A tool to help families of ICU patients stay calm and make better decisions
Official title: A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill
Funded at Case Western Reserve University · NIH-11345828 · Data updated 2026-11-12
A brief, tablet-based program helps surrogate decision-makers in the ICU manage emotions and make clearer treatment choices.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Case Western Reserve University NIH-funded |
| Lab location | 1 site (Cleveland, United States) |
| Project start | June 1, 2026 |
| Project end | May 31, 2031 |
| Funding year | 2026 |
| Award (this year) | $784,590 |
| NIH project number | 1R01AG100745-01 |
| Project ID | NIH-11345828 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults who are surrogate decision-makers for critically ill patients in ICU settings, able to use a tablet.
✕Less likely to help
Family members who do not engage with the intervention or whose emotional distress does not respond to the program.
What this research studies
If a loved one is in the ICU, this project tests a short, self-guided program on a tablet that teaches simple emotion-regulation skills. It compares REFRAME to a basic information-only control to see if it reduces distress and improves decision quality during critical moments. The study will enroll about 387 surrogate decision-makers of critically ill patients and measure psychological outcomes and decision-related effects over time. Results could show a scalable way to support families during intensely stressful hospital experiences.
Why it matters
Potential benefit: If successful, families may experience less distress and make choices that better reflect the patient’s values.
How similar studies have gone: Previous similar approaches show promise, but this trial tests a brief, scalable digital intervention specifically for SDMs in the ICU.
Where this research is happening
-
Case Western Reserve University
Cleveland, United States Active
Researchers
- Principal investigator: Pignatiello, Grant — Case Western Reserve University
- Study coordinator: Pignatiello, Grant
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.