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.
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
- What is being tested?
- Pain-CPG-EIT and Pain-CPG-Education Only
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- 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
- Completed
Future Care Coldspring
Baltimore, Maryland, 21218-1708
- Completed
Future Care Courtland
Baltimore, Maryland, 21218-1708
- Active, not recruiting
Futurecare Northpoint
Baltimore, Maryland, 21224
- Active, not recruiting
Futurecare Irvington
Baltimore, Maryland, 21229
- Active, not recruiting
Lorein Bel Aire
Bel Air, Maryland, 21015
- Not yet recruiting
Lorien Columbia
Columbia, Maryland, 21045
wayne Brannock, 410-531-5300, wbrannock@lorienhealth.com
- Completed
Communicare Ellicott City
Ellicott City, Maryland, 21042
- Completed
communicare Marley Station
Glen Burnie, Maryland, 21060
- Active, not recruiting
Lorien Bulle Rock
Havre de Grace, Maryland, 21078
- Completed
Charles E Smilth Life Community
Rockville, Maryland, 20852
- Recruiting
Lorien Mays Chapel
Timonium, Maryland, 21093
wayne Brannock, 410-252-0880, wbrannock@lorienhealth.com
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.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Pain-CPG-Education Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment completed
whether or not an appropriate pain assessment is completed
Measured: baseline
pain assessment completed
whether or not an appropriate pain assessment is completed
Measured: four months
pain assessment completed
whether or not an appropriate pain assessment is completed
Measured: twelve months
Pain management in careplan
evidence that there is a pain management plan in the careplan
Measured: baseline
Pain management in careplan
evidence that there is a pain management plan in the careplan
Measured: 4 months
Pain management in careplan
evidence that there is a pain management plan in the careplan
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (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: baseline
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
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.
- First posted15 May 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Resnick, University of Maryland, Baltimore
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Pain Clinical Practice Guideline Using the Evidence Integration Triangle
- ClinicalTrials.gov ID
- NCT05858996
- Acronym / sponsor ID
- HP-00105286
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain-CPG-EIT | Experimental | Behavioral: Pain-CPG-EITThe 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. |
| Pain-CPG-Education Only | Active comparator | Other: Pain-CPG-Education OnlyCommunities 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- admitted to the nursing home for short-stay rehabilitation or other subacute needs (e.g., intravenous antibiotics);
- receiving Hospice care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain-CPG-EITFollowing 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. | Behavioural | Pain-CPG-EIT |
| Pain-CPG-Education OnlyAlso: EOThe 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). | Other | Pain-CPG-Education Only |
Primary outcome
pain assessment completed
Time frame: baseline
whether or not an appropriate pain assessment is completed
pain assessment completed
Time frame: four months
whether or not an appropriate pain assessment is completed
pain assessment completed
Time frame: twelve months
whether or not an appropriate pain assessment is completed
Pain management in careplan
Time frame: baseline
evidence that there is a pain management plan in the careplan
Pain management in careplan
Time frame: 4 months
evidence that there is a pain management plan in the careplan
Pain management in careplan
Time frame: 12 months
evidence that there is a pain management plan in the careplan
Appropriate use of opioids
Time frame: baseline
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.
Appropriate use of opioids
Time frame: four months
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.
Appropriate use of opioids
Time frame: 12 months
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.
3 secondary outcomes
Pain in Alzheimer's Disease (PAIN-AD)
Time frame: baseline
Pain in Alzheimer's Disease (PAIN-AD)
Time frame: 4 months
Pain in Alzheimer's Disease (PAIN-AD)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. The plan is to provide any information requested by other researchers with a plan for rationale for the request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
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.