Colorectal Cancer ScreeningNCT00955344
Increasing Primary Care Physician Colorectal Cancer Screening Rates
A study testing eToolbox and no link to eToolbox in people with Colorectal Cancer Screening, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study is to determine if a Web-based intervention increases physician rates of colorectal cancer recommendation rates in a group of physicians participating in the American Board of Internal Medicine's Maintenance of Certification Program. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- eToolbox and no link to eToolbox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2011
- 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
- ABIM certification and have or plan to enroll in the Maintenance of Certification program
- Primary Care Physicians
Who cannot join
- Diplomats are not able to participate in this study if they are retired physicians, do not practice a primary care practice or who have already taken part in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
The purpose of the study is to determine if a Web-based intervention increases physician rates of colorectal cancer recommendation rates in a group of physicians participating in the American Board of Internal Medicine's Maintenance of Certification Program. This study will also compare the content of practice improvement plans submitted by the diplomats in each study arm to determine the components of the plans that are associated with colorectal cancer rates.
Read the detailed description
Colorectal cancer is the 2nd leading cause of cancer deaths in the U.S. Although colorectal cancer screening (CRCS) is effective, cost-effective and consistently recommended by clinical practice guidelines, only 57.3% of the adults over 50 years have been screened within the recommended interval. Preliminary research conducted by this PI demonstrates that approximately 90% of patients who have not had CRCS report that a doctors recommendation would motivate them to undergo screening. However, research also shows that physicians do not consistently recommend CRCS to each eligible patient. In this study the barriers of and facilitators to physician recommendation of CRCS are tested in the to proposed randomized controlled trial. The trial will pilot test an interactive, multifaceted, Web-based intervention (eToolbox) to increase primary care physician rates of CRCS. This application innovatively proposes to pilot test the eToolbox in the setting of the American Board of Internal Medicine (ABIM) Maintenance of Certification process within the Preventive Services Practice Improvement Module, a physician-directed measurement of their performance and quality improvement requirement for board re-certification.
- Conditions
- Colorectal Cancer Screening
- Being tested
- eToolbox, no link to eToolbox
- Keywords
- colorectal cancer screening, American Board of Internal Medicine Maintenance of Certification program, Currently enrolled in or plan to enroll in the American Board of Internal Medicine Maintenance of Certification program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eToolboxBehavioural
Participants randomized to the Web-based intervention will be automatically routed to a URL that will contain the Web-based intervention.
no link to eToolboxBehavioural
Participants randomized to the Practice Improvement Module will not be automatically routed to a URL that will contain the Web-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| Web-based intervention (eToolbox) | Experimental | This arm will allow diplomats of the American Board of Internal Medicine to complete the Practice Improvement Module that will embed a link to the web-based intervention (eToolbox). Receives: Behavioral: eToolbox |
| Practice Improvement Module | Active comparator | This arm will allow diplomats of the American Board of Internal Medicine to complete the Practice Improvement Module without any link to the Web-based eToolbox. Receives: Behavioral: no link to eToolbox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer Screening Rates
Measured: 3 years (2012)
Secondary outcomes (1)
Content of practice improvement plan
Measured: 3 years (2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services
- Investigators
- Carmen E Guerra, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955344
- Sponsor's protocol ID
- K22CA133186-01
- Status last verified
- Aug 2016
- First submitted
- 6 Aug 2009
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Primary Care Physician Colorectal Cancer Screening Rates
- ClinicalTrials.gov ID
- NCT00955344
- Acronym / sponsor ID
- K22CA133186-01
- Conditions
- Colorectal Cancer Screening
- Keywords
- colorectal cancer screening, American Board of Internal Medicine Maintenance of Certification program, Currently enrolled in or plan to enroll in the American Board of Internal Medicine Maintenance of Certification program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 Aug 2009 (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.
The purpose of the study is to determine if a Web-based intervention increases physician rates of colorectal cancer recommendation rates in a group of physicians participating in the American Board of Internal Medicine's Maintenance of Certification Program. This study will also compare the content of practice improvement plans submitted by the diplomats in each study arm to determine the components of the plans that are associated with colorectal cancer rates.
Detailed description
Colorectal cancer is the 2nd leading cause of cancer deaths in the U.S. Although colorectal cancer screening (CRCS) is effective, cost-effective and consistently recommended by clinical practice guidelines, only 57.3% of the adults over 50 years have been screened within the recommended interval. Preliminary research conducted by this PI demonstrates that approximately 90% of patients who have not had CRCS report that a doctors recommendation would motivate them to undergo screening. However, research also shows that physicians do not consistently recommend CRCS to each eligible patient. In this study the barriers of and facilitators to physician recommendation of CRCS are tested in the to proposed randomized controlled trial. The trial will pilot test an interactive, multifaceted, Web-based intervention (eToolbox) to increase primary care physician rates of CRCS. This application innovatively proposes to pilot test the eToolbox in the setting of the American Board of Internal Medicine (ABIM) Maintenance of Certification process within the Preventive Services Practice Improvement Module, a physician-directed measurement of their performance and quality improvement requirement for board re-certification.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based intervention (eToolbox) | Experimental | Behavioral: eToolboxThis arm will allow diplomats of the American Board of Internal Medicine to complete the Practice Improvement Module that will embed a link to the web-based intervention (eToolbox). |
| Practice Improvement Module | Active comparator | Behavioral: no link to eToolboxThis arm will allow diplomats of the American Board of Internal Medicine to complete the Practice Improvement Module without any link to the Web-based eToolbox. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ABIM certification and have or plan to enroll in the Maintenance of Certification program
- Primary Care Physicians
Key exclusion criteria (1 listed)
- Diplomats are not able to participate in this study if they are retired physicians, do not practice a primary care practice or who have already taken part in the study
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 |
|---|---|---|
| eToolboxParticipants randomized to the Web-based intervention will be automatically routed to a URL that will contain the Web-based intervention. | Behavioural | Web-based intervention (eToolbox) |
| no link to eToolboxParticipants randomized to the Practice Improvement Module will not be automatically routed to a URL that will contain the Web-based intervention. | Behavioural | Practice Improvement Module |
Primary outcome
Colorectal Cancer Screening Rates
Time frame: 3 years (2012)
1 secondary outcome
Content of practice improvement plan
Time frame: 3 years (2012)
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 17 Aug 2016.
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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.
Carmen E Guerra, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eToolbox and no link to eToolbox in people with Colorectal Cancer Screening, run by University of Pennsylvania 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 2 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 17 Aug 2016. 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. 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?
Colorectal Cancer Screening Rates (time frame: 3 years (2012)). 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 17 Aug 2016.