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NCT05929703NARecruiting

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

University of Michigan

Start Date

12/4/2023

Completion Date

8/1/2027

Summary

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.

Detailed Description

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

Age Range: 70 years to No maximum

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)

Interventions

BEHAVIORAL

HELP

BEHAVIORAL

FAM-HELP

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Conditions

DeliriumNeurocognitive DisordersMild Cognitive ImpairmentAlzheimer DiseaseAgingFamily SupportFamily MembersCaregiver BurdenImplementation SciencePatient Satisfaction

Locations

Saddleback Medical Center

Orange, California 92868

United States

MaineHealth

Portland, Maine 04102

United States

Michigan Medicine

Ann Arbor, Michigan 48109

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

University of Utah

Salt Lake City, Utah 84132

United States

Meriter Hospital

Madison, Wisconsin 53715

United States