Colorectal Cancer Screening With Improved Shared Decision Making

Not Applicable

Completed

• Conditions: Colorectal Cancer Screening; Shared Decision Making
• Interventions: Behavioral: Shared Decision Making for Colorectal Cancer Screening

• Registration Number: NCT01519999
• Lead Sponsor: Virginia Commonwealth University

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).

Study Timeline

• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-27
• Study Start: 2012-05
• Primary Completion: 2017-07-18
• Study Completion: 2017-07-18
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206721

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shared Decision Making	Shared Decision Making for Colorectal Cancer Screening	-

Primary Outcome Measures

Name	Time	Method
Change in colorectal cancer screening adherence	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 Outcome Measures

Name	Time	Method
Decisional conflict	Baseline up to 24 months post intervention initiation	A previously validated decisional conflict scale, will be used, which includes 16 items all measured on a 5-point Likert-type scale. (e.g. difficulty in decision making, certainty with a decision, demonstrated feeling of understanding about risks and benefits of a decision, and satisfaction with a decision). Responses will be coded so that higher responses represent greater decisional conflict.
Modality-specific colorectal cancer screening barriers	Baseline up to 24 months post intervention initiation	A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement.
Colorectal cancer screening-related confusion	Baseline up to 24 months post intervention initiation	Colorectal cancer-related confusion will be measured using 9 items which will be coded on a scale from 1 to 5 where 5 represents greater confusion endorsement.
Patients' shared decision-making experience	Baseline up to 12 months post intervention initiation	Patients will answer multiple questions relating to their experience with the implementation of shared decision-making and their interactions with clinical staff. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.
Providers'/staff shared decision-making experience	Baseline up to 24 months post intervention initiation	Providers and staff will answer multiple questions relating to their experience with the implementation of shared decision-making with their patients in clinical practice. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.

Trial Locations

Locations (1)

Allina Health Systems - Commons; 🇺🇸 Minneapolis, Minnesota, United States