Testing the Implementation of EIT-4-BPSD

NCT03014570 | Completed Results DMC

• 1 other identifier: HP-00069354
• Study Type: interventional
• Target: 553
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Behavioral and Psychological Symptoms of Dementia (BPSD)

Keywords

behavior,; apathy; mood; function; cognition

Outcome Measures

Primary Outcomes (3)

• Physical Function as Determined by Barthel Index

  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

  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)

  The CMAI score ranges from 0-70 with higher scores indicating more agitation

  Baseline, 4 months, 12 months

Study Arms (2)

Education-Only Control

ACTIVE COMPARATOR

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

EIT-4-BPSD

EXPERIMENTAL

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

Interventions

EIT-4-BPSD BEHAVIORAL

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.

EIT-4-BPSD

Education-only Control BEHAVIORAL

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.

Education-Only Control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Penn State University: collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• 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.

  PMID: 34551782 DERIVED

• 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.

  PMID: 34253099 DERIVED

MeSH Terms

Conditions

Dementia; Behavior; Lethargy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Barbara Resnick PhD, CRNP Professor and PI among MPIs of the trial
• Organization: University of Maryland School of Nursing

resnick@umaryland.edu

410 706 5178

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 9, 2017
• Study Start: April 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)