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

Primary Purpose

Cardiac Arrest, Pregnancy Related

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic curriculum and instructor-led course, then placebo
Placebo, then electronic curriculum and instructor-led course
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrest focused on measuring The Obstetric Life Support Program (OBLS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UConn HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Curriculum and Instructor-Led Course

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 21, 2022
Last Updated
April 29, 2022
Sponsor
UConn Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT05355519
Brief Title
Obstetric Life Support, a Curriculum to Effectively Resuscitate Pregnant Patients Experiencing Cardiac Arrest.
Acronym
OBLS
Official Title
Advances in Patient Safety Through Simulation Research
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Pregnancy Related
Keywords
The Obstetric Life Support Program (OBLS)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The investigators will perform a prospective, single-blinded randomized cross-over trial of the OBLS intervention.
Masking
Outcomes Assessor
Masking Description
Megacode evaluators will be masked to the arm in which the participants are randomized.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Curriculum and Instructor-Led Course
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electronic curriculum and instructor-led course, then placebo
Intervention Description
Electronic curriculum and instructor-led course
Intervention Type
Other
Intervention Name(s)
Placebo, then electronic curriculum and instructor-led course
Intervention Description
Electronic curriculum and instructor-led course
Primary Outcome Measure Information:
Title
Change from Baseline in the Mean Participant Knowledge Assessment
Description
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.
Time Frame
From baseline to immediately upon completing training
Title
Comparison of Scores Between Two Arms
Description
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.
Time Frame
Immediately upon completing training
Secondary Outcome Measure Information:
Title
Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients
Description
Frequency (percent) of participants who self-report that they are confident or very confident in managing procedures in pregnant patients.
Time Frame
From baseline to 6 months
Title
Self-Reported Confidence Level in Assessing and Managing Critical Care Scenarios in Pregnant Patients
Description
Frequency (%) of participants who self-report that they are confident or very confident in managing procedures in pregnant patients.
Time Frame
From baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie Kavanagh, MPH
Phone
206-399-0531
Email
kavanagh@uchc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Thurlow, MSN
Phone
860-679-4637
Email
thurlow@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Shields, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Shields, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31575778
Citation
Collier AY, Molina RL. Maternal Mortality in the United States: Updates on Trends, Causes, and Solutions. Neoreviews. 2019 Oct;20(10):e561-e574. doi: 10.1542/neo.20-10-e561.
Results Reference
background
PubMed Identifier
25979616
Citation
Hameed AB, Lawton ES, McCain CL, Morton CH, Mitchell C, Main EK, Foster E. Pregnancy-related cardiovascular deaths in California: beyond peripartum cardiomyopathy. Am J Obstet Gynecol. 2015 Sep;213(3):379.e1-10. doi: 10.1016/j.ajog.2015.05.008. Epub 2015 May 13.
Results Reference
background
PubMed Identifier
28383382
Citation
Briller J, Koch AR, Geller SE; Illinois Department of Public Health Maternal Mortality Review Committee Working Group. Maternal Cardiovascular Mortality in Illinois, 2002-2011. Obstet Gynecol. 2017 May;129(5):819-826. doi: 10.1097/AOG.0000000000001981.
Results Reference
background
PubMed Identifier
26443610
Citation
Jeejeebhoy FM, Zelop CM, Lipman S, Carvalho B, Joglar J, Mhyre JM, Katz VL, Lapinsky SE, Einav S, Warnes CA, Page RL, Griffin RE, Jain A, Dainty KN, Arafeh J, Windrim R, Koren G, Callaway CW; American Heart Association Emergency Cardiovascular Care Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular Diseases in the Young, and Council on Clinical Cardiology. Cardiac Arrest in Pregnancy: A Scientific Statement From the American Heart Association. Circulation. 2015 Nov 3;132(18):1747-73. doi: 10.1161/CIR.0000000000000300. Epub 2015 Oct 6.
Results Reference
background
PubMed Identifier
1599071
Citation
Goodwin AP, Pearce AJ. The human wedge. A manoeuvre to relieve aortocaval compression during resuscitation in late pregnancy. Anaesthesia. 1992 May;47(5):433-4. doi: 10.1111/j.1365-2044.1992.tb02228.x.
Results Reference
background
PubMed Identifier
21549495
Citation
Jeejeebhoy FM, Zelop CM, Windrim R, Carvalho JC, Dorian P, Morrison LJ. Management of cardiac arrest in pregnancy: a systematic review. Resuscitation. 2011 Jul;82(7):801-9. doi: 10.1016/j.resuscitation.2011.01.028. Epub 2011 May 6.
Results Reference
background
PubMed Identifier
24781570
Citation
Lipman S, Cohen S, Einav S, Jeejeebhoy F, Mhyre JM, Morrison LJ, Katz V, Tsen LC, Daniels K, Halamek LP, Suresh MS, Arafeh J, Gauthier D, Carvalho JC, Druzin M, Carvalho B; Society for Obstetric Anesthesia and Perinatology. The Society for Obstetric Anesthesia and Perinatology consensus statement on the management of cardiac arrest in pregnancy. Anesth Analg. 2014 May;118(5):1003-16. doi: 10.1213/ANE.0000000000000171.
Results Reference
background
PubMed Identifier
21524838
Citation
King SE, Gabbott DA. Maternal cardiac arrest--rarely occurs, rarely researched. Resuscitation. 2011 Jul;82(7):795-6. doi: 10.1016/j.resuscitation.2011.03.029. Epub 2011 Apr 6. No abstract available.
Results Reference
background
Links:
URL
http://wonder.cdc.gov/ucd-icd10.html
Description
Related Info
URL
http://cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm
Description
Related Info
URL
http://apps.who.int/iris/bitstream/handle/10665/194254/9789241565141_eng.pdf;jsessionid=57219BDB4E7FBED75BD83BCDE36F17BF?sequence=1
Description
Related Info
URL
https://www.unfpa.org/sites/default/files/pub-pdf/9789241507226_eng.pdf
Description
Related Info

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

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