Back to resultsPerinatal Care and Medication Assisted Treatment: Carbon/Emery Counties
Primary Purpose
Opioid-use Disorder, Pregnancy Related
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care
Sponsored by
About this trial
This is an interventional health services research trial for Opioid-use Disorder
Eligibility Criteria
Provider Inclusion Criteria:
- Must be employed as staff at one of our sub-contracted agencies or community partners
- Must directly provide care to pregnant women with OUD in Carbon and/or Emery Counties, UT
Provider Exclusion Criteria:
- Unwilling or unable to adopt treatment approaches presented from University of Utah clinicians to patient care
- Not directly working with pregnant patients with OUD
Sites / Locations
- Eastern Utah Women's Health LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enhanced Perinatal Care
Arm Description
Pregnant women enrolled in the study will receive enhanced perinatal care from community healthcare providers that have participated in the perinatal OUD education curriculum.
Outcomes
Primary Outcome Measures
Self-report of linkage and adherence to treatment as assessed by the Treatment Service Review- 6 (TSR-6)
Patients will complete the Treatment Services Review-6 (TSR-6) in order to measure changes in service across time. The TSR-6 is a clinically validated 56-item measure with excellent reliability for assessing drug and alcohol treatment engagement, medication use (including drug, alcohol, psychiatric, and physical health medications), psychiatric care, family services, financial/employment/housing, and legal services. This measure captures linkage/retention in care, that is to say: initiation and daily engagement in services. Specifically, the research team will capture frequency of meetings/sessions/days in OUD and other substance counseling and psychiatric care and social services. The research team will also use the TSR-6 medication use section to capture adherence to buprenorphine or methadone. Data collected will be used to measure change across time in linkage and retention in health and behavioral health services.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04448015
Brief Title
Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties
Official Title
Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to enhance perinatal opioid use disorder (OUD) treatment in a rural setting by developing an evaluated curriculum of perinatal OUD provider education.
Detailed Description
The research team will establish and evaluate a perinatal model of care for OUD serving two counties, Carbon and Emery, which have high rates of OUD and overdose. This model of care will entail University of Utah medical clinicians providing education and webinars to healthcare providers in Carbon/Emery counties who care for pregnant women with OUD and their babies. This model of care will also help other social and behavioral health care providers in the area to understand how to treat and better coordinate care. No clinical services are being provided by University of Utah investigators or staff.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Pregnancy Related
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Perinatal Care
Arm Type
Experimental
Arm Description
Pregnant women enrolled in the study will receive enhanced perinatal care from community healthcare providers that have participated in the perinatal OUD education curriculum.
Intervention Type
Other
Intervention Name(s)
Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care
Intervention Description
University of Utah clinicians will provide face-to-face, online, and written training materials for health, mental health, and substance use service providers in Carbon and Emery Counties, UT.
Primary Outcome Measure Information:
Title
Self-report of linkage and adherence to treatment as assessed by the Treatment Service Review- 6 (TSR-6)
Description
Patients will complete the Treatment Services Review-6 (TSR-6) in order to measure changes in service across time. The TSR-6 is a clinically validated 56-item measure with excellent reliability for assessing drug and alcohol treatment engagement, medication use (including drug, alcohol, psychiatric, and physical health medications), psychiatric care, family services, financial/employment/housing, and legal services. This measure captures linkage/retention in care, that is to say: initiation and daily engagement in services. Specifically, the research team will capture frequency of meetings/sessions/days in OUD and other substance counseling and psychiatric care and social services. The research team will also use the TSR-6 medication use section to capture adherence to buprenorphine or methadone. Data collected will be used to measure change across time in linkage and retention in health and behavioral health services.
Time Frame
This data will be collected from each participant during a baseline assessment, a pre-delivery assessment occurring between 34 and 40 weeks of gestation, and a final assessment conducted within 30-days following delivery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Provider Inclusion Criteria:
Must be employed as staff at one of our sub-contracted agencies or community partners
Must directly provide care to pregnant women with OUD in Carbon and/or Emery Counties, UT
Provider Exclusion Criteria:
Unwilling or unable to adopt treatment approaches presented from University of Utah clinicians to patient care
Not directly working with pregnant patients with OUD
Facility Information:
Facility Name
Eastern Utah Women's Health LLC
City
Price
State/Province
Utah
ZIP/Postal Code
84501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33129355
Citation
Bryan MA, Smid MC, Cheng M, Fortenberry KT, Kenney A, Muniyappa B, Pendergrass D, Gordon AJ, Cochran G. Addressing opioid use disorder among rural pregnant and postpartum women: a study protocol. Addict Sci Clin Pract. 2020 Oct 31;15(1):33. doi: 10.1186/s13722-020-00206-6.
Results Reference
derived
Learn more about this trial
Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties
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