RecruitingNot ApplicableNCT05929703

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

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

Sponsor

University of Michigan

Enrollment

3,000 participants

Start Date

Dec 4, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 70 Years

Inclusion Criteria6

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 Criteria5

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

BEHAVIORALHELP

This is usual (standard) care across hospitals in this trial. A multidisciplinary team of nurse specialists, social workers, and volunteers implement daily protocols focused on orientation, cognitive stimulation, early mobilization, sleep enhancement, support with visual and hearing aids, mealtime assistance, hydration, reduction in polypharmacy, and nursing-based delirium prevention protocols.

BEHAVIORALFAM-HELP

Family members and care partners will provide daily emotional and social support during hospitalization. Additionally, family members and care partners will engage in HELP-based protocols throughout the day. The rationale for this protocol augmentation is two-fold: (1) HELP may not consistently have available volunteers (e.g., short-staffing) during a hospital stay, and (2) patients may be more likely to engage in therapeutic activities with a family member given the connection and comfort level.