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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

• See above for inclusion criteria for interview participants.

• 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

Locations
United States
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Penn Center for Women's Behavioral Wellness
RECRUITING
Philadelphia
Pennsylvania Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Sara Kornfield, PhD
sarakorn@pennmedicine.upenn.edu
215-746-1255
Backup
Emma Farber, BA
emma.farber@pennmedicine.upenn.edu
215-746-3338
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 50
Treatments
Other: Case Series
In Aim 3, all recruited participants will receive the intervention.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov