[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07707115":3,"trial-entities:NCT07707115":91,"trial-summary:NCT07707115":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":58,"locations":61,"central_contacts":77,"overall_officials":83,"references":89,"see_also_links":90},"NCT07707115","IRB_00167800","Interprofessional Simulation Program for Clinical Resilience and Empathy: Project INSPIRE","Interprofessional Simulation Program for Clinical Resilience and Empathy (INSPIRE) for Healthcare Teams Caring for Birthing Individuals With Substance Use Disorder in Utah","NOT_YET_RECRUITING","2027-12-31","2026-07","2026-07-16","2026-08-05","University of Utah","OTHER",false,"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.","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.",[19,20,21,22,23],"Substance Use Disorders","Simulation Training","Pregnancy Related","Patient-centered Care","Bias, Implicit",[25,26],"substance use disorders","Care received in hospital during labor & delivery and post-partum","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[30],"NA",{"count":32,"type":33},300,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"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.",[40],"INSPIRE provider training",[42],{"measure":43,"description":44,"timeFrame":45},"Medical Condition Regard Scale (MCRS)","MCRS is","Administered at Baseline and 1 month, 3 months, and 6 months after Baseline",[],"ALL","18 Years",null,{"inclusion":51,"exclusion":55,"raw_text":57},[52,53,54],"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",[56],"Unable to provide informed consent","Inclusion Criteria:\n\n* Employed at the University of Utah Hospital\n* Directly interfaces with birthing individuals (as clinical or non-clinical team member, e.g., physician, nurse, emergency medical technician, social worker)\n* English speaking\n\nExclusion Criteria:\n\n* Unable to provide informed consent",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":74},"University of Utah Health","Salt Lake City","Utah","84102","United States",[69],{"name":70,"role":71,"phone":72,"email":73},"Assumpta Nantume","CONTACT","801-585-6011","assumpta.nantume@hsc.utah.edu",{"lat":75,"lon":76},40.76078,-111.89105,[78,79],{"name":70,"role":71,"phone":72,"email":73},{"name":80,"role":71,"phone":81,"email":82},"Erin Johnson","801-646-7065","erin.p.johnson@hsc.utah.edu",[84,87],{"name":85,"affiliation":13,"role":86},"Susanna Cohen, DNP, CNM, CHSE, FAAN","PRINCIPAL_INVESTIGATOR",{"name":88,"affiliation":13,"role":86},"Melissa Watt, PhD",[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"Substance use disorder",[],{"nct_id":4,"found":96,"summary":97,"prompt_version":107},true,{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an interventional study planning to enroll up to 300 healthcare team members. All participants will receive the INSPIRE training.","completed","Project INSPIRE: Improving Care for Birthing Individuals with Substance Use Disorder","This study, called Project INSPIRE, is testing a training program for healthcare teams at the University of Utah Hospital. The goal is to improve care for birthing individuals (people giving birth) who have substance use disorders (SUD) by reducing negative attitudes and behaviors from healthcare providers. The INSPIRE program involves online learning and in-person simulation training. Researchers want to see if this training changes how healthcare providers feel and act towards these patients. You could join if you work at the University of Utah Hospital, interact with birthing individuals, and speak English. The study is currently unclear on its status and plans to enroll up to 300 healthcare team members.","Your progress will be followed for 6 months after the initial assessment.",110,"You would complete two online learning modules and participate in a 4-hour in-person simulation. Assessments will be done at the start, and then 1, 3, and 6 months later.","Not stated in the trial record.",[37],"v2"]