Breast CancerNCT02430948
Improving Compliance With Medical Testing Guidelines
A study testing Color-coded materials, Academic detailing and Standard support in people with Breast Cancer and Cervical Cancer, run by Beth Israel Medical Center at 2 sites in United States.
Trial summary
The study hypothesis is that clearer visual presentation of guideline recommendations and educational outreach, or academic detailing, can improve guideline compliance. However, it will investigate other aspects of screening-related decision-making, such as provider and patient beliefs about screening… Read more about this study
- Who is it for?
- Ages 30 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer, Prostate Cancer
- What is being tested?
- Color-coded materials, Academic detailing and Standard support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Feb 2017
- 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 30 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients: healthy men and women ages 30-89 seeing their primary care provider for routine visit
- Providers: non-pediatric primary care physicians from Mount Sinai Beth Israel or St. Luke's-Roosevelt associated practices
Who cannot join
- Patient life expectancy of less than 1 year in primary care provider's judgment
- Inability to read and understand English
- Transgender status
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai Beth Israel
New York, New York, 10003
St. Luke's-Roosevelt
New York, New York, 10019
About this study
The study hypothesis is that clearer visual presentation of guideline recommendations and educational outreach, or academic detailing, can improve guideline compliance. However, it will investigate other aspects of screening-related decision-making, such as provider and patient beliefs about screening, provider-patient communication and patient's willingness to forgo expected testing. The research question is whether educational interventions can decrease non-compliance with screening guidelines for 5 common cancers.
Read the detailed description
This study is a cluster randomized trial that compares the immediate post-encounter impressions of 12 physicians and 18 of their patients about the discussion of screening for breast, cervical, colorectal, lung and prostate cancer as well as their beliefs about screening efficacy and patient reports of the screening experience. The interventions are educational materials and academic detailing (educational outreach) for providers. The investigators are particularly interested in contrasting the patient and provider recollections, the differential impact on underuse and overuse compliance and whether patient behaviors are consistent with their stated screening plans.
- Conditions
- Breast Cancer, Cervical Cancer, Prostate Cancer, Colon Cancer, Lung Cancer
- Being tested
- Color-coded materials, Academic detailing, Standard support, No academic detailing
- Keywords
- Screening, Shared Decision Making
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Prostatic Neoplasms, Colonic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color-coded materialsOther
A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation
Academic detailingOther
Educational outreach to address the rationale and data supporting recommendations for and against screening
Standard supportOther
Screening recommendations presented in standard format
No academic detailingOther
Physician receives study orientation for not the academic detailing curriculum
| Study group | Role | What they receive |
|---|---|---|
| Standard Support Outreach | Active comparator | Providers receive standard written screening recommendations and do not receive academic detailing (educational outreach) Receives: Other: Standard support; Other: No academic detailing |
| Standard materials and academic detailing | Experimental | Providers receive standard written screening recommendations and receive academic detailing (educational outreach) Receives: Other: Academic detailing; Other: Standard support |
| Color-coded materials and no academic detailing | Experimental | Providers receive color-coded written screening recommendations and do not receive academic detailing (educational outreach) Receives: Other: Color-coded materials; Other: No academic detailing |
| Color-coded materials and academic detailing | Experimental | Providers receive color-coded written screening recommendations and receive academic detailing (educational outreach) Receives: Other: Color-coded materials; Other: Academic detailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of educational intervention on providers' recommendations
Incidence of guidance compliance
Measured: Baseline
Effect of educational intervention on providers' recommendations
Incidence of guidance compliance
Measured: 3 months
Effect of educational intervention on providers' recommendations
Incidence of guidance compliance
Measured: 6 months
Effect of educational intervention on providers' recommendations
Incidence of guidance compliance
Measured: 12 months
Secondary outcomes (8)
Patients' belief in the value of screening
measured by survey to be determined
Measured: Baseline
Patients' belief in the value of screening
measured by survey to be determined
Measured: 3 months
Patients' belief in the value of screening
measured by survey to be determined
Measured: 6 months
Patients' belief in the value of screening
measured by survey to be determined
Measured: 12 months
Patient compliance
measured by self- report in surveys to be determined
Measured: Baseline
Patient compliance
measured by self- report in surveys to be determined
Measured: 3 months
Patient compliance
measured by self- report in surveys to be determined
Measured: 6 months
Patient compliance
measured by self- report in surveys to be determined
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James A Talcott, MD SM, Principal investigator, Mount Sinai Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430948
- Sponsor's protocol ID
- OGARA CAN-264
- Status last verified
- Jul 2019
- First submitted
- 29 Sep 2014
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Compliance With Medical Testing Guidelines
- ClinicalTrials.gov ID
- NCT02430948
- Acronym / sponsor ID
- OGARA CAN-264
- Conditions
- Breast Cancer, Cervical Cancer, Prostate Cancer, Colon Cancer, Lung Cancer
- Keywords
- Screening, Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 30 Apr 2015 (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 study hypothesis is that clearer visual presentation of guideline recommendations and educational outreach, or academic detailing, can improve guideline compliance. However, it will investigate other aspects of screening-related decision-making, such as provider and patient beliefs about screening, provider-patient communication and patient's willingness to forgo expected testing. The research question is whether educational interventions can decrease non-compliance with screening guidelines for 5 common cancers.
Detailed description
This study is a cluster randomized trial that compares the immediate post-encounter impressions of 12 physicians and 18 of their patients about the discussion of screening for breast, cervical, colorectal, lung and prostate cancer as well as their beliefs about screening efficacy and patient reports of the screening experience. The interventions are educational materials and academic detailing (educational outreach) for providers. The investigators are particularly interested in contrasting the patient and provider recollections, the differential impact on underuse and overuse compliance and whether patient behaviors are consistent with their stated screening plans.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Support Outreach | Active comparator | Other: Standard support, Other: No academic detailingProviders receive standard written screening recommendations and do not receive academic detailing (educational outreach) |
| Standard materials and academic detailing | Experimental | Other: Academic detailing, Other: Standard supportProviders receive standard written screening recommendations and receive academic detailing (educational outreach) |
| Color-coded materials and no academic detailing | Experimental | Other: Color-coded materials, Other: No academic detailingProviders receive color-coded written screening recommendations and do not receive academic detailing (educational outreach) |
| Color-coded materials and academic detailing | Experimental | Other: Color-coded materials, Other: Academic detailingProviders receive color-coded written screening recommendations and receive academic detailing (educational outreach) |
Who may qualify
- Ages
- 30 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients: healthy men and women ages 30-89 seeing their primary care provider for routine visit
- Providers: non-pediatric primary care physicians from Mount Sinai Beth Israel or St. Luke's-Roosevelt associated practices
Key exclusion criteria (3 listed)
- Patient life expectancy of less than 1 year in primary care provider's judgment
- Inability to read and understand English
- Transgender status
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 |
|---|---|---|
| Color-coded materialsA summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation | Other | Color-coded materials and academic detailing, Color-coded materials and no academic detailing |
| Academic detailingEducational outreach to address the rationale and data supporting recommendations for and against screening | Other | Color-coded materials and academic detailing, Standard materials and academic detailing |
| Standard supportScreening recommendations presented in standard format | Other | Standard Support Outreach, Standard materials and academic detailing |
| No academic detailingPhysician receives study orientation for not the academic detailing curriculum | Other | Color-coded materials and no academic detailing, Standard Support Outreach |
Primary outcome
Effect of educational intervention on providers' recommendations
Time frame: Baseline
Incidence of guidance compliance
Effect of educational intervention on providers' recommendations
Time frame: 3 months
Incidence of guidance compliance
Effect of educational intervention on providers' recommendations
Time frame: 6 months
Incidence of guidance compliance
Effect of educational intervention on providers' recommendations
Time frame: 12 months
Incidence of guidance compliance
8 secondary outcomes
Patients' belief in the value of screening
Time frame: Baseline
Patients' belief in the value of screening
Time frame: 3 months
Patients' belief in the value of screening
Time frame: 6 months
Patients' belief in the value of screening
Time frame: 12 months
Patient compliance
Time frame: Baseline
Patient compliance
Time frame: 3 months
Patient compliance
Time frame: 6 months
Patient compliance
Time frame: 12 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 26 Jul 2019.
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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.
James A Talcott, MD SM principal investigator
Mount Sinai Beth Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Color-coded materials, Academic detailing and Standard support in people with Breast Cancer and Cervical Cancer, run by Beth Israel Medical Center at 2 sites 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 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Effect of educational intervention on providers' recommendations (time frame: Baseline). The study lists 4 primary outcomes in all. 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 26 Jul 2019.