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

Conditions

• Neonatal Abstinence Syndrome
• Opioid Use Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU — BEHAVIORAL
  We will use implementation mapping to develop a suite of implementation strategies to deliver evidence-based MOUD prescription to mothers attending the bedside of their infants hospitalized in the NICU. The intervention itself is buprenorphine induction and treatment, however the model for delivery is not yet developed, consistent with the need for results from Aim 1 to inform the approach used to develop the implementation model in Aim 2.

Study Details

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 acceptability and feasibility of applying the adapted model.

Key Dates

Start date

Jul 1, 2024

Status verified

Jul 2025

Primary completion

Jun 1, 2026

Completion

Jun 1, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Other: Case Series
  In Aim 3, all recruited participants will receive the intervention.

Primary Outcome Measure

Qualitative Interview for NICU Providers [ Time Frame: Time 1 (baseline) ]

Central Contacts

• Sara Kornfield, PhD
  215-746-1255
  [email protected]
• Emma Farber, BA
  215-746-3338
  [email protected]

Locations (3)

Find similar trials in Philadelphia, PA

Related Studies

• A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
  PHASE4 · Recruiting · VA Office of Research and Development · Tuscaloosa, Alabama
• Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement
  Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania
• MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
  Recruiting · Milton S. Hershey Medical Center · Hershey, Pennsylvania
• Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
  Recruiting · Ilana Hull · Pittsburgh, Pennsylvania