Comparing two approaches to prevent delirium in hospitalized older adults
Official title: Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)
Run by University of Michigan · NCT05929703 · Data updated 2026-11-12
This study tests whether involving family members in care can help prevent delirium in older adults during hospital stays better than the standard Hospital Elder Life Program alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 70 Years and up |
| Sex | All |
| Enrollment | 1900 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Locations | 7 sites (Orange, California and 6 other locations) |
| Status | Recruiting |
| Started | December 4, 2023 |
| Main results expected | May 2027 |
| Study ends | August 2027 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT05929703 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are older adults aged 70 and above who are hospitalized for at least 72 hours and have at least one risk factor for delirium.
✕Probably not a fit
Patients who are already experiencing delirium upon admission or those unable to communicate or participate in interventions will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Hospital Elder Life Program (HELP) versus a family-augmented version called FAM-HELP in preventing delirium among older patients during hospital stays. The study will assess both the incidence and severity of delirium, as well as patient and family-reported outcomes. Additionally, it will explore how the FAM-HELP program can be implemented across various hospital settings. By involving family members in care activities, the trial seeks to determine if this collaborative approach yields better results than traditional HELP alone.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of delirium in hospitalized older adults, improving their overall health outcomes and quality of life.
How similar studies have gone: Other studies have shown promise in using family involvement to enhance care for older adults, suggesting that this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of informed consent * At least 70 years of age * Anticipated length of hospital stay at least 72 hours * Family member or care partner available to be on-site in the hospital * At least one delirium risk factor (e.g., cognitive or functional impairment, dehydration, vision or hearing impairment) * Evaluable cognitive function at baseline (i.e., ability to complete baseline cognitive function assessment) Exclusion Criteria: * Delirium on admission * Unable to communicate verbally (e.g., coma, mechanical ventilation) * Unable to participate fully in interventions (e.g., terminal condition, advanced dementia) * Staff safety concerns (e.g., violent behavior) * Cardiac or intracranial surgery (due to competing causes of delirium) * Active neurologic disease (as primary reason for admission)
Where it's running
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Saddleback Medical Center
Orange, California, United States Recruiting -
MaineHealth
Portland, Maine, United States Recruiting -
Michigan Medicine
Ann Arbor, Michigan, United States Recruiting -
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States Recruiting -
University of Utah
Salt Lake City, Utah, United States Recruiting
Show 1 more location
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Meriter Hospital
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Sharon K Inouye, MD — Hebrew SeniorLife
- Study coordinator: Eva Schmitt, PhD
- Email: EvaSchmitt@hsl.harvard.edu
- Phone: 617-971-5390
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.