Clinical trial NCT01519999: Colorectal Cancer Screening With Improved Shared Decision Making
Official title: Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Shared Decision Making
Keywords: Shared decision making
Ambulatory Care
Patient-Centered Care
Community-wide intervention
Intervention Study
Longitudinal Studies
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Allina Health System
name: Blue Cross Blue Shield
First posted: 2012-01-27
Enrollment: 206721
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change in colorectal cancer screening adherence
timeFrame: Baseline up to 24 months post intervention initiation
Secondary outcomes:
measure: Decisional conflict
timeFrame: Baseline up to 24 months post intervention initiation
measure: Modality-specific colorectal cancer screening barriers
timeFrame: Baseline up to 24 months post intervention initiation
measure: Colorectal cancer screening-related confusion
timeFrame: Baseline up to 24 months post intervention initiation
measure: Patients' shared decision-making experience
timeFrame: Baseline up to 12 months post intervention initiation
measure: Providers'/staff shared decision-making experience
timeFrame: Baseline up to 24 months post intervention initiation
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Allina Health Systems - Commons
state: Minnesota
Study officials:
affiliation: Virginia Commonwealth University and Temple University
name: Resa M Jones, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: