Best Case/Worst Case-ICU: protocol for a multisite, stepped-wedge, randomised clinical trial of scenario planning to improve communication in the ICU in US trauma centres for older adults with serious injury

Lily Stalter; Bret M Hanlon; Kyle J Bushaw; Kristine L Kwekkeboom; Amy Zelenski; Melanie Fritz; Anne Buffington; Deborah M Stein; Christine S Cocanour; Anamaria J Robles; Jan Jansen; Karen Brasel; Kathleen M O'Connell; Mark D Cipolle; Patricia Ayoung-Chee; Rachel Morris; Rondi B Gelbard; Rosemary A Kozar; Stephanie Lueckel; Margaret Schwarze

doi:10.1136/bmjopen-2023-083603

Best Case/Worst Case-ICU: protocol for a multisite, stepped-wedge, randomised clinical trial of scenario planning to improve communication in the ICU in US trauma centres for older adults with serious injury

BMJ Open. 2024 Aug 28;14(8):e083603. doi: 10.1136/bmjopen-2023-083603.

Authors

Lily Stalter¹, Bret M Hanlon^{1

2}, Kyle J Bushaw¹, Kristine L Kwekkeboom³, Amy Zelenski⁴, Melanie Fritz¹, Anne Buffington¹, Deborah M Stein⁵, Christine S Cocanour⁶, Anamaria J Robles⁶, Jan Jansen⁷, Karen Brasel⁸, Kathleen M O'Connell⁹, Mark D Cipolle¹⁰, Patricia Ayoung-Chee¹¹, Rachel Morris¹², Rondi B Gelbard⁷, Rosemary A Kozar⁵, Stephanie Lueckel¹³, Margaret Schwarze¹⁴

Affiliations

¹ Department of Surgery, University of Wisconsin-Madison, Madison, Wisconsin, USA.
² Department of Biostatistics & Medical Informatics, University of Wisconsin-Madison, Madison, Wisconsin, USA.
³ School of Nursing, University of Wisconsin-Madison, Madison, Wisconsin, USA.
⁴ Department of Medicine, University of Wisconsin-Madison, Madison, Wisconsin, USA.
⁵ Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, USA.
⁶ Department of Surgery, University of California Davis, Davis, California, USA.
⁷ Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA.
⁸ School of Medicine, Oregon Health and Science University, Portland, Oregon, USA.
⁹ Department of Medicine, University of Washington, Seattle, Washington, USA.
¹⁰ Division of Trauma-Surgical Critical Care, Lehigh Valley Health Network, Allentown, Pennsylvania, USA.
¹¹ Department of Surgery, Morehouse School of Medicine, Morehouse School of Medicine, Atlanta, Georgia, USA.
¹² Department of Surgery, Division of Trauma and Acute Care Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
¹³ Division of Acute Care Surgery and Surgical Critical Care, Brown University, Providence, Rhode Island, USA.
¹⁴ Department of Surgery, University of Wisconsin-Madison, Madison, Wisconsin, USA schwarze@surgery.wisc.edu.

Abstract

Introduction: Poor communication about serious injury in older adults can lead to treatment that is inconsistent with patient preferences, create conflict and strain healthcare resources. We developed a communication intervention called Best Case/Worst Case-intensive care unit (ICU) that uses daily scenario planning, that is, a narrative description of plausible futures, to support prognostication and facilitate dialogue among patients, their families and the trauma ICU team. This article describes a protocol for a multisite, randomised, stepped-wedge study to test the effectiveness of the intervention on the quality of communication (QOC) in the ICU.

Methods and analysis: We will follow all patients aged 50 and older admitted to the trauma ICU for 3 or more days after a serious injury at eight high-volume level 1 trauma centres. We aim to survey one family or 'like family' member per eligible patient 5-7 days following their loved ones' admission and clinicians providing care in the trauma ICU. Using a stepped-wedge design, we will use permuted block randomisation to assign the timing for each site to begin implementation of the intervention and routine use of the Best Case/Worst Case-ICU tool. We will use a linear mixed-effects model to test the effect of the tool on family-reported QOC (using the QOC scale) as compared with usual care. Secondary outcomes include the effect of the tool on reducing clinician moral distress (using the Measure of Moral Distress for Healthcare Professionals scale) and patients' length of stay in the ICU.

Ethics and dissemination: Institutional review board (IRB) approval was granted at the University of Wisconsin, and all study sites ceded review to the primary IRB. We plan to report results in peer-reviewed publications and national meetings.

Trial registration number: NCT05780918.

Keywords: adult intensive & critical care; clinical trial; medical ethics; palliative care; trauma management.

Publication types

Clinical Trial Protocol

MeSH terms

Aged
Communication*
Family / psychology
Female
Humans
Intensive Care Units*
Male
Middle Aged
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Trauma Centers*
United States
Wounds and Injuries / therapy

Associated data

ClinicalTrials.gov/NCT05780918

Grants and funding

R01 AG078242/AG/NIA NIH HHS/United States