Testing the Pain Clinical Practice Guideline

Recruiting now · Phase 2

Conditions studied: Pain, Dementia

In brief

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.

Key facts

Study ID: NCT05858996
Run by: University of Maryland, Baltimore
People needed: 300
Starts: 2023-12-01
Expected to finish: 2028-12-31
Last updated by the study team: 2026-07-23

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Living in a participating community
60 years of age or older
Evidence of dementia based on a score of 0-12 on the Brief Interview of Mental Status (BIMS); a score of >2 on the AD8 Dementia Screening Interview; a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale (CDR); and lastly to differentiate between dementia and mild cognitive impairment a score of 9 or greater on the Functional Activities Questionnaire (FAQ).
have evidence of pain at the time of recruitment based on the Minimum Data set assessment item: How much of the time over the past 5 days have you experienced pain or hurting with eligibility based on the following responses or evidence: occasionally, frequently or almost constantly, or staff report of pain at the same frequency; or if the resident is receiving nonpharmacological or pharmacological treatment for pain.

You may not qualify if…

admitted to the nursing home for short-stay rehabilitation or other subacute needs (e.g., intravenous antibiotics);
receiving Hospice care.

Where it is running

Lorien Mays Chapel — Timonium, Maryland, United States (enrolling)
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
Future Care Coldspring — Baltimore, 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 Columbia — Columbia, Maryland, United States

Full record on ClinicalTrials.gov

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