- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07707115
Interprofessional Simulation Program for Clinical Resilience and Empathy: Project INSPIRE (INSPIRE)
10. juli 2026 opdateret af: Melissa Watt, University of Utah
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Assumpta Nantume
- Telefonnummer: 801-585-6011
- E-mail: assumpta.nantume@hsc.utah.edu
Undersøgelse Kontakt Backup
- Navn: Erin Johnson
- Telefonnummer: 801-646-7065
- E-mail: erin.p.johnson@hsc.utah.edu
Studiesteder
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84102
- University of Utah Health
-
Kontakt:
- Assumpta Nantume
- Telefonnummer: 801-585-6011
- E-mail: assumpta.nantume@hsc.utah.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: INSPIRE provider training
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Medical Condition Regard Scale (MCRS)
Tidsramme: Administered at Baseline and 1 month, 3 months, and 6 months after Baseline
|
MCRS is
|
Administered at Baseline and 1 month, 3 months, and 6 months after Baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Melissa Watt, PhD, University of Utah
- Ledende efterforsker: Susanna Cohen, DNP, CNM, CHSE, FAAN, University of Utah
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
5. august 2026
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
10. juli 2026
Først indsendt, der opfyldte QC-kriterier
10. juli 2026
Først opslået (Faktiske)
16. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB_00167800
- U54HD113169 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
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.
IPD-delingsadgangskriterier
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.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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