Pain Management for Dementia

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Maryland, Baltimore

Disqualifiers: Short-stay rehabilitation, Hospice care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve pain management for people with dementia in nursing homes. It will test a new approach, Pain-CPG-EIT, which combines staff education, mentoring, and regular evaluations to determine if it reduces pain more effectively than education alone, known as Pain-CPG-Education Only. Participants will include residents with dementia who experience frequent pain. By comparing these methods, the study seeks to find better ways to manage pain and enhance the quality of life for these residents. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on managing pain with both medications and other methods, so you might be able to continue your current treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Pain-CPG-EIT treatment aims to improve pain management for nursing home residents with dementia. Although specific safety data from past studies on this approach is lacking, its focus on education and team support suggests it is likely well-tolerated.

This is a Phase 2 trial, indicating that the treatment has already been tested in smaller groups and appears safe and tolerated. The trial will provide more information about its safety in a larger group.

The trial's goal is to better manage pain, potentially enhancing the quality of life for people with dementia. This involves educating staff and providing ongoing support, which generally do not pose safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage pain in people with dementia, focusing on a structured approach rather than medication. Traditional pain management often relies on medications like acetaminophen or opioids, which can have side effects, especially in older adults. The trial's "Pain-CPG-EIT" approach is distinctive because it involves a comprehensive program facilitated by a research nurse, including team meetings, staff education, and ongoing mentoring to improve pain management practices. Meanwhile, the "Pain-CPG-Education Only" arm provides structured education sessions, which are more detailed than typical care. Together, these methods aim to improve pain management in a way that is sustainable and tailored to the needs of dementia care communities.

What evidence suggests that this trial's treatments could be effective for pain management in dementia?

Research has shown that the Pain-CPG-EIT method, one of the approaches tested in this trial, can enhance the assessment, diagnosis, and management of pain in people with dementia. Early results suggest that this method reduces pain levels for those living in nursing homes. The PAIN-CPG-EIT involves a team effort, with a research nurse collaborating closely with community leaders and other key individuals to implement pain management guidelines. Studies have demonstrated that better pain management can improve the quality of life for people with dementia. Therefore, the Pain-CPG-EIT appears promising for effectively managing pain in this group. Another approach in this trial, Pain-CPG-Education Only, focuses on providing staff education to improve pain management practices. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for nursing home residents aged 65 or older with dementia and pain. They must show signs of dementia through various tests like BIMS, AD8, CDR, or FAQ and have experienced pain recently as per staff reports or assessments.

Inclusion Criteria

Living in a participating community

Evidence of dementia based on specific scores on various cognitive assessment tools

I am currently experiencing pain.

Exclusion Criteria

I am in a nursing home for short-term rehab or other urgent care needs.

I am currently receiving Hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Research nurse facilitator works with community champions and stakeholder team to implement the PAIN-CPG-EIT components

12 months

Weekly visits by research nurse facilitator

Education

Education of staff about assessment, diagnosis, and management of pain based on the Pain Management CPG

12 months

Monthly meetings and ongoing education sessions

Follow-up

Participants are monitored for effectiveness of pain management strategies and health equity outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pain-CPG-Education Only
• Pain-CPG-EIT

Trial Overview The study is testing a Pain Management Clinical Practice Guideline (Pain-CPG) using the Evidence Integration Triangle (EIT). It involves education, mentoring by nurses, stakeholder teamwork, and ongoing evaluation to improve pain management in people with dementia.

How Is the Trial Designed?

Group I: Pain-CPG-EIT Experimental Treatment 1 Intervention

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: Pain-CPG-Education Only Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

A study involving 147 medical students revealed significant gaps in their knowledge about pain assessment in patients with advanced dementia, with only 3.4% recognizing the DOLOPLUS behavioral pain scale as a valid assessment tool.

Despite recognizing non-verbal cues like body language and facial expressions as indicators of pain, many students lacked comprehensive understanding of pain management strategies, indicating a need for improved training in medical curricula to enhance future care for dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain in Advanced Stages of Dementia: The Perspective of Medical Students. Neumann-Podczaska, A., Tobis, S., Yermukhanova, L., et al.[2020]

The Pain Identification and Communication Toolkit (PICT) was successfully implemented in a pilot trial with family caregivers of 34 individuals with dementia, showing that 100% of participants completed the intervention and 94% completed follow-up assessments.

Caregivers who used PICT reported increased confidence in recognizing (67%) and communicating about pain symptoms (83%), indicating that the toolkit may effectively enhance caregivers' skills in managing pain in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. Riffin, C., Brody, L., Mukhi, P., et al.[2023]

The study highlights the significant challenge of accurately assessing pain in elderly patients with dementia, as cognitive deficits can hinder their ability to self-report pain, leading to underdiagnosis and undertreatment.

The Algoplus® scale was evaluated for its effectiveness in detecting acute pain in hospitalized older patients with dementia and was found to be comparable to the PAINAID scale, suggesting it could be a valuable tool for improving pain management in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Algoplus® Scale in Older Patients with Dementia: A Reliable Real-World Pain Assessment Tool. Monacelli, F., Signori, A., Roffredo, L., et al.[2019]

The Pain Assessment in Advanced Dementia (PAINAD) tool was developed and validated for assessing pain in individuals with advanced dementia who cannot communicate their pain, showing good reliability and validity in a study involving 19 residents and expert clinicians.

PAINAD effectively detected changes in pain levels before and after analgesic medication was administered, indicating its potential utility in clinical settings for improving pain management in noncommunicative patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. Warden, V., Hurley, AC., Volicer, L.[2022]

Medical students who completed an e-learning module on pain management in dementia during a geriatrics course showed a significant increase in knowledge compared to those who completed the module without the course context, indicating the effectiveness of integrated learning (P < 0.001).

While attitudes towards pain management did not improve, all student groups reported increased confidence in evaluating and managing pain in dementia patients, highlighting the importance of educational interventions in enhancing clinical skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Teach Medical Students About Pain and Dementia: E-Learning, Experiential Learning, or Both? Moehl, K., Wright, RM., Shega, J., et al.[2022]

Accurate pain management in patients with advanced dementia and Alzheimer's Disease requires individualized and ongoing pain assessment, as self-reports may not be possible due to communication difficulties.

The article introduces a scientifically validated pain assessment tool specifically designed for non-verbal patients, emphasizing the importance of recognizing the patient's authority on their pain experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pain assessment tool for people with advanced Alzheimer's and other progressive dementias. Lane, P., Kuntupis, M., MacDonald, S., et al.[2019]

Hospital patients with dementia should receive routine pain relief to ensure they are not left untreated, especially since they may be unable to communicate their pain.

This approach emphasizes the importance of proactive pain management in vulnerable populations to improve their overall care and comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert advocates pain relief for all patients with dementia. Gillen, S.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05858996

NCT05858996 | Testing the Pain Clinical Practice Guideline 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 ...

2. reporter.nih.gov reporter.nih.gov/project-details/10711409

Testing the Pain-CPG-EIT The purpose of this study is to improve the assessment, diagnosis, and management of pain among residents living with dementia in nursing homes.

3. nursing.umaryland.edu nursing.umaryland.edu/news-events/news/umson-researcher-awarded-213m-to-revolutionize-pain-management-for-dementia-patients-in-nursing-homes/

UMSON Researcher Awarded $2.13M to Revolutionize Pain ... The primary aims are to evaluate the effectiveness of PAIN-CPG-EIT to improve the assessment, diagnosis, and management of pain and decrease ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1524904225001584

Pain Assessment and Management Among Nursing Home ... The purpose of this study was to describe adherence to survey guidance for the assessment, diagnosis and management of pain across four nursing home ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40360333/

Pain Assessment and Management Among Nursing Home ... The purpose of this study was to describe adherence to survey guidance for the assessment, diagnosis and management of pain across four nursing home ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354327/

Pain Assessment and Management Among Nursing Home ... Chronic pain is a common symptom among older adults in nursing home settings affecting 30% to 80% of residents living with dementia (Agit et al.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1524904224001656

Pain Prevalence and Pain Management in Nursing Home ... Pain Prevalence and Pain Management in Nursing Home Residents With Cognitive Impairment. Results From Five Multicenter Cross-Sectional Surveys in Germany ...