Shock, SepticNCT02427048
Clinical Practice Guidelines and Impact of Audit and Feedback in the Emergency Department
A study testing Feedback with Peer Comparison in people with Shock, Septic and Community Acquired Pneumonia, run by Denver Health and Hospital Authority.
Trial summary
This study will develop and test an intervention given to emergency medicine providers to improve adherence to clinical practice guidelines (CPGs) for pneumonia and sepsis. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Shock, Septic, Community Acquired Pneumonia
- What is being tested?
- Feedback with Peer Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2016
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attending emergency medicine physicians working clinically in the Adult Emergency Department at Denver Health Medical Center at the start of the study.
Who cannot join
- None. All eligible physicians will be included.
About this study
Official title: Adherence to Clinical Practice Guidelines and the Impact of Audit and Feedback in the Emergency Department
This study will develop and test an intervention given to emergency medicine providers to improve adherence to clinical practice guidelines (CPGs) for pneumonia and sepsis.
Read the detailed description
This study will be performed at Denver Health Medical Center, a 477-bed urban, safety-net, acute-care hospital located in Denver, Colorado. The adult ED is staffed by board-certified emergency physicians at all times. These physicians supervise the care of all patients being managed by resident physicians, nurse practitioners, physician assistants, and medical students. Approximately 430 patients are admitted to the hospital from the ED each year with community-acquired pneumonia (CAP) and severe sepsis (SS).
Adherence to CPGs will be measured at the level of the attending emergency physician. All employed, attending emergency physicians working clinically in the adult ED at Denver Health Medical Center at the start of the study will be included.
The investigators will use a step-wedge design to randomize physicians into clusters. Randomization of physicians into clusters and randomization of clusters to intervention timing will occur one week prior to delivery of the intervention to cluster one. he intervention will consist of monthly audit and feedback on adherence to CPGs for CAP and SS. Once a cluster enters its first intervention month, all physicians in that cluster will receive an email detailing their adherence to both CAP and SS CPG for every month since the start of the study. Adherence to the entire CPG as well as each component of the CPG will be provided. In addition, physicians will be shown the median prevalence of adherence for all physicians as well as where their adherence ranks among their physician group. Lastly, in a separate secure email, physicians will be given patient identifiers (i.e., name, MRN, date of visit) for each patient that received non-adherent care and will be told which component of care was not adherent to the respective CPG so that they can review the case themselves, if desired.
- Conditions
- Shock, Septic, Community Acquired Pneumonia
- Being tested
- Feedback with Peer Comparison
- Keywords
- Clinical Practice Guidelines
- Medical subject headings
- Shock, Septic, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback with Peer ComparisonBehavioural
Email detailing adherence to CAP and SS CPG for every month since start of study. Physicians will be provided individualized feedback and given patient identifiers for each patient that received non-adherent care.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | No intervention | Delayed feedback and peer comparison |
| Feedback with Peer Comparison | Experimental | Individualized adherence feedback with peer comparison Receives: Behavioral: Feedback with Peer Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adherence to Community-Acquired Pneumonia and Severe Sepsis Clinical Practice Guidelines
Adherence will be determined via chart review of patients and will be measured by concordance with published clinical practice guidelines
Measured: 30 days post-intervention and 60 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy Trent, MD, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427048
- Sponsor's protocol ID
- 15-0400
- Status last verified
- Feb 2017
- First submitted
- 15 Apr 2015
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Clinical Practice Guidelines and the Impact of Audit and Feedback in the Emergency Department
- ClinicalTrials.gov ID
- NCT02427048
- Acronym / sponsor ID
- 15-0400
- Conditions
- Shock, Septic, Community Acquired Pneumonia
- Keywords
- Clinical Practice Guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Apr 2015 (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.
This study will develop and test an intervention given to emergency medicine providers to improve adherence to clinical practice guidelines (CPGs) for pneumonia and sepsis.
Detailed description
This study will be performed at Denver Health Medical Center, a 477-bed urban, safety-net, acute-care hospital located in Denver, Colorado. The adult ED is staffed by board-certified emergency physicians at all times. These physicians supervise the care of all patients being managed by resident physicians, nurse practitioners, physician assistants, and medical students. Approximately 430 patients are admitted to the hospital from the ED each year with community-acquired pneumonia (CAP) and severe sepsis (SS).
Adherence to CPGs will be measured at the level of the attending emergency physician. All employed, attending emergency physicians working clinically in the adult ED at Denver Health Medical Center at the start of the study will be included.
The investigators will use a step-wedge design to randomize physicians into clusters. Randomization of physicians into clusters and randomization of clusters to intervention timing will occur one week prior to delivery of the intervention to cluster one. he intervention will consist of monthly audit and feedback on adherence to CPGs for CAP and SS. Once a cluster enters its first intervention month, all physicians in that cluster will receive an email detailing their adherence to both CAP and SS CPG for every month since the start of the study. Adherence to the entire CPG as well as each component of the CPG will be provided. In addition, physicians will be shown the median prevalence of adherence for all physicians as well as where their adherence ranks among their physician group. Lastly, in a separate secure email, physicians will be given patient identifiers (i.e., name, MRN, date of visit) for each patient that received non-adherent care and will be told which component of care was not adherent to the respective CPG so that they can review the case themselves, if desired.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | No intervention | –Delayed feedback and peer comparison |
| Feedback with Peer Comparison | Experimental | Behavioral: Feedback with Peer ComparisonIndividualized adherence feedback with peer comparison |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Attending emergency medicine physicians working clinically in the Adult Emergency Department at Denver Health Medical Center at the start of the study.
Key exclusion criteria (1 listed)
- None. All eligible physicians will be included.
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 |
|---|---|---|
| Feedback with Peer ComparisonEmail detailing adherence to CAP and SS CPG for every month since start of study. Physicians will be provided individualized feedback and given patient identifiers for each patient that received non-adherent care. | Behavioural | Feedback with Peer Comparison |
Primary outcome
Change in Adherence to Community-Acquired Pneumonia and Severe Sepsis Clinical Practice Guidelines
Time frame: 30 days post-intervention and 60 days post-intervention
Adherence will be determined via chart review of patients and will be measured by concordance with published clinical practice guidelines
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 2 Feb 2017.
- Individual participant dataSharing planned: No
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Sepsis
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.
Stacy Trent, MD principal investigator
Denver Health and Hospital Authority
Questions about this trial
What is this clinical trial studying?
A study testing Feedback with Peer Comparison in people with Shock, Septic and Community Acquired Pneumonia, run by Denver Health and Hospital Authority.
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 2 Feb 2017. 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?
Change in Adherence to Community-Acquired Pneumonia and Severe Sepsis Clinical Practice Guidelines (time frame: 30 days post-intervention and 60 days post-intervention). 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 2 Feb 2017.