Safety IssuesEMNCT03006549
Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?
A study testing Emergency Manual (Crisis Checklist) in people with Safety Issues, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
Despite increasing interest in emergency manuals (EMs), relatively little is known about their effectiveness and limitations in the perioperative setting. Prior studies have been limited in that they evaluated EMs using crises that were tailor-made to match one of their chapters, and there has been minimal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- Emergency Manual (Crisis Checklist)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Jan 2015to 13 May 2019
- 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
- Healthcare providers (anesthesiologists, surgeons, nurses) participating in the crisis management curriculum at each participating simulation site
Who cannot join
- Those unwilling to be recorded during the simulation scenario
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02116
About this study
Despite increasing interest in emergency manuals (EMs), relatively little is known about their effectiveness and limitations in the perioperative setting. Prior studies have been limited in that they evaluated EMs using crises that were tailor-made to match one of their chapters, and there has been minimal participation by attending surgeons and other experienced personnel. The Investigators' preliminary experience suggests less-than-expected EM use and suboptimal usage, which may be due to the simulation scenario falling "halfway between" two different chapters of the EM, raising the question of whether limitations were due to the EM content, team dynamics, or inadequate training in the EM use. In this randomized, prospective, two-center simulation-based study, the investigators utilize clinical scenarios specifically designed to observe the patterns of use and to test the limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen, clinical performance in situations that do not exactly match a specific chapter of that EM, and that EM usage patterns will identify both strengths and limitations of the tools and its implementation. The participating healthcare providers consisting of experienced surgeons, anesthesiologists, and nurses will be randomized into four experimental groups, each exposed to either a "specific" or "non-specific" simulation scenario, along with or without the availability of the EM. The major experimental endpoint will be how many "critical actions" each team performs, scored as the percentage of actions taken from a pre-determined list. The goal of this study is to improve EM content and use by understanding its limitations during interprofessional team-training simulations and to study whether EMs enhance or detract from clinical performance. This is especially a concern in situations that do not exactly match a specific chapter of the EM, such as cases that are vague and represent multi-factorial diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen patient safety by providing guidance for improving EM content, use, and training protocols.
- Conditions
- Safety Issues
- Being tested
- Emergency Manual (Crisis Checklist)
- Keywords
- Emergency Manual, Crisis Checklist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Manual (Crisis Checklist)Behavioural
participants will have an Emergency Manual available to them during the crisis simulation scenario.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Manual | Experimental | emergency manual present Receives: Behavioral: Emergency Manual (Crisis Checklist) |
| No Emergency | No intervention | NO emergency manual present |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct Diagnosis identified during the simulation by the participants through a grading scale tool
Measured: through scenario completion, an average of 1 hour
Secondary outcomes (1)
Clinical actions taken during the scenario evaluated by a grading scale tool
Measured: through scenario completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start10 Jan 2015
- Primary completion15 Mar 2018
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Richard D Urman, Brigham and Women's Hospital
- Investigators
- Richard Urman, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006549
- Sponsor's protocol ID
- 2014P000133
- Acronym
- EM
- Status last verified
- Aug 2019
- First submitted
- 23 Dec 2016
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?
- ClinicalTrials.gov ID
- NCT03006549
- Acronym / sponsor ID
- EM / 2014P000133
- Conditions
- Safety Issues
- Keywords
- Emergency Manual, Crisis Checklist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 30 Dec 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.
Despite increasing interest in emergency manuals (EMs), relatively little is known about their effectiveness and limitations in the perioperative setting. Prior studies have been limited in that they evaluated EMs using crises that were tailor-made to match one of their chapters, and there has been minimal participation by attending surgeons and other experienced personnel. The Investigators' preliminary experience suggests less-than-expected EM use and suboptimal usage, which may be due to the simulation scenario falling "halfway between" two different chapters of the EM, raising the question of whether limitations were due to the EM content, team dynamics, or inadequate training in the EM use. In this randomized, prospective, two-center simulation-based study, the investigators utilize clinical scenarios specifically designed to observe the patterns of use and to test the limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen, clinical performance in situations that do not exactly match a specific chapter of that EM, and that EM usage patterns will identify both strengths and limitations of the tools and its implementation. The participating healthcare providers consisting of experienced surgeons, anesthesiologists, and nurses will be randomized into four experimental groups, each exposed to either a "specific" or "non-specific" simulation scenario, along with or without the availability of the EM. The major experimental endpoint will be how many "critical actions" each team performs, scored as the percentage of actions taken from a pre-determined list. The goal of this study is to improve EM content and use by understanding its limitations during interprofessional team-training simulations and to study whether EMs enhance or detract from clinical performance. This is especially a concern in situations that do not exactly match a specific chapter of the EM, such as cases that are vague and represent multi-factorial diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen patient safety by providing guidance for improving EM content, use, and training protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency Manual | Experimental | Behavioral: Emergency Manual (Crisis Checklist)emergency manual present |
| No Emergency | No intervention | –NO emergency manual present |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare providers (anesthesiologists, surgeons, nurses) participating in the crisis management curriculum at each participating simulation site
Key exclusion criteria (1 listed)
- Those unwilling to be recorded during the simulation scenario
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 |
|---|---|---|
| Emergency Manual (Crisis Checklist)participants will have an Emergency Manual available to them during the crisis simulation scenario. | Behavioural | Emergency Manual |
Primary outcome
Correct Diagnosis identified during the simulation by the participants through a grading scale tool
Time frame: through scenario completion, an average of 1 hour
1 secondary outcome
Clinical actions taken during the scenario evaluated by a grading scale tool
Time frame: through scenario completion, an average of 1 hour
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 5 Aug 2019.
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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.
Richard Urman, MD principal investigator
Brigham and Women's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Manual (Crisis Checklist) in people with Safety Issues, run by Brigham and Women's Hospital at 3 sites in United States.
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 1 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Correct Diagnosis identified during the simulation by the participants through a grading scale tool (time frame: through scenario completion, an average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2019.