STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Project STEPuP: A Prenatal Provider Education and Training Program to Improve Medication-assisted Treatment Use During Pregnancy and Maternal and Child Health Outcomes

Conditions
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Opioid-use Disorder, Pregnancy Related

Intervention / Treatment
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* Behavioral: STEPuP Intervention
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEPuP Intervention<br>STEPuP interventions | Behavioral: STEPuP Intervention<br>* 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.<br>* Other names: Project STEPuP(Substance abuse Treatment and Education during Pregnancy and Postpartum);|
| Active Comparator: Usual Care<br>Standard of Care | Behavioral: Usual Care<br>* Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Year 1 | 
| 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. | Year 1 | 
| 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. | Year 1 | 
| 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. | Year 1 | 
| 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. | Year 1 | 
| 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. | Year 4 | 
| 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. | Year 5 | 
| 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. | Year 1 | 
| 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. | Year 2 | 
| 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. | Year 3 | 
| 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. | Year 4 | 
| 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. | Year 5 | 
| 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. | Year 1 | 
| 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. | Year 2 | 
| 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. | Year 3 | 
| 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. | Year 4 | 
| 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. | Year 5 | 
| 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). | Year 1 | 
| 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). | Year 2 | 
| 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). | Year 3 | 
| 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). | Year 4 | 
| 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). | Year 5 | 
| 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. | Year 1 | 
| 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. | Year 2 | 
| 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. | Year 3 | 
| 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. | Year 4 | 
| 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. | Year 5 | 
| 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. | Year 1 | 
| 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. | Year 2 | 
| 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. | Year 3 | 
| 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. | Year 4 | 
| 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. | Year 5 | 
| 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. | Year 1 | 
| 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. | Year 2 | 
| 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. | Year 3 | 
| 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. | Year 4 | 
| 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. | Year 5 | 
| 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. | Year 1 | 
| 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. | Year 2 | 
| 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. | Year 3 | 
| 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. | Year 4 | 
| 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. | Year 5 | 
| 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. | Year 1 | 
| 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. | Year 2 | 
| 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. | Year 3 | 
| 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. | Year 4 | 
| 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. | Year 5 | 
| 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. | Birth hospitalization through 1 year | 
| 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. | Birth hospitalization through 1 year | 
| 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. | Birth hospitalization through 1 year | 
| 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. | Birth hospitalization through 1 year | 
| 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. | Birth hospitalization through 1 year | 
| 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. | Birth hospitalization through 1 year | 
| 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. | Birth hospitalization through 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid-use Disorder, Medication-assisted Treatment, Pregnancy