Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)
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|ClinicalTrials.gov Identifier: NCT01519999|
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Screening Shared Decision Making||Behavioral: Shared Decision Making for Colorectal Cancer Screening||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||206721 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||July 18, 2017|
|Actual Study Completion Date :||July 18, 2017|
|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 Name: CRCS-WISDM
|No Intervention: Comparison (control)|
- 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.
- Decisional conflict [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519999
|United States, Minnesota|
|Allina Health Systems - Commons|
|Minneapolis, Minnesota, United States, 55404|
|Principal Investigator:||Resa M Jones, MPH, PhD||Virginia Commonwealth University and Temple University|