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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Pain-CPG-Education Only, Pain-CPG-EIT for pain management in dementia?

The research highlights the importance of proper pain assessment and management in dementia, emphasizing tools like the Algoplus® and PAINAD scales for accurate pain detection. Additionally, caregiver training in pain identification and communication has shown promise in improving pain management for individuals with dementia. ^{1 2 3 4 5}

How does the Pain-CPG-Education Only and Pain-CPG-EIT treatment for dementia differ from other treatments?

The Pain-CPG-Education Only and Pain-CPG-EIT treatments focus on educating caregivers and healthcare providers about pain management in dementia, which is unique because it emphasizes understanding non-verbal pain indicators and improving assessment skills, rather than relying solely on medication. ^{1 2 3 6 7}

Eligibility Criteria

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

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

I am currently experiencing pain.

Living in a participating community

Exclusion Criteria

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

I am currently receiving Hospice care.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

How to Teach Medical Students About Pain and Dementia: E-Learning, Experiential Learning, or Both? [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Algoplus® Scale in Older Patients with Dementia: A Reliable Real-World Pain Assessment Tool. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pain in Advanced Stages of Dementia: The Perspective of Medical Students. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

A pain assessment tool for people with advanced Alzheimer's and other progressive dementias. [2019]