EIT-4_BPSD: Testing the Implementation of EIT-4-BPSD

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Completed
CT.gov ID
NCT03014570
Collaborator
Penn State University (Other)
553
1
2
62
8.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: EIT-4-BPSD
  • Behavioral: Education-only Control
N/A

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 Design

Study Type:
Interventional
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 :
Apr 1, 2016
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in behaviors associated with dementia, psychotropic medication use, physical function, number of falls, and quality of life [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 [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 [12 months]

    Cost of the intervention with regard to research and clinical staff time and activities

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Baltimore Maryland United States 21201

Sponsors and Collaborators

  • University of Maryland, Baltimore
  • Penn State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barbara Resnick, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT03014570
Other Study ID Numbers:
  • HP-00069354
First Posted:
Jan 9, 2017
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Barbara Resnick, Professor, University of Maryland, Baltimore
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2021