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

NCT06576323 | Recruiting

• 1 other identifier: R21DA058815
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Opioid Use Disorder; Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (5)

• Qualitative Interview for NICU Providers

  In-depth qualitative interview focused on providers' attitudes and knowledge about barriers and facilitators of buprenorphine induction for mothers in the NICU. This interview will be guided by the Consolidated Framework for Implementation Research to query about barriers and facilitators of MOUD provision in the NICU, with the primary goal of identifying contextual determinants of co-located care.

  Time 1 (baseline)

• Qualitative Interview for Parents

  In-dept qualitative interview focused on mothers' attitudes about receiving MOUD in the NICU while caring for their hospitalized infant. This interview will be guided by the Consolidated Framework for Implementation Research to query about what would make this more attractive, feasible, and engagement more likely.

  Time 1 (baseline)

• Feasibility of Intervention Measure

  A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is feasible.

  Up to 9 months

• Acceptability of Intervention Measure

  A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is acceptable.

  Up to 9 months

• Recruitment and Retention Statistics

  The proportion of mothers of babies in the NICU who agree to receive MOUD in the NICU (Time 2; T2), who remain in care for the duration of their baby's stay (Time 3; T3), and length of time they remain in outpatient treatment after treatment (Time 4; T4).

  Up to 1 year.

Other Outcomes (1)

• Demographics survey

  Time 1 (baseline)

Study Arms (1)

Case Series

OTHER

In Aim 3, all recruited participants will receive the intervention.

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

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.

Case Series

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participants should be biological mothers of children hospitalized in the UPHS NICU for NAS
• Participants should be diagnosed with opioid use disorder
• 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.
• 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

You may not qualify if:

• \- None
• \- None
• \- None
• \- Active suicidal ideation, or other severe psychopathology that must be addressed before effective MOUD can be prescribed

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (3)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Penn Center for Women's Behavioral Wellness

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (55)

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  BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Neonatal Abstinence Syndrome

Interventions

Prescriptions

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sara Kornfield, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Kornfield, PhD

CONTACT

215-746-1255; sarakorn@pennmedicine.upenn.edu

Emma Farber, BA

CONTACT

215-746-3338; emma.farber@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 28, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)