Information With or Without Numbers For Optimizing Reasoning About Medical Decisions (INFORM)
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|ClinicalTrials.gov Identifier: NCT02477553|
Recruitment Status : Completed
First Posted : June 23, 2015
Last Update Posted : September 28, 2017
Experts believe that increasing the low uptake of screening for colorectal cancer (CRC) requires educating patients about all approved tests and helping them choose one that fits their preferences. As one motto puts it: "The best test is the one that gets done." Screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). But it is unclear how best to educate patients about the options and the tradeoffs involved. Some guidelines recommend that decision aids, a promising tool in this area, provide patients with detailed quantitative information, including baseline risk, risk reduction, and chance of negative outcomes. But this sort of "comparative effectiveness" data can confuse patients, especially those with limited mathematical ability. Previous studies have not measured the effect of providing quantitative information to patients with varying levels of ability or interest or asked them whether such data is essential for their decision-making.
The investigators will conduct a clinical trial to determine the impact on patients who view a decision aid (DA) that includes quantitative information versus a DA without such data. The investigators will also seek to determine whether numeracy moderates the effect of quantitative information.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Screening||Behavioral: DA - Quantitative Behavioral: DA - Verbal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||728 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Describing the Comparative Effectiveness of Colorectal Cancer Screening Tests: The Impact of Quantitative Information|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||August 25, 2017|
|Actual Study Completion Date :||August 25, 2017|
Behavioral: DA - Quantitative
Active Comparator: Verbal
Behavioral: DA - Verbal
- Self-report CRC screening completion with medical record verification of screening test completion [ Time Frame: 6 months post intervention ]Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test, based on self-report and medical record verification.
- Self-report CRC screening intention [ Time Frame: 1 day ]Multiple choice questions assessing subject's intention in getting a CRC screening test in the next 6 months and a single question assessing subject's preferred test.
- Self-report perceived risk of CRC [ Time Frame: 1 day ]Multiple choice questions assessing subject's perception of how likely they are to get colon cancer in the next 5 years, in the next 10 years, and sometime during their lifetime; One multiple choice question assessing subject's perceived age and gender-adjusted comparative risk. Two items assessing subject's perceived likelihood of getting CRC if they do and do not have regular colon testing.
- Self-report perceived benefits of CRC screening with FIT and colonoscopy [ Time Frame: 1 day ]Assessed separately for colonoscopy and FIT, using items drawn from validated scales for measuring benefits and self-efficacy of colonoscopy and FIT. All items are measured using a 5-point Likert scale.
- Self-report perceived barriers to CRC screening with FIT or colonoscopy [ Time Frame: 1 day ]Assessed separately for colonoscopy and FIT, using items drawn from validated scales for measuring barriers and self-efficacy of colonoscopy and FIT. All items are measured using a 5-point Likert scale.
- Knowledge of CRC and screening as measured by questionnaire [ Time Frame: 1 day ]Qualitative knowledge is assessed with multiple choice and True/False questions regarding general information (including risk factors, screening test options, and test frequency). Quantitative knowledge is assessed with multiple choice questions regarding the probability of outcomes related to CRC screening.
- Decision conflict as measured by the Decision Conflict Scale [ Time Frame: 1 day ]Decision conflict is assessed using the16-item Decision Conflict Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477553
|United States, Indiana|
|Indianapolis, Indiana, United States, 462020|
|Principal Investigator:||Peter H Schwartz, M.D., Ph.D||Indiana University|