NCT Number: NCT05929703
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.
Interested in participating?
Request Info70 year and older
All sexes
Interventional
Not applicable
Saddleback Medical Center, Orange, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: Day of trial enrollment through 30 days after hospital discharge
Proportion of participants in each group (%) experiencing at least one fall
Time frame: 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
Time frame: 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)
Time frame: Day of hospital discharge through 30 days after discharge
Proportion of participants in each group (%) requiring hospital readmission
Time frame: Day of trial enrollment through day of hospital discharge, up to 14 days
Proportion of participants in each group (%) requiring antipsychotic medications during hospitalization
Time frame: Day of trial enrollment through day of hospital discharge, up to 14 days
Proportion of participants in each group (%) requiring restraint use during hospitalization
Time frame: Day of trial enrollment through 30 days after discharge
Incidence (%)
Contact information is provided by the study sponsor or research team.
University of Michigan
Other
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)
Acronym: ENHANCE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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