Comparing two approaches to prevent delirium in hospitalized older adults

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)

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

• Phase: NA
• Study type: Interventional
• Enrollment: 1900 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: University of Michigan (other)
• Locations: 7 sites (Orange, California and 6 other locations)
• Trial ID: NCT05929703 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Other studies have shown promise in using family involvement to enhance care for older adults, suggesting that this approach may be beneficial.

Eligibility 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)

Where this trial is running

Orange, California and 6 other locations

• 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)
• Meriter Hospital — Madison, Wisconsin, United States (RECRUITING)

Study contacts

• Principal investigator: Sharon K Inouye, MD — Hebrew SeniorLife
• Study coordinator: Eva Schmitt, PhD

Conditions: Delirium, Neurocognitive Disorders, Mild Cognitive Impairment, Alzheimer Disease, Aging, Family Support, Family Members, Caregiver Burden