Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

NCT05929703 | Recruiting

• 2 other identifiers: HUM00227397DE-2022C1-25666
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 7

Brief 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. 1.To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity.
2. 2.To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes.
3. 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

Keywords

Delirium; Clinical Trial; Comparative Effectiveness Research; Implementation Science

Outcome Measures

Primary Outcomes (2)

• Delirium Incidence

  Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM), supplemented by a validated chart review approach for delirium.

  Day of trial enrollment through day of hospital discharge, up to 14 days

• Delirium Severity

  Delirium severity will be scored using the Confusion Assessment Method Long Form Severity Score (CAM-S) (n, 0-19, with higher number indicating more severe delirium). Score derived from the same CAM instrument and items used for delirium incidence.

  Day of trial enrollment through day of hospital discharge, up to 14 days

Secondary Outcomes (13)

• Delirium Duration

  Day of trial enrollment through day of hospital discharge, up to 14 days

• Persistent Delirium

  30 days after hospital discharge

• Delirium Burden - Patient

  Day of trial enrollment through 30 days after discharge

• Delirium Burden - Family and Care Partners

  Day of trial enrollment through 30 days after discharge

• Caregiving Strain

  Hospital discharge through 30 days after discharge

Other Outcomes (3)

• Antipsychotic use

  Day of trial enrollment through day of hospital discharge, up to 14 days

• Restraint use

  Day of trial enrollment through day of hospital discharge, up to 14 days

• Mortality

  Day of trial enrollment through 30 days after discharge

Study Arms (2)

Hospital Elder Life Program (HELP)

ACTIVE COMPARATOR

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.

Behavioral: HELP

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

ACTIVE COMPARATOR

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.

Behavioral: FAM-HELP

Interventions

HELP BEHAVIORAL

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.

Hospital Elder Life Program (HELP)

FAM-HELP BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hebrew SeniorLife: collaborator
• MaineHealth: collaborator
• University of Pennsylvania: collaborator
• UnityPoint Health - Meriter Hospital: collaborator
• University of Utah: collaborator
• MemorialCare Saddleback Medical Center: collaborator
• Indiana University: collaborator
• West Penn Allegheny Health System: collaborator
• Brandeis University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• University of Michigan: lead

Study Sites (7)

Saddleback Medical Center

Orange, California, 92868, United States

RECRUITING

MaineHealth

Portland, Maine, 04102, United States

RECRUITING

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Meriter Hospital

Madison, Wisconsin, 53715, United States

RECRUITING

MeSH Terms

Conditions

Delirium; Neurocognitive Disorders; Cognitive Dysfunction; Alzheimer Disease; Caregiver Burden; Patient Satisfaction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Cognition Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Sharon K Inouye, MD

  Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

• Phillip E Vlisides, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Schmitt, PhD

CONTACT

617-971-5390; EvaSchmitt@hsl.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology; Executive Director, Neuroscience Research

Model Details: Stepped-wedge, cluster randomized

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 3, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (7)