Testing the Implementation of the PAIN-CPG-EIT: Protocol for a Randomized Clinical Trial.

Background: Pain is a common symptom among older adults in nursing home settings, affecting 30% to 80% of residents living with dementia. Pain is not assessed; the underlying cause is not identified, and treatment is not initiated for a large percentage of residents. Untreated or overtreated pain can lower quality of life, negatively impact function, impair sleep, and increase behavioral and psychological symptoms associated with dementia. Objective: The purpose of this National Institute of Aging-funded study is to use our theoretically based approach that includes the social ecological model, social cognitive theory, and the evidence integration triangle to translate the use of the Pain Management Clinical Practice Guideline (Pain Management CPG) into nursing home settings and improve the assessment, diagnosis, and management of pain among residents living with dementia. Our theoretically based approach, combined with the Pain Management CPG, is referred to as PAIN-CPG-EIT (Pain-Clinical Practice Guideline-Using the Evidence Integration Triangle). Methods: The study is a cluster-randomized clinical trial, with communities assigned to receive treatment with the PAIN-CPG-EIT vs pain education only (EO). The nursing homes have been randomized equally into intervention and control groups. The goal is to recruit a total of 300 residents from 12 nursing homes (25 residents from each community). Implementation of the study is being done via 3 cohorts, with 4 communities included in each cohort. The PAIN-CPG-EIT is implemented by a research nurse facilitator and includes 4 components, namely, component I: establishing and meeting with a stakeholder team; component II: education of the staff; component III: mentoring and motivating the staff to address pain; and component IV: ongoing monitoring of pain management in the community. The EO intervention is also implemented by a research nurse facilitator and consists of component II only, which is education of the staff. Results: Study activities began in September 2023, and recruitment of residents and intervention activities started with cohort 1 in January 2024. Cohort 2 was initiated in February 2025, and cohort 3 was initiated in June 2026 and is currently ongoing. A total of 208 residents have been recruited from the first 10 study sites. All intervention activities have been implemented as intended. The study is expected to be completed by December 2027. Conclusions: Outcomes are evaluated at baseline, 4 months, and 12 months after implementation of the intervention, and include improvement in the assessment, diagnosis, and management of pain; a decrease in pain; and evidence of more appropriate use of opioids. The findings from this study will provide evidence of the effectiveness of our implementation approach and use of the Pain Management CPG. The theoretically based approach may be useful for the implementation of other CPGs in nursing homes.