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

University of Michigan

Status: Enrolling

Conditions: Family Members; Implementation Science; Aging; Family Support; Alzheimer Disease; Delirium; Mild Cognitive Impairment; Patient Satisfaction; Caregiver Burden; Neurocognitive Disorders

Treatments: Behavioral: HELP; Behavioral: FAM-HELP

Study type: Interventional

Funder types: Other

Identifiers

NCT05929703

HUM00227397

DE-2022C1-25666 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,000 participants in 2 patient groups

Hospital Elder Life Program (HELP)

Active Comparator group

Description:

Hospital Elder Life Program (HELP) is built upon multicomponent, non-pharmacologic strategies that target delirium risk factors to optimize cognitive and clinical function during hospitalization.

Treatment:

Behavioral: HELP

Family-Augmented Hospital Elder Life Program (FAM-HELP)

Active Comparator group

Description:

The FAM-HELP program will incorporate a family member and/or care partner, who will play a central role with providing bedside support for delirium risk reduction. Family members and care partners will provide social and emotional support along with augmentation of HELP-based protocols.

Treatment:

Behavioral: FAM-HELP