Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03407638
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2018-01-16
Brief Title:
PRimary Care Opioid Use Disorders Treatment PROUD Trial
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
PRimary Care Opioid Use Disorders Treatment PROUD Trial
Status:
COMPLETED
Status Verified Date:
2024-10
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:
PROUD
Brief Summary:
Effective treatment for opioid use disorders OUDs requires medications Two medications for treating OUDs-buprenorphine and injectable naltrexone-can be prescribed in primary care PC However despite the current opioid epidemic and expert recommendations that OUDs should be treated in PC most PC clinics do not offer treatment for OUDs This reflects a lack of consensus among health system leaders and clinicians that OUDs should be treated in PC
The PRimary care Opioid Use Disorders treatment PROUD Trial is a pragmatic cluster-randomized quality improvement trial that evaluates implementation of a team-based approach to PC supported by a full time nurse the PROUD intervention This type of team-based PC is often referred to as collaborative care for management of OUDs in PC and this type of trial is often referred to as a Hybrid Type III implementation trial
The trial is being conducted in 6 diverse health systems spanning 5 states New York Florida Michigan Texas and Washington with 2 PC clinics in each system randomized One clinic is randomly selected to implement the PROUD intervention and the other continues usual PC UPC
The overall objective of the PROUD trial is to provide information to guide health system leaders who are faced with the decision of whether or not to treat OUDs in PC by evaluating the benefits of implementing the PROUD intervention that integrates high quality OUD treatment ie buprenorphine or injectable naltrexone into the normal flow of PC
The primary objective of the PROUD trial is to evaluate whether the PROUD intervention increases OUD treatment with buprenorphine or injectable naltrexone documented in the electronic health records EHRs of PC patients over a 2 year follow-up as compared to UPC
The primary hypothesis is that there will be a significant increase in the number of patient-days of medication treatment for OUDs documented in the EHR of PC patients in the 2 years after clinics are randomized to the PROUD intervention compared to PC clinics randomized to UPC This implementation objective reflects whether the PROUD intervention increases initiation of andor retention in OUD treatment documented in EHRs within medical settings
The main secondary objective is to test the hypothesis that PC patients with OUDs documented in their EHRs in the 3 years prior to randomization who receive care in PROUD intervention clinics compared to those who receive care in UPC clinics will have fewer days of acute care utilization including urgent care emergency department ED and hospital care in the 2 years after randomization This effectiveness objective assesses whether implementation of the MA Model improves patient outcomes
The PRimary care Opioid Use Disorders treatment PROUD Trial is a pragmatic cluster-randomized quality improvement trial that evaluates implementation of a team-based approach to PC supported by a full time nurse the PROUD intervention This type of team-based PC is often referred to as collaborative care for management of OUDs in PC and this type of trial is often referred to as a Hybrid Type III implementation trial
The trial is being conducted in 6 diverse health systems spanning 5 states New York Florida Michigan Texas and Washington with 2 PC clinics in each system randomized One clinic is randomly selected to implement the PROUD intervention and the other continues usual PC UPC
The overall objective of the PROUD trial is to provide information to guide health system leaders who are faced with the decision of whether or not to treat OUDs in PC by evaluating the benefits of implementing the PROUD intervention that integrates high quality OUD treatment ie buprenorphine or injectable naltrexone into the normal flow of PC
The primary objective of the PROUD trial is to evaluate whether the PROUD intervention increases OUD treatment with buprenorphine or injectable naltrexone documented in the electronic health records EHRs of PC patients over a 2 year follow-up as compared to UPC
The primary hypothesis is that there will be a significant increase in the number of patient-days of medication treatment for OUDs documented in the EHR of PC patients in the 2 years after clinics are randomized to the PROUD intervention compared to PC clinics randomized to UPC This implementation objective reflects whether the PROUD intervention increases initiation of andor retention in OUD treatment documented in EHRs within medical settings
The main secondary objective is to test the hypothesis that PC patients with OUDs documented in their EHRs in the 3 years prior to randomization who receive care in PROUD intervention clinics compared to those who receive care in UPC clinics will have fewer days of acute care utilization including urgent care emergency department ED and hospital care in the 2 years after randomization This effectiveness objective assesses whether implementation of the MA Model improves patient outcomes
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1DA040314 | NIH | None | httpsreporternihgovquickSearchUG1DA040314 |