall goal of this exploratory sequential mixed methods research study is to conduct a formative intervention adaptation and a small-scale pilot randomized controlled trial of a supportive care intervention for family caregivers of patients listed for transplantation. We will assemble an advisory group of patients, caregivers, transplant providers, and lay navigators to elicit feedback on the design, implementation, and results of Project ANCHOR using focus groups and qualitative formative evaluation interviews. The newly tailored intervention will then be tested for feasibility, acceptability, and potential efficacy in a small scale RCT vs. standard-of-care for 60 caregivers, allowing us to 1) to assess instruments and observed differences between the intervention and standard-of-care group; 2) to collect pilot data to evaluate the RCT design to prepare for a larger intervention study in the future, and 3) to identify strategies to recruit and retain participants. Results from this study will allow us to provide tailored support to family caregivers of patients awaiting transplantation and reduce caregiver burden, improve post-transplant outcomes by providing tools and resources to mitigate caregiver burden, and improve informed consent for caregivers considering living donation.