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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046121
• Other study ID #: R01AG054425
• Secondary ID: R01AG054425
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: December 23, 2023

Study information

• Verified date: May 2024
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: December 23, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Patient Inclusion Criteria: medical patients who: are age =65, speak English or Spanish, live in the community prior to admission to the hospital, screen positive for dementia on well-validated scales (Montreal Cognitive Assessment {MoCA} = 25 123-127 and AD8 >2 128,129), and score 0.5 to 2.0 on the Clinical Dementia Rating Scale; and have a family CG as the designated study partner for the duration of the study.

Patient Exclusion Criteria: mild cognitive impairment (CDR 0.5 without functional or ADL impairments), severe dementia (CDR 3), any significant neurological condition associated with cognitive impairment other than dementia (e.g. brain tumor), a major acute psychiatric disorder, have no family caregiver to participate, are enrolled in hospice and/or have a life expectancy of six months or less, are admitted from a nursing home, or experience transfers to another unit for stays longer than 48 hours.

Family Inclusion Criteria: age 18 and above whose relatives meet inclusion criteria will be eligible if they can speak and read English or Spanish; and are related to the patient by blood, marriage, adoption, or affinity as a significant other (defined as or by the patient/legally authorized person as the primary person providing oversight and support on an ongoing basis); participate, at a minimum, in the initial assessment and development of FamPath; and able to recall at least two words on the MiniCog

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Lancaster General Medical Center	Lancaster	Pennsylvania
United States	Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Chester County Hospital	West Chester	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Penn State University	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Care Cost	cost equals staff and research nurse time (hours worked and training time) to conduct intervention.	end of intervention at each study site, 12 months after enrollment initiated
Primary	Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge).	Assessed using the Barthel Index, comparing the change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge. Return to baseline physical function (yes/no) was scored as yes if the participant's functional status was the same as baseline, within five points or less than baseline, or greater than baseline. Scores ranged from 0 to 1, with higher scores representing better outcomes.	Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge
Primary	Caregiver Preparedness	Assessed by the Preparedness for Caregiving Scale with scores ranging from 0 to 4 and higher scores indicating greater perceived preparedness.	Discharge and 2 and 6 months post-discharge
Secondary	Delirium Severity	Assessed by the Confusion Assessment Method Short Form with scores ranging from 0-7 and higher scores indicating more delirium severity.	Admission, Discharge, 2 and 6 months post-discharge
Secondary	Behavior	Assessed by the Brief Neuropsychiatric Inventory with scores ranging from 0 to 36 and higher scores indicating greater behavioral and psychological symptoms of dementia.	Admission, Discharge, 2 and 6 months post-discharge
Secondary	Moderate Physical Activity Level	Actigraphy data, measured by the MotionWatch 8, includes minutes spent in moderate activity.	admission, discharge, 2 and 6 months post-discharge
Secondary	Depression	Assessed by the Cornell Scale for Depression in Dementia with total scores ranging between 0 to 38 and higher scores indicate more depressive symptoms.	admission, discharge, 2 and 6 months post-discharge
Secondary	Caregiver Strain	Assessed by the Modified Caregiver Strain Index with total scores ranging from 0 to 26 and higher scores indicating greater caregiver strain.	Discharge and 2 and 6 months post-discharge
Secondary	Caregiver Burden	Assessed using the Short Form Zarit Burden Interview with total scores total scores ranging from 0 to 48, with higher scores corresponding to higher levels of caregiver burden.	Discharge and 2 and 6 months post discharge.
Secondary	Caregiver Anxiety	Assessed by the Hospital Anxiety and Depression subscale with total scores ranging from 0 to 21 and higher scores indicating greater levels of caregiver anxiety.	Discharge and 2 and 6 months
Secondary	Falls	Number of falls a week after hospital discharge and 2 and 6 months post discharge.	discharge and 2 and 6 months
Secondary	Hospitalizations	Number of hospitalizations within a week after discharge; number of hospitalizations between discharge to 2 months post-discharge; number of hospitalizations between 2 months post-discharge and 6 months post-discharge.	discharge and 2 and 6 months
Secondary	Emergency Room (ER) Visits	Number of ER visits within a week after discharge; number of ER visits between discharge to 2 months post-discharge; number of ER visits between 2 months post-discharge and 6 months post-discharge.	discharge and 2 and 6 months