An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
NCT Number: NCT06576323
Acronym: SUPPORT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder|Neonatal Abstinence Syndrome
Interventions: BEHAVIORAL: An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU
Sponsor: University of Pennsylvania
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-01
Completion Date: 2025-12-31
Locations: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Penn Center for Women's Behavioral Wellness, Philadelphia, Pennsylvania, 19104, United States|Pennsylvania Hospital, Philadelphia, Pennsylvania, 19107, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Demographics survey, Brief questionnaire about provider and parent demographic (e.g., age, gender) and professional characteristics (e.g., provider role, years of experience, level of training), and work setting, Time 1 (baseline)