Opioid-use DisorderNCT04448015
Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties
A study testing Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care in people with Opioid-use Disorder and Pregnancy Related, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Pregnancy Related
- What is being tested?
- Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 29 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Opioid-use Disorder, Pregnancy Related
- Being tested
- Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Feb 2019
- Primary completion1 Aug 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerry Cochran, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448015
- Sponsor's protocol ID
- A02769
- Status last verified
- Nov 2020
- First submitted
- 18 Jun 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33129355
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties
- ClinicalTrials.gov ID
- NCT04448015
- Acronym / sponsor ID
- A02769
- Conditions
- Opioid-use Disorder, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced Perinatal Care | Experimental | Other: Perinatal Opioid Use Disorder Education and Enhanced Perinatal CarePregnant women enrolled in the study will receive enhanced perinatal care from community healthcare providers that have participated in the perinatal OUD education curriculum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perinatal Opioid Use Disorder Education and Enhanced Perinatal CareUniversity 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. | Other | Enhanced Perinatal Care |
Primary outcome
Self-report of linkage and adherence to treatment as assessed by the Treatment Service Review- 6 (TSR-6)
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 33129355Bryan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care in people with Opioid-use Disorder and Pregnancy Related, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report of linkage and adherence to treatment as assessed by the Treatment Service Review- 6 (TSR-6) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.