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

1,900 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

Plain Language Summary

Simplified for easier understanding

This trial tests new hospital care approaches — including family involvement and specialized monitoring — to prevent delirium (sudden confusion) in older adults during their hospital stay. **You may be eligible if...** - You are 70 years or older - You are expected to be in the hospital for at least 3 days (72 hours) - You have a family member or care partner who can be present at the hospital - You have at least one risk factor for delirium - You are able to complete a baseline thinking and memory assessment - You have provided informed consent **You may NOT be eligible if...** - You already have delirium when admitted to the hospital - You are unable to communicate verbally - You have a terminal condition or advanced dementia that prevents full participation - There are staff safety concerns - You are having heart surgery or brain surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.