The Recovering Together study protocol: A single-blind RCT to prevent chronic emotional distress in patient-cargiver dyads in the Neuro-ICU.

Autor: Vranceanu AM; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America. Electronic address: avranceanu@mgh.harvard.edu., Woodworth EC; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America., Kanaya MR; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America., Bannon S; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America., Mace RA; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America., Manglani H; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America., Duarte BA; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America., Rush CL; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America., Choukas NR; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America., Briskin EA; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America., Cohen J; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America., Parker R; Harvard Medical School, Boston, MA, United States of America; Biostatistics Center, Massachusetts General Hospital, Boston, MA, United States of America., Macklin E; Harvard Medical School, Boston, MA, United States of America; Biostatistics Center, Massachusetts General Hospital, Boston, MA, United States of America., Lester E; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America., Traeger L; Cancer Center, Massachusetts General Hospital, Boston, MA, United States of America., Rosand J; Harvard Medical School, Boston, MA, United States of America; Henry and Allison McCance Center for Brain Health, Massachusetts General Hospital, Boston, MA, United States of America; Neuroscience Intensive Care Unit, Massachusetts General Hospital, Boston, MA, United States of America., Grunberg VA; Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Division of Newborn Medicine, MassGeneral for Children, Boston, MA, United States of America.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2022 Dec; Vol. 123, pp. 106998. Date of Electronic Publication: 2022 Nov 08.
DOI: 10.1016/j.cct.2022.106998
Abstrakt: Introduction: Patients admitted to the Neuroscience Intensive Care Unit (Neuro-ICU) with acute neurological illnesses (ANI; e.g., stroke, tumor, TBI) and their informal caregivers experience high rates of anxiety, depression, and posttraumatic stress. To address this need, we previously developed the Recovering Together (RT) dyadic intervention to help prevent chronic emotional distress in both patients and caregivers. Currently, we are conducting a fully-powered, single-blind randomized clinical trial (RCT) to evaluate the efficacy of RT versus an attention matched health education control. Here, we describe the protocol and current status of this RCT.
Methods: We aim to recruit 194 at risk patient-caregiver dyads from the Neuro-ICU at MGH. Eligible dyads include patients diagnosed with ANI, cognitively intact, at least one partner endorses emotional distress (on Hospital Anxiety and Depression Scale), English speaking, age 18 or older. Dyads are randomized to the intervention (RT-1) or control condition (RT-2) (both six sessions). RT-1 teaches resiliency (e.g., coping, mindfulness) and interpersonal skills. RT-2 provides education on health-related topics (e.g., stress, self-care, adhering to medical recommendations). Blinded research assistants collect measures at baseline, post-intervention, and three months follow-up. We will conduct mixed linear, mediation, and actor-partner interdependence models to examine changes in dyads' outcomes across time.
Results: We have recruited 41 dyads and aim to recruit 194 total.
Discussion: If successful, we plan to test RT in a large-scale, multisite hybrid effectiveness-implementation study in Neuro-ICUs across the country. Enhancing psychosocial supports for patients and families could improve health outcomes, healthcare efficiency, and the culture of these units.
Competing Interests: Declaration of Competing Interest We declare no relevant conflicts of interest.
(Copyright © 2022. Published by Elsevier Inc.)
Databáze: MEDLINE
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