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

• Type of Material: Article
• 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
• Language: English
• Date: 2018-01-01
• Publisher: Elsevier: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2017 Elsevier Inc.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.cct.2017.10.005
• Title of Journal or Parent Work: Contemporary Clinical Trials
• ISSN: 1551-7144
• Volume: 64
• Start Page: 188
• End Page: 194
• Grant/Funding Information: This work is supported by NIH/NINR 1R01NR017018-01 (PI, Song)
• Keywords: Cluster randomized trial; POSTTRAUMATIC-STRESS-DISORDER; TREATMENT INTENSITY; Medicine, Research & Experimental; REPRESENTATIONAL APPROACH; FAMILY CAREGIVERS; Dialysis; AFRICAN-AMERICAN; LIFE DECISION-MAKING; Research & Experimental Medicine; IMPLEMENTATION-RESEARCH; AMERICAN DIALYSIS PATIENTS; Advance care planning; Pragmatic trial; Science & Technology; Pharmacology & Pharmacy; End-stage renal disease; OF-LIFE; Life Sciences & Biomedicine; PATIENT EDUCATION
• Research Categories: Biology, Biostatistics; Health Sciences, Pharmacology; Health Sciences, Nursing

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.