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Clinical Trials/NCT05355519
NCT05355519
Unknown
Not Applicable

Advances in Patient Safety Through Simulation Research

UConn Health1 site in 1 country48 target enrollmentOctober 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Arrest
Sponsor
UConn Health
Enrollment
48
Locations
1
Primary Endpoint
Comparison of Scores Between Two Arms
Last Updated
4 years ago

Overview

Brief Summary

The objective of the study is to determine if Obstetric Life Support Program (OBLS) has an effect on the confidence and skills knowledge in participants.

Detailed Description

Enrolled participants with healthcare experience will be randomized to intervention with an electronic curriculum and instructor-led course or placebo first and then will be crossed over to receive the intervention. Participants will undergo assessments pre and post intervention, as well as repeat assessments after three washout periods separated by six months each.

Registry
clinicaltrials.gov
Start Date
October 21, 2021
End Date
July 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
UConn Health
Responsible Party
Principal Investigator
Principal Investigator

Andrea Shields

Associate Professor of Obstetrics & Gynecology Division of Maternal Fetal Medicine Program Director, Maternal Fetal Medicine Fellowship University of Connecticut School of Medicine

UConn Health

Eligibility Criteria

Inclusion Criteria

  • All genders
  • EMS healthcare providers of all levels including basic, advanced, paramedics; firefighters, law enforcement officers, and trainees in any of these programs.
  • 18 years old or older
  • Ability to read, write and speak in English
  • All genders
  • Emergency medicine providers (ED, FP, ICU) surgeons (OB), anesthesiologists, trainees of GME, and nurses from ED, FP, ICU/NICU, or OB/L\&D.
  • 18 years or older
  • Ability to read, write and speak in English

Exclusion Criteria

  • Participants included in the pilot-testing sessions
  • Participants from other medical specialties not listed in the inclusion criteria.

Outcomes

Primary Outcomes

Comparison of Scores Between Two Arms

Time Frame: Immediately upon completing training

Mean (standard deviation) of participant megacode checklist scores post-training stratified by treatment arm. Minimum value is zero and maximum value is 200. A higher score means a better outcome.

Change from Baseline in the Mean Participant Knowledge Assessment

Time Frame: From baseline to immediately upon completing training

Mean (standard deviation) of participant knowledge assessment scores post-training stratified by treatment arm. Minimum value is zero and maximum value is 100. A higher score means a better outcome.

Secondary Outcomes

  • Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients(From baseline to 12 months)

Study Sites (1)

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