RecruitingPhase 2NCT05858996

Testing the Pain Clinical Practice Guideline

Testing the Pain Clinical Practice Guideline Using the Evidence Integration Triangle


Sponsor

University of Maryland, Baltimore

Enrollment

300 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

There are evidence based processes for assessment and management of pain using pharmacologic and nonpharmacological approaches. These were reviewed and included within the Pain Management Clinical Practice Guideline (Pain Management CPG) recently developed by AMDA: The Society for Post-Acute and Long-Term Care Medicine. There are, however, many challenges to translating the use of Clinical Practice Guidelines into clinical settings. To overcome these challenges we developed and previously tested a theoretically based approach and merged this approach with the Pain Management CPG, which is referred to as the PAIN-CLINICAL PRACTICE GUIDELINE-USING THE EVIDENCE INTEGRATION TRIANGLE (PAIN-CPG-EIT). The PAIN-CPG-EIT involves a research nurse facilitator working with an identified community champion(s) and stakeholder team for 12 months to provide the following four components: Component I: Establishing and meeting monthly with a Stakeholder Team; Component II: Education of the staff; Component III: Mentoring and motivating the staff to address pain; Component IV: Ongoing evaluation of resident pain outcomes. Twelve communities will be included with 25 residents living with dementia and pain recruited from each community. Six communities will be randomized to treatment (PAIN-CPG-EIT) and six randomized to education only (EO) which involves providing the same education to staff as is done in Component II of PAIN-CPG-EIT. The primary aim of this study is to test the effectiveness of use of the PAIN-CPG-EIT to improve the assessment, diagnosis and management of pain and decrease pain intensity among nursing home residents living with dementia between baseline, 4 and 12 months and evaluate treatment fidelity. A secondary aim of the study is to consider differences in measurement, treatment and response to treatment between male and female and Black versus White residents living with dementia. Findings from this study will help build on the currently limited information about pain presentation and management among older adults living with dementia in nursing homes and improve health equity of aging populations experiencing pain.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Pain-CPG-EIT and Pain-CPG-Education Only for people with dementia and pain. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPain-CPG-EIT

Following randomization champions and stakeholder team members from the communities will be identified. The investigators will recommend the following individuals to be members of the stakeholder team: a nurse in a leadership position (e.g., director of nursing); the designated champion(s); nursing home administrator; physician/medical director, nurse practitioner and/or physician assistant; unit nurse; nursing assistant; activity staff; social worker; pharmacist; and rehabilitation therapists. Following the first stakeholder team meeting, treatment communities will be provided with a research nurse facilitator to work 8 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months to provide the four components of the PAIN-CPG-EIT.

OTHERPain-CPG-Education Only

The Pain-CPG-Education only group will be provided with the same education as used in Component II of the Pain-CPG-EIT intervention. The education will be provided based on the preferences of the community (this may be face-to-face; online; or via handouts).


Locations(11)

Future Care Coldspring

Baltimore, Maryland, United States

Future Care Courtland

Baltimore, Maryland, United States

Futurecare Northpoint

Baltimore, Maryland, United States

Futurecare Irvington

Baltimore, Maryland, United States

Lorein Bel Aire

Bel Air, Maryland, United States

Lorien Columbia

Columbia, Maryland, United States

Communicare Ellicott City

Ellicott City, Maryland, United States

communicare Marley Station

Glen Burnie, Maryland, United States

Lorien Bulle Rock

Havre de Grace, Maryland, United States

Charles E Smilth Life Community

Rockville, Maryland, United States

Lorien Mays Chapel

Timonium, Maryland, United States

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NCT05858996


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