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

April 29, 2022 updated by: Andrea Shields, UConn Health

Advances in Patient Safety Through Simulation Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • UConn Health
        • Principal Investigator:
          • Andrea Shields, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Curriculum and Instructor-Led Course
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
Electronic curriculum and instructor-led course
Placebo Comparator: Placebo
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
Electronic curriculum and instructor-led course

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to immediately upon completing training
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.
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
Time Frame: From baseline to 6 months
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
Time Frame: From baseline to 12 months
Frequency (%) of participants who self-report that they are confident or very confident in managing procedures in pregnant patients.
From baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Andrea Shields, MD, UConn Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22X-137
  • 5R18HS026169 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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