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Pulmonary EmbolismNCT02283086

Effects of Performance Feedback on Imaging Use in the Emergency Department

A study testing Physician Feedback Reporting in people with Pulmonary Embolism, run by Brigham and Women's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted from January 1, 2012-December 31, 2013. SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
Pulmonary Embolism
What is being tested?
Physician Feedback Reporting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
No sites listed yet
Study dates
Jan 2012to Dec 2013
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 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • All attending physicians in the emergency department

Who cannot join

  • None

About this study

DESIGN: An IRB-approved, HIPAA-compliant prospective randomized controlled trial conducted from January 1, 2012-December 31, 2013.

SETTING: The ED of an urban Level-I adult trauma center with existing CDS for CTPE.

PARTICIPANTS: All attending physicians were stratified into quartiles by 2012 CTPE use and randomized to receive feedback reporting or not.

INTERVENTION: Quarterly performance feedback reports consisting of individual and anonymized group data on EBG adherence (using the Wells criteria), CTPE use (CTPEs per 1,000 patients), and yield (percentage of CTPEs positive for PE) beginning January 2013.

Read the detailed description

Setting and Subjects This IRB-approved and HIPAA-compliant prospective randomized controlled trial was conducted from January 1, 2012 to December 31, 2013 in the ED of an urban Level-I adult trauma center. Imaging CDS was deployed for all CTPE requests throughout the study period as previously reported. Ordering providers could ignore the evidence presented in CDS and proceed with CTPE requests deviating from evidence-based guidelines without interference. The investigators included all attending emergency physicians and, prior to randomization, stratified them into quartiles by 2012 CTPE use. Physicians were randomized by quartile into two groups using a random number generator: the intervention group received individualized feedback reports on CTPE adherence to EBG, use (defined as number of CTPEs per 1,000 patients), and yield (percentage of CTPEs positive for PE), and the control group did not.

Data Collection Use of CTPEs for each physician was calculated using the number of completed CTPE examinations and the total number of patients seen during the quarter. Yield of CTPEs for acute PE was determined using a previously validated natural language processing tool and reported as a percentage of total CTPEs completed. Adherence to EBG was determined by applying the Wells Criteria and reviewing the serum D-dimer levels (if obtained). The discrete criteria making up the Wells Criteria were prospectively documented in the investigators computerized order entry (CPOE) system at the time of order entry, as previously reported.

In order to determine whether any differences observed in guideline adherence were the result of "gaming" (erroneous data entry to either avoid potentially onerous CDS interactions or to enhancing the physician's apparent performance on feedback reports) the investigators performed manual chart reviews of 100 randomly chosen charts from each of the two groups. These chart reviews were performed by an attending physician to assess concordance between adherence to EBG calculated from the CDS data, and adherence to EBG calculated from data documented in the ED visit clinical note. The sample size was determined using a baseline concordance of 90% as previously reported, and chosen to detect a difference in concordance of 15% between groups with a power of 80% and an alpha error rate of 5%. Demographic data (including gender and both age and years since residency training as measured at the beginning of the study period) was also captured for all the attending physicians in the study.

Being tested
Physician Feedback Reporting
Keywords
Quality Improvement, Physician Feedback
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physician Feedback ReportingBehavioural

    The performance feedback reports displayed both individual physicians' statistics as well as their performance compared to anonymized results for the entire group of emergency physicians.

Study groups in NCT02283086
Study groupRoleWhat they receive
ControlNo interventionNot described
InterventionExperimentalThe intervention consisted of quarterly performance feedback reports sent via e-mail.
Receives: Behavioral: Physician Feedback Reporting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to Evidence-Based Guidelines

    Percentage of CTPE orders that adhere to evidence-based guidelines for the ordering of CTs for PE

    Measured: 2 years

Secondary outcomes (2)
  1. Use of Computed Tomography for Pulmonary Embolism

    #CTPEs/1,000 ED visits for each physician

    Measured: 2 years

  2. Yield of Computed Tomography for Pulmonary Embolism

    Percentage of CTPE orders that are positive for acute PE

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283086
Sponsor's protocol ID
2009-P001587
Status last verified
Nov 2014
First submitted
2 Nov 2014
Last updated
5 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Physician Feedback Reporting in people with Pulmonary Embolism, run by Brigham and Women's Hospital.

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 Nov 2014. 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?

Adherence to Evidence-Based Guidelines (time frame: 2 years). 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 Nov 2014.

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