- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298762
The Effect of Peer Comparison Emails on Oncologists' Documentation of Cancer Stage
March 4, 2020 updated by: Anna Sinaiko, Harvard School of Public Health (HSPH)
Documenting cancer stage is the most important determinant of treatment approach and survival for cancer patients.
However, oncologists do not routinely document a patient's cancer stage in the structured field in electronic health records.
This quality improvement pilot study evaluated the impact of sending an email to physicians at a cancer center of a large academic hospital with individualized data on their rates of cancer stage documentation using a structured field.
The investigators assessed patient-level documentation and physician-level rates of staging documentation over 15 months including a three-month pre-period, a six-month pilot phase and a six-month follow-up period.
The investigators also estimated staging documentation rates separately for each physician's new versus established patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Attending physicians who had been at one of three sites of hospital between January - August 2018
Exclusion Criteria:
- Physicians treating cancer patients where American Joint Committee on Cancer (AJCC) staging modules were less clinically relevant
- Physicians with low clinical volume (<5 patients over 3 months)
- Physicians without any outpatient visits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Comparison Group
Physicians in the control group did not receive peer comparison emails.
|
The comparison group received no email communication on their cancer stage documentation activity.
|
Experimental: Intervention Group
Physicians in the intervention group received peer comparison emails.
|
The intervention group received three separate emails with individualized data on their cancer stage documentation activity in the previous 1-3 months.
The email described the number and percent of attributed patients for whom cancer stage was documented, and included a figure showing their staging documentation rate compared to their peers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring if a patient's cancer stage was documented in a structured field in the Electronic Health Record on the date of the patient's first ambulatory care visit
Time Frame: 15 months
|
Indicator of whether the structured field for cancer stage in the patient's electronic health record (EHR) was populated on the date of the first outpatient encounter that a patient had during the study period (1=yes, 0=no)
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Staging documentation rate (monthly)
Time Frame: 15 months
|
Percentage of patients whose first outpatient encounter occurred in a given month for whom cancer stage was documented
|
15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Anna Sinaiko, PhD, Harvard School of Public Health (HSPH)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
February 11, 2020
First Submitted That Met QC Criteria
March 4, 2020
First Posted (Actual)
March 6, 2020
Study Record Updates
Last Update Posted (Actual)
March 6, 2020
Last Update Submitted That Met QC Criteria
March 4, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- staging_documentation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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