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Implementation of Function Focused Care in Acute Care

Primary Purpose

Dementia, Acute Medical Event, Hospitalization

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FFC-AC-EIT
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Luminus Anne Arundel Medical CenterRecruiting
  • University of Maryland Baltimore Washington Medical Center
  • University of Maryland Hospital
  • Midtown Hospital
  • University of Maryland Baltimore Washington Medical Center
  • University of maryland Upper Chesapeake Hospital
  • University of Maryland Saint Joseph Medical Center
  • Jefferson Abbington
  • Lancaster Hospital
  • Jefferson Lansdale
  • Jefferson Lansdale (control);
  • Hospital University of Pennsylvania - Cedar Avenue
  • Jefferson Methodist
  • Chester County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FFC-AC-EIT

Education Only

Arm Description

The stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion 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 to implement Steps 1 to 4 of FFC-AC-EIT [(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. 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.

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.

Outcomes

Primary Outcome Measures

Barthel Index
A measure of activities of daily living with scores ranging from 0 to 100 and higher scores indicating better function
The Physical Activity Survey
Overall daily physical activity with scores indicating the amount of time in activity
Motionwatch8 data
Actigraphy data that includes minutes of sedentary, moderate and vigorous activity
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
The Confusion Assessment Method
An assessment for evidence of delirium with scores ranging from 0 to 7 and higher scores indicating more confusion
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
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.
Pain in Advanced Dementia Scale (PAINAD)
An objective measure of pain that ranges from 0 to 10 with higher scores indicative of more pain.

Secondary Outcome Measures

Falls
numbers of falls
hospitalizations
number of hospitalizations
Emergency room (ER) visits
number of emergency room (ER) visits
nursing home (NH) admissions
number of new nursing home (NH) admissions

Full Information

First Posted
January 15, 2020
Last Updated
August 2, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Aging (NIA), Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT04235374
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Aging (NIA), Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Acute Medical Event, Hospitalization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized trial with treatment and control sites. Patients are followed for 12 months. Facilities are worked with for 12 months.
Masking
Participant
Masking Description
Participants as hospitals will be randomized to treatment or control
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFC-AC-EIT
Arm Type
Experimental
Arm Description
The stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion 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 to implement Steps 1 to 4 of FFC-AC-EIT [(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. 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.
Arm Title
Education Only
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FFC-AC-EIT
Other Intervention Name(s)
FFC-AC-EO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Barthel Index
Description
A measure of activities of daily living with scores ranging from 0 to 100 and higher scores indicating better function
Time Frame
change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Title
The Physical Activity Survey
Description
Overall daily physical activity with scores indicating the amount of time in activity
Time Frame
change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Title
Motionwatch8 data
Description
Actigraphy data that includes minutes of sedentary, moderate and vigorous activity
Time Frame
Amount of time spent in activity during the hospital admission period (generally 3 days )
Title
Patient Checklist for Function Focused Care
Description
Patient participation in care related activities with a total possible of 19 activities and higher scores indicating more participation in function focused care
Time Frame
Change between baseline to discharge from the hospital (approximately 3 days)
Title
The Confusion Assessment Method
Description
An assessment for evidence of delirium with scores ranging from 0 to 7 and higher scores indicating more confusion
Time Frame
change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Title
Delirium Rating Scale
Description
An assessment of the intensity of the delirium with scors ranging from 0 to 30 and higher scores indicating more severe delirium
Time Frame
change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Title
the Brief Neuropsychiatric Invesntory
Description
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.
Time Frame
change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Title
Pain in Advanced Dementia Scale (PAINAD)
Description
An objective measure of pain that ranges from 0 to 10 with higher scores indicative of more pain.
Time Frame
change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Secondary Outcome Measure Information:
Title
Falls
Description
numbers of falls
Time Frame
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
Title
hospitalizations
Description
number of hospitalizations
Time Frame
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
Title
Emergency room (ER) visits
Description
number of emergency room (ER) visits
Time Frame
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
Title
nursing home (NH) admissions
Description
number of new nursing home (NH) admissions
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
barbara resnick, PhD
Phone
4107065178
Email
resnick@umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Boltz, PhD
Phone
18148620245
Email
mpb40@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Resnick, PhD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luminus Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathaleen Ley, PhD
Facility Name
University of Maryland Baltimore Washington Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Completed
Facility Name
University of Maryland Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Completed
Facility Name
Midtown Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
Individual Site Status
Completed
Facility Name
University of Maryland Baltimore Washington Medical Center
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Individual Site Status
Completed
Facility Name
University of maryland Upper Chesapeake Hospital
City
Perryville
State/Province
Maryland
ZIP/Postal Code
21903
Country
United States
Individual Site Status
Completed
Facility Name
University of Maryland Saint Joseph Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Completed
Facility Name
Jefferson Abbington
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Completed
Facility Name
Lancaster Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Individual Site Status
Completed
Facility Name
Jefferson Lansdale
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Individual Site Status
Completed
Facility Name
Jefferson Lansdale (control);
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Individual Site Status
Completed
Facility Name
Hospital University of Pennsylvania - Cedar Avenue
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19143
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Boltz, PhD
Phone
215-748-9000
Email
mpb40@psu.edu
Facility Name
Jefferson Methodist
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Individual Site Status
Completed
Facility Name
Chester County Hospital
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

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Implementation of Function Focused Care in Acute Care

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