Aging, Alzheimer Disease, Caregiver Burden, Delirium, Family Members, Family Support, Implementation Science, Mild Cognitive Impairment, Neurocognitive Disorders, Patient Satisfaction
Conditions
Keywords
Delirium, Clinical Trial, Comparative Effectiveness Research, Implementation Science
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.
Interventions
BEHAVIORALHELP
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.
BEHAVIORALFAM-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.
Sponsors
University of Michigan
Hebrew SeniorLife
MaineHealth
University of Pennsylvania
West Penn Allegheny Health System
UnityPoint Health - Meriter Hospital
University of Utah
MemorialCare Saddleback Medical Center
Brandeis University
Indiana University
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Stepped-wedge, cluster randomized
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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) * Active neurologic disease (as primary reason for admission)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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), supplemented by a validated chart review approach for delirium. |
| Delirium Severity | Day of trial enrollment through day of hospital discharge, up to 14 days | Delirium severity will be scored using the Confusion Assessment Method Long Form Severity Score (CAM-S) (n, 0-19, with higher number indicating more severe delirium). Score derived from the same CAM instrument and items used for delirium incidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTEva Schmitt, PhD
PRINCIPAL_INVESTIGATORSharon K Inouye, MD
Hebrew SeniorLife
PRINCIPAL_INVESTIGATORPhillip E Vlisides, MD
University of Michigan
Outcome results
None listed