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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)

RecruitingNAAges 18 Years - anyAllUniversity of Pennsylvania
NCT06576323 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies to provide evidence-based OUD treatment to postpartum mothers in NICUs. First, the investigators will conduct a needs assessment via in-depth qualitative interviews with NICU mothers and clinicians. Then, with the expertise of the advisory board, the the researchers will create a protocol for implementing maternal OUD treatment at the NICU bedside. The researchers will then implement the protocol in two partner NICUs and evaluate the acceptability and feasibility to patients, providers, and clinical, and administrative leaders. The goal of this research study is to integrate maternal mental health and substance abuse treatment in pediatric settings and to refine, test, and examine the acce

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📋 Eligibility rules (as published)
Inclusion Criteria for Interview Participants in Aim 1: * Participants should be healthcare providers working within UPHS, who generally treat perinatal women or any individuals with OUD; for the purposes of this study, provider refers to a Medical Doctor (MD) or Doctor of Osteopathy (DO), Advanced Practice Practitioner, Nurse, or Social Worker. * Participants should provide direct care to NICU patients and/or their mothers * Participants should be proficient in English language * Participants should have access to a computer with internet connectivity or phone Inclusion Criteria for Mothers in Aim 1: * Participants should be biological mothers of children hospitalized in the UPHS NICU for NAS * Participants should be diagnosed with opioid use disorder Inclusion Criteria for Clinicians in Aim 3: * See above for inclusion criteria for interview participants. * We will use this same criteria to recruit new participants for Aim 3 if the same stakeholder interviewees are unavailable at the time of Aim 3. Inclusion Criteria for Mothers in Aim 3: * Participants should be biological mothers of a child hospitalized in either of the two UPHS NICU for NAS (either HUP or PAH) * Participants should be no more than 4 weeks postpartum * Participants should have an Opioid Use Disorder than is currently untreated with medication assisted treatment or buprenorphine Exclusion Criteria for Interview Participants in Aim 1: \- None Exclusion Criteria for Mothers in Aim 1: \- None Exclusion Criteria for Clinicians in Aim 3: \- None Exclusion Criteria for Mothers in Aim 3: \- Active suicidal ideation, or other severe psychopathology that must be addressed before effective MOUD can be prescribed
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What it tests

  • An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU
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Where

3 sites
Hospital of the University of Pennsylvania
Philadelphia, United States
Penn Center for Women's Behavioral Wellness
Philadelphia, United States
Pennsylvania Hospital
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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