Improving pain management for older adults with dementia
Testing the Pain Clinical Practice Guideline Using the Evidence Integration Triangle
PHASE2 · University of Maryland, Baltimore · NCT05858996
This study is testing a new way to help nursing home staff better manage pain for older adults with dementia to improve their quality of life.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore (other) |
| Locations | 11 sites (Baltimore, Maryland and 10 other locations) |
| Trial ID | NCT05858996 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance pain assessment and management in older adults living with dementia in nursing homes by implementing the Pain Management Clinical Practice Guideline (Pain Management CPG) through a structured approach called PAIN-CPG-EIT. The intervention involves a research nurse facilitator collaborating with a community champion and a stakeholder team over 12 months to address challenges in pain management. Key components include establishing a stakeholder team, educating staff on pain evaluation and treatment, and utilizing observational methods for pain assessment in individuals with moderate to severe dementia. The goal is to improve the quality of life for residents by ensuring appropriate pain management.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 60 and older living in nursing homes who have a diagnosis of dementia and are experiencing pain.
Not a fit: Patients who are admitted to nursing homes for short-stay rehabilitation or do not have evidence of pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for older adults with dementia by ensuring better pain management.
How similar studies have performed: Previous studies have shown that structured approaches to pain management in dementia care can lead to improved outcomes, suggesting this method may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * admitted to the nursing home for short-stay rehabilitation or other subacute needs (e.g., intravenous antibiotics); * receiving Hospice care.
Where this trial is running
Baltimore, Maryland and 10 other locations
- Future Care Coldspring — Baltimore, Maryland, United States (COMPLETED)
- Future Care Courtland — Baltimore, Maryland, United States (ACTIVE_NOT_RECRUITING)
- Futurecare Northpoint — Baltimore, Maryland, United States (ACTIVE_NOT_RECRUITING)
- Futurecare Irvington — Baltimore, Maryland, United States (ACTIVE_NOT_RECRUITING)
- Lorein Bel Aire — Bel Air, Maryland, United States (NOT_YET_RECRUITING)
- Lorien Columbia — Columbia, Maryland, United States (NOT_YET_RECRUITING)
- Communicare Ellicott City — Ellicott City, Maryland, United States (COMPLETED)
- communicare Marley Station — Glen Burnie, Maryland, United States (COMPLETED)
- Lorien Bulle Rock — Havre de Grace, Maryland, United States (RECRUITING)
- Charles E Smilth Life Community — Rockville, Maryland, United States (COMPLETED)
- Lorien Mays Chapel — Timonium, Maryland, United States (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.