Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

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.

Conditions

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

Interventions

BEHAVIORAL

HELP

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.

BEHAVIORAL

FAM-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.

Sponsors & Collaborators

• Hebrew SeniorLife

  collaborator OTHER

• MaineHealth

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• West Penn Allegheny Health System

  collaborator OTHER

• UnityPoint Health - Meriter Hospital

  collaborator UNKNOWN

• University of Utah

  collaborator OTHER

• MemorialCare Saddleback Medical Center

  collaborator UNKNOWN

• Brandeis University

  collaborator OTHER

• Indiana University

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Michigan

  lead OTHER

Principal Investigators

• Sharon K Inouye, MD · Hebrew SeniorLife

• Phillip E Vlisides, MD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-04

Primary Completion

2027-05-31

Completion

2027-08-31

Countries

• United States

Study Locations