Clinical trial NCT05929703: Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
Official title: Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Hebrew SeniorLife
name: MaineHealth
name: University of Pennsylvania
name: West Penn Allegheny Health System
name: UnityPoint Health - Meriter Hospital
name: University of Utah
name: MemorialCare Saddleback Medical Center
name: Brandeis University
name: Indiana University
name: Patient-Centered Outcomes Research Institute
First posted: 2023-07-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge, cluster randomized
Primary purpose: PREVENTION

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. 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Delirium Incidence
timeFrame: Day of trial enrollment through day of hospital discharge, up to 14 days
measure: Delirium Severity
timeFrame: Day of trial enrollment through day of hospital discharge, up to 14 days
Secondary outcomes:
measure: Delirium Duration
timeFrame: Day of trial enrollment through day of hospital discharge, up to 14 days
measure: Persistent Delirium
timeFrame: 30 days after hospital discharge
measure: Delirium Burden - Patient
timeFrame: Day of trial enrollment through 30 days after discharge
measure: Delirium Burden - Family and Care Partners
timeFrame: Day of trial enrollment through 30 days after discharge
measure: Caregiving Strain
timeFrame: Hospital discharge through 30 days after discharge
measure: Cognitive Function - Subjective Reporting
timeFrame: Hospital discharge through 30 days after discharge
measure: Hospital Experience
timeFrame: Day of hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
measure: Global Health
timeFrame: Hospital discharge through 30 days after discharge
measure: Physical Function
timeFrame: 30 days after hospital discharge
measure: Falls
timeFrame: Day of trial enrollment through 30 days after hospital discharge
measure: Length of Hospital Stay
timeFrame: Day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
measure: Discharge Disposition
timeFrame: Day of hospital discharge through 30 days after discharge
measure: 30-Day Readmission
timeFrame: Day of hospital discharge through 30 days after discharge
Other outcomes:
measure: Antipsychotic use
timeFrame: Day of trial enrollment through day of hospital discharge, up to 14 days
measure: Restraint use
timeFrame: Day of trial enrollment through day of hospital discharge, up to 14 days
Locations:
city: Orange
country: United States
facility: Saddleback Medical Center
state: California
city: Portland
country: United States
facility: MaineHealth
state: Maine
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburg
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Madison
country: United States
facility: Meriter Hospital
state: Wisconsin
Study officials:
affiliation: Hebrew SeniorLife
name: Sharon K Inouye, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Phillip E Vlisides, MD
role: PRINCIPAL_INVESTIGATOR
References: