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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• 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.

Primary outcome measures

• Qualitative Interview for NICU Providers [Time frame: Time 1 (baseline)]
• Qualitative Interview for Parents [Time frame: Time 1 (baseline)]
• Feasibility of Intervention Measure [Time frame: Up to 9 months]
• Acceptability of Intervention Measure [Time frame: Up to 9 months]
• Recruitment and Retention Statistics [Time frame: Up to 1 year.]

Eligibility criteria

Inclusion Criteria for Interview Participants in Aim 1:

• 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

Inclusion Criteria for Mothers in Aim 1:

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

Inclusion Criteria for Clinicians in Aim 3:

• 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.

Inclusion Criteria for Mothers in 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 3 centers

• Hospital of the University of Pennsylvania — Philadelphia
• Penn Center for Women's Behavioral Wellness — Philadelphia
• Pennsylvania Hospital — Philadelphia

Publications

• Hirai AH, Ko JY, Owens PL, Stocks C, Patrick SW. Neonatal Abstinence Syndrome and Maternal Opioid-Related Diagnoses in the US, 2010-2017. JAMA. 2021 Jan 12;325(2):146-155. doi: 10.1001/jama.2020.24991. PMID 33433576
• Winkelman TNA, Villapiano N, Kozhimannil KB, Davis MM, Patrick SW. Incidence and Costs of Neonatal Abstinence Syndrome Among Infants With Medicaid: 2004-2014. Pediatrics. 2018 Apr;141(4):e20173520. doi: 10.1542/peds.2017-3520. PMID 29572288
• Ray-Griffith S, Tharp E, Coker JL, Catlin D, Knight B, Stowe ZN. Buprenorphine Medication for Opioid Use Disorder: A Study of Factors Associated With Postpartum Treatment Retention. Am J Addict. 2021 Jan;30(1):43-48. doi: 10.1111/ajad.13084. Epub 2020 Jul 16. PMID 32673447
• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50. PMID 19664226
• Becker-Haimes EM, Mandell DS, Fishman J, Williams NJ, Wolk CB, Wislocki K, Reich D, Schaechter T, Brady M, Maples NJ, Creed TA. Assessing Causal Pathways and Targets of Implementation Variability for EBP use (Project ACTIVE): a study protocol. Implement Sci Commun. 2021 Dec 20;2(1):144. doi: 10.1186/s43058-021-00245-3. PMID 34930483
• Fernandez ME, Ten Hoor GA, van Lieshout S, Rodriguez SA, Beidas RS, Parcel G, Ruiter RAC, Markham CM, Kok G. Implementation Mapping: Using Intervention Mapping to Develop Implementation Strategies. Front Public Health. 2019 Jun 18;7:158. doi: 10.3389/fpubh.2019.00158. eCollection 2019. PMID 31275915
• Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235. PMID 28742676
• Ko JY, Patrick SW, Tong VT, Patel R, Lind JN, Barfield WD. Incidence of Neonatal Abstinence Syndrome - 28 States, 1999-2013. MMWR Morb Mortal Wkly Rep. 2016 Aug 12;65(31):799-802. doi: 10.15585/mmwr.mm6531a2. PMID 27513154

Identifiers

NCT: NCT06576323 · R21DA058815

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗