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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Allina Health System
Blue Cross Blue Shield
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01519999
First received: January 13, 2012
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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 Intervention
Colorectal Cancer Screening
Shared Decision Making
Behavioral: Shared Decision Making for Colorectal Cancer Screening

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Change in colorectal cancer screening adherence [ Time Frame: Baseline up to 24 months post intervention initiation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 24 months post intervention initiation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 24 months post intervention initiation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2150
Study Start Date: May 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

Clinical practice: N=all patients 50-75 years seen in the clinic during the study period who are non-adherent to CRCS recommendation.

Community engagement: Includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (N=2150).

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519999

Locations
United States, Minnesota
Allina Health Systems - Commons
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Virginia Commonwealth University
Allina Health System
Blue Cross Blue Shield
Investigators
Principal Investigator: Resa M Jones, MPH, PhD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01519999     History of Changes
Other Study ID Numbers: WISDM-106965
Study First Received: January 13, 2012
Last Updated: August 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Shared decision making
Ambulatory Care
Patient-Centered Care
Community-wide intervention
Intervention Study
Longitudinal Studies

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 26, 2014