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

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

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).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Screening; Shared Decision Making
• Intervention / Treatment: Behavioral: Shared Decision Making for Colorectal Cancer Screening

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 Type: Interventional
• Enrollment (Actual): 206721
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Allina Health Systems - Commons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared Decision Making	Behavioral: Shared Decision Making for Colorectal Cancer Screening; Age-eligible adults in the intervention communities will be exposed to the shared decision-making intervention when they are seen in the primary care clinics (N=all patients 50-75 years seen during the study period who are non-adherent to CRCS recommendation). Additionally, among patients with primary care visits scheduled one week or more before the visit, they will be randomized to receive either a mailed decision aid booklet or an informational flyer on shared decision making and CRCS prior to the visit. Patients with primary care visits scheduled less than one week prior to the visit will not be mailed materials in advance. The effect of the pre-visit materials on referral to SDM session and CRCS adherence between these groups will be compared. They will also be exposed to shared decision-making tools and resources available through the community-wide intervention activities.; Other Names: CRCS-WISDM
No Intervention: Comparison (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in colorectal cancer screening adherence	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.	Baseline up to 24 months post intervention initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional conflict	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.	Baseline up to 24 months post intervention initiation
Modality-specific colorectal cancer screening barriers	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.	Baseline up to 24 months post intervention initiation
Colorectal cancer screening-related confusion	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.	Baseline up to 24 months post intervention initiation
Patients' shared decision-making experience	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.	Baseline up to 12 months post intervention initiation
Providers'/staff shared decision-making experience	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.	Baseline up to 24 months post intervention initiation

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Blue Cross Blue Shield; Allina Health System
• Investigators: Principal Investigator: Resa M Jones, MPH, PhD, Virginia Commonwealth University and Temple University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 18, 2017
• Study Completion (Actual): July 18, 2017

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 27, 2012

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Longitudinal Studies; Shared decision making; Intervention Study; Ambulatory Care; Patient-Centered Care; Community-wide intervention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: HM14436; WISDM-106965 (Other Identifier: Virginia Commonwealth University)