- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014570
Testing the Implementation of EIT-4-BPSD (EIT-4_BPSD)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Education-Only Control
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 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.
|
Experimental: EIT-4-BPSD
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Function as Determined by Barthel Index
Time Frame: Baseline, 4 months and 12 months
|
The Barthel index has a score range of 0-100 with higher scores indicating higher physical function
|
Baseline, 4 months and 12 months
|
Depression as Determined by the Cornell Scale for Depression in Dementia
Time Frame: Baseline, 4 months, 12 months
|
The Cornell scale ranges from 0-19 with higher scores representing more depressive symptoms
|
Baseline, 4 months, 12 months
|
Agitation as Assessed by the Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame: Baseline, 4 months, 12 months
|
The CMAI score ranges from 0-70 with higher scores indicating more agitation
|
Baseline, 4 months, 12 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00069354
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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