Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое HELP
  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.
• Поведенческое FAM-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

Первичные конечные точки

• Delirium Incidence [Срок оценки: Day of trial enrollment through day of hospital discharge, up to 14 days]
• Delirium Severity [Срок оценки: Day of trial enrollment through day of hospital discharge, up to 14 days]

Вторичные конечные точки (12)

• Delirium Duration [Срок оценки: Day of trial enrollment through day of hospital discharge, up to 14 days]
• Persistent Delirium [Срок оценки: 30 days after hospital discharge]
• Delirium Burden - Patient [Срок оценки: Day of trial enrollment through 30 days after discharge]
• Delirium Burden - Family and Care Partners [Срок оценки: Day of trial enrollment through 30 days after discharge]
• Caregiving Strain [Срок оценки: Hospital discharge through 30 days after discharge]
• Cognitive Function - Subjective Reporting [Срок оценки: Hospital discharge through 30 days after discharge]
• Hospital Experience [Срок оценки: Day of hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)]
• Global Health [Срок оценки: Hospital discharge through 30 days after discharge]
• Physical Function [Срок оценки: 30 days after hospital discharge]
• Falls [Срок оценки: Day of trial enrollment through 30 days after hospital discharge]
• Length of Hospital Stay [Срок оценки: Day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)]
• Discharge Disposition [Срок оценки: Day of hospital discharge through 30 days after discharge]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 7 центров

• Saddleback Medical Center — Orange
• MaineHealth — Portland
• Michigan Medicine — Ann Arbor
• Hospital of the University of Pennsylvania — Philadelphia
• Allegheny General Hospital — Pittsburgh
• University of Utah — Salt Lake City
• Meriter Hospital — Madison

Идентификаторы

NCT: NCT05929703 · HUM00227397 · DE-2022C1-25666

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗