STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy (STEPuP)
Primary Purpose
Opioid-use Disorder, Pregnancy Related
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEPuP Intervention
Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Opioid-use Disorder focused on measuring Opioid-use Disorder, Medication-assisted Treatment, Pregnancy
Eligibility Criteria
Inclusion Criteria:
Providers-
- provides prenatal care (i.e. obstetricians, nurse midwives, advanced practice providers) at obstetric sites,
- provides care to pregnant women with OUD
- English speaking. Patient- Maternal and child outcome data will be collected from the EHR and individual patients will not be recruited to participate in the RCT. A small subset of pregnant women (n=50) who 1) meet DSM-V criteria for OUD and 2) received care at participating sites while pregnant during the study time period will be recruited for a one-time qualitative interview and (3) speak English.
Exclusion Criteria:
- None
Sites / Locations
- Magee Womens Hospital of UPMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STEPuP Intervention
Usual Care
Arm Description
STEPuP interventions
Standard of Care
Outcomes
Primary Outcome Measures
Create organizational readiness to facilitate Project STEPuP implementation acceptability
Acceptability will be measured using the Organizational Readiness to Change Assessment (ORCA) evidence subscales, which examine providers' perceptions that the intervention is supported by research, clinical experiences, and would be acceptable to patients. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation acceptability.
Create organizational readiness to facilitate Project STEPuP implementation acceptability
Acceptability will also be measured with the Brief Substance Abuse Attitude Scale (BSAAS), a validated tool to assess provider attitudes toward substance use, which includes one item specific to substance use in pregnancy. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation acceptability.
Create organizational readiness to facilitate Project STEPuP implementation context
Context for evidence based practices will be measured using the Organizational Readiness to Change Assessment (ORCA) context subscales, which focus on leadership and culture. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation context.
Create organizational readiness to facilitate Project STEPuP implementation context
Context for Evidence Based Practices will also be measured using the Evidence Based Practice Attitude Scale (EBPAS), a validated tool to measure providers' attitudes toward adoption of EBP. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation context.
Create organizational readiness to facilitate Project STEPuP implementation facilitation
Facilitation will be measured using the Organizational Readiness to Change Assessment (ORCA) facilitation subscales, which measure clinical championship, implementation capacity and communication. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation facilitation.
Create organizational readiness to facilitate Project STEPuP implementation sustainability
Sustainability will be measured 5 by ongoing assessments of provider adoption of Evidence Based Practices after completing the Project STEPuP intervention.
Create organizational readiness to facilitate Project STEPuP implementation sustainability
Sustainability will be measured 5 by ongoing assessments of provider adoption of Evidence Based Practices after completing the Project STEPuP intervention.
Assess the effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Assess the effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Opioid Use Disorder Treatment from Electronic Health Record encounters, prescription orders, and laboratory orders measured by % days covered with buprenorphine/methadone in pregnancy.
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Opioid Use Disorder Treatment from Electronic Health Record encounters, prescription orders, and laboratory orders measured by positive urine test for illicit drug use in pregnancy.
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Opioid Use Disorder Treatment from Electronic Health Record encounters, prescription orders, and laboratory orders measured by % days retained in treatment 1 year postpartum.
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Maternal health from hospital discharge records, Electronic Health Record encounters, and prescription orders measured by Neonatal Abstinence Syndrome indicated in Finnegan Score or ICD-10 codes at birth hospitalization.
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Maternal health from hospital discharge records, EHR encounters, and prescription orders measured by gestational age in weeks and birthweight.
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Maternal health from hospital discharge records, EHR encounters, and prescription orders measured by number of well-child visits in first year of life.
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Maternal health from hospital discharge records, EHR encounters, and prescription orders measured by removal from the home due to Child Welfare Agency action.
Secondary Outcome Measures
Full Information
NCT ID
NCT04527926
First Posted
August 18, 2020
Last Updated
March 20, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04527926
Brief Title
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
Acronym
STEPuP
Official Title
Project STEPuP: A Prenatal Provider Education and Training Program to Improve Medication-assisted Treatment Use During Pregnancy and Maternal and Child Health Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research will test the effectiveness of a prenatal provider education and training program designed to facilitate provider adoption of evidence-based practices for the treatment of OUD during pregnancy. Findings from this research will provide high quality evidence about how to increase evidence-based treatment for pregnant women with OUD and subsequent maternal-child health outcomes.
Detailed Description
The prevalence of opioid use disorder (OUD) during pregnancy has quadrupled over the past decade, as have maternal and neonatal morbidity and mortality related to substance use. Medication assisted treatment (MAT) use during pregnancy reduces adverse outcomes and is the recommended, evidence-based practice (EBP) for OUD treatment during pregnancy. Despite this, 40% of pregnant women with OUD do not receive MAT. Currently, there are no effective strategies to expand MAT access and availability for pregnant women, especially in rural, low-resource settings where maternal opioid use is disproportionately high. As an initial step to address this gap, the investigators engaged key stakeholders across a large health system in Pennsylvania to determine barriers and facilitators to expanding treatment services in high need, low-resource obstetric settings. The stakeholders identified a critical need for a women-centered, low resource, sustainable, provider-level intervention to facilitate the adoption of MAT in obstetric settings. Therefore, the investigators objective is to test the effectiveness of a prenatal provider education and training program designed to facilitate the adoption of EBP for OUD during pregnancy called Project STEPuP (Substance abuse Treatment and Education during Pregnancy and Postpartum). Project STEPuP, grounded in preliminary and pilot work conducted by the research team, has 4 components designed to address barriers to MAT and EBP adoption: 1) a "hub and spoke," remotely-supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs. To achieve this objective, the research team will conduct a cluster-randomized clinical trial across 12 obstetric sites in Pennsylvania and New York. Outcomes among 870 patients will be assessed during pregnancy, at delivery and through 1 year postpartum. The investigators central hypothesis is that Project STEPuP will facilitate EBP adoption, increase MAT utilization and improve health outcomes among pregnant and postpartum women with OUD and their children. Specifically, the investigators aim to: 1) Create organizational readiness to facilitate Project STEPuP implementation; 2) Assess the effect of Project STEPuP on provider adoption of EBP for OUD during pregnancy; and 3) Evaluate the effect of provider adoption of EBP on maternal and child health outcomes. The investigators research is significant by addressing the substantial knowledge gap of how to increase MAT use in pregnancy and innovative by examining the role that prenatal providers can play in expanding treatment access.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Pregnancy Related
Keywords
Opioid-use Disorder, Medication-assisted Treatment, Pregnancy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STEPuP Intervention
Arm Type
Experimental
Arm Description
STEPuP interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Standard of Care
Intervention Type
Behavioral
Intervention Name(s)
STEPuP Intervention
Other Intervention Name(s)
Project STEPuP(Substance abuse Treatment and Education during Pregnancy and Postpartum)
Intervention Description
Project STEPup has 4 components designed to address barriers to MAT and EBP adoption: 1) a "hub and spoke" remotely-supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Create organizational readiness to facilitate Project STEPuP implementation acceptability
Description
Acceptability will be measured using the Organizational Readiness to Change Assessment (ORCA) evidence subscales, which examine providers' perceptions that the intervention is supported by research, clinical experiences, and would be acceptable to patients. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation acceptability.
Time Frame
Year 1
Title
Create organizational readiness to facilitate Project STEPuP implementation acceptability
Description
Acceptability will also be measured with the Brief Substance Abuse Attitude Scale (BSAAS), a validated tool to assess provider attitudes toward substance use, which includes one item specific to substance use in pregnancy. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation acceptability.
Time Frame
Year 1
Title
Create organizational readiness to facilitate Project STEPuP implementation context
Description
Context for evidence based practices will be measured using the Organizational Readiness to Change Assessment (ORCA) context subscales, which focus on leadership and culture. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation context.
Time Frame
Year 1
Title
Create organizational readiness to facilitate Project STEPuP implementation context
Description
Context for Evidence Based Practices will also be measured using the Evidence Based Practice Attitude Scale (EBPAS), a validated tool to measure providers' attitudes toward adoption of EBP. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation context.
Time Frame
Year 1
Title
Create organizational readiness to facilitate Project STEPuP implementation facilitation
Description
Facilitation will be measured using the Organizational Readiness to Change Assessment (ORCA) facilitation subscales, which measure clinical championship, implementation capacity and communication. The minimum value option is strongly disagree, and the maximum value option is strongly agree. Level of agreement/disagreement indicates level of implementation facilitation.
Time Frame
Year 1
Title
Create organizational readiness to facilitate Project STEPuP implementation sustainability
Description
Sustainability will be measured 5 by ongoing assessments of provider adoption of Evidence Based Practices after completing the Project STEPuP intervention.
Time Frame
Year 4
Title
Create organizational readiness to facilitate Project STEPuP implementation sustainability
Description
Sustainability will be measured 5 by ongoing assessments of provider adoption of Evidence Based Practices after completing the Project STEPuP intervention.
Time Frame
Year 5
Title
Assess the effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Time Frame
Year 1
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Time Frame
Year 2
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Time Frame
Year 3
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Time Frame
Year 4
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by % patients with buprenorphine induction by prenatal providers.
Time Frame
Year 5
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Time Frame
Year 1
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Time Frame
Year 2
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Time Frame
Year 3
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Time Frame
Year 4
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of buprenorphine prescribing from prenatal providers.
Time Frame
Year 5
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Time Frame
Year 1
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Time Frame
Year 2
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Time Frame
Year 3
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Time Frame
Year 4
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Medicated Assisted Treatment adoption from Electronic Health Record encounters, prescription orders, and documentation in provider progress notes as measured by rate of referrals to other treatment providers (methadone).
Time Frame
Year 5
Title
Assess the effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Time Frame
Year 1
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Time Frame
Year 2
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Time Frame
Year 3
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Time Frame
Year 4
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HIV.
Time Frame
Year 5
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Time Frame
Year 1
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Time Frame
Year 2
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Time Frame
Year 3
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Time Frame
Year 4
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for HCV.
Time Frame
Year 5
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Time Frame
Year 1
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Time Frame
Year 2
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Time Frame
Year 3
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Time Frame
Year 4
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Co-morbidity screening from Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients screened for depression and anxiety.
Time Frame
Year 5
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Time Frame
Year 1
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Time Frame
Year 2
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Time Frame
Year 3
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Time Frame
Year 4
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by % patients receiving contraceptive counseling.
Time Frame
Year 5
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Time Frame
Year 1
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Time Frame
Year 2
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Time Frame
Year 3
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Time Frame
Year 4
Title
Effect of Project STEPuP on provider adoption of Evidence Based Practices for Opioid Use Disorder in pregnancy
Description
Preventative health services from the Electronic Health Record encounters; prescription orders; documentation in provider progress notes as measured by and % patients receiving breastfeeding support.
Time Frame
Year 5
Title
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Description
Opioid Use Disorder Treatment from Electronic Health Record encounters, prescription orders, and laboratory orders measured by % days covered with buprenorphine/methadone in pregnancy.
Time Frame
Birth hospitalization through 1 year
Title
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Description
Opioid Use Disorder Treatment from Electronic Health Record encounters, prescription orders, and laboratory orders measured by positive urine test for illicit drug use in pregnancy.
Time Frame
Birth hospitalization through 1 year
Title
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Description
Opioid Use Disorder Treatment from Electronic Health Record encounters, prescription orders, and laboratory orders measured by % days retained in treatment 1 year postpartum.
Time Frame
Birth hospitalization through 1 year
Title
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Description
Maternal health from hospital discharge records, Electronic Health Record encounters, and prescription orders measured by Neonatal Abstinence Syndrome indicated in Finnegan Score or ICD-10 codes at birth hospitalization.
Time Frame
Birth hospitalization through 1 year
Title
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Description
Maternal health from hospital discharge records, EHR encounters, and prescription orders measured by gestational age in weeks and birthweight.
Time Frame
Birth hospitalization through 1 year
Title
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Description
Maternal health from hospital discharge records, EHR encounters, and prescription orders measured by number of well-child visits in first year of life.
Time Frame
Birth hospitalization through 1 year
Title
Effect of provider adoption of Evidence Based Practices on maternal and child health outcomes
Description
Maternal health from hospital discharge records, EHR encounters, and prescription orders measured by removal from the home due to Child Welfare Agency action.
Time Frame
Birth hospitalization through 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Providers-
provides prenatal care (i.e. obstetricians, nurse midwives, advanced practice providers) at obstetric sites,
provides care to pregnant women with OUD
English speaking. Patient- Maternal and child outcome data will be collected from the EHR and individual patients will not be recruited to participate in the RCT. A small subset of pregnant women (n=50) who 1) meet DSM-V criteria for OUD and 2) received care at participating sites while pregnant during the study time period will be recruited for a one-time qualitative interview and (3) speak English.
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Krans, MD
Organizational Affiliation
UPMC Magee-Womens Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marian Jarlenski, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
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