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Not yet recruiting NCT07707115

Interprofessional Simulation Program for Clinical Resilience and Empathy: Project INSPIRE

No phase Interventional Substance Use Disorders Simulation Training Pregnancy Related Patient-centered Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INSPIRE.
Who it may be relevant to
Registry conditions: Substance Use Disorders, Simulation Training, Pregnancy Related, Patient-centered Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Interprofessional Simulation Program for Clinical Resilience and Empathy (INSPIRE) for Healthcare Teams Caring for Birthing Individuals With Substance Use Disorder in Utah

Overview

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.

Detailed description

Individuals with substance use disorder (SUD) face a higher risk of severe maternal morbidity and mortality. Provider stigma contribute to these outcomes by attenuating the provision of evidence-based, person-centered care. The goal of this study is to evaluate INSPIRE, an intervention for interprofessional healthcare teams to improve care for individuals with substance use disorder (SUD) during their peri-delivery care. INSPIRE includes three core modules (an online training on SUD in birth, an in-person simulation training, and an additional online training to assess and build clinical empathy skills). We will evaluate INSPIRE at the University of Utah hospital using a quasi-experimental design to determine impact on healthcare team outcomes. We will enroll up to 300 healthcare team members across clinical specialties that support birthing individuals. All enrolled providers will receive INSPIRE training, and assessments will be conducted at baseline, 1 month, 3 months, and 6 months. The primary outcome for providers is stigma. We will assess change in stigma scores from baseline to 6 months using a mixed effects linear regression model, specified to provide a paired-sample comparison between pre- and post-intervention scores.

Interventions

  • Behavioral INSPIRE
    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.

Primary outcome measures

  • Medical Condition Regard Scale (MCRS) [Time frame: Administered at Baseline and 1 month, 3 months, and 6 months after Baseline]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Unable to provide informed consent

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Utah Health — Salt Lake City

Identifiers

NCT: NCT07707115 · IRB_00167800 · U54HD113169

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗