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

Study 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.

Official Title
-----------------
Advances in Patient Safety Through Simulation Research

Conditions
-----------------
Cardiac Arrest, Pregnancy Related

Intervention / Treatment
-----------------
* Other: Electronic curriculum and instructor-led course, then placebo
* Other: Placebo, then electronic curriculum and instructor-led course


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PH 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 IH 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The investigators will perform a prospective, single-blinded randomized cross-over trial of the OBLS intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Curriculum and Instructor-Led Course<br>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. | Other: Electronic curriculum and instructor-led course, then placebo<br>* Electronic curriculum and instructor-led course<br>|
| Placebo Comparator: Placebo<br>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. | Other: Placebo, then electronic curriculum and instructor-led course<br>* Electronic curriculum and instructor-led course<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Mean Participant Knowledge Assessment | 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. | From baseline to immediately upon completing training | 
| Comparison of Scores Between Two Arms | 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. | Immediately upon completing training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients | Frequency (percent) of participants who self-report that they are confident or very confident in managing procedures in pregnant patients. | From baseline to 6 months | 
| Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients | Frequency (%) of participants who self-report that they are confident or very confident in managing procedures in pregnant patients. | From baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The Obstetric Life Support Program (OBLS)