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NCT01596582 · ClinicalTrials.gov registry record · NA
Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 352
- Enrollment target
NCT01596582: Completed NA study, sponsored by Boston Medical Center.
NCT01596582 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 352 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596582, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 352 participants
- Enrollment target
Study Summary
Shared decision-making (SDM) has been advocated as a strategy for increasing colorectal cancer (CRC) screening rates. Our studies to date suggest that while the use of a novel computer-based decision aid facilitates several components of SDM from both the patient and provider perspective, there is a reluctance among providers to acquiesce to patient preferences for a particular screening strategy when its differs from their own. The overall objective of this study is to assess whether risk stratification for advanced colorectal neoplasia influences clinical decision-making related to screening test selection and adherence within a SDM framework. Eligible subjects will be randomized to either an experimental arm, in which they will be asked to complete a 6-item risk assessment questionnaire known as the "Advanced Colorectal Neoplasia Index \[ACNI\]" after reviewing a web-based decision aid, or a control arm, in which they will only review the decision aid. Both interventions will take place just before a prearranged office visit with their provider. The primary outcome will be screening test ordered; secondary outcomes will include test completion rates, concordance between test preference and test ordered,, patient satisfaction with decision-making process, screening intentions, 6-month test completion rates and provider satisfaction. Outcomes will be evaluated using computerized tracking systems or validated instruments.
Primary Outcome
Concordance is a measure of the agreement between the patient's test preference and actual test ordered for standard care vs. risk assessment patients. It is defined as the number of patients who had their preferred test ordered.
Interventions
- BEHAVIORAL Risk Assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2012-04 |
| Est. Completion | 2016-06 |
| Phase | NA |
What the finished NCT01596582 record still lists
NCT01596582 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Risk Assessment is the first listed.
NCT01596582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01596582 about?
NCT01596582 is a clinical study titled "Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening". Shared decision-making (SDM) has been advocated as a strategy for increasing colorectal cancer (CRC) screening rates. Our studies to date suggest that while the use of a novel computer-based decision aid facilitates several components of SDM from both the patient and provider perspective, there is a...
What is the current status of trial NCT01596582?
This trial is currently completed. It is a NA study. The enrollment target is 352 participants. The study started on 2012-04. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01596582?
The interventions under investigation include: Risk Assessment (BEHAVIORAL).
Who is sponsoring clinical trial NCT01596582?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01596582's enrollment target sits among peer trials
352 292nd of 2000 higher than 1,709 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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