Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
Recruiting · NCT05929703 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following: 1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity. 2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes. 3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.
Who can take part
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 is running
7 locations listed across 6 US states.
- Saddleback Medical Center - Orange, California, United States
- MaineHealth - Portland, Maine, United States
- Michigan Medicine - Ann Arbor, Michigan, United States
- Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Allegheny General Hospital - Pittsburgh, Pennsylvania, United States
- University of Utah - Salt Lake City, Utah, United States
- Meriter Hospital - Madison, Wisconsin, United States