Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014570
Recruitment Status : Active, not recruiting
First Posted : January 9, 2017
Last Update Posted : November 4, 2019
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Barbara Resnick, University of Maryland, Baltimore

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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral and Psychological Symptoms of Dementia (BPSD) Behavioral: EIT-4-BPSD Behavioral: Education-only Control Not Applicable

  Hide Detailed Description

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 553 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Testing the Implementation of EIT-4-BPSD
Study Start Date : April 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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.
Behavioral: Education-only Control
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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in behaviors associated with dementia, psychotropic medication use, physical function, number of falls, and quality of life [ Time Frame: baseline, 4 and 12 months ]
    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. Specifically: 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.

  2. Change in phsyical environment and policies within facilities [ Time Frame: baseline, 12, 18, and 24 months ]
    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


Secondary Outcome Measures :
  1. Descript Cost data [ Time Frame: 12 months ]
    Cost of the intervention with regard to research and clinical staff time and activities



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014570


Locations
Layout table for location information
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Penn State University

Layout table for additonal information
Responsible Party: Barbara Resnick, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03014570     History of Changes
Other Study ID Numbers: HP-00069354
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Barbara Resnick, University of Maryland, Baltimore:
behavior,
apathy
mood
function
cognition
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders