Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

University of Michigan3,000 enrolled

Overview

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.

Delirium is a common complication of hospitalization and major surgery for older adults, and it can lead to loss of independence and substantial healthcare costs. One approach to preventing delirium is through the Hospital Elder Life Program (HELP). HELP personnel work to prevent delirium by providing orienting communication, assisting patients with walking and exercise, providing help with nutrition and fluids, implementing sleep protocols, and helping patients with vision and hearing aids. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

3,000

Conditions

Interventions

HELPBEHAVIORAL

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-HELPBEHAVIORAL

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

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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)

Locations (7)

Saddleback Medical Center

Orange, California, United States

RECRUITING

MaineHealth

Portland, Maine, United States

RECRUITING

Michigan Medicine

Ann Arbor, Michigan, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

RECRUITING

University of Utah

Salt Lake City, Utah, United States

RECRUITING

Meriter Hospital

Madison, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

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

Secondary Outcomes

Delirium Duration

The cumulative number of days (n) with a positive delirium screen will be calculated for all participants

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

Persistent Delirium

Positive delirium screen (yes/no) 30 days after hospital discharge as determined by the long-form Confusion Assessment Method (AM)

Time frame: 30 days after hospital discharge

Delirium Burden - Patient

Delirium burden will be calculated using the Patient Delirium Burden Scale (DEL-B-P) (n, 0-40, with higher number indicating more severe burden)

Time frame: Day of trial enrollment through 30 days after discharge

Delirium Burden - Family and Care Partners

Delirium burden will be calculated using the Patient Delirium Family Caregiver Scale (DEL-B-C) (n, 0-40, with higher number indicating more severe burden)

Time frame: Day of trial enrollment through 30 days after discharge

Caregiving Strain

Strain associated with patient caregiving will be assessed via Modified Caregiver Strain Index (MCSI) (n, 0-26, with higher number indicating more caregiver strain)

Time frame: Hospital discharge through 30 days after discharge

Cognitive Function - Subjective Reporting

Subjective reporting of cognitive function will be assessed via PROMIS Cognitive Function - Short Form 6a (n, 6-30, with higher number indicating better subjective cognitive function)

Time frame: Hospital discharge through 30 days after discharge

Hospital Experience

Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey (n, 7-28, with higher score indicating better hospital experience)

Time frame: Day of hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)

Global Health

Assessment of overall physical and mental health via PROMIS Global Health-10. Two separate subscales will be calculated, Global Physical Health (n, 4-20) and Global Mental Health (n, 4-20), with higher scores indicating better health.

Time frame: Hospital discharge through 30 days after discharge

Physical Function

Assessment of physical function via PROMIS Physical Short Form 10a (n, 10-50, with higher scores indicating better physical function).

Time frame: 30 days after hospital discharge

Falls

Proportion of participants in each group (%) experiencing at least one fall

Time frame: Day of trial enrollment through 30 days after hospital discharge

Length of Hospital Stay

Total number of days (n) spent in the hospital

Time frame: Day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)

Discharge Disposition

Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility)

Time frame: Day of hospital discharge through 30 days after discharge

30-Day Readmission

Proportion of participants in each group (%) requiring hospital readmission

Time frame: Day of hospital discharge through 30 days after discharge

Central Contacts

Eva Schmitt, PhD

CONTACT

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

Data from ClinicalTrials.gov

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