Implementation of Function Focused Care in Acute Care

Dementia Clinical Trial

Official title:

Testing the Efficacy of FFC-AC-EIT in Patients With Alzheimer's Disease and Related Dementias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235374
• Other study ID #: 00089301
• Secondary ID: R01AG065338-01
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: University of Maryland, Baltimore
• Contact: barbara resnick, PhD
• Phone: 4107065178
• Email: resnick[@]umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Medical Event
• Dementia
• Hospitalization

Intervention

Behavioral:
• FFC-AC-EIT
The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute on Aging (NIA), Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel Index	A measure of activities of daily living with scores ranging from 0 to 100 and higher scores indicating better function	change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Primary	The Physical Activity Survey	Overall daily physical activity with scores indicating the amount of time in activity	change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Primary	Motionwatch8 data	Actigraphy data that includes minutes of sedentary, moderate and vigorous activity	Amount of time spent in activity during the hospital admission period (generally 3 days )
Primary	Patient Checklist for Function Focused Care	Patient participation in care related activities with a total possible of 19 activities and higher scores indicating more participation in function focused care	Change between baseline to discharge from the hospital (approximately 3 days)
Primary	The Confusion Assessment Method	An assessment for evidence of delirium with scores ranging from 0 to 7 and higher scores indicating more confusion	change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Primary	Delirium Rating Scale	An assessment of the intensity of the delirium with scors ranging from 0 to 30 and higher scores indicating more severe delirium	change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Primary	the Brief Neuropsychiatric Invesntory	Assessment of behavioral symptoms associated with dementia (e.g., apathy, anxiety, depression) with scores ranging from 0 to 186 and higher scores indicative of more behavioral and psychological symptoms associated with dementia.	change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Primary	Pain in Advanced Dementia Scale (PAINAD)	An objective measure of pain that ranges from 0 to 10 with higher scores indicative of more pain.	change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Secondary	Falls	numbers of falls	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
Secondary	hospitalizations	number of hospitalizations	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
Secondary	Emergency room (ER) visits	number of emergency room (ER) visits	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
Secondary	nursing home (NH) admissions	number of new nursing home (NH) admissions	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