OncologyNCT04298762
The Effect of Peer Comparison Emails on Oncologists' Documentation of Cancer Stage
A study testing No peer comparison email and Peer comparison email in people with Oncology, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oncology
- What is being tested?
- No peer comparison email and Peer comparison email
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Sep 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Attending physicians who had been at one of three sites of hospital between January - August 2018
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Oncology
- Being tested
- No peer comparison email, Peer comparison email
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No peer comparison emailOther
The comparison group received no email communication on their cancer stage documentation activity.
Peer comparison emailOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparison Group | Placebo comparator | Physicians in the control group did not receive peer comparison emails. Receives: Other: No peer comparison email |
| Intervention Group | Experimental | Physicians in the intervention group received peer comparison emails. Receives: Other: Peer comparison email |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Measured: 15 months
Secondary outcomes (1)
Staging documentation rate (monthly)
Percentage of patients whose first outpatient encounter occurred in a given month for whom cancer stage was documented
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Jul 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Anna Sinaiko, Harvard School of Public Health (HSPH)
- Investigators
- Anna Sinaiko, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298762
- Sponsor's protocol ID
- staging_documentation
- Status last verified
- Mar 2020
- First submitted
- 11 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peer Comparison Emails on Oncologists' Documentation of Cancer Stage
- ClinicalTrials.gov ID
- NCT04298762
- Acronym / sponsor ID
- staging_documentation
- Conditions
- Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Mar 2020 (actual)
- 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison Group | Placebo comparator | Other: No peer comparison emailPhysicians in the control group did not receive peer comparison emails. |
| Intervention Group | Experimental | Other: Peer comparison emailPhysicians in the intervention group received peer comparison emails. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Attending physicians who had been at one of three sites of hospital between January - August 2018
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| No peer comparison emailThe comparison group received no email communication on their cancer stage documentation activity. | Other | Comparison Group |
| Peer comparison emailThe 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. | Other | Intervention Group |
Primary outcome
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)
1 secondary outcome
Staging documentation rate (monthly)
Time frame: 15 months
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 6 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Anna Sinaiko, PhD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No peer comparison email and Peer comparison email in people with Oncology, run by Harvard School of Public Health (HSPH) at 1 site 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 3 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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
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). 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 6 Mar 2020.