Testing the Pain Clinical Practice Guideline
NCT05858996 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-05-08
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.
Conditions
Interventions
- BEHAVIORAL
-
Pain-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.
- OTHER
-
Pain-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).
Sponsors & Collaborators
-
University of Maryland, Baltimore
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- United States
Study Locations
More Related Trials
-
Supporting Family Caregivers of Persons With Dementia
NCT05336344 ·Status: COMPLETED ·Phase: NA
-
Pain With Dementia
NCT06854718 ·Status: RECRUITING ·Phase: NA
-
Telephone Support for Dementia Caregivers
NCT00735800 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Caregiver Connections Via Technology for Patients With Alzheimer's and Other Types of Dementia
NCT05497817 ·Status: WITHDRAWN ·Phase: NA
-
Pain in Patients With Dementia and Behavioural Disturbances
NCT01021696 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Dissemination and Implementation of Function Focused Care for Assisted Living
NCT03459118 ·Status: COMPLETED ·Phase: NA
-
PainChek® US Validation Nursing Home Study
NCT06049732 ·Status: COMPLETED
-
Impact of Hypno-analgesia on Pain During a Lumbar Puncture for Diagnosis of Alzheimer's Disease
NCT03352024 ·Status: WITHDRAWN ·Phase: NA
-
Effect of Soundscape on People With Dementia.
NCT04809545 ·Status: COMPLETED ·Phase: NA
-
Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
NCT06264362 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Care Management for Patients With Alzheimer Disease and Their Family Caregivers
NCT00246896 ·Status: COMPLETED ·Phase: NA
-
Sensory Support Care for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease
NCT01819714 ·Status: COMPLETED ·Phase: NA
-
PACT: Providers and Alzheimer's Caregivers Together
NCT00182897 ·Status: COMPLETED ·Phase: NA
-
Testing the Effectiveness of Telephone Support for Dementia Caregivers
NCT00119561 ·Status: COMPLETED ·Phase: NA
-
Developing a Pain Identification and Communication Toolkit
NCT03853291 ·Status: TERMINATED ·Phase: NA
-
Effect of Cognitive Empathy Training on Dementia Caregivers
NCT06650527 ·Status: RECRUITING ·Phase: NA
-
Validation of Blood Biomarkers for Alzheimer's Disease
NCT05427448 ·Status: COMPLETED ·Phase: NA
-
Enhanced Medical Rehabilitation in Older Adults
NCT02114879 ·Status: COMPLETED ·Phase: NA
-
Stress Management Toolkit for People Living With Dementia and Their Care Partners
NCT05465551 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
MIND: Care Coordination for Community-living Person With Dementia
NCT02396082 ·Status: COMPLETED ·Phase: NA
-
Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers
NCT04058886 ·Status: COMPLETED ·Phase: NA
-
Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia
NCT02686554 ·Status: UNKNOWN
-
AIDMA: A Psycho-educational Program Designed to Support and Train Carers of Alzheimer's Disease (AD) Patients
NCT00190372 ·Status: COMPLETED ·Phase: NA
-
Mobile App Psychological Interventions for Family Dementia Caregivers
NCT05253443 ·Status: COMPLETED ·Phase: NA
-
Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments
NCT06370572 ·Status: COMPLETED ·Phase: NA