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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2023-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementation of Function Focused Care in Acute Care

NCT04235374

Dementia Acute Medical Event Hospitalization

COMPLETED NA

Dissemination and Implementation of Function Focused Care for Assisted Living

NCT03459118

Dementia Pain

COMPLETED NA

Function Focused Care: Fracture Care at Home

NCT03147222

Fractures, Bone Dementia

COMPLETED NA

Reducing Behavioral and Psychological Symptoms of Dementia: Hospital Caregivers (Aim 2)

NCT04179721

Alzheimer's Disease and Related Dementias

COMPLETED NA

Promoting Positive Care Interactions (PPCI) in Assisted Living

NCT05618834

Alzheimer Disease and Related Dementias

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fam-FFC

The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan.

Group Type EXPERIMENTAL

Family-centered Function-focused Care (Fam-FFC)

Intervention Type BEHAVIORAL

An educational empowerment model for family CGs that includes a care pathway, 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 during hospitalization and the immediate post-acute period.

Attention Control (Fam- FFC Ed-only)

Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Family-centered Function-focused Care (Fam-FFC)

An educational empowerment model for family CGs that includes a care pathway, 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 during hospitalization and the immediate post-acute period.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Staff nurses (at the conclusion of the intervention at each site) who identify the intervention unit as the primary unit worked, and speak English or Spanish, will be included in focus groups

For the exploratory aim of assessing the cultural appropriateness of the intervention, we will recruit family caregivers who self-identify as black, Latino, Asian and white, randomly selected from the Fam-FFC sample. Approximately 10 percent of families from each ethnic group represented in the study will be approached for consent for participation in interviews. (If theoretical saturation is not reached, interviews will continue until saturation is reached). Additionally, the six nurse champions will be consented and interviewed after the study ends in his/her particular unit/setting to provide their perspective on the cultural appropriateness of Fam-FFC.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No