Pain Management for Dementia
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Maryland, Baltimore
Disqualifiers: Short-stay rehabilitation, Hospice care
No Placebo Group
Prior Safety Data
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.
12345How 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.
12367Eligibility 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
+1 more
Exclusion Criteria
I am in a nursing home for short-term rehab or other urgent care needs.
I am currently receiving Hospice care.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Pain-CPG-EITExperimental Treatment1 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 OnlyActive Control1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Communicare Marley StationGlen Burnie, MD
Communicare Ellicott CityEllicott City, MD
Future Care ColdspringBaltimore, MD
Future Care CourtlandBaltimore, MD
More Trial Locations
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
References
How to Teach Medical Students About Pain and Dementia: E-Learning, Experiential Learning, or Both? [2022]Pain management in persons with mild to moderate dementia poses unique challenges because of altered pain modulation and the tendency of some individuals to perseverate. We aimed to test the impact of an e-learning module about pain in communicative people with dementia on third-year medical students who had or had not completed an experiential geriatrics course.
Algoplus® Scale in Older Patients with Dementia: A Reliable Real-World Pain Assessment Tool. [2019]Pain is still a neglected clinical issue in elderly people with dementia and/or communicative disorders, with an unacceptable higher rate of under diagnosis and under treatment. Cognitive deficit and emotional and psychological disturbances entangle pain symptoms, affecting patient self-report. So far, observational pain tools do not have fully adequate clinimetric properties and quality requirements for easy-to-use daily rating. Older patients with dementia represent a clinical challenge. The assessment of pain is important for improving clinical outcomes, such as functional status, frailty trajectories, comorbidity, and quality of life. The PAINAID scale appears to be the most accurate pain tool in people with dementia along with the Algoplus® scale, a recently developed tool to rapidly assess acute pain in hospitals settings. The present study aimed to assess the clinimetric properties of the Algoplus®, as compared to PAINAID, for detecting acute pain in a real-world cohort of hospitalized older patients with dementia.
Pain in Advanced Stages of Dementia: The Perspective of Medical Students. [2020]Background and objective: The number of studies related to medical students' attitude toward pain is limited. The aim of our study was, thus, to assess the medical students' knowledge of pain assessment and treatment in advanced stages of dementia in order to improve the existing curriculum in this area. Material and methods: We analyzed the medical students' knowledge about pain in advanced dementia based on a short questionnaire. The research was anonymous. The questionnaire was completed by 147 students. Results: The students most often suggested that pain in patients with advanced dementia could be manifested via body language and facial expression (107 students-72.8% and 100 students-68.0%, respectively). Vocalization was the third most frequently reported pain manifestation (84-57.1%). Other groups of pain symptoms (changes in activity patterns, changes in interpersonal interactions, and mental status changes) were indicated less often (p < 0.0001). Only five students (3.4%) listed the DOLOPLUS behavioral pain scale as an assessment tool for patients with advanced dementia, and 16 (10.9%) indicated observational scale elements or a necessity to observe the patient. Still, 110 students (74.5%) correctly characterized pain treatment in patients with advanced dementia. Conclusions: To the best of our knowledge, our study is pioneering in defining the deficits of medical students' knowledge on pain assessment and treatment in patients with advanced dementia. We highlighted knowledge gaps in the area of pain assessment which might make medical students incapable of proper pain treatment. Following the International Association for the Study of Pain considerations regarding the need for excellence in pain education, these results can contribute to the improvement of existing medical curricula in Poznan University of Medical Sciences to include pain management in dementia in a more "patient-centered" way in order to increase future staff's competency and to assure a better quality of care.
Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. [2023]Despite its prevalence and impact, pain is underdetected and undermanaged in persons with dementia. Family caregivers are well positioned to detect pain and facilitate its management in their care recipients, but they lack training in symptom recognition and communication. This study reports findings from a pilot trial evaluating the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention that provides training in observational pain assessment and coaching in pain communication techniques.
Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. [2022]To develop a clinically relevant and easy to use pain assessment tool for individuals with advanced dementia that has adequate psychometric properties.
Expert advocates pain relief for all patients with dementia. [2016]Pain relief should be given routinely to all hospital patients who have dementia to prevent those who are unable to communicate that they are in pain being left untreated.
A pain assessment tool for people with advanced Alzheimer's and other progressive dementias. [2019]Appropriate pain management can only be achieved through accurate pain assessment that is individualized, ongoing, and well documented. Assessment tools must focus on the patient as the authority on pain's existence and severity; however, self-reports are not feasible when patients lose their ability to verbally communicate. This article describes a scientifically proven pain assessment tool that can be used for patients with advanced dementia and Alzheimer's Disease.