Testing the Pain Clinical Practice Guideline

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Dementia
• Intervention / Treatment: Behavioral: Pain-CPG-EIT; Other: Pain-CPG-Education Only

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Ellicott City, Maryland, United States, 21042
      • Recruiting
      • Communicare Ellicott City
      • Contact: Tarnisha Fitzgerald, RN; Phone Number: 443-812-2735; Email: tafitzgerald@chs-corp.com
    • Glen Burnie, Maryland, United States, 21060
      • Not yet recruiting
      • Communicare Marley Station
      • Contact: Mike Lavin, BA; Phone Number: 410-768-8200
    • Rockville, Maryland, United States, 20852
      • Recruiting
      • Charles E Smilth Life Community
      • Contact: Susan Boettger, MBA; Phone Number: 301-816-5092; Email: boettger@ceslc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain-CPG-EIT; 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.	Behavioral: Pain-CPG-EIT; 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.
Active Comparator: Pain-CPG-Education Only; 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).	Other: Pain-CPG-Education Only; 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).; Other Names: EO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain assessment completed	whether or not an appropriate pain assessment is completed	baseline
pain assessment completed	whether or not an appropriate pain assessment is completed	four months
pain assessment completed	whether or not an appropriate pain assessment is completed	twelve months
Pain management in careplan	evidence that there is a pain management plan in the careplan	baseline
Pain management in careplan	evidence that there is a pain management plan in the careplan	4 months
Pain management in careplan	evidence that there is a pain management plan in the careplan	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.	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.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	12 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: HP-00105286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The plan is to provide any information requested by other researchers with a plan for rationale for the request.
• IPD Sharing Time Frame: At the end of the study and following publication of major outcome paper.
• IPD Sharing Access Criteria: Request from others
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No