Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
About this study
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.
- Condition
- Delirium, Neurocognitive Disorders, Mild Cognitive Impairment, Alzheimer Disease, Aging, Family Support, Family Members, Caregiver Burden, Implementation Science, Patient Satisfaction
- Tested
- HELP, FAM-HELP
- Sponsor
- University of Michigan
Who can join
- Age
- 70 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 70 years
- Study condition: Delirium, Neurocognitive Disorders, Mild Cognitive Impairment, Alzheimer Disease, Aging, Family Support, Family Members, Caregiver Burden, Implementation Science, Patient Satisfaction
- 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 6
- 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
7 sites, 7 recruiting
Michigan Medicine
Ann Arbor, Michigan, United States
Meriter Hospital
Madison, Wisconsin, United States
Saddleback Medical Center
Orange, California, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
MaineHealth
Portland, Maine, United States
and 1 more site on ClinicalTrials.gov
Contact
-
Eva Schmitt, PhD
617-971-5390 EvaSchmitt@hsl.harvard.edu
Potential match only. Final eligibility is determined by the study team.