An interventional study of Web-based decision aid plus personalized risk assessment and Web-based decision aid alone in Colorectal Cancer, sponsored by Agency for Healthcare Research and Quality (AHRQ). Completed at 2 sites in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-12-27.
Sponsored by Agency for Healthcare Research and Quality (AHRQ) · Not applicable, Interventional, and Prevention
The overall objective of this study is to conduct a three-arm randomized controlled trial to evaluate the impact of an interactive, web-based decision aid on shared decision-making and patient adherence to colorectal cancer (CRC) screening recommendations.
Colorectal cancer (CRC) is the second leading cause of cancer-related death and third most commonly diagnosed cancer among men and women in the United States. Screening has been shown to be a cost-effective strategy for reducing both CRC mortality through early detection and incidence through the detection and removal of precancerous adenomatous polyps (adenomas). Despite a compelling rationale and widespread endorsement by authoritative groups, screening rates remain far below those necessary to achieve significant reductions in CRC mortality or incidence. Poor patient acceptance and non-adherence to screening recommendations are partly responsible for low screening rates. Shared decision-making has been advocated as a potentially effective yet unproven strategy for addressing this problem. Implicit in this approach is the need for an unbiased decision aid that not only educates patients about the pros and cons of the different strategies so as to enable them to identify a preferred strategy but also empowers patients to take a proactive role in the decision-making process, thereby increasing satisfaction and promoting adherence. From a logistical standpoint, the decision aid must also be easy to implement in the ambulatory setting so as to maximize use but minimize demands on physician time and office resources. To address this need, we have developed an interactive, web-based decision aid and implementation strategy for use in routine clinical practice.
Comparison(s): Average risk subjects assigned to one of two intervention arms (decision aid alone versus decision aid plus personalized risk assessment with feedback) compared to a control arm(generic website that discusses lifestyle changes that can reduce overall cancer risk).
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 825 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Agency for Healthcare Research and Quality (AHRQ) is the lead sponsor of 32 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients viewed the decision aid and completed the Your Disease Risk risk assessment tool prior to visit with their primary care provider.
Behavioral: Web-based decision aid plus personalized risk assessment
Patient's viewed decision aid only prior to a visit with their primary care provider.
Behavioral: Web-based decision aid alone
Standard care
Behavioral: Generic website
Patients review a computer-based decision aid that discuss the pros and cons of of 5 recommended CRC screening options and provides personalized 10-year estimates of CRC risk prior to meeting with their provider to discuss CRC screening.
Also known as: Decision aid, personalized risk assessment tool
Patients review a computer-based decision aid that discuss the pros and cons of the 5 recommended CRC screening options prior to meeting with their provider to discuss CRC screening.
Also known as: Decision aid
Patients review a generic website that discuss ways to reduce overall cancer risk.
Also known as: Control condtion
Patient Adherence (Test Completion)
Completion of a screening test within 12 months of the study visit.
Time frame: 12 months post-intervention
Patient Knowledge
Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don't know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.
Time frame: Immediate post-intervention study visit
Patient Satisfaction With Decision Making Process
Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for "strongly disagree" (or "poor") to 5 for "strongly agree" (or "excellent"). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data.
Time frame: Immediate post-intervention primary care provider (PCP) visit
Screening Intentions
Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for "not at all sure" to 5 for "completely sure".
Time frame: Immediate post-intervention study visit
| Milestone | DA + YDR | DA Alone | Control |
|---|---|---|---|
| Started | 280 | 269 | 276 |
| Completed | 280 | 269 | 276 |
| Not completed | 0 | 0 | 0 |
Completion of a screening test within 12 months of the study visit.
| participants | DA + YDR | DA Alone | Control |
|---|---|---|---|
| Patient Adherence (Test Completion) | 104 | 116 | 96 |
Knowledge was assessed at baseline (pretest) and at the time of the exit survey (posttest) based on responses to a 12-item questionnaire (True/False/Don't know) that inquired about CRC risk factors, the rationale and goals of screening, and age at which screening should begin. Cumulative knowledge scores (range, 0-12) were derived by summing correct responses to the 12 individual knowledge questions.
| units on a scale | DA + YDR | DA Alone | Control |
|---|---|---|---|
| Patient Knowledge | 10.7 ± 1.9 | 10.9 ± 1.6 | 8.6 ± 2.6 |
Patient satisfaction with the decision-making process (SDMP) was assessed using the validated 12-item Satisfaction with the Decision-Making Process scale. Five ordered response categories were used for each item. Each response was assigned a point score ranging from 1 for "strongly disagree" (or "poor") to 5 for "strongly agree" (or "excellent"). A cumulative score was calculated based on the summed response scores for each item (maximum score = 60). Mean item substitution was used to impute missing data.
| units on a scale | DA + YDR | DA Alone | Control |
|---|---|---|---|
| Patient Satisfaction With Decision Making Process | 49.0 ± 6.2 | 49.7 ± 6.4 | 45.5 ± 7.8 |
Screening intentions were also assessed as part of the posttest. Subjects were asked how sure they were that they would schedule an appointment to get screened for colorectal cancer and how sure they were that they would complete the screening test they scheduled. An ordered 5-point response frame was used ranging from 1 for "not at all sure" to 5 for "completely sure".
| units on a scale | DA + YDR | DA Alone | Control |
|---|---|---|---|
| Screening Intentions | 4.4 ± 1.0 | 4.4 ± 1.0 | 4.0 ± 1.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DA + YDR | — | 0/280 (0%) | 0/280 (0%) |
| DA Alone | — | 0/269 (0%) | 0/269 (0%) |
| Control | — | 0/276 (0%) | 0/276 (0%) |
| Age, Categorical(Participants) | DA + YDR | DA Alone | Control | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 232 | 234 | 230 | 696 |
| >=65 years | 48 | 35 | 46 | 129 |
| Sex: Female, Male(Participants) | DA + YDR | DA Alone | Control | Total |
|---|---|---|---|---|
| Female | 163 | 164 | 159 | 486 |
| Male | 117 | 105 | 117 | 339 |
| Ethnicity (NIH/OMB)(Participants) | DA + YDR | DA Alone | Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 18 | 10 | 15 | 43 |
| Not Hispanic or Latino | 262 | 259 | 261 | 782 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DA + YDR | DA Alone | Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 3 | 7 | 2 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 172 | 160 | 180 | 512 |
| White | 99 | 96 | 88 | 283 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 6 | 6 | 18 |
| Region of Enrollment(participants) | DA + YDR | DA Alone | Control | Total |
|---|---|---|---|---|
| United States | 280 | 269 | 276 | 825 |
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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