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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium; Neurocognitive Disorders; Alzheimer Disease; Caregiver Burden; Aging; Mild Cognitive Impairment; Patient Satisfaction; Implementation Science; Family Members; Family Support
• Intervention / Treatment: Behavioral: HELP; Behavioral: FAM-HELP

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 Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Schmitt, PhD; Phone Number: 617-971-5390; Email: EvaSchmitt@hsl.harvard.edu

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Saddleback Medical Center
      • Contact: Jessica Dela Rosa, MSN, MBA; Phone Number: 949-607-6030; Email: jdelarosa2@memorialcare.org
  • Maine
    • Portland, Maine, United States, 04102
      • Recruiting
      • MaineHealth
      • Contact: Emily Carter, MD; Phone Number: 207-662-3157; Email: Emily.Carter1@mainehealth.org
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • Michigan Medicine
      • Contact: Jocelyn Wiggins, MD; Phone Number: 734-647-7299; Email: wiggi@med.umich.edu
      • Contact: Shenbagam Dewar, MBBS; Phone Number: 734-647-7299; Email: sdewar@med.umich.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Rebecca Trotta, PhD; Phone Number: 215-615-4925; Email: Rebecca.Trotta@pennmedicine.upenn.edu
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny General Hospital
      • Contact: Lyn Weinberg, MD; Phone Number: 412-235-5810; Email: Lyn.WEINBERG@ahn.org
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah
      • Contact: Mark Supiano, MD; Phone Number: 801-587-9103; Email: mark.supiano@utah.edu
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Recruiting
      • Meriter Hospital
      • Contact: Carrie Bennett, DNP; Phone Number: 608-417-5724; Email: carrie.bennett@unitypoint.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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)
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
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
Falls	Proportion of participants in each group (%) experiencing at least one fall	Day of trial enrollment through 30 days after hospital discharge
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)
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
30-Day Readmission	Proportion of participants in each group (%) requiring hospital readmission	Day of hospital discharge through 30 days after discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Patient-Centered Outcomes Research Institute; University of Pennsylvania; University of Utah; West Penn Allegheny Health System; Indiana University; MaineHealth; Hebrew SeniorLife; Brandeis University; UnityPoint Health - Meriter Hospital; MemorialCare Saddleback Medical Center
• Investigators: Principal Investigator: Phillip E Vlisides, MD, University of Michigan; Principal Investigator: Sharon K Inouye, MD, Hebrew SeniorLife

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Clinical Trial; Delirium; Implementation Science; Comparative Effectiveness Research
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurodegenerative Diseases; Stress, Psychological; Dementia; Tauopathies; Cognition Disorders; Delirium; Alzheimer Disease; Cognitive Dysfunction; Caregiver Burden; Neurocognitive Disorders
• Other Study ID Numbers: HUM00227397; DE-2022C1-25666 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No