Decision Aid to Technologically Enhance Shared Decision Making

Study Overview
=================
Brief Summary
-----------------
Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence.

Detailed Description
-----------------
This two-armed randomized controlled trial (300 patients/arm) will compare Colorectal Web (CW), the interactive DA, to a non-interactive control website in ten practices in Metro Detroit. Patients will be adults aged 50 years and over, not current on CRCS. In the clinic before the patient-physician encounter, participants will complete a Patient Baseline Survey. They will be randomized to CW or the control website. Data will be collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording), and after it (Post-Encounter Survey). Chart audit will be performed six months after the encounter to determine whether the patient underwent CRCS.

Official Title
-----------------
Decision Aid to Technologically Enhance Shared Decision Making

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Colorectal Web


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50-75 years of age not current with colorectal cancer screening scheduled for HME, Health Maintenance Exam, or chronic care visit with participating physician able to read English current contact information Exclusion Criteria: history of colon cancer or adenomatous polyps history of dementia or psychosis contraindication to CRCS

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment. | |
| Active Comparator: Intervention with Colorectal Website<br>Intervention website includes an interactive component including preferences and risk assessment. | Behavioral: Colorectal Web<br>* The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits | Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening. | 6 months following intervention a chart audit will be conducted to determine if CRCS was completed. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Cancer, Screening, Prevention