Substance Use DisordersINSPIRENCT07707115
Interprofessional Simulation Program for Clinical Resilience and Empathy: Project INSPIRE
A study testing INSPIRE in people with Substance Use Disorders and Simulation Training, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Simulation Training, Pregnancy Related
- What is being tested?
- INSPIRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah Health
Salt Lake City, Utah, 84102
Assumpta Nantume, 801-585-6011, assumpta.nantume@hsc.utah.edu
About this study
Official title: Interprofessional Simulation Program for Clinical Resilience and Empathy (INSPIRE) for Healthcare Teams Caring for Birthing Individuals With Substance Use Disorder in Utah
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.
Read the 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). The study team will evaluate INSPIRE at the University of Utah hospital using a quasi-experimental design to determine impact on healthcare team outcomes. The study 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. The study team 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.
- Conditions
- Substance Use Disorders, Simulation Training, Pregnancy Related, Patient-centered Care, Bias, Implicit
- Being tested
- INSPIRE
- Keywords
- substance use disorders, Care received in hospital during labor & delivery and post-partum
- Medical subject headings
- Substance-Related Disorders, Bias, Implicit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSPIREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: INSPIRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Administered at Baseline and 1 month, 3 months, and 6 months after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Melissa Watt, University of Utah
- Investigators
- Susanna Cohen, DNP, CNM, CHSE, FAAN, Principal investigator, University of UtahMelissa Watt, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707115
- Sponsor's protocol ID
- IRB_00167800
- Other IDs
- U54HD113169
- Acronym
- INSPIRE
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interprofessional Simulation Program for Clinical Resilience and Empathy (INSPIRE) for Healthcare Teams Caring for Birthing Individuals With Substance Use Disorder in Utah
- ClinicalTrials.gov ID
- NCT07707115
- Acronym / sponsor ID
- INSPIRE / IRB_00167800
- Conditions
- Substance Use Disorders, Simulation Training, Pregnancy Related, Patient-centered Care, Bias, Implicit
- Keywords
- substance use disorders, Care received in hospital during labor & delivery and post-partum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). The study team will evaluate INSPIRE at the University of Utah hospital using a quasi-experimental design to determine impact on healthcare team outcomes. The study 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. The study team 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| INSPIRE provider training | Experimental | Behavioral: INSPIREAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INSPIREThe 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. | Behavioural | INSPIRE provider training |
Primary outcome
Medical Condition Regard Scale (MCRS)
Time frame: Administered at Baseline and 1 month, 3 months, and 6 months after Baseline
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanna Cohen, DNP, CNM, CHSE, FAAN principal investigator
University of Utah
Melissa Watt, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSPIRE in people with Substance Use Disorders and Simulation Training, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assumpta Nantume (801-585-6011, assumpta.nantume@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Condition Regard Scale (MCRS) (time frame: Administered at Baseline and 1 month, 3 months, and 6 months after Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.