Obstetric Life Support, a Curriculum to Effectively Resuscitate Pregnant Patients Experiencing Cardiac Arrest.

Not Applicable

• Conditions: Pregnancy Related; Cardiac Arrest
• Interventions: Other: Placebo, then electronic curriculum and instructor-led course; Other: Electronic curriculum and instructor-led course, then placebo

• Registration Number: NCT05355519
• Lead Sponsor: UConn Health

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.

Study Timeline

• Study Start: 2021-10-21
• Status Verified: 2022-04
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-29
• Last Update Submitted: 2022-04-29
• Study First Posted: 2022-05-02
• Last Update Posted: 2022-05-02
• Primary Completion: 2023-01
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

PH

1. All genders
2. EMS healthcare providers of all levels including basic, advanced, paramedics; firefighters, law enforcement officers, and trainees in any of these programs.
3. 18 years old or older
4. Ability to read, write and speak in English

IH

1. All genders
2. Emergency medicine providers (ED, FP, ICU) surgeons (OB), anesthesiologists, trainees of GME, and nurses from ED, FP, ICU/NICU, or OB/L&D.
3. 18 years or older
4. Ability to read, write and speak in English

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo, then electronic curriculum and instructor-led course	On a specific day, participants will go to a designated center to complete an online cognitive assessment and participate in simulated medical scenarios. Once complete, study staff will email the electronic curriculum for participants to read. After a washout period of six months, participants will return to the designated center to participate in an instructor-led course and simulated medical scenarios and complete a megapode and online cognitive assessment. After a second washout period of six months, participants will take an online cognitive assessment again.
Curriculum and Instructor-Led Course	Electronic curriculum and instructor-led course, then placebo	Participants first complete an online cognitive assessment. Once complete, staff email the electronic curriculum for participants to read. On a specific day, participants will go to the designated center to participate in an instructor-led course and simulated medical scenarios and complete megapode and online cognitive assessment. After a washout period of six months, participants return to the designated center to participate in simulated medical scenarios and complete the online cognitive assessment again. After a second washout period of six months, participants will take the online cognitive assessment again.

Primary Outcome Measures

Name	Time	Method
Comparison of Scores Between Two Arms	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	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 Outcome Measures

Name	Time	Method
Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients	From baseline to 12 months	Frequency (%) of participants who self-report that they are confident or very confident in managing procedures in pregnant patients.

Trial Locations

Locations (1)

UConn Health; 🇺🇸 Farmington, Connecticut, United States