search
Back to results

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

Primary Purpose

Colorectal Cancer Screening, Shared Decision Making

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Decision Making for Colorectal Cancer Screening
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer Screening focused on measuring Shared decision making, Ambulatory Care, Patient-Centered Care, Community-wide intervention, Intervention Study, Longitudinal Studies

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Allina Health Systems - Commons

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Shared Decision Making

Comparison (control)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
January 13, 2012
Last Updated
January 31, 2019
Sponsor
Virginia Commonwealth University
Collaborators
Allina Health System, Blue Cross Blue Shield
search

1. Study Identification

Unique Protocol Identification Number
NCT01519999
Brief Title
Colorectal Cancer Screening With Improved Shared Decision Making
Acronym
CRCS-WISDM
Official Title
Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 18, 2017 (Actual)
Study Completion Date
July 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Allina Health System, Blue Cross Blue Shield

4. Oversight

Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening, Shared Decision Making
Keywords
Shared decision making, Ambulatory Care, Patient-Centered Care, Community-wide intervention, Intervention Study, Longitudinal Studies

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
206721 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shared Decision Making
Arm Type
Experimental
Arm Title
Comparison (control)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Shared Decision Making for Colorectal Cancer Screening
Other Intervention Name(s)
CRCS-WISDM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in colorectal cancer screening adherence
Description
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.
Time Frame
Baseline up to 24 months post intervention initiation
Secondary Outcome Measure Information:
Title
Decisional conflict
Description
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.
Time Frame
Baseline up to 24 months post intervention initiation
Title
Modality-specific colorectal cancer screening barriers
Description
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.
Time Frame
Baseline up to 24 months post intervention initiation
Title
Colorectal cancer screening-related confusion
Description
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.
Time Frame
Baseline up to 24 months post intervention initiation
Title
Patients' shared decision-making experience
Description
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.
Time Frame
Baseline up to 12 months post intervention initiation
Title
Providers'/staff shared decision-making experience
Description
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.
Time Frame
Baseline up to 24 months post intervention initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Resa M Jones, MPH, PhD
Organizational Affiliation
Virginia Commonwealth University and Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allina Health Systems - Commons
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Colorectal Cancer Screening With Improved Shared Decision Making

We'll reach out to this number within 24 hrs