SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD

• Authors: Mi-Kyung Song, Emory University; Mark L Unruh, University of New Mexico; Amita Manatunga, Emory University; Laura Plantinga, Emory University; Janice Lea, Emory University; Manisha Jhamb, University of Pittsburgh; Abhijit V. Kshirsagar, University of North Carolina; Sandra E. Ward, University of Wisconsin
• Journal Title: Contemporary Clinical Trials
• Volume: Volume 64
• Publisher: Elsevier: 12 months | 2018-01-01, Pages 188-194
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1016/j.cct.2017.10.005
• Subjects: Health Sciences, Pharmacology; Health Sciences, Nursing; Biology, Biostatistics
• Keywords: Science & Technology; Life Sciences & Biomedicine; Medicine, Research & Experimental; Pharmacology & Pharmacy; Research & Experimental Medicine; End-stage renal disease; Dialysis; Advance care planning; Pragmatic trial; Cluster randomized trial; LIFE DECISION-MAKING; POSTTRAUMATIC-STRESS-DISORDER; AMERICAN DIALYSIS PATIENTS; OF-LIFE; AFRICAN-AMERICAN; REPRESENTATIONAL APPROACH; IMPLEMENTATION-RESEARCH; TREATMENT INTENSITY; PATIENT EDUCATION; FAMILY CAREGIVERS

Abstract

Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials, SPIRIT was delivered by trained research nurses. Findings consistently revealed that patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. As a critical next step, we are conducting an effectiveness-implementation study. This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics, compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care. Trial registration: ClinicalTrials.gov NCT03138564, registered 05/01/2017.