Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Delirium, Neurocognitive Disorders, Mild Cognitive Impairment, Alzheimer Disease, Aging, Family Support, Family Members, Caregiver Burden, Implementation Science, Patient Satisfaction

Intervention / Treatment
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* Behavioral: HELP
* Behavioral: FAM-HELP


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped-wedge, cluster randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hospital Elder Life Program (HELP)<br>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<br>* 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.<br>|
| Active Comparator: Family-Augmented Hospital Elder Life Program (FAM-HELP)<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Clinical Trial, Comparative Effectiveness Research, Implementation Science