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| ID | Type | Description | Link |
|---|---|---|---|
| CDR-1403-11040 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quantitative | Experimental | Subjects view:
|
|
| Verbal | Active Comparator | Subjects view:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA - Quantitative | Behavioral |
| ||
| DA - Verbal |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer (CRC) Screening Completion | Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test within 6 months of enrollment, based on documentation in the participants' electronic health record. If a patient completed both screening tests and the colonoscopy was a follow-up to a positive FIT, they were considered having completed a FIT only. If the FIT was negative and the patient still had a colonoscopy, they were considered to have completed both tests. | 6 months post intervention |
| Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention | Multiple choice question assessing subject's intention in getting a CRC screening test in the next 6 months. The response options were: 5=Definitely, 4=Probably, 3=May or may not, 2=Probably not, and 1=Definitely not. Higher positive change means CRC screening intention increased. Increased intention to be screened is a better outcome. | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention | 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. Each had response options: 4=very likely, 3=somewhat likely, 2=somewhat unlikely, and 1=very unlikely. The mean of the 3 questions was calculated (each combined score has a range of 1 to 4) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be from -3 to 3 with higher values meaning an increase in perceived risk which is a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter H Schwartz, M.D., Ph.D | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 462020 | United States |
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Participants were recruited from primary care practices between June 2015 and December 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Verbal | Subjects view:
Decision Aid (DA) - Verbal |
| FG001 | Quantitative | Subjects view:
Decision Aid (DA) - Quantitative |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population includes only those participants who completed the study. There were 20 participants in each arm that were withdrawn; these participant's data were not included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Verbal | Subjects view:
DA - Verbal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Colorectal Cancer (CRC) Screening Completion | Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test within 6 months of enrollment, based on documentation in the participants' electronic health record. If a patient completed both screening tests and the colonoscopy was a follow-up to a positive FIT, they were considered having completed a FIT only. If the FIT was negative and the patient still had a colonoscopy, they were considered to have completed both tests. | All participants who agreed to having their electronic health record (EHR) checked by the researchers. There were 12 participants in the Verbal arm and 4 participants in the Quantitative arm who would not agree for their EHRs to be checked by the researchers; therefore, assessment of uptake was not performed with those participants. | Posted | Count of Participants | Participants | 6 months post intervention |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quantitative | Subjects view:
DA - Quantitative |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter H. Schwartz, M.D., Ph.D. | Indiana University | 317-278-4037 | phschwar@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2015 | Jul 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
| Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention | Assessed separately for colonoscopy (4 questions) and FIT (4 questions), using items drawn from validated scales for measuring benefits and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with higher values meaning perceived benefits increased which is a better outcome. | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
| Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention | Assessed separately for colonoscopy (11 questions) and FIT (9 questions), using items drawn from validated scales for measuring barriers and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with lower values meaning perceived barriers decreased which is a better outcome. | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
| Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention | Qualitative knowledge is assessed with five multiple choice and five true/false questions regarding general information (including risk factors, screening test options, and test frequency) of CRC and CRC screening. Knowledge scores were derived by summing correct responses to the 10 individual knowledge questions (range, 0-10), and change from baseline was calculated using the knowledge score at post-intervention minus the knowledge score at baseline. The range for change could be 0 to 10 with higher values meaning an increase in knowledge which is a better outcome. | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
| Decision Conflict: Change in Conflict From Baseline to Post-intervention | Decision conflict is assessed using the16-item Decision Conflict Scale. Scores will range from 0 (low decision conflict) to 100 (high decision conflict). Negative change means decision conflict decreased. A decrease in decision conflict is a better outcome. | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
| Number of Patients With High and Low Subjective Numeracy | Subjective numeracy was determined using the Subjective Numeracy Scale (SNS), a validated instrument that involves 8 Likert-type questions regarding the participant's preference for or dislike of numeric information and their perception of their ability to understand it. Each item has a six-point response option from 1-6. The higher the number, the higher the subjective numeracy. All participants were divided into two groups: above (high numeracy) and below (low numeracy) the median for their total subjective numeracy score. | 1 day |
| Workup consistent w/CRC |
|
| Technical issues with intervention |
|
| Elevated risk for CRC |
|
| MD advised against screening |
|
| patient deceased |
|
| BG001 | Quantitative | Subjects view:
DA - Quantitative |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Relationship | Count of Participants | Participants |
|
| Employed? | Count of Participants | Participants |
|
| Health Insurance? | Count of Participants | Participants |
|
| Insurance Lapse over past 12 months? | Count of Participants | Participants |
|
| Self-reported health status at baseline | Count of Participants | Participants |
|
| Income Level (yearly) | Count of Participants | Participants |
|
| Income Level Subjective | Count of Participants | Participants |
|
Subjects view:
DA - Verbal
| OG001 | Quantitative | Subjects view:
DA - Quantitative |
|
|
| Primary | Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention | Multiple choice question assessing subject's intention in getting a CRC screening test in the next 6 months. The response options were: 5=Definitely, 4=Probably, 3=May or may not, 2=Probably not, and 1=Definitely not. Higher positive change means CRC screening intention increased. Increased intention to be screened is a better outcome. | All participants with both baseline and post-intervention responses to CRC screening intent items. There were 2 participants in each arm who did not respond to at least one of the intent items. | Posted | Mean | Standard Deviation | units on a scale | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
|
|
|
| Secondary | Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention | 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. Each had response options: 4=very likely, 3=somewhat likely, 2=somewhat unlikely, and 1=very unlikely. The mean of the 3 questions was calculated (each combined score has a range of 1 to 4) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be from -3 to 3 with higher values meaning an increase in perceived risk which is a better outcome. | All participants with baseline (T0) and post-intervention (T1) perceived risk items. Missing responses were not used. | Posted | Mean | Standard Deviation | units on a scale | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
|
|
|
| Secondary | Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention | Assessed separately for colonoscopy (4 questions) and FIT (4 questions), using items drawn from validated scales for measuring benefits and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with higher values meaning perceived benefits increased which is a better outcome. | Participants who completed both the baseline and post-intervention benefit questions. For colonoscopy, it was 324 in Verbal and 332 in Quantitative. For FIT, it was 320 in Verbal and 330 in Quantitative. | Posted | Mean | Standard Deviation | units on a scale | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
|
|
|
| Secondary | Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention | Assessed separately for colonoscopy (11 questions) and FIT (9 questions), using items drawn from validated scales for measuring barriers and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with lower values meaning perceived barriers decreased which is a better outcome. | Participants who completed both the baseline and post-intervention barrier questions. For colonoscopy, it was 322 in Verbal and 330 in Quantitative. For FIT, it was 321 in Verbal and 327 in Quantitative. | Posted | Mean | Standard Deviation | units on a scale | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
|
|
|
| Secondary | Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention | Qualitative knowledge is assessed with five multiple choice and five true/false questions regarding general information (including risk factors, screening test options, and test frequency) of CRC and CRC screening. Knowledge scores were derived by summing correct responses to the 10 individual knowledge questions (range, 0-10), and change from baseline was calculated using the knowledge score at post-intervention minus the knowledge score at baseline. The range for change could be 0 to 10 with higher values meaning an increase in knowledge which is a better outcome. | All participants who completed at least 7 knowledge questions at both baseline (T0) and post-intervention (T1). | Posted | Mean | Standard Deviation | correct answers | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
|
|
|
| Secondary | Decision Conflict: Change in Conflict From Baseline to Post-intervention | Decision conflict is assessed using the16-item Decision Conflict Scale. Scores will range from 0 (low decision conflict) to 100 (high decision conflict). Negative change means decision conflict decreased. A decrease in decision conflict is a better outcome. | All participants with at least 11 responses to the 16-item Decision Conflict Scale at both baseline (T0) and post-intervention (T1). | Posted | Mean | Standard Deviation | units on a scale | 1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid]) |
|
|
|
| Secondary | Number of Patients With High and Low Subjective Numeracy | Subjective numeracy was determined using the Subjective Numeracy Scale (SNS), a validated instrument that involves 8 Likert-type questions regarding the participant's preference for or dislike of numeric information and their perception of their ability to understand it. Each item has a six-point response option from 1-6. The higher the number, the higher the subjective numeracy. All participants were divided into two groups: above (high numeracy) and below (low numeracy) the median for their total subjective numeracy score. | Subjects who completed the Subjective Numeracy Scale. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| 0 |
| 364 |
| 0 |
| 364 |
| 0 |
| 364 |
| EG001 | Verbal | Subjects view:
DA - Verbal | 0 | 364 | 0 | 364 | 0 | 364 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| FIT Benefits |
|
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| FIT Barriers |
|
|