What this study is
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.
What's being tested
- REFRAME
Intervention · BEHAVIORAL
consists of three self-guided, tablet-based modules that align with the process model of emotion regulation. Each module lasts approximately 10-20 minutes and is delivered sequentially over three sessions, spaced 24-48 hours apart after enrollment.
- Informational Support
Intervention · BEHAVIORAL
The informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.
Study details
- Official title
- A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill
- Sponsor
- Case Western Reserve University
- Conditions
- Critical Illness
- Enrolling
- 387 people
- Starts
- 2027-01-04
- Est. completion
- 2031-04-04
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥ 35 years
- Lacks decision-making capacity
- Not expected to be discharged from the ICU in 24 hours (including death) Legally Authorized Representative Inclusion Criteria (Primary Participant)
- Age ≥ 18 years
- Identified as LAR by ICU team
- Able to speak and understand English
- Able to visualize content on a tablet device
You can't join if
- Age < 35 years
- Possesses decision-making capacity
- Anticipated discharge from ICU within next 24 hours. Legally Authorized Representative Exclusion Criteria:; Age < 18 years; Not recognized as LAR by ICU team; Unable to speak and understand English; Unable to visualize content on a tablet device
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
- Grant Pignatiello, PhD · Contact216-368-4480gap54@case.edu
Study team
Sponsor
Case Western Reserve University
Study ID STUDY20260222
Principal investigator
Grant Pignatiello, PhD
Case Western Reserve University
Principal investigator
S. Alan Hoffer, MD
University Hospitals Cleveland Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.