Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Alzheimer Disease Clinical Trial

— ENHANCE  

Official title:

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929703
• Other study ID #: HUM00227397
• Secondary ID: DE-2022C1-25666
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: August 2027

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Eva Schmitt, PhD
• Phone: 617-971-5390
• Email: EvaSchmitt[@]hsl.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan
United States	Meriter Hospital	Madison	Wisconsin
United States	Saddleback Medical Center	Orange	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	MaineHealth	Portland	Maine
United States	University of Utah	Salt Lake City	Utah

Sponsors (11)

Lead Sponsor	Collaborator
University of Michigan	Brandeis University, Hebrew SeniorLife, Indiana University, MaineHealth, MemorialCare Saddleback Medical Center, Patient-Centered Outcomes Research Institute, UnityPoint Health - Meriter Hospital, University of Pennsylvania, University of Utah, West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antipsychotic use	Proportion of participants in each group (%) requiring antipsychotic medications during hospitalization	Day of trial enrollment through day of hospital discharge, up to 14 days
Other	Restraint use	Proportion of participants in each group (%) requiring restraint use during hospitalization	Day of trial enrollment through day of hospital discharge, up to 14 days
Primary	Delirium Incidence	Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM)	Day of trial enrollment through day of hospital discharge, up to 14 days
Primary	Delirium Severity	Delirium severity score will be recorded using the Confusion Assessment Method Long Form Severity Score (CAM-S) (n, 0-19, with higher number indicating more severe delirium)	Day of trial enrollment through day of hospital discharge, up to 14 days
Secondary	Delirium Duration	The cumulative number of days (n) with a positive delirium screen will be calculated for all participants	Day of trial enrollment through day of hospital discharge, up to 14 days
Secondary	Persistent Delirium	Positive delirium screen (yes/no) 30 days after hospital discharge as determined by the long-form Confusion Assessment Method (AM)	30 days after hospital discharge
Secondary	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)	Day of trial enrollment through 30 days after discharge
Secondary	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)	Day of trial enrollment through 30 days after discharge
Secondary	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)	Hospital discharge through 30 days after discharge
Secondary	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)	Hospital discharge through 30 days after discharge
Secondary	Hospital Experience	Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey (n, 7-28, with higher score indicating better hospital experience)	Day of hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
Secondary	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.	Hospital discharge through 30 days after discharge
Secondary	Physical Function	Assessment of physical function via PROMIS Physical Short Form 10a (n, 10-50, with higher scores indicating better physical function).	30 days after hospital discharge
Secondary	Falls	Proportion of participants in each group (%) experiencing at least one fall	Day of trial enrollment through 30 days after hospital discharge
Secondary	Length of Hospital Stay	Total number of days (n) spent in the hospital	Day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)
Secondary	Discharge Disposition	Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility)	Day of hospital discharge through 30 days after discharge
Secondary	30-Day Readmission	Proportion of participants in each group (%) requiring hospital readmission	Day of hospital discharge through 30 days after discharge