Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05858996
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-04-25
Brief Title:
Testing the Pain Clinical Practice Guideline
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Testing the Pain Clinical Practice Guideline Using the Evidence Integration Triangle
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 champions 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 sexgender 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 champions 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 gendersex and race invariance in pain measurement based on the Pain in Alzheimers 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
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 sexgender 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 champions 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 gendersex and race invariance in pain measurement based on the Pain in Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None