Using Patients' Social Contact to Improve Out-Patient Endoscopy Among Blacks

Study Overview
=================
Brief Summary
-----------------
Non-attendance to out-patient endoscopic procedures is high among underserved blacks. The overall goal of this proposal is to evaluate the effect of directly involving a social contact (chosen by the patient) on completion and quality of out-patient endoscopy recommended for the patient by his/her primary care physician, or after scheduling by the gastrointestinal endoscopist. Improved adherence and better quality of procedures are postulated with involvement of social contacts.

Detailed Description
-----------------
The overarching goal of this proposal is to determine whether directly involving a social contact, chosen by the patient, will improve the completion and quality of scheduled out-patient endoscopy among blacks. These are three sub-projects: Project 1: Involves recruiting 400 patients referred for colonoscopy by their primary care physicians Project 2: Involves recruiting 400 patients scheduled for colonoscopy by their endoscopist Project 3: Involves recruiting 200 patients scheduled for upper endoscopy by their endoscopists

Official Title
-----------------
Improving Attendance to Outpatient Endoscopy Among Blacks

Conditions
-----------------
Compliance, Colon Cancer

Intervention / Treatment
-----------------
* Behavioral: Social contact intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred for out-patient colonoscopy by primary care physicians Patients scheduled for out-patient screening colonoscopy Patients scheduled for out-patient upper endoscopy Exclusion Criteria: Patients who were referred for colorectal cancer (CRC) screening as in-patients Patients with personal history of familial adenomatous polyposis syndrome (FAP) Patients with family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC) Patients with inflammatory bowel disease Patients with Crohn's disease Patients with ulcerative colitis Patients with personal history of CRC Patients who have had colonic resection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>The social contact of patients in this arm will not be contacted | |
| Active Comparator: Social contact intervention<br>The social contact of patients in this arm will be contacted and asked to facilitate the endoscopy care plan of the patient | Behavioral: Social contact intervention<br>* The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with appointment and colonoscopy | For primary care subjects: Making appointment with Gastrointestinal endoscopist within 3 months and completing colonoscopy within 6 months of enrolment | 6 months | 
| Compliance with scheduled upper endoscopy and colonoscopy | For specialty subjects: Completing scheduled upper endoscopy or colonoscopy | Scheduled procedure time, an average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel preparation quality | Adequacy of bowel preparation with ratings of good to excellent on Aronchick scale | At scheduled colonoscopy, an average of 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, Upper endoscopy, Adherence, Disparities