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

Not Applicable

Completed

• Conditions: Compliance; Colon Cancer
• Interventions: Behavioral: Social contact intervention

• Registration Number: NCT02464618
• Lead Sponsor: Howard University

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

Study Timeline

• Study Start: 2014-06-26
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Primary Completion: 2017-03-07
• Study Completion: 2017-03-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 812

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social contact intervention	Social contact intervention	The social contact of patients in this arm will be contacted and asked to facilitate the endoscopy care plan of the patient

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Bowel preparation quality	At scheduled colonoscopy, an average of 8 weeks	Adequacy of bowel preparation with ratings of good to excellent on Aronchick scale

Trial Locations

Locations (1)

Howard University; 🇺🇸 Washington, District of Columbia, United States