Testing the Pain Clinical Practice Guideline

NCT05858996 | Recruiting Phase 2

• 1 other identifier: HP-00105286
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

Brief 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

Dementia; Pain

Outcome Measures

Primary Outcomes (9)

• pain assessment completed

  whether or not an appropriate pain assessment is completed

  baseline

• pain assessment completed

  whether or not an appropriate pain assessment is completed

  four months

• pain assessment completed

  whether or not an appropriate pain assessment is completed

  twelve months

• Pain management in careplan

  evidence that there is a pain management plan in the careplan

  baseline

• Pain management in careplan

  evidence that there is a pain management plan in the careplan

  4 months

• Pain management in careplan

  evidence that there is a pain management plan in the careplan

  12 months

• Appropriate use of opioids

  Review of 10 factors that indicate that opioids are being used appropriately as per the CPG. scores can range from 0 to 10 and higher scores indicate more appropriate use of opioids.

  baseline

• Appropriate use of opioids

  Review of 10 factors that indicate that opioids are being used appropriately as per the CPG. scores can range from 0 to 10 and higher scores indicate more appropriate use of opioids.

  four months

• Appropriate use of opioids

  Review of 10 factors that indicate that opioids are being used appropriately as per the CPG. scores can range from 0 to 10 and higher scores indicate more appropriate use of opioids.

  12 months

Secondary Outcomes (3)

• Pain in Alzheimer's Disease (PAIN-AD)

  baseline

• Pain in Alzheimer's Disease (PAIN-AD)

  4 months

• Pain in Alzheimer's Disease (PAIN-AD)

  12 months

Study Arms (2)

Pain-CPG-EIT

EXPERIMENTAL

The four components of the PAIN-CPG-EIT are provided by a research nurse facilitator working with the champion(s) and stakeholder team. Following the first stakeholder team meeting, the research nurse facilitator works 8 hours weekly during months one and two and then for four hours weekly months three to 12 to implement: Component I: Stakeholder team meeting and goal setting; Component II: Education of the staff; Component III: Mentoring and motivating the staff to address pain using the Pain Management CPG ; and Component IV: Ongoing monitoring of pain management in the community based on the Pain Management CPG.

Behavioral: Pain-CPG-EIT

Pain-CPG-Education Only

ACTIVE COMPARATOR

Communities randomized to education only will be provided with staff education using our developed Powerpoint for Component II of the PAIN-CPG-EIT intervention in 30 minute sessions as is currently done in usual practice. They will also be given access to an online copy of the Pain Management CPG. The education will be provided in the preferred format (e.g., face-to-face; webinar).

Other: Pain-CPG-Education Only

Interventions

Pain-CPG-EIT BEHAVIORAL

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.

Pain-CPG-EIT

Pain-CPG-Education Only OTHER

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).

Also known as: EO

Pain-CPG-Education Only

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in a participating community
• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (7)

Future Care Coldspring

Baltimore, Maryland, 21218-1708, United States

COMPLETED

Future Care Courtland

Baltimore, Maryland, 21218-1708, United States

ACTIVE NOT RECRUITING

Futurecare Northpoint

Baltimore, Maryland, 21224, United States

ACTIVE NOT RECRUITING

Futurecare Irvington

Baltimore, Maryland, 21229, United States

RECRUITING

Communicare Ellicott City

Ellicott City, Maryland, 21042, United States

COMPLETED

communicare Marley Station

Glen Burnie, Maryland, 21060, United States

COMPLETED

Charles E Smilth Life Community

Rockville, Maryland, 20852, United States

COMPLETED

MeSH Terms

Conditions

Pain; Dementia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 15, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At the end of the study and following publication of major outcome paper.
• Access Criteria: Request from others

Locations

US (7)