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NCT07630844
REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill
Conditions: Critical Illness
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 387
Sponsor: Case Western Reserve University
Location: University Hospitals Cleveland Medical Center Cleveland Ohio
Summary
Every year in the United States, millions of adults make crucial medical decisions for loved ones in the intensive care unit while facing extreme emotional stress. This project will assess REFRAME, a brief tablet-based program designed to help decision-makers manage their emotions in these situations. Results from this study may lead to the creation of a widely accessible tool that alleviates emotional suffering and enhances the quality of medical decision-making for families in crisis.
Eligibility Criteria
Patient Inclusion Criteria:
* 1\. Age ≥ 35 years
* 2\. Lacks decision-making capacity
* 3\. Not expected to be discharged from the ICU in 24 hours (including death)
Legally Authorized Representative Inclusion Criteria (Primary Participant)
* 1\. Age ≥ 18 years
* 2\. Identified as LAR by ICU team
* 3\. Able to speak and understand English
* 4\. Able to visualize content on a tablet device
Patient Exclusion Criteria:
* 1\. Age \< 35 years
* 2\. Possesses decision-making capacity
* 3\. Anticipated discharge from ICU within next 24 hours.
Legally Authorized Representative Exclusion Criteria:
* 1\. Age \< 18 years
* 2\. Not recognized as LAR by ICU team
* 3\. Unable to speak and understand English
* 4\. Unable to visualize content on a tablet device
Source: ClinicalTrials.gov (NCT07630844). StuddyBuddy aggregates publicly available trial information.