Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527599
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Screening in Trauma for Opioid Misuse Prevention - an Adaptive Intervention STOMP-AI
Status:
RECRUITING
Status Verified Date:
2024-08
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:
STOMP-AI
Brief Summary:
The primary objective of the present pilot sequential multiple-assignment randomized trial Pilot SMART is to determine feasibility and acceptability of delivering from the perspective of the treatmentintervention staff and receiving from the perspective of the patient an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury A complimentary secondary objective is to ensure the feasibility of conducting a future multi-site full-scale SMART
Approximately 107 participants will be enrolled and can expect to be on study for up to 6 months
Approximately 107 participants will be enrolled and can expect to be on study for up to 6 months
Detailed Description:
The proposed project would be the first clinical trial to assess the feasibility of implementing a preventative treatment design that specifically targets the needs of individuals receiving opioid prescriptions following surgery for traumatic injury The project will operationalize a standardized approach to screening treating and monitoring risk of opioid misuse following traumatic injury If funded the project would provide a personalized approach to post-injury monitoring and management through an adaptive intervention designed to target the needs of the individual rather than implementing a rigid one-size-fits-all intervention model to prevent opioid misuse
Approximately 107 participants will be enrolled into the study approximately 54 participants at UW and 53 participants at MCW At or very shortly after within 1-2 days discharge participants will be randomized using a 2x2 factorial design to initially receive any one of the following four interventions
1 standard Trauma Care Coordination sTCC
2 sTCC an abbreviated Pain Coping Skills Training PCST-Lite
3 enhanced Trauma Care Coordination eTCC
4 eTCC PCST-Lite
Four weeks following hospital discharge participants will be evaluated for risk of opioid misuse measured using the Pain Catastrophizing Scale PCS modified Pain Enjoyment of life and General activities PEG scale and the modified 9-item Current Opioid Misuse Measure mCOMM-9 Participants identified as being at greater than low risk for opioid misuse will be randomized to continuing their current clinical management plan vs an augmented more intensive intervention plan participants scoring at low risk will continue with the intervention they were initially randomized to receive
Components of the adaptive intervention will be iteratively refined at various points before during and after the pilot SMART in order to maximize feasibility and acceptability
Primary Objective Determine the feasibility of delivering an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury
Specific Aim 1 Evaluate the feasibility of delivering the proposed adaptive intervention as measured by rates of recruitment and retention at Weeks 4 and 12
Specific Aim 2 Evaluate the acceptability and appropriateness of the adaptive intervention from the perspective of treatment providers and recipients
Secondary Objective Obtain the preliminary data necessary for a successful NIH R01 Application
Specific Aim 3 Construct a randomized trial protocol informed by data from the present study to be used in the proposed subsequent full-scale sequential multiple assignment randomized trial
Specific Aim 4 Construct an initial implementation strategy manual to evaluate implementation of the future R01 and support the installation of the adaptive intervention in future hospitals by future implementers
Specific Aim 5 Construct a manual for the adaptive intervention to enhance fidelity in the subsequent full-scale trial
Safety Objective Determine rates and severity of treatment-related adverse events
Specific Aim 6 Evaluate the frequency and presentation of adverse events associated with each arm of the adaptive intervention
Exploratory Objective 1 Identify associations between the interventions delivered and opioid usemisuse
Exploratory Objective 2 Identify associations between the interventions delivered and the physical social and psychological antecedents of opioid misuse
Approximately 107 participants will be enrolled into the study approximately 54 participants at UW and 53 participants at MCW At or very shortly after within 1-2 days discharge participants will be randomized using a 2x2 factorial design to initially receive any one of the following four interventions
1 standard Trauma Care Coordination sTCC
2 sTCC an abbreviated Pain Coping Skills Training PCST-Lite
3 enhanced Trauma Care Coordination eTCC
4 eTCC PCST-Lite
Four weeks following hospital discharge participants will be evaluated for risk of opioid misuse measured using the Pain Catastrophizing Scale PCS modified Pain Enjoyment of life and General activities PEG scale and the modified 9-item Current Opioid Misuse Measure mCOMM-9 Participants identified as being at greater than low risk for opioid misuse will be randomized to continuing their current clinical management plan vs an augmented more intensive intervention plan participants scoring at low risk will continue with the intervention they were initially randomized to receive
Components of the adaptive intervention will be iteratively refined at various points before during and after the pilot SMART in order to maximize feasibility and acceptability
Primary Objective Determine the feasibility of delivering an adaptive intervention for reducing rates of opioid misuse and preventing development of opioid use disorder in individuals hospitalized for traumatic injury
Specific Aim 1 Evaluate the feasibility of delivering the proposed adaptive intervention as measured by rates of recruitment and retention at Weeks 4 and 12
Specific Aim 2 Evaluate the acceptability and appropriateness of the adaptive intervention from the perspective of treatment providers and recipients
Secondary Objective Obtain the preliminary data necessary for a successful NIH R01 Application
Specific Aim 3 Construct a randomized trial protocol informed by data from the present study to be used in the proposed subsequent full-scale sequential multiple assignment randomized trial
Specific Aim 4 Construct an initial implementation strategy manual to evaluate implementation of the future R01 and support the installation of the adaptive intervention in future hospitals by future implementers
Specific Aim 5 Construct a manual for the adaptive intervention to enhance fidelity in the subsequent full-scale trial
Safety Objective Determine rates and severity of treatment-related adverse events
Specific Aim 6 Evaluate the frequency and presentation of adverse events associated with each arm of the adaptive intervention
Exploratory Objective 1 Identify associations between the interventions delivered and opioid usemisuse
Exploratory Objective 2 Identify associations between the interventions delivered and the physical social and psychological antecedents of opioid misuse
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