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Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
NCT05929703 · University of Michigan
In plain English
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Official title
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)
About this study
Delirium is a common complication of hospitalization and major surgery for older adults, and it can lead to loss of independence and substantial healthcare costs. One approach to preventing delirium is through the Hospital Elder Life Program (HELP). HELP personnel work to prevent delirium by providing orienting communication, assisting patients with walking and exercise, providing help with nutrition and fluids, implementing sleep protocols, and helping patients with vision and hearing aids.
However, it is unknown whether involving family members in these activities along with HELP staff (i.e., "FAM-HELP") might be more effective with preventing delirium. The objective of this clinical trial is thus to compare the traditional HELP program with a family-augmented version of HELP (FAM-HELP) to determine which program is more effective with preventing delirium and related complications in older, hospitalized patients.
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)
Study design
Enrollment target: 1900 participants
Allocation: randomized
Masking: double
Age groups: older_adult
Timeline
Starts: 2023-12-04
Estimated completion: 2027-08
Last updated: 2026-03-24
Interventions
Behavioral: HELPBehavioral: FAM-HELP
Primary outcomes
- • Delirium Incidence (Day of trial enrollment through day of hospital discharge, up to 14 days)
- • Delirium Severity (Day of trial enrollment through day of hospital discharge, up to 14 days)
Sponsor
University of Michigan · other
With: Hebrew SeniorLife, MaineHealth, University of Pennsylvania, West Penn Allegheny Health System, UnityPoint Health - Meriter Hospital, University of Utah, MemorialCare Saddleback Medical Center, Brandeis University, Indiana University, Patient-Centered Outcomes Research Institute
Contacts & investigators
ContactEva Schmitt, PhD · contact · EvaSchmitt@hsl.harvard.edu · 617-971-5390
InvestigatorSharon K Inouye, MD · principal_investigator, Hebrew SeniorLife
InvestigatorPhillip E Vlisides, MD · principal_investigator, University of Michigan
All locations (7)
Saddleback Medical CenterRecruiting
Orange, California, United States
MaineHealthRecruiting
Portland, Maine, United States
Michigan MedicineRecruiting
Ann Arbor, Michigan, United States
Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Allegheny General HospitalRecruiting
Pittsburgh, Pennsylvania, United States
University of UtahRecruiting
Salt Lake City, Utah, United States
Meriter HospitalRecruiting
Madison, Wisconsin, United States