A Family-centered Intervention for Acutely-ill Persons With Dementia

Alzheimer Disease Clinical Trial

Official title: Reducing Disability Via a Family-centered Intervention for Acutely-ill Persons With Alzheimer's Disease and Related Dementias

Status Completed

Clinical Trial Summary

This study will address the effectiveness of Family-centered Function Focused Care (Fam-FFC). Fam-FFC is a theoretically-based approach to care in which family caregivers partner with nurses to prevent functional decline and other complications related to hospitalization in older adults with Alzheimer's disease and related dementias. A systematic care pathway promotes information-sharing and decision-making that promotes physical activity, function, and cognitive stimulation during the hospitalization and immediate post-acute period. Our goal in this work is to establish a practical and effective way to optimize function and physical activity; decrease neuropsychiatric symptoms, delirium, and depression; prevent avoidable post-acute care dependency; and prevent unnecessary rehospitalizations and long-stay nursing home admissions, while mitigating family caregiver strain and burden.

Clinical Trial Description

Older persons with Alzheimer's disease and related dementias (ADRD) are about two times as likely to be hospitalized as their peers who are cognitively healthy. The care of hospitalized persons with ADRD has traditionally focused on the acute medical problem that led to admission with little attention paid to functional recovery. Older persons with ADRD are at greater risk for functional decline and increased care dependency after discharge due to a combination of intrinsic factors, environmental, policy, and care practices that restrict physical and cognitive activity, and limited staff knowledge of dementia care. Family caregivers (CGs) can play an important role in promoting the functional recovery of hospitalized older adults. They can provide vital information, offer motivation and support of function-focused care, and assume responsibility in varying degrees for post-acute care delivery and coordination. Family-centered FFC (Fam-FFC) incorporates an educational empowerment model for family CGs provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an "enabling" milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery. In this patient/family-centered care approach, nurses purposefully engage family CGs in the assessment, decision-making, care delivery and evaluation of function-focused care during hospitalization and the 60-day post-acute period. In the proposed project, we will implement Fam-FFC in a cluster randomized trial of 438 patient/CG dyads in six hospital units randomized within three hospitals (73 dyads per unit) to accomplish the following aims: Aim 1: Validate the efficacy of Fam-FFC on physical function (ADLs/ performance and physical activity), delirium occurrence and severity, neuropsychiatric symptoms, and mood; Aim 2: Evaluate the impact of Fam-FFC on family CG-centered outcomes (preparedness for caregiving, strain, burden, and desire to institutionalize); and Aim 3: Evaluate the relative costs for Fam-FFC v. control condition, and calculate health care cost (post-acute health care utilization) and total cost savings for Fam-FFC. We will also evaluate the cultural appropriateness of Fam-FCC for diverse families in our sample. Dyads will be composed of community-residing, hospitalized medical patients with very mild to moderate dementia (0.5 to 2.0 on the Clinical Dementia Rating Scale) and their CG (defined as the primary person providing oversight and support on an ongoing basis). Outcomes will be evaluated at hospital admission, within 72 hours of discharge, and two and six months post-discharge. This study will be a critical next step in delineating how to partner with family CGs to change acute care approaches provided to patients with ADRD so as to optimize function after discharge, and promote delirium abatement and well-being in these individuals. The societal implications of helping older individuals with Alzheimer's disease and related dementias avoid functional decline are enormous in terms of aging in place, quality of life, cost, and caregiver burden. The study findings will be relevant for other areas of behavior change research in acute care, specifically those related to engaging patients and families in health care planning, delivery, and evaluation. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

• NCT number: NCT03046121
• Study type: Interventional
• Source: Penn State University
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Completion date: December 23, 2023