NCT04448015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

June 18, 2020

Last Update Submit

November 9, 2020

Conditions

Opioid-use DisorderPregnancy Related

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Enhanced Perinatal Care

EXPERIMENTAL

Pregnant women enrolled in the study will receive enhanced perinatal care from community healthcare providers that have participated in the perinatal OUD education curriculum.

Other: Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care

Interventions

Perinatal Opioid Use Disorder Education and Enhanced Perinatal CareOTHER

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.

Enhanced Perinatal Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling or unable to adopt treatment approaches presented from University of Utah clinicians to patient care
  • Not directly working with pregnant patients with OUD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Utah Women's Health LLC

Price, Utah, 84501, United States

Location

Related Publications (1)

  • 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.

    PMID: 33129355DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 25, 2020

Study Start

February 1, 2019

Primary Completion

August 1, 2020

Study Completion

September 29, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)