Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526143
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
M2VA Pain Care Pathway
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementation Facilitation of Screening Brief Intervention and Referral to Treatment for Pain Management for Veterans Separating From Military Service
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M2VAPCP
Brief Summary:
The goal of this 2-cohort cluster randomized type 2 hybrid trial is to test the effectiveness cost-effectiveness and patient-level effects of an implementation facilitation strategy in helping M2VA case managers adopt a Military2VA Pain Care Pathway M2VAPCP intervention
The main questions it aims to answer are
Will adding implementation facilitation to training-as-usual for M2VAPCP result in a higher proportion of Veterans who receive M2VAPCP compared to training-as-usual alone Will adding implementation facilitation to training-as-usual for M2VAPCP result in better adherence to the M2VAPCP protocol compared to training-as-usual alone Will implementation facilitation improve Veterans clinical outcomes pain risky substance use and increase the number of non-pharmacological pain treatments used compared to training-as-usual alone
The main questions it aims to answer are
Will adding implementation facilitation to training-as-usual for M2VAPCP result in a higher proportion of Veterans who receive M2VAPCP compared to training-as-usual alone Will adding implementation facilitation to training-as-usual for M2VAPCP result in better adherence to the M2VAPCP protocol compared to training-as-usual alone Will implementation facilitation improve Veterans clinical outcomes pain risky substance use and increase the number of non-pharmacological pain treatments used compared to training-as-usual alone
Detailed Description:
Investigators will conduct a type 2 hybrid cluster randomized trial to test the effectiveness cost-effectiveness and patient-level effects of an implementation facilitation strategy to train case managers in the Post-911 Military2VA M2VA program in a pain and substance use-focused Military2VA Pain Care Pathway M2VAPCP intervention
Aim 1 Determine if implementation facilitation IF of training case managers in M2VAPCP more effectively fosters M2VAPCPs use than training-as-usual The primary implementation outcome will be the proportion of participants who receive any M2VAPCP Reach Other implementation outcomes will be the proportion of case managers who receive training in M2VAPCP and proportion of those trained who used M2VAPCP with at least three participants Adoption and the integrity of case managers use of Motivational Interviewing in M2VAPCP sessions Implementation Factors affecting case managers ongoing use of M2VAPCP as part of their practice Maintenance and experience with implementation facilitation M2VAPCP and navigating VA pain care services will be explored qualitatively for each cohort in a formative evaluation
Aim 2 Determine if implementation facilitation of M2VAPCP improves participants clinical outcomes The primary clinical outcome is the PEG measure of pain Secondary outcomes will be the ASSIST-3 measure of substance use with biochemical verification of alcohol report using fingernails and EHR-derived number of nonpharmacologic pain management services used
Aim 3 Determine the cost-effectiveness and budget impact of implementation facilitation relative to training-as-usual to reach Veterans with M2VAPCP and improve their clinical outcomes
Aim 1 Determine if implementation facilitation IF of training case managers in M2VAPCP more effectively fosters M2VAPCPs use than training-as-usual The primary implementation outcome will be the proportion of participants who receive any M2VAPCP Reach Other implementation outcomes will be the proportion of case managers who receive training in M2VAPCP and proportion of those trained who used M2VAPCP with at least three participants Adoption and the integrity of case managers use of Motivational Interviewing in M2VAPCP sessions Implementation Factors affecting case managers ongoing use of M2VAPCP as part of their practice Maintenance and experience with implementation facilitation M2VAPCP and navigating VA pain care services will be explored qualitatively for each cohort in a formative evaluation
Aim 2 Determine if implementation facilitation of M2VAPCP improves participants clinical outcomes The primary clinical outcome is the PEG measure of pain Secondary outcomes will be the ASSIST-3 measure of substance use with biochemical verification of alcohol report using fingernails and EHR-derived number of nonpharmacologic pain management services used
Aim 3 Determine the cost-effectiveness and budget impact of implementation facilitation relative to training-as-usual to reach Veterans with M2VAPCP and improve their clinical outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None