Recruiting

Pain Management Guideline for Dementia in Nursing Homes

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Study Aim

This study aims to evaluate the appropriate use of opioids and completion of pain assessments in developing effective pain management guidelines for dementia patients in nursing homes.

What is being tested

Pain-CPG-EIT

+ Pain-CPG-Education Only

BehavioralOther
Who is being recruted

Mental Disorders+7

+ Brain Diseases

+ Central Nervous System Diseases

Over 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorUniversity of Maryland, Baltimore
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2023

Actual date on which the first participant was enrolled.

This clinical trial is focused on improving how pain is assessed, diagnosed, and managed in older adults with dementia living in nursing homes. Many residents with dementia experience pain that is not properly identified or treated, often because staff may lack the necessary knowledge or resources. This can lead to untreated or over-treated pain, which can severely affect the residents' quality of life. The study aims to implement a new Pain Management Clinical Practice Guideline (Pain CPG) to ensure better care for these residents. By doing so, the study seeks to address the disparities in pain management based on sex, race, and ethnicity, and improve overall treatment outcomes. Participants in the study will be nursing home residents with dementia and pain, and they will be part of communities that are randomly assigned to either receive the new Pain Management CPG approach (PAIN-CPG-EIT) or standard education. A research nurse facilitator will work closely with community champions and a stakeholder team over 12 months to implement the guideline. The study will measure how effectively the guideline improves pain assessment and management, the appropriate use of opioids, and the inclusion of pain management plans in care plans. It will also evaluate how consistently the guideline is implemented and whether there are differences in pain treatment and outcomes based on gender and race. This study hopes to demonstrate that using the Pain Management CPG can lead to better pain care for older adults with dementia.

Official TitleTesting the Pain Clinical Practice Guideline Using the Evidence Integration Triangle
NCT05858996
Principal SponsorUniversity of Maryland, Baltimore
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive Disorders

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

Futurecare Irvington

Baltimore, United StatesOpen Futurecare Irvington in Google Maps
Suspended

Future Care Coldspring

Baltimore, United States
Suspended

Future Care Courtland

Baltimore, United States
Suspended

Futurecare Northpoint

Baltimore, United States
Recruiting
7 Study Centers