Support tool for families of critically ill patients

Randomized Trial of a Scalable, Interactive Tool to Support Surrogate Decision-makers of Critically Ill Older Adults

This study is testing a new support tool to help families of critically ill older adults communicate better with doctors and feel less stressed during tough times.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1163 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 7 sites (Springfield, Massachusetts and 6 other locations)
• Trial ID: NCT05019261 on ClinicalTrials.gov

What this trial studies

This intervention aims to improve the care experience for critically ill older adults and their families by providing a multi-component family support tool. The tool includes proactive clinician-family meetings, an interactive web-based resource for families, and structured preparation for family meetings to enhance communication and decision-making. The study will involve 370 incapacitated patients at high risk of death or severe impairment, their surrogate decision-makers, and ICU clinicians across multiple centers. The goal is to improve patient- and family-centered care and reduce psychological distress among family members.

Who should consider this trial

Good fit: Ideal candidates include incapacitated older adults aged 18 and above with a high risk of death or severe functional impairment who lack decision-making capacity.

Not a fit: Patients who have a surrogate decision maker unavailable or are already receiving comfort measures only will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance the quality of care and emotional support for families of critically ill patients.

How similar studies have performed: Other studies have shown promise in improving family support and communication in critical care settings, suggesting this approach may be effective.

Eligibility criteria

INCLUSION

Patient

1. Age ≥18
2. Lack of decision-making capacity as determined by clinical examination by the attending physician or designee
3. Clinical indication of at least 40% risk of death or ≥40% chance of new, severe long-term functional impairment (needs assistance with ≥ 2 ADLs), as judged by the patient's attending physician or designee

Surrogate

1. The primary surrogate is determined by the patient's advance directive or, if no directive exists, by following the hierarchy of surrogates codified in state law.
2. Up to 3 additional surrogates

Clinician

1. Patient's primary attending (or their designee)

EXCLUSION

Patient

1. Lack of a surrogate decision maker
2. Family not available for study
3. Imminent death (within 24 hours); goals of care are already "comfort measures only"; decision to withdraw life support has already been made
4. Currently participating in a competing research study that does not allow co-enrollment
5. Incarcerated or on an involuntary hold
6. Died prior to enrollment
7. Discharged prior to enrollment
8. Regained capacity prior to enrollment
9. Physician declined patient's participation
10. Physician and designee declined own participation
11. Patient does not meet inclusion criteria within 5 days of ICU admission
12. MD expects transfer orders will be written or the patient will be transferred within 36 hours of screening
13. Greater than 5 ICU days during the current hospitalization

Surrogate

1. Age \<18 years
2. Cannot read or understand English
3. Cannot complete questionnaires due to physical or cognitive limitations
4. Has no access to or cannot travel to access the internet

Where this trial is running

Springfield, Massachusetts and 6 other locations

• Baystate Medical Center — Springfield, Massachusetts, United States (Recruiting)
• NYC Health + Hospitals/Lincoln Hospital — New York, New York, United States (Recruiting)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
• Pittsburgh VA Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Douglas B White, MD, MAS — University of Pittsburgh
• Study coordinator: Douglas B White, MD, MAS

Conditions Critical Illness; Patient centeredness of care; Psychological Distress; End of Life Care; Surrogate Decision Making; Goal Concordant Care