Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
NCT ID: NCT05929703
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3000 participants
INTERVENTIONAL
2023-12-04
2027-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Hospital Elder Life Program (HELP)
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.
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.
Family-Augmented Hospital Elder Life Program (FAM-HELP)
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
70 Years
ALL
No
Sponsors
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Hebrew SeniorLife
OTHER
MaineHealth
OTHER
University of Pennsylvania
OTHER
West Penn Allegheny Health System
OTHER
UnityPoint Health - Meriter Hospital
UNKNOWN
University of Utah
OTHER
MemorialCare Saddleback Medical Center
UNKNOWN
Brandeis University
OTHER
Indiana University
OTHER
Patient-Centered Outcomes Research Institute
OTHER
University of Michigan
OTHER
Responsible Party
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Phillip Vlisides
Assistant Professor of Anesthesiology; Executive Director, Neuroscience Research
Principal Investigators
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Sharon K Inouye, MD
Role: PRINCIPAL_INVESTIGATOR
Hebrew SeniorLife
Phillip E Vlisides, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Saddleback Medical Center
Orange, California, United States
MaineHealth
Portland, Maine, United States
Michigan Medicine
Ann Arbor, Michigan, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Meriter Hospital
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DE-2022C1-25666
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HUM00227397
Identifier Type: -
Identifier Source: org_study_id
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