An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU
BehavioralWe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Case SeriesOther 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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 months4
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 monthsOther outcomes
1
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)Sponsors and contacts
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Source ClinicalTrials.gov