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

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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

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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



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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
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United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Penn State University

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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:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders