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PainPhase 2NCT05858996

Testing the Pain Clinical Practice Guideline

A Phase 2 study testing Pain-CPG-EIT and Pain-CPG-Education Only in people with Pain and Dementia, run by University of Maryland, Baltimore at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Pain, Dementia
What is being tested?
Pain-CPG-EIT and Pain-CPG-Education Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
11 sitesUnited States
Study dates
1 Dec 2023to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • admitted to the nursing home for short-stay rehabilitation or other subacute needs (e.g., intravenous antibiotics);
  • receiving Hospice care.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

11 sites in 1 country

United States11 sites, 2 recruiting
  • Future Care Coldspring

    Baltimore, Maryland, 21218-1708

    Completed
  • Future Care Courtland

    Baltimore, Maryland, 21218-1708

    Completed
  • Futurecare Northpoint

    Baltimore, Maryland, 21224

    Active, not recruiting
  • Futurecare Irvington

    Baltimore, Maryland, 21229

    Active, not recruiting
  • Lorein Bel Aire

    Bel Air, Maryland, 21015

    Active, not recruiting
  • Lorien Columbia

    Columbia, Maryland, 21045

    wayne Brannock, 410-531-5300, wbrannock@lorienhealth.com

    Not yet recruiting
  • Communicare Ellicott City

    Ellicott City, Maryland, 21042

    Completed
  • communicare Marley Station

    Glen Burnie, Maryland, 21060

    Completed
  • Lorien Bulle Rock

    Havre de Grace, Maryland, 21078

    Active, not recruiting
  • Charles E Smilth Life Community

    Rockville, Maryland, 20852

    Completed
  • Lorien Mays Chapel

    Timonium, Maryland, 21093

    wayne Brannock, 410-252-0880, wbrannock@lorienhealth.com

    Recruiting

Other trials in United States

About this study

Official title: Testing the Pain Clinical Practice Guideline Using the Evidence Integration Triangle

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.

Read the detailed description

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 living with dementia in nursing homes. Lack of accurate pain evaluation results in untreated or over-treated pain. Untreated or over-treated pain can lower quality of life, negatively impact function, impair sleep, and increase behavioral and psychological symptoms associated with dementia. Reasons for lack of pain assessment, diagnosis and management for residents living with dementia include lack of knowledge among staff on how to evaluate and treat pain, limited options for complete pain relief, concerns related to use of opioids, and beliefs that pain is a normal part of aging among others.

For those with moderate to severe dementia verbal reporting of pain may not be reliable and observational approaches are recommended. Pain in individuals living with dementia is more likely to present with aggression, agitation, repetitive vocalizations, restlessness, sleep disturbances, withdrawal, and apathy and may be incorrectly treated with psychotropic medications. Evaluation and management of pain is also complicated by differences between sex/gender, racial and ethnic groups. In some studies individuals living with dementia who were older, male, or Black were less likely to verbally report having pain or to be treated for pain compared to those who were younger, female, or white. With regard to treatment, there is some evidence that nonpharmacological treatments and analgesics can decrease pain among individuals living with dementia. Engaging individuals, particularly those living with dementia, in interventions to manage pain such as physical activity or positioning can be difficult and staff need education and techniques to use to motivate residents in these activities.

Evidence based pain assessment, diagnosis and management approaches for nursing home residents, including residents living with dementia, were recently incorporated into a new Pain Management Clinical Practice Guideline (Pain CPG). Translation of Clinical Practice Guidelines or evidence based practices into real world settings are slow to occur and innovative approaches are needed. In prior work to facilitate translation of best practices the investigators developed a successful theoretically based approach that utilized the Social Ecological Model and Social Cognitive Theory and was guided by the Evidence Integration Triangle. Using this theoretically based approach there was a change in staff and resident behavior related to increasing residents' physical activity using a function focused care approach and increased use of nonpharmacological approaches to address behavioral symptoms associated with dementia. The purpose of this study is to utilize the previously established theoretically based approach to translate use of the new Pain Management CPG into nursing home settings and improve the assessment, diagnosis and management of pain among residents living with dementia. The theoretically based approach combined with the Pain Management CPG is referred to as the PAIN-CPG-EIT. The PAIN-CPG-EIT is initiated by a research nurse facilitator who works with community champions and a stakeholder team for 12 months to provide four components: Component I: Establishing and meeting monthly with a stakeholder team and champion(s) to establish community goals related to pain and review the Pain Management CPG; Component II: Education of the staff about assessment, diagnosis and management of pain of residents living with dementia based on the Pain Management CPG; Component III: Mentoring and motivating staff to assess, diagnose and manage pain; and Component IV: Ongoing monitoring of pain assessment, diagnosis and management and feedback to the stakeholder team. Twelve communities will be randomized to treatment (PAIN-CPG-EIT) or Education Only (EO) and 25 residents living with dementia and pain will be recruited per community. The first 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. The second aim is to evaluate treatment fidelity related to use of the PAIN-CPG-EIT based on delivery, receipt and enactment. The third aim is to: a. test for gender/sex and race invariance in pain measurement based on the Pain in Alzheimer's Disease (PAIN-AD) measure; and b. test for differences in treatment of pain and response to treatment between male and female and Black versus White residents living with dementia. Findings will help to improve the assessment, diagnosis and management of pain and evaluate health disparities and equity among older adults living with dementia experiencing pain. Demonstrating effectiveness of this approach to using the Pain Management CPG will facilitate future work disseminating and implementing this CPG.

Conditions
Pain, Dementia
Being tested
Pain-CPG-EIT, Pain-CPG-Education Only
Medical subject headings
Pain, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain-CPG-EITBehavioural

    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-Education OnlyOther

    Also called EO

    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).

Study groups in NCT05858996
Study groupRoleWhat they receive
Pain-CPG-EITExperimentalThe 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.
Receives: Behavioral: Pain-CPG-EIT
Pain-CPG-Education OnlyActive comparatorCommunities 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).
Receives: Other: Pain-CPG-Education Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain assessment completed

    whether or not an appropriate pain assessment is completed

    Measured: baseline

  2. pain assessment completed

    whether or not an appropriate pain assessment is completed

    Measured: four months

  3. pain assessment completed

    whether or not an appropriate pain assessment is completed

    Measured: twelve months

  4. Pain management in careplan

    evidence that there is a pain management plan in the careplan

    Measured: baseline

  5. Pain management in careplan

    evidence that there is a pain management plan in the careplan

    Measured: 4 months

  6. Pain management in careplan

    evidence that there is a pain management plan in the careplan

    Measured: 12 months

  7. 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.

    Measured: baseline

  8. 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.

    Measured: four months

  9. 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.

    Measured: 12 months

Secondary outcomes (3)
  1. Pain in Alzheimer's Disease (PAIN-AD)

    The PAIN-AD is a 5 item observation measure of pain for older adults living with dementia. Scores can range from 0 to 10 and higher scores indicate more pain

    Measured: baseline

  2. Pain in Alzheimer's Disease (PAIN-AD)

    The PAIN-AD is a 5 item observation measure of pain for older adults living with dementia. Scores can range from 0 to 10 and higher scores indicate more pain.

    Measured: 4 months

  3. Pain in Alzheimer's Disease (PAIN-AD)

    The PAIN-AD is a 5 item observation measure of pain for older adults living with dementia. Scores can range from 0 to 10 and higher scores indicate more pain.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2023
  2. Study start1 Dec 2023
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05858996
Sponsor's protocol ID
HP-00105286
Status last verified
Jul 2026
First submitted
25 Apr 2023
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The plan is to provide any information requested by other researchers with a plan for rationale for the request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pain-CPG-EIT and Pain-CPG-Education Only in people with Pain and Dementia, run by University of Maryland, Baltimore at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain assessment completed (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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Testing the Pain Clinical Practice Guideline | AzTrials