Clinical trial NCT04235374: Implementation of Function Focused Care in Acute Care
Official title: Testing the Efficacy of FFC-AC-EIT in Patients With Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Acute Medical Event
Hospitalization
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Penn State University
First posted: 2020-01-21
Enrollment: 455
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized trial with treatment and control sites. Patients are followed for 12 months. Facilities are worked with for 12 months.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: After hospitals are recruited they will be randomized to cohort and randomly assigned to treatment so that the hospital will receive either FFC-AC-EIT or EO. FFC-AC-EIT is implemented by a Research Nurse Facilitator working with the stakeholder team and unit champions for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months. Timing of the intervention activities will be flexible based on the needs of the unit. The first meeting with the stakeholder team will be 1-2 hours and the remaining meetings will be approximately 30 minutes monthly to update the stakeholders on progress and any challenges associated with implementation of FFC-AC-EIT. The majority of the time on the unit by the Research Nurse Facilitator will be spent with the champions helping and assuring that they are engaging staff in function focused care activities via the four steps of FFC-AC-EIT. Once hospitals are randomized we will set up a time to meet with the identified contact to determine the stakeholder team members and champions and organize the first stakeholder team meeting. The first meeting will provide an overview of the implementation of Steps 1 to 4 \[(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families\] and will address the unit challenges to implementing function focused care using a Brainstorming approach. In the first two months the Research Nurse Facilitator completes the environment and policy assessments with the champions and implements appropriate changes on the units and plans and provides staff education and makes available information for patients and families/ caregivers. The education reviews function focused care. Ongoing work between the champions and the Research Nurse Facilitator focuses on motivating staff and patients to work toward achievement of patient goals and established unit goals. The stakeholder team will continue to meet with the Research Nurse Facilitator monthly (approximately 30 minutes) over the 12-month intervention period to review progress and to help champions overcome any identified multilevel challenges. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with ADRD in physical activity while hospitalized. To further facilitate implementation we will give each treatment site: 1) a 100 dollar gift certificate from Nasco (Nasco.com) to buy supplies for the unit to engage patients with ADRD in physical activities (e.g., age-appropriate weights; soft horseshoe toss game); 2) 1000 dollars at the end of the study for each champion to attend a conference and submit an abstract focused on optimizing function and physical activity of hospitalized older adults with ADRD. Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice.

Eligibility criteria: Inclusion Criteria:

1. are admitted into the hospital from any setting during the 12 month implementation period;
2. are 55 years of age or older;
3. are admitted onto a medical unit for any medical diagnosis; and
4. 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).

Exclusion Criteria:

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

Primary outcomes:
measure: Barthel Index
timeFrame: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
measure: The Physical Activity Survey
timeFrame: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
measure: Motionwatch8 data
timeFrame: Amount of time spent in activity during the hospital admission period (generally 3 days )
measure: Patient Checklist for Function Focused Care
timeFrame: Change between baseline to discharge from the hospital (approximately 3 days)
measure: The Confusion Assessment Method
timeFrame: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
measure: Delirium Rating Scale
timeFrame: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
measure: the Brief Neuropsychiatric Invesntory
timeFrame: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
measure: Pain in Advanced Dementia Scale (PAINAD)
timeFrame: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Secondary outcomes:
measure: Falls
timeFrame: Number of falls between admission to discharge; Number of falls in the first month post discharge; number of falls between the first month to sixth month post discharge; number of falls between 6 and 12th month
measure: hospitalizations
timeFrame: Number of hospitalizations in the 1st month post discharge; number of hospitalizations between the 1st month to 6th month post discharge; number of hospitalizations between 6th and 12th months post discharge
measure: Emergency room (ER) visits
timeFrame: Number of ER visits in the 1st month post discharge; number of ER visits between the 1st month to 6th month post discharge; number of ER visits between 6th and 12th months post discharge
measure: nursing home (NH) admissions
timeFrame: Number of NH admissions in the 1st month post discharge; number of NH admissions between the 1st month to 6th month post discharge; number of NH admissions between 6th and 12th months post discharge
Other outcomes:
Locations:
city: Annapolis
country: United States
facility: Luminus Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Baltimore Washington Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Hospital
state: Maryland
city: Baltimore
country: United States
facility: Midtown Hospital
state: Maryland
city: Glen Burnie
country: United States
facility: University of Maryland Baltimore Washington Medical Center
state: Maryland
city: Perryville
country: United States
facility: University of maryland Upper Chesapeake Hospital
state: Maryland
city: Towson
country: United States
facility: University of Maryland Saint Joseph Medical Center
state: Maryland
city: Abington
country: United States
facility: Jefferson Abbington
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Hospital
state: Pennsylvania
city: Lansdale
country: United States
facility: Jefferson Lansdale
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Lansdale (control);
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital University of Pennsylvania - Cedar Avenue
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Methodist
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hospital
state: Pennsylvania
Study officials:
affiliation: University of Maryland
name: Barbara Resnick, PhD
role: PRINCIPAL_INVESTIGATOR
References: