Implementation of Function Focused Care in Acute Care

Completed · Not applicable

Conditions studied: Dementia, Acute Medical Event, Hospitalization

In brief

Older adults with Alzheimer's Disease and Related Dementias (ADRD) comprise approximately 25% of hospitalized older adults. These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay. Physical activity during hospitalization (e.g., mobility,bathing, dressing) has a positive impact on older adults including prevention of functional decline, less pain, less delirium, less BPSD, fewer falls, shorter length of stay and decreased unplanned hospital readmissions. Despite known benefits, physical activity is not routinely encouraged and older hospitalized patients spend over 80% of their acute care stay in bed. Challenges to increasing physical activity among older patients with ADRD include environment and policy issues (e.g., lack of access to areas to walk); lack of knowledge among nurses on how to evaluate, prevent and manage delirium and BPSD; inappropriate use of tethers; beliefs among patients, families, and nurses that bed rests helps recovery and prevents falls; and lack of motivation/willingness of patients to get out of bed. To increase physical activity and prevent functional decline while hospitalized we developed Function Focused Care for Acute Care (FFC-AC-EIT) for patients with ADRD. Implementation of FFC-AC-EIT changes how care is provided by having nurses teach, cue, and help patients with ADRD engage in physical activity during all care interactions. FFC-AC-EIT was developed using a social ecological model, social cognitive theory and the Evidence Integration Triangle. It involves a four-step approach that includes: (1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families. The purpose of this study is to test the efficacy of FFC-AC-EIT within 12 hospitals in Maryland and Pennsylvania randomized to FFC-AC-EIT or Function Focused Care Education Only (EO) with 50 patients recruited per hospital (total sample 600 patients). Aim 1 will focus on efficacy at the patient level based primarily on physical activity, function, and participation in function focused care, and secondarily on delirium, BPSD, pain, falls, use of tethers, and length of stay; and all of these outcomes (except length of stay and tethers) along with emergency room visits, re-hospitalizations and new long term care admissions at 1, 6 and 12 months post discharge; and at the unit level the aim is to evaluate the impact of FFC-AC-EIT on policies and environments that facilitate function and physical activity at 6, 12 and 18 months post implementation. Hospitals randomized to FFC-AC-EIT will be compared with those randomized to Function Focused Care Education Only (EO). Aim 2 will evaluate the feasibility, based on treatment fidelity (delivery, receipt, enactment)136, and relative cost and cost savings of FFC-AC-EIT versus EO. Findings will address several prioritized areas of research: a focus on ADRD; improving physical function; and training of hospital staff and will demonstrate efficacy of an approach to care for patients with ADRD that can be disseminated and implemented across all acute care facilities.

Key facts

Study ID: NCT04235374
Run by: University of Maryland, Baltimore
People needed: 455
Starts: 2020-10-19
Expected to finish: 2025-05-14
Last updated by the study team: 2025-08-05

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

are admitted into the hospital from any setting during the 12 month implementation period;
are 55 years of age or older;
are admitted onto a medical unit for any medical diagnosis; and
screen positive for dementia based on two well-validated scales: a score of ≤ 25 on the Montreal Cognitive Assessment (MoCA) and a score of >2 on the AD8 Dementia Screening Interview; have mild to moderate stage dementia based a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale (CDR); and lastly to differentiate between dementia and mild cognitive impairment eligibility is based on evidence of functional impairment with a score of 9 or greater on the Functional Activities Questionnaire (FAQ).

You may not qualify if…

are enrolled in Hospice;
have been on the unit for greater than 48 hours;
do not have a family member/caregiver that we can contact;
anticipate surgery; or
have a major acute psychiatric disorder, or significant neurological condition associated with cognition other than dementia.

Where it is running

Luminus Anne Arundel Medical Center — Annapolis, Maryland, United States
University of Maryland Baltimore Washington Medical Center — Baltimore, Maryland, United States
University of Maryland Hospital — Baltimore, Maryland, United States
Midtown Hospital — Baltimore, Maryland, United States
University of Maryland Baltimore Washington Medical Center — Glen Burnie, Maryland, United States
University of maryland Upper Chesapeake Hospital — Perryville, Maryland, United States
University of Maryland Saint Joseph Medical Center — Towson, Maryland, United States
Jefferson Abbington — Abington, Pennsylvania, United States
Lancaster Hospital — Lancaster, Pennsylvania, United States
Jefferson Lansdale — Lansdale, Pennsylvania, United States
Jefferson Lansdale (control); — Philadelphia, Pennsylvania, United States
Hospital University of Pennsylvania - Cedar Avenue — Philadelphia, Pennsylvania, United States
Jefferson Methodist — Philadelphia, Pennsylvania, United States
Chester County Hospital — West Chester, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.