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| ID | Type | Description | Link |
|---|---|---|---|
| R61DA061377 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Magee-Women's Research Institute | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The investigators seek to adapt a collaborative care model (CCM) for community-based, low-resource obstetric settings and to test the effects of this adapted CCM on health outcomes among Pregnant, postpartum, and parenting person (PPPP) with Opioid use disorder (OUD) and their families. To achieve this goal, investigators will conduct a nonrandomized, Type 1 hybrid implementation-effectiveness study across 3 community-based, low-resource obstetric sites in Northwest PA, a region with rates of maternal opioid-related diagnoses 4 times higher than national averages.
Our central hypothesis is that person-centered, recovery supports, provided in the CCM will increase medication for OUD (MOUD) initiation and continuation, decrease overdose and reduce child removal rates among PPPP with OUD.
Specifically, investigators will:
Investigators will also:
Research findings will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted Collaborative Care Model (CCM) | Person-centered, recovery supports. |
| |
| Usual care | Usual, referral-based, care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Behavioral | Usual, referral-based, care. |
| |
| Adapted Collaborative Care Model (CCM) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Initiation of Medication for Opioid Use Disorder (MOUD) | Patient Initiation of Medication for Opioid Use Disorder (MOUD) as measured by total buprenorphine or methadone initiation in Electronic Health Record (EHR) and Medicaid claims data | During pregnancy (up to 40 weeks), up to 1 year post delivery |
| Patient Duration of MOUD | Patient Duration of MOUD as measured by proportion of days' covered incorporating buprenorphine or methadone treatment in EHR and claims data | During pregnancy (up to 40 weeks), up to 1 year post delivery |
| Patient Overdose | Patient Overdose as measured by total count of nonfatal or fatal overdose events in EHR and claims data | During pregnancy (up to 40 weeks), up to 1 year post delivery |
| Patient child foster care placement | Patient child foster care placement as measured by total child placements in foster care system according to child protective service data linked with Medicaid data | Delivery through 1 year postpartum |
| Patient utilization of well-child services | Patient utilization of well-child services as measured by total well-child visits in EHR and claims data | Delivery through 1 year postpartum |
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Inclusion Criteria:
(Stakeholder Participant)
(Patient Participant)
Exclusion Criteria:
1. Unwillingness to have participation audio recorded.
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A core team of clinical providers at each obstetric site (i.e., nurse case manager, peer navigator, advanced practice provider, behavioral health provider, and lead obstetrician/gynecologist) have already committed to providing clinical care for the adapted CCM and participate in all stages of the research process. As such, they will not need to be recruited for participation.
Maternal and child outcome data will be collected retrospectively from the EHR and individual patients will not be recruited to participate in the study. A small subset of pregnant women (n=50) who meet DSM-V criteria for OUD and who receive care at obstetric sites will be recruited for a one-time, semi-structured qualitative interview.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Krans, MD | University of Pittsburgh | Principal Investigator |
| Marian Jarlenski, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
HEAL Data Platform (HDP01418); NAHDAP data repository.
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Before publishing and/or at the end of the study period with results.
Public Access and Data Sharing Plan: A Public Access and Data Sharing Plan describes the plan for releasing Publications and sharing the Underlying Primary Data for an NIH HEAL Initiative Research Project.
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| Behavioral |
Person-centered, recovery supports. |
|
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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