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Clinical Trials/NCT01519999
NCT01519999
Completed
Not Applicable

Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)

Virginia Commonwealth University1 site in 1 country206,721 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer Screening
Sponsor
Virginia Commonwealth University
Enrollment
206721
Locations
1
Primary Endpoint
Change in colorectal cancer screening adherence
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. The investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).

Detailed Description

Clinical practice: All patients 50-75 years seen in the participating primary care clinics during the study period who are non-adherent to CRCS recommendation. This sample is anticipated to be N\~50,000 patients. Community engagement: Includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (N=2150).

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
July 18, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 50 to 75 years of age
  • Lives in or receives care in the selected intervention or comparison (control) communities
  • Average-risk for colorectal cancer
  • Non-adherent to CRCS recommendation
  • English-speaking
  • People who consent to participate

Exclusion Criteria

  • \<50 years of age or \>75 years of age
  • Not living in or receiving care in the selected intervention or comparison communities
  • High-risk for colorectal cancer
  • Adherent to CRCS recommendation
  • Non-English speaking
  • People who do not consent to participate

Outcomes

Primary Outcomes

Change in colorectal cancer screening adherence

Time Frame: Baseline up to 24 months post intervention initiation

Colorectal cancer screening adherence will be defined as having screening according to the recommendations of the United States Preventive Services Task Force. Participants will be classified as screened per recommendations if they have had fecal occult blood testing in the last year, flexible sigmoidoscopy in the last five years, or colonoscopy in the last ten years. Participants will be classified as non-adherent if they have not had any of the modalities within the recommended timeframe.

Secondary Outcomes

  • Decisional conflict(Baseline up to 24 months post intervention initiation)
  • Modality-specific colorectal cancer screening barriers(Baseline up to 24 months post intervention initiation)
  • Colorectal cancer screening-related confusion(Baseline up to 24 months post intervention initiation)
  • Patients' shared decision-making experience(Baseline up to 12 months post intervention initiation)
  • Providers'/staff shared decision-making experience(Baseline up to 24 months post intervention initiation)

Study Sites (1)

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