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Testing the Implementation of EIT-4-BPSD (EIT-4_BPSD)

Primary Purpose

Dementia, Behavioral and Psychological Symptoms of Dementia (BPSD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EIT-4-BPSD
Education-only Control
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring behavior,, apathy, mood, function, cognition

Eligibility Criteria

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

Inclusion Criteria:

Living in the nursing home; 55 years of age or older; score 0-12 on the Brief Interview of Mental Status

Exclusion Criteria:

  • Enrolled in hospice
  • in the nursing home for short stay rehabilitation

Sites / Locations

  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Education-Only Control

EIT-4-BPSD

Arm Description

This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.

This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.

Outcomes

Primary Outcome Measures

Physical Function as Determined by Barthel Index
The Barthel index has a score range of 0-100 with higher scores indicating higher physical function
Depression as Determined by the Cornell Scale for Depression in Dementia
The Cornell scale ranges from 0-19 with higher scores representing more depressive symptoms
Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)
The CMAI score ranges from 0-70 with higher scores indicating more agitation

Secondary Outcome Measures

Full Information

First Posted
January 4, 2017
Last Updated
March 5, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT03014570
Brief Title
Testing the Implementation of EIT-4-BPSD
Acronym
EIT-4_BPSD
Official Title
Testing the Implementation of EIT-4-BPSD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Penn State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pragmatic trial focuses on implementation of an evidence based process to increase person-centered management of behavioral and psychological symptoms of dementia (BPSD) in nursing homes, referred to as EIT-4-BPSD. The findings from this study will add to what is known about implementation of effective interventions in nursing homes, will serve as a model for other programs and care approaches, and will help facilities and staff implement quality person-centered care, which is the goal of the National Partnership to Improve Dementia Care and Reduce Antipsychotic Use in Nursing Homes.
Detailed Description
Behavioral and Psychological Symptoms of Dementia (BPSD) include aggression, agitation, depression, anxiety, apathy and hallucinations and are exhibited by up to 90% of nursing facility residents with dementia. BPSD result in negative health outcomes decline in physical functioning and high cost of care. In addition, BPSD put residents at risk for inappropriate use of antipsychotic drugs and other restraining methods that reduce function, increase social isolation, and increase risk of physical abuse. Prior NIH-funded clinical trials show that behavioral approaches reduce BPSD. These behavioral approaches are endorsed as the first line of treatment for BPSD. In fact, the Centers for Medicare and Medicaid Services (CMS) National Partnership to Improve Dementia Care and Reduce Antipsychotic Use in Nursing Homes requires that care for residents with dementia be delivered using person-centered behavioral approaches. Despite regulatory requirements, less than 2% of nursing homes (also referred to as facilities) consistently implement these approaches. Established barriers to use of behavioral approaches include limited knowledge, skills, and experience with non-pharmacological approaches, beliefs in the superiority of psychotropic medications over behavioral interventions, and lack of staff motivation to use non-pharmacologic strategies consistently. The proposed project responds to this gap between knowledge and practice. A novel implementation approach will be tested to assure that staff in nursing homes [i.e., those who provide direct care to residents] use non-pharmacologic, behavioral approaches for the management of BPSD. To advance the CMS National Partnership, a comprehensive compendium of peer-reviewed/expert-endorsed resources was developed for utilizing person-centered, behavioral approaches for BPSD (the Nursing Home Toolkit: www.nursinghometoolkit.com). The Toolkit has resources that support a theoretically-based 4-step approach that we found effective in prior implementation work. The four steps include: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. While the Toolkit is free and accessible, staff in nursing homes need help with implementation. Implementation of the theoretically based 4-step approach is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals. This implementation framework was merged with the 4-step approach and the Nursing Home Toolkit resources to develop the intervention, EIT-4-BPSD. The goal is to demonstrate that EIT-4-BPSD is an implementation strategy that enables staff in nursing homes to reduce BPSD using behavioral approaches while optimizing function, preventing adverse events and improving quality of life of residents. A Hybrid III cluster randomized trial will be done with 50 nursing facilities randomized to EIT-4-BPSD or Education Only (EO). The aims are: Primary Aim 1: To implement and test the implementation of EIT-4-BPSD. Facility Level Outcome: Research question: Do facilities exposed to EIT-4-BPSD demonstrate evidence of implementation at 12 months evaluated by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) criteria? For evaluation of Effectiveness within RE-AIM: Resident Level Outcomes: Hypothesis: Residents in EIT-4-BPSD facilities will experience less BPSD, maintain or improve function, have reduced use of psychotropic medications, experience fewer adverse events, and have improved quality of life compared to residents in EO facilities. We will measure these outcomes at baseline, 4 and 12 months post implementation of the intervention. Facility Level Outcomes: Hypotheses: (1) EIT-4-BPSD facilities will demonstrate improvements in Environment and Policy assessments that reflect support for behavioral approaches for BPSD, and will have a greater percentage of residents with behavioral approaches incorporated into their care plans at 12 months post-implementation when compared to EO facilities; (2) We will examine Maintenance of EIT-4-BPSD facility outcomes at 12 months and then at 24 months post-implementation. Primary Aim 2: Evaluation of the Feasibility, Utility and Cost of EIT Approach in EIT-4-BPSD Facilities. Using descriptive and qualitative data captured during the intervention and from focus groups at 12 months,use of the EIT strategy and the participatory implementation process with the Stakeholder Team and facility staff will be evaluated. In addition a description of the costs of implementation using an activity-based costing method will be completed. This study will add critical knowledge to what little is known about implementation of effective interventions in nursing facilities. It will serve as an implementation model with potential to be widely disseminated. In addition, the study will demonstrate how facilities can implement person-centered dementia care and decrease BPSD, the ultimate goal of the CMS National Partnership.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Behavioral and Psychological Symptoms of Dementia (BPSD)
Keywords
behavior,, apathy, mood, function, cognition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
553 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education-Only Control
Arm Type
Active Comparator
Arm Description
This arm includes the education provided to all sites (this is Step 2 of the EIT-4-BPSD intervention). The sites are given the opportunity to decide how they want the education around management of behavioral symptoms to occur-face-to-face by a research staff member, via a powerpoint they can use on their own or via a webinar.
Arm Title
EIT-4-BPSD
Arm Type
Experimental
Arm Description
This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
Intervention Type
Behavioral
Intervention Name(s)
EIT-4-BPSD
Intervention Description
This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
Intervention Type
Behavioral
Intervention Name(s)
Education-only Control
Intervention Description
This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.
Primary Outcome Measure Information:
Title
Physical Function as Determined by Barthel Index
Description
The Barthel index has a score range of 0-100 with higher scores indicating higher physical function
Time Frame
Baseline, 4 months and 12 months
Title
Depression as Determined by the Cornell Scale for Depression in Dementia
Description
The Cornell scale ranges from 0-19 with higher scores representing more depressive symptoms
Time Frame
Baseline, 4 months, 12 months
Title
Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)
Description
The CMAI score ranges from 0-70 with higher scores indicating more agitation
Time Frame
Baseline, 4 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Living in the nursing home; 55 years of age or older; score 0-12 on the Brief Interview of Mental Status Exclusion Criteria: Enrolled in hospice in the nursing home for short stay rehabilitation
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34551782
Citation
Behrens L, Boltz M, Riley K, Eshraghi K, Resnick B, Galik E, Ellis J, Kolanowski A, Van Haitsma K. Process evaluation of an implementation study in dementia care (EIT-4-BPSD): stakeholder perspectives. BMC Health Serv Res. 2021 Sep 23;21(1):1006. doi: 10.1186/s12913-021-07001-2.
Results Reference
derived
PubMed Identifier
34253099
Citation
Kolanowski A, Zhu S, Van Haitsma K, Resnick B, Boltz M, Galik E, Behrens L, Eshraghi K, Ellis J. 12-month trajectory and predictors of affect balance in nursing home residents living with dementia. Aging Ment Health. 2022 Aug;26(8):1686-1692. doi: 10.1080/13607863.2021.1947964. Epub 2021 Jul 12.
Results Reference
derived

Learn more about this trial

Testing the Implementation of EIT-4-BPSD

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