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

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

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.

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.

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

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.

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.

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.

Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM)

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)

The cumulative number of days (n) with a positive delirium screen will be calculated for all participants

Positive delirium screen (yes/no) 30 days after hospital discharge as determined by the long-form Confusion Assessment Method (AM)

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 will be calculated using the Patient Delirium Family Caregiver Scale (DEL-B-C) (n, 0-40, with higher number indicating more severe burden)

Strain associated with patient caregiving will be assessed via Modified Caregiver Strain Index (MCSI) (n, 0-26, with higher number indicating more caregiver strain)

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 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)

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.

Assessment of physical function via PROMIS Physical Short Form 10a (n, 10-50, with higher scores indicating better physical function).

Day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)

Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility)

Proportion of participants in each group (%) requiring antipsychotic medications during hospitalization

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)