Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04330365
Status:
UNKNOWN
Last Update Posted:
2020-10-23
First Post:
2020-03-23
Brief Title:
Pragmatic Trial of WHT vs PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans
Sponsor:
San Francisco Veterans Affairs Medical Center
Organization:
San Francisco Veterans Affairs Medical Center
Study Overview
Official Title:
Implementation of a Pragmatic Trial of Whole Health Team vs Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain Functioning and Quality of Life in Veterans
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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:
wHOPE
Brief Summary:
The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans In UH3 Aim 1 the investigators will conduct a 12-month pragmatic effectiveness trial at 5 VA sites across the country to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team WHT intervention are more likely than those receiving Primary Care Group Education PC-GE to Hypothesis 1 Experience improved pain interference primary outcome pain intensity functioning and quality of life secondary outcomes Hypothesis 2 Decrease use of higher-risk pain medications including opioids or high-risk combinations Hypothesis 3 Engage in a greater number of non-pharmacological pain management activities and Hypothesis 4 Experience improved mental health-related symptoms including sleep problems and suicidality In addition both the WHT and PC-GE arms will be compared to a third group of veterans randomized to Usual Primary Care UPC Control on the same primary and secondary outcomes above After the baseline assessment masked telephone assessments will be administered to participants at 3 6 9 and 12 months UH3 Aim 2 is to conduct a process evaluation of the two active interventions WHT and PC-GE and a budget impact analysis that includes costs to implement and execute the two active interventions as well as the control condition UPC to inform the development of an implementation toolkit for scaling and dissemination Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for 6 months The total sample size for the population is based on our main study aimhypothesis and is N745 This breaks down to n341 in each of the active interventions WHT and PC-GE and N63 in the Usual Primary Care arm Control Results of this UG3UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIHVADoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel
Detailed Description:
None
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