CRCS-WISDM: Colorectal Cancer Screening With Improved Shared Decision Making

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Completed

CT.gov ID

NCT01519999

Collaborator

Allina Health System (Other), Blue Cross Blue Shield (Other)

206,721

Enrollment

Location

Arms

62.6

Duration (Months)

3304.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Screening Shared Decision Making	Behavioral: Shared Decision Making for Colorectal Cancer Screening	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

206721 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jul 18, 2017

Actual Study Completion Date :

Jul 18, 2017

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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