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

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05929703

Collaborator

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

3,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

428.6

Patients Per Site

9.1

Patients Per Site Per Month

Study Details

Study Description

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:

To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity.
To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes.
To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.

Condition or Disease	Intervention/Treatment	Phase
Delirium Neurocognitive Disorders Mild Cognitive Impairment Alzheimer Disease Aging Family Support Family Members Caregiver Burden Implementation Science Patient Satisfaction	Behavioral: HELP Behavioral: FAM-HELP	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Stepped-wedge, cluster randomizedStepped-wedge, cluster randomized

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

May 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	Behavioral: 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.

Arm

Intervention/Treatment

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.

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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Delirium Incidence [Day of trial enrollment through day of hospital discharge, up to 14 days]
Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM)
Delirium Severity [Day of trial enrollment through day of hospital discharge, up to 14 days]
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)

Secondary Outcome Measures

Delirium Duration [Day of trial enrollment through day of hospital discharge, up to 14 days]
The cumulative number of days (n) with a positive delirium screen will be calculated for all participants
Persistent Delirium [30 days after hospital discharge]
Positive delirium screen (yes/no) 30 days after hospital discharge as determined by the long-form Confusion Assessment Method (AM)
Delirium Burden - Patient [Day of trial enrollment through 30 days after discharge]
Delirium burden will be calculated using the Patient Delirium Burden Scale (DEL-B-P) (n, 0-40, with higher number indicating more severe burden)
Delirium Burden - Family and Care Partners [Day of trial enrollment through 30 days after discharge]
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)
Caregiving Strain [Hospital discharge through 30 days after discharge]
Strain associated with patient caregiving will be assessed via Modified Caregiver Strain Index (MCSI) (n, 0-26, with higher number indicating more caregiver strain)
Cognitive Function - Subjective Reporting [Hospital discharge through 30 days after discharge]
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 Experience [Day of hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)]
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey (n, 7-28, with higher score indicating better hospital experience)
Global Health [Hospital discharge through 30 days after discharge]
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.
Physical Function [30 days after hospital discharge]
Assessment of physical function via PROMIS Physical Short Form 10a (n, 10-50, with higher scores indicating better physical function).
Falls [Day of trial enrollment through 30 days after hospital discharge]
Proportion of participants in each group (%) experiencing at least one fall
Length of Hospital Stay [Day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)]
Total number of days (n) spent in the hospital
Discharge Disposition [Day of hospital discharge through 30 days after discharge]
Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility)
30-Day Readmission [Day of hospital discharge through 30 days after discharge]
Proportion of participants in each group (%) requiring hospital readmission

Other Outcome Measures

Antipsychotic use [Day of trial enrollment through day of hospital discharge, up to 14 days]
Proportion of participants in each group (%) requiring antipsychotic medications during hospitalization
Restraint use [Day of trial enrollment through day of hospital discharge, up to 14 days]
Proportion of participants in each group (%) requiring restraint use during hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saddleback Medical Center	Orange	California	United States	92868
2	MaineHealth	Portland	Maine	United States	04102
3	Michigan Medicine	Ann Arbor	Michigan	United States	48109
4	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
5	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
6	University of Utah	Salt Lake City	Utah	United States	84132
7	Meriter Hospital	Madison	Wisconsin	United States	53715