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Capnography At the Bedside: Leading Educational Efforts (CapABLE)

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ClinicalTrials.gov Identifier: NCT02901197
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this dual-site quasi-experimental pilot study is to evaluate if the implementation of an educational intervention paired with an environmental assessment to address accessibility barriers is associated with improvement in staff knowledge and skills, and adherence to national guidelines for use (evaluation in the knowledge transfer framework) in an emergency department (ED) setting.

Condition or disease Intervention/treatment Phase
Emergency Behavioral: Education and Reminder Posters Other: Policy Change Not Applicable

Detailed Description:

The objective of this study is to develop a multi-faceted implementation program (referred to as the Capnography At the Bedside: Leading Emergency Education (CapABLE Trial)) to increase the use of capnography during two critical events in the emergency department, intubation and CPR, for better detection of endotracheal intubation, endotracheal tube dislodgement, and quality CPR.

The specific aims of the proposed study are to examine:

  1. the effect of a comprehensive theory-based educational intervention on staff knowledge and skills related to capnography (outcome measure).
  2. the effect of a multi-faceted implementation program on the adherence to national guidelines regarding the use of capnography during critical events in the emergency department (process measure).
  3. the sustainability of effects of the implementation program on adherence, knowledge and skills (outcome and process measure).

The design and methods of this study are based on the knowledge transfer framework, which dictates identification of the message, target audience, messenger, process and communication, and evaluation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 902 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Capnography At the Bedside: Leading Educational Efforts (CapABLE Trial)
Actual Study Start Date : September 15, 2016
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : October 17, 2017

Arm Intervention/treatment
Active Comparator: Education and Reminder
This arm will consist of participants in a location that receive with web based training and exposure to reminder posters in the workplace.
Behavioral: Education and Reminder Posters
See arm description

Active Comparator: Policy Change
This arm's participants will not receive an active intervention (education and reminders), however, policy change will take place in this location.
Other: Policy Change
See arm description




Primary Outcome Measures :
  1. Average Monitoring Frequency [ Time Frame: Pre intervention 3 months and Post intervention about 6 months ]
    This outcome will reflect the number of patients the staff applied the monitoring to pre and post intervention.


Secondary Outcome Measures :
  1. Knowledge [ Time Frame: Pre intervention ]
    A tool will be developed as part of the study to assess knowledge and how that might change over time (from pre to post)

  2. Knowledge [ Time Frame: Post intervention (within 1 month of intervention) ]
    A tool will be developed as part of the study to assess knowledge and how that might change over time (from pre to post)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Emergency department (ED) staff
  • Staff will include registered nurses, respiratory therapists, technical associates, physicians, physician's assistants and advanced practice nurse practitioners who fulfill the majority of their clinical duties in the ED.

Exclusion Criteria:

  • Staff who are assigned to work on other units, but who work in the ED on a casual or per diem status will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901197


Sponsors and Collaborators
Yale University
Medtronic - MITG
Investigators
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Principal Investigator: Melissa Langhan, MD Yale University Dept of Pediatrics, Section of Emergency Medicine

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02901197    
Other Study ID Numbers: 1503015415
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yale University:
capnography
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes