Piloting a Web Resource for Pregnancy OUD in Jail

NCT05853289 | Completed

• 2 other identifiers: IRB003818451R34DA056014-01A1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to pilot an adaptable, user-friendly, web-accessible toolkit and implementation strategy for jails to be able to provide access to pregnancy-specific opioid use disorder (OUD) care. The main question it aims to answer is: \- What support and tools do jails that vary in size, resources, and health care delivery systems need for pregnancy care that can be tailored to the environment? Jail staff will use the implementation resource to provide care to pregnant people in and leaving custody through facilitated guidance. While using the resource, jail staff will:

• Complete 6-month and 12-month surveys assessing the participants use of the tool
• Complete baseline, 6-month, and 12-month qualitative interviews assessing the participants perspectives on using the tool
• Report de-identified jail outcomes data monthly on the pregnant people in the jail's care
• Report jail policy and financial data as it pertains to pregnant people with OUD at baseline Pregnant people with OUD in custody at pilot jails will be asked to participate in qualitative interviews as baseline and 1- and 6 months after release to assess the participants perspectives on the care received in jail and continuity of care.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• Change in organizational readiness as assessed by the ORIC scale

  Staff surveys will be administered to assess organizational readiness at baseline before implementation using the organizational readiness for implementing change (ORIC) scale. The scale is a 12-item instrument used to assess how staff at an organization feel they can implement the change in process proposed by an intervention. Each instrument item uses a Likert scale from 1 (disagree) to 5 (agree). A higher score indicates higher organizational readiness.

  Baseline, 6 months, 12 months

• Change in technology usage, attitudes and satisfaction as assessed by the UTAUT

  Staff interviews will be administered to assess technology usage, attitudes and satisfaction using the unified theory of acceptance and use of technology (UTAUT). The UTAUT uses four constructs to determine user acceptance and usage behavior that include performance expectancy, effort expectancy, social influence and facilitating conditions. UTAUT proposes sub-constructs for each of the 4 categories that we will use to inform the interview guide.

  6 months, 12 months

• Satisfaction, autonomy, discrimination and other experiences for pregnant people with OUD (PPwOUD) in jail as assessed by the RRDS

  Mixed methods will be used to assess patient-level outcomes for PPwOUD who are in each jail during the pilot phase. Collecting both quantitative and qualitative data that can be triangulated is necessary to assess health outcomes and experiential dimensions of how the jail's bundle implementation affects patient care in and out of jail. The Recovery-related Discrimination Scale (RRDS) is designed to assess self-reported perceived frequency of personal experiences of slights and violation of personal rights due to their alcohol or drug problems. It includes micro and macro discrimination items that are scored from 'never' to 'often.' The more often the items occurred, the more discrimination the individual experienced. These scale questions will inform the interview guide.

  Post release from jail up to 1 month

Secondary Outcomes (2)

• Change in financial assessment of caring for PPwOUD in jail

  Baseline, 12 months

• Change in relational coordination as assessed by the Relational Coordination Survey

  baseline, 6 months, 12 months

Study Arms (1)

Jail staff at pilot jails

EXPERIMENTAL

Jail staff will be asked to use the implementation resource with guided facilitation to care for pregnant people in and leaving custody.

Other: Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in Custody

Interventions

Maternal Opioid use Disorder Management and Care Resources (MOM CARE) in Custody OTHER

MOM CARE is a web-based implementation resource designed for jail staff to help the staff provide evidence-based, trauma-informed and patient-centered care and support to pregnant people with opioid use disorder in and leaving custody. MOM CARE's content will include medical guidance and best-practices from intake to discharge, reentry steps and recommendations, and implementation 'how to' content. There will be specific content for jail administrators, medical and custody staff. Content will be curated from existing resources regarding this topic with new original tools specific to pregnant people with OUD in jail.

Jail staff at pilot jails

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Jail custody staff who are employed at a jail that holds pregnant women with OUD and are involved in the care of pregnant women with opioid use disorder

You may not qualify if:

• non-English speaking
• pregnant people with OUD who are in custody at a pilot jail during the study period
• jail stay of at least 24 hours
• non-English speaking
• women who are intoxicated or actively withdrawing
• women are actively psychotic

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21224, United States

Location

Related Publications (5)

• Vilsaint CL, Hoffman LA, Kelly JF. Perceived discrimination in addiction recovery: Assessing the prevalence, nature, and correlates using a novel measure in a U.S. National sample. Drug Alcohol Depend. 2020 Jan 1;206:107667. doi: 10.1016/j.drugalcdep.2019.107667. Epub 2019 Oct 25.

  PMID: 31780300 BACKGROUND

• Connolly SL, Sullivan JL, Ritchie MJ, Kim B, Miller CJ, Bauer MS. External facilitators' perceptions of internal facilitation skills during implementation of collaborative care for mental health teams: a qualitative analysis informed by the i-PARIHS framework. BMC Health Serv Res. 2020 Mar 4;20(1):165. doi: 10.1186/s12913-020-5011-3.

  PMID: 32131824 BACKGROUND

• Hunter SC, Kim B, Mudge A, Hall L, Young A, McRae P, Kitson AL. Experiences of using the i-PARIHS framework: a co-designed case study of four multi-site implementation projects. BMC Health Serv Res. 2020 Jun 23;20(1):573. doi: 10.1186/s12913-020-05354-8.

  PMID: 32576197 BACKGROUND

• Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014 Jan 10;9:7. doi: 10.1186/1748-5908-9-7.

  PMID: 24410955 BACKGROUND

• Molfenter T, Vechinski J, Taxman FS, Breno AJ, Shaw CC, Perez HA. Fostering MOUD use in justice populations: Assessing the comparative effectiveness of two favored implementation strategies to increase MOUD use. J Subst Abuse Treat. 2021 Sep;128:108370. doi: 10.1016/j.jsat.2021.108370. Epub 2021 Mar 17.

  PMID: 33762145 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Carolyn Sufrin, MD, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: May 14, 2024
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)