Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Conditions

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

Eligibility Criteria

Sex

ALL

Age

70 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Dec 4, 2023

Status verified

Mar 2026

Primary completion

May 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

1,900 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: 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.
• Active Comparator: 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.

Primary Outcome Measure

Delirium Incidence [ Time Frame: Day of trial enrollment through day of hospital discharge, up to 14 days ]

Central Contacts

• Eva Schmitt, PhD
  617-971-5390
  [email protected]

Locations (7)

Find similar trials in Orange, CA

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