EmergencyCapABLENCT02901197
Capnography At the Bedside: Leading Educational Efforts
A study testing Education and Reminder Posters and Policy Change in people with Emergency, run by Yale University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency
- What is being tested?
- Education and Reminder Posters and Policy Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 902 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2016to 17 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Capnography At the Bedside: Leading Educational Efforts (CapABLE Trial)
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.
Read the 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:
- the effect of a comprehensive theory-based educational intervention on staff knowledge and skills related to capnography (outcome measure).
- 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).
- 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.
- Conditions
- Emergency
- Being tested
- Education and Reminder Posters, Policy Change
- Keywords
- capnography
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Reminder PostersBehavioural
See arm description
Policy ChangeOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Education and Reminder | Active comparator | This arm will consist of participants in a location that receive with web based training and exposure to reminder posters in the workplace. Receives: Behavioral: Education and Reminder Posters |
| Policy Change | Active comparator | This arm's participants will not receive an active intervention (education and reminders), however, policy change will take place in this location. Receives: Other: Policy Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Monitoring Frequency
This outcome will reflect the number of patients the staff applied the monitoring to pre and post intervention.
Measured: Pre intervention 3 months and Post intervention about 6 months
Secondary outcomes (2)
Knowledge
A tool will be developed as part of the study to assess knowledge and how that might change over time (from pre to post)
Measured: Pre intervention
Knowledge
A tool will be developed as part of the study to assess knowledge and how that might change over time (from pre to post)
Measured: Post intervention (within 1 month of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study start15 Sep 2016
- Primary completion15 Sep 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmergencyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Melissa Langhan, MD, Principal investigator, Yale University Dept of Pediatrics, Section of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901197
- Sponsor's protocol ID
- 1503015415
- Acronym
- CapABLE
- Status last verified
- Aug 2018
- First submitted
- 9 Sep 2016
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Shah R, Streat DA, Auerbach M, Shabanova V, Langhan ML. Improving Capnography Use for Critically Ill Emergency Patients: An Implementation Study. J Patient Saf. 2022 Jan 1;18(1):e26-e32. doi: 10.1097/PTS.0000000000000683.
PubMed 32175968
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capnography At the Bedside: Leading Educational Efforts (CapABLE Trial)
- ClinicalTrials.gov ID
- NCT02901197
- Acronym / sponsor ID
- CapABLE / 1503015415
- Conditions
- Emergency
- Keywords
- capnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 902 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- the effect of a comprehensive theory-based educational intervention on staff knowledge and skills related to capnography (outcome measure).
- 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).
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and Reminder | Active comparator | Behavioral: Education and Reminder PostersThis arm will consist of participants in a location that receive with web based training and exposure to reminder posters in the workplace. |
| Policy Change | Active comparator | Other: Policy ChangeThis arm's participants will not receive an active intervention (education and reminders), however, policy change will take place in this location. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and Reminder PostersSee arm description | Behavioural | Education and Reminder |
| Policy ChangeSee arm description | Other | Policy Change |
Primary outcome
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.
2 secondary outcomes
Knowledge
Time frame: Pre intervention
Knowledge
Time frame: Post intervention (within 1 month of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Derived from this study: PubMed 32175968Shah R, Streat DA, Auerbach M, Shabanova V, Langhan ML. Improving Capnography Use for Critically Ill Emergency Patients: An Implementation Study. J Patient Saf. 2022 Jan 1;18(1):e26-e32. doi: 10.1097/PTS.0000000000000683.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Langhan, MD principal investigator
Yale University Dept of Pediatrics, Section of Emergency Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Education and Reminder Posters and Policy Change in people with Emergency, run by Yale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Monitoring Frequency (time frame: Pre intervention 3 months and Post intervention about 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02901197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.