Ignite Creation Date:
2024-05-06 @ 9:34 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03014570
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2017-01-04
Brief Title:
Testing the Implementation of EIT-4-BPSD
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Testing the Implementation of EIT-4-BPSD
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EIT-4_BPSD
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
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 ie 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-reviewedexpert-endorsed resources was developed for utilizing person-centered behavioral approaches for BPSD the Nursing Home Toolkit wwwnursinghometoolkitcom 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 monthsuse 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
To advance the CMS National Partnership a comprehensive compendium of peer-reviewedexpert-endorsed resources was developed for utilizing person-centered behavioral approaches for BPSD the Nursing Home Toolkit wwwnursinghometoolkitcom 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 monthsuse 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None