Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties

Pregnancy Related Clinical Trial

Official title:

Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448015
• Other study ID #: A02769
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: September 29, 2020

Study information

• Verified date: November 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 29, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-use Disorder
• Pregnancy Related

Intervention

Other:
• Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care
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.

Locations

Country	Name	City	State
United States	Eastern Utah Women's Health LLC	Price	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.