An interventional study of An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU in Opioid Use Disorder and Neonatal Abstinence Syndrome, sponsored by University of Pennsylvania. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research
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.
The increasing prevalence of pregnant and postpartum women affected by Opioid Use Disorder (OUD) in the US is highlighted by the growing number of babies referred to the NICU for Neonatal Abstinence Syndrome after birth. Despite recent advances in integrating mental health and substance abuse treatment into adult healthcare settings, no current treatment options exist to integrate maternal OUD treatment and referrals into the pediatric care setting making it unlikely that mothers will be able to access care. In order to preserve the dyadic bond, improve maternal functioning, and provide a more stable environment for the infant after discharge from the NICU, the researchers now embark on a study utilizing steps from intervention mapping to identify facilitators and barriers to integrated maternal OUD treatment and referral in the NICU, adapt existing evidence-based models of co-located OUD care to the NICU setting, and test the feasibility and acceptability of the new model. In Aim 1, the researchers will collect qualitative data via in-depth interviews with 32 NICU providers, social workers, administrators, and parents to determine barriers and facilitators to offering bedside buprenorphine induction and treatment. In Aim 2, the researchers will convene an advisory board to review data collected in Aim 1 and to develop a plan for implementing buprenorphine initiation into the study's unique setting to address the issue- the provision of adult focused OUD care in a pediatric care setting. Aim 2 does not constitute Human Subjects research. The primary outcome of Aim 2 will be a suite of implementation strategies to pilot test in Aim 3. Aim 3 is a pilot case series implementation trial where the researchers will test the adapted intervention to determine feasibility and acceptability to both providers and patients. As this is a case series the investigators propose to recruit 10 participants from each of the two partner NICUs for a total enrollment of N= 20 in Aim 3. A formal sample size calculation was not performed as there is no data on which to a base a formal sample size calculation. For pilot studies with an expected medium standardized effect size, a case number of N= 15 per group has been recommended for pilot studies preceding a possible main study with a power of 90%. The investigators plan to recruit 20 participants to account for possible attrition. The researchers are not necessarily powered to detect an effect. Participants will not be randomized to condition; all NICU mothers meeting inclusion criteria during the study timeline for Aim 3 will be invited to participate in Aim 3. The outcomes of acceptability and feasibility will be measured through questionnaires, interviews, and treatment initiation and retention statistics.
Inclusion Criteria for Interview Participants in Aim 1:
Inclusion Criteria for Mothers in Aim 1:
Inclusion Criteria for Clinicians in Aim 3:
Inclusion Criteria for Mothers in Aim 3:
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
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
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.
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 frame: 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 frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to 1 year.
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 frame: Time 1 (baseline)
Plan to share: No
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