NCT07707115

Brief Summary

The goal of this clinical trial is to develop and evaluate INSPIRE, an intervention for healthcare teams to improve care for individuals with substance use disorder (SUD) during their peri-delivery care. The main question it aims to answer is whether healthcare provider stigmas and behaviors change after receiving the training. The study will be implemented at the University of Utah.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Aug 2026Dec 2027

First Submitted

Initial submission to the registry

July 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

1.4 years

First QC Date

July 10, 2026

Last Update Submit

August 5, 2026

Conditions

Substance Use DisordersSimulation TrainingPregnancy RelatedPatient-centered CareBias, Implicit

Keywords

substance use disordersCare received in hospital during labor & delivery and post-partum

Outcome Measures

Primary Outcomes (1)

  • Medical Condition Regard Scale (MCRS)

    Medical Condition Regard Scale scores range from a minimum of 11 to a maximum of 66. Higher scores mean a better outcome, representing a more positive attitude, higher regard, and greater willingness in treating or caring for a specific medical condition

    Administered at Baseline and 1 month, 3 months, and 6 months after Baseline

Study Arms (1)

INSPIRE provider training

EXPERIMENTAL

All providers will receive the INSPIRE intervention. The INSPIRE intervention includes: 1) online learning modules #1, which is completed individually and should take approximately 2 hours, and 2) in-person simulation, which is done as a group and scheduled for 4 hours, and 3) online learning module #2.

Behavioral: INSPIRE

Interventions

INSPIREBEHAVIORAL

The INSPIRE intervention includes: 1) online learning modules #1, which is completed individually and should take approximately 2 hours, and 2) in-person simulation, which is done as a group and scheduled for 4 hours, and 3) online learning module #2.

INSPIRE provider training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employed at the University of Utah Hospital
  • Directly interfaces with birthing individuals (as clinical or non-clinical team member, e.g., physician, nurse, emergency medical technician, social worker)
  • English speaking

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Health

Salt Lake City, Utah, 84102, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersBias, Implicit

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPrejudiceSocial BehaviorBehavior

Study Officials

  • Susanna Cohen, DNP, CNM, CHSE, FAAN

    University of Utah

    PRINCIPAL INVESTIGATOR

  • Melissa Watt, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Assumpta Nantume

CONTACT

801-585-6011assumpta.nantume@hsc.utah.edu

Erin Johnson

CONTACT

801-646-7065erin.p.johnson@hsc.utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Providers will be assessed at baseline prior to intervention exposure, at midline (between modules 2 and 3, roughly 2 months later) and at post (6 months after baseline)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 16, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Deidentified data aligning with the Maternal Health Common Data Elements outlined by the IMPROVE Data Hub will be shared with the Maternal Health Data Innovation and Coordination Hub ("Data Hub"). The Data Hub will determine timing and methods of sharing gathered data from IMPROVE Centers and uploading congregated data into DASH.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Supporting information will be shared with the Data Hub within 6 months of the completion of data collection, and available through DASH for as long as DASH maintains the data.
Access Criteria
All deidentified data and supporting information will be maintained by the DASH. Access will be determined by the structures set forth by the Data Hub and DASH.

Locations

US(1)