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

Sponsor
UConn Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05355519
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
48
Enrollment
1
Location
2
Arms
32.3
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Electronic curriculum and instructor-led course, then placebo
  • Other: Placebo, then electronic curriculum and instructor-led course
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The investigators will perform a prospective, single-blinded randomized cross-over trial of the OBLS intervention.The investigators will perform a prospective, single-blinded randomized cross-over trial of the OBLS intervention.
Masking:
Single (Outcomes Assessor)
Masking Description:
Megacode evaluators will be masked to the arm in which the participants are randomized.
Primary Purpose:
Other
Official Title:
Advances in Patient Safety Through Simulation Research
Actual Study Start Date :
Oct 21, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients [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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UConn Health Farmington Connecticut United States 06030

Sponsors and Collaborators

  • UConn Health
  • Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Andrea Shields, MD, UConn Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
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
ClinicalTrials.gov Identifier:
NCT05355519
Other Study ID Numbers:
  • 22X-137
  • 5R18HS026169
First Posted:
May 2, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by 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
The Obstetric Life Support Program (OBLS)
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of May 2, 2022