Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513156
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Continuum of Care in Hospitalized Patients With Opioid Use Disorder and Infectious Complications From Drug Use
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Continuum of Care in Hospitalized Patients With Opioid Use Disorder and Infectious Complications of Drug Use - NavSTAR Treatment as Usual AddictionID Integrated Clinic to Prevent Infection Related Readmission
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:
CHOICE-STAR
Brief Summary:
This is a three-group randomized controlled trial conducted at five hospitals across the US designed to test the effectiveness of two interventions 1 Integrated infectious diseases and Medication for Opioid Use Disorder outpatient clinic IC and 2 NavSTAR Intervention NS compared to treatment as usual aimed at reducing infection related readmissions and improving health outcomes in people hospitalized with an infection related to injecting opioids
Detailed Description:
This is a phase III three arm randomized controlled trial to determine the impact of two interventions 1 Integrated infectious diseases ID and Medication for Opioid Use Disorder outpatient clinic IC and 2 Navigation Services To Avoid Rehospitalization NavSTAR Intervention NS compared to treatment as usual on infection related rehospitalization in individuals hospitalized with infections due to injecting opioids in the 6 month time period after discharge This study includes both cost effectiveness and implementation outcomes
1 The Integrated IDMOUD Clinic IC will provide facilitated linkage to a clinic providing medical treatment aimed at treating opioid use disorer OUD resolving the index infection treating existing ID complications of OUD HIV HCV wounds and preventing subsequent infections by providing accessible care for infectious diseases and medication for OUD MOUD treatment that is integrated into a single appointment and co-located at a single site either in person or via telemedicine for a minimum of monthly appointments over a 6 month time period A feature of the IC will be weekly care coordination meetings between the ID and MOUD providers
2 The NavSTAR Arm NS aims to targeted support delivered by a Patient Navigation team to enhance participants linkage with outpatient OUD treatment and recommended medical care for infections and other presenting illnesses The Navigation Dyad will work in concert with existing resources in the hospital system and broader community to ensure continuity of care initial linkage and subsequent retention during the 6-month period after hospital discharge when patients are at elevated risk of disengaging from care inpatient readmission and other adverse outcomes
The study will recruit patients during hospitalization for an infection due to injecting opioids at four hospital systems five hospitals and randomly assign approximately 608 inpatients in 111 ratio to IC vs NS vs TAU
Participants will be followed for 12 months
1 The Integrated IDMOUD Clinic IC will provide facilitated linkage to a clinic providing medical treatment aimed at treating opioid use disorer OUD resolving the index infection treating existing ID complications of OUD HIV HCV wounds and preventing subsequent infections by providing accessible care for infectious diseases and medication for OUD MOUD treatment that is integrated into a single appointment and co-located at a single site either in person or via telemedicine for a minimum of monthly appointments over a 6 month time period A feature of the IC will be weekly care coordination meetings between the ID and MOUD providers
2 The NavSTAR Arm NS aims to targeted support delivered by a Patient Navigation team to enhance participants linkage with outpatient OUD treatment and recommended medical care for infections and other presenting illnesses The Navigation Dyad will work in concert with existing resources in the hospital system and broader community to ensure continuity of care initial linkage and subsequent retention during the 6-month period after hospital discharge when patients are at elevated risk of disengaging from care inpatient readmission and other adverse outcomes
The study will recruit patients during hospitalization for an infection due to injecting opioids at four hospital systems five hospitals and randomly assign approximately 608 inpatients in 111 ratio to IC vs NS vs TAU
Participants will be followed for 12 months
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