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.
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
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)
Parallel
HELP
BehavioralThis 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.
FAM-HELP
BehavioralFamily 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.
Delirium Incidence
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
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.
Delirium Duration
The cumulative number of days (n) with a positive delirium screen will be calculated for all participants
Persistent Delirium
Positive delirium screen (yes/no) 30 days after hospital discharge as determined by the long-form Confusion Assessment Method (AM)
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)
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)
Antipsychotic use
Proportion of participants in each group (%) requiring antipsychotic medications during hospitalization
Restraint use
Proportion of participants in each group (%) requiring restraint use during hospitalization
Mortality
Incidence (%)
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University of Michigan
Lead sponsor
Hebrew SeniorLife
Collaborator
MaineHealth
Collaborator
University of Pennsylvania
Collaborator
West Penn Allegheny Health System
Collaborator
UnityPoint Health - Meriter Hospital
Collaborator
University of Utah
Collaborator
MemorialCare Saddleback Medical Center
Collaborator
Brandeis University
Collaborator
Indiana University
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
