Colorectal NeoplasmsPhase 4NCT00134589
CHOICE: Communicating Health Options Through Information and Cancer Education
A Phase 4 study testing Academic Detailing (Medical Practices)+Decision Aids (Patients) in people with Colorectal Neoplasms, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of a two-component intervention, that combines academic detailing at the medical practice level and distribution of decision aids at the patient level, on adherence to colorectal cancer screening guidelines. Read more about this study
- Who is it for?
- Ages 52 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Academic Detailing (Medical Practices)+Decision Aids (Patients)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2009
- Phase
- Phase 4
- 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 52 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 52-75
- Aetna Health Plan member
- Average risk for colorectal cancer
- Did not have colorectal cancer screening within guideline time frame (1 to 10 years, depending on individual's age and type of screening)
Who cannot join
- History of colorectal cancer, polyps, inflammatory bowel disease, upper or lower gastrointestinal bleeding, cirrhosis, chronic obstructive pulmonary disease, cancer, blindness, uncorrectable hearing loss, severe dementia, severe heart failure, severe coronary artery disease
- Family history of colorectal cancer/polyps
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Rollins School of Public Health
Atlanta, Georgia, 30322
About this study
Official title: Increasing CRC Screening in Health Plan Members
The purpose of this study is to determine the effectiveness of a two-component intervention, that combines academic detailing at the medical practice level and distribution of decision aids at the patient level, on adherence to colorectal cancer screening guidelines.
Read the detailed description
Colorectal cancer is the second most common cause of cancer death in the United States. Early detection and intervention can significantly reduce morbidity and mortality from colorectal cancer (CRC), and current guidelines recommend that asymptomatic adults over age 50 periodically obtain screening by one of several modalities (FOBT, sigmoidoscopy, colonoscopy, or double contrast barium enema). However, CRC screening remains substantially underutilized in the U.S., and more than half of all adults do not adhere to these recommendations. This study was designed to increase CRC screening among health plan members, and involves the collaboration of a major health insurer.
We are conducting a cluster-randomized trial in health practices in Georgia and Florida, to test the effectiveness of a decision aid (video + brochures) for increasing adherence to CRC screening guidelines. Thirty-two large group practices were recruited and randomized to receive usual care (routine reminders) or an evidence-based decision aid intervention. In each practice, patients between the ages of 52 and 75, without current CRC screening history, were enrolled into the study.
In early 2007, we received a full HIPAA waiver that permitted us to send the decision aid intervention to long-term non-responders in the intervention group, and to access claims data for this group and the long-term non-responders in the usual care group. This procedure will make it possible for us to learn more about the real-world impact of the intervention.
The intervention will continue for up to 2 years for still-unscreened participants. The main outcome is receipt of an evidence-based modality of CRC screening according to the US Preventive Services Task Force Guidelines (FOBT, flexible sigmoidoscopy, colonoscopy, or double contrast barium enema).
Unique features of the proposed study include its potential to establish systems to increase screening uptake that will help fulfill HEDIS requirements; improving our understanding of how screening promotion interventions work in both White and Black populations; collaboration with a community partner of the Emory Prevention Research Center, and forging collaborative relationships between public health and health care researchers, and the affected communities of health plans and health care providers.
- Conditions
- Colorectal Neoplasms
- Being tested
- Academic Detailing (Medical Practices)+Decision Aids (Patients)
- Keywords
- Academic Detailing, Decision Aid, Colorectal Cancer Screening, RECTAL NEOPLASMS, COLONIC POLYPS
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic Detailing (Medical Practices)+Decision Aids (Patients)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of colorectal cancer screening
Secondary outcomes (1)
Patient's intention to ask/patient asking medical provider for colorectal cancer screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies 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 4
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of North Carolina, Aetna, Inc.
- Investigators
- Karen Glanz, PhD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134589
- Sponsor's protocol ID
- CDC-NCCDPHP-R-01-PH-000018
- Status last verified
- Jul 2007
- First submitted
- 23 Aug 2005
- Last updated
- 4 Aug 2009
- Results posted
- No
Publications
Pignone M, Winquist A, Schild LA, Lewis C, Scott T, Hawley J, Rimer BK, Glanz K. Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. Cancer. 2011 Aug 1;117(15):3352-62. doi: 10.1002/cncr.25924. Epub 2011 Feb 11.
PubMed 21319147Pignone M, Scott TL, Schild LA, Lewis C, Vazquez R, Glanz K. Yield of claims data and surveys for determining colon cancer screening among health plan members. Cancer Epidemiol Biomarkers Prev. 2009 Mar;18(3):726-31. doi: 10.1158/1055-9965.EPI-08-0751.
PubMed 19273480
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing CRC Screening in Health Plan Members
- ClinicalTrials.gov ID
- NCT00134589
- Acronym / sponsor ID
- CDC-NCCDPHP-R-01-PH-000018
- Conditions
- Colorectal Neoplasms
- Keywords
- Academic Detailing, Decision Aid, Colorectal Cancer Screening, RECTAL NEOPLASMS, COLONIC POLYPS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of North Carolina, Aetna, Inc.
- Study start
- Apr 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Aug 2005 (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 this study is to determine the effectiveness of a two-component intervention, that combines academic detailing at the medical practice level and distribution of decision aids at the patient level, on adherence to colorectal cancer screening guidelines.
Detailed description
Colorectal cancer is the second most common cause of cancer death in the United States. Early detection and intervention can significantly reduce morbidity and mortality from colorectal cancer (CRC), and current guidelines recommend that asymptomatic adults over age 50 periodically obtain screening by one of several modalities (FOBT, sigmoidoscopy, colonoscopy, or double contrast barium enema). However, CRC screening remains substantially underutilized in the U.S., and more than half of all adults do not adhere to these recommendations. This study was designed to increase CRC screening among health plan members, and involves the collaboration of a major health insurer.
We are conducting a cluster-randomized trial in health practices in Georgia and Florida, to test the effectiveness of a decision aid (video + brochures) for increasing adherence to CRC screening guidelines. Thirty-two large group practices were recruited and randomized to receive usual care (routine reminders) or an evidence-based decision aid intervention. In each practice, patients between the ages of 52 and 75, without current CRC screening history, were enrolled into the study.
In early 2007, we received a full HIPAA waiver that permitted us to send the decision aid intervention to long-term non-responders in the intervention group, and to access claims data for this group and the long-term non-responders in the usual care group. This procedure will make it possible for us to learn more about the real-world impact of the intervention.
The intervention will continue for up to 2 years for still-unscreened participants. The main outcome is receipt of an evidence-based modality of CRC screening according to the US Preventive Services Task Force Guidelines (FOBT, flexible sigmoidoscopy, colonoscopy, or double contrast barium enema).
Unique features of the proposed study include its potential to establish systems to increase screening uptake that will help fulfill HEDIS requirements; improving our understanding of how screening promotion interventions work in both White and Black populations; collaboration with a community partner of the Emory Prevention Research Center, and forging collaborative relationships between public health and health care researchers, and the affected communities of health plans and health care providers.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 52 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 52-75
- Aetna Health Plan member
- Average risk for colorectal cancer
- Did not have colorectal cancer screening within guideline time frame (1 to 10 years, depending on individual's age and type of screening)
Key exclusion criteria (2 listed)
- History of colorectal cancer, polyps, inflammatory bowel disease, upper or lower gastrointestinal bleeding, cirrhosis, chronic obstructive pulmonary disease, cancer, blindness, uncorrectable hearing loss, severe dementia, severe heart failure, severe coronary artery disease
- Family history of colorectal cancer/polyps
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 |
|---|---|---|
| Academic Detailing (Medical Practices)+Decision Aids (Patients) | Behavioural | – |
Primary outcome
Completion of colorectal cancer screening
1 secondary outcome
Patient's intention to ask/patient asking medical provider for colorectal cancer screening
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 4 Aug 2009.
- Derived from this study: PubMed 21319147Pignone M, Winquist A, Schild LA, Lewis C, Scott T, Hawley J, Rimer BK, Glanz K. Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. Cancer. 2011 Aug 1;117(15):3352-62. doi: 10.1002/cncr.25924. Epub 2011 Feb 11.
- Derived from this study: PubMed 19273480Pignone M, Scott TL, Schild LA, Lewis C, Vazquez R, Glanz K. Yield of claims data and surveys for determining colon cancer screening among health plan members. Cancer Epidemiol Biomarkers Prev. 2009 Mar;18(3):726-31. doi: 10.1158/1055-9965.EPI-08-0751.
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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.
Karen Glanz, PhD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Academic Detailing (Medical Practices)+Decision Aids (Patients) in people with Colorectal Neoplasms, run by Centers for Disease Control and Prevention 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 4 inclusion and 2 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 4 Aug 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Completion of colorectal cancer screening. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00134589, which also lists 2 linked publications.
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 4 Aug 2009.