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

Colon Cancer Clinical Trial

Official title:

Improving Attendance to Outpatient Endoscopy Among Blacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464618
• Other study ID #: IRB-14-MED-11
• Status: Completed
• Phase: N/A
• Start date: June 26, 2014
• Est. completion date: March 7, 2017

Study information

• Verified date: June 2018
• Source: Howard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: March 7, 2017
• Est. primary completion date: March 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Compliance

Intervention

Behavioral:
• Social contact intervention
The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy

Locations

Country	Name	City	State
United States	Howard University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Howard University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Badurdeen DS, Umar NA, Begum R, Sanderson AK 2nd, Jack M, Mekasha G, Kwagyan J, Smoot DT, Laiyemo AO. Timing of procedure and compliance with outpatient endoscopy among an underserved population in an inner-city tertiary institution. Ann Epidemiol. 2012 Jul;22(7):531-5. doi: 10.1016/j.annepidem.2012.04.013. Epub 2012 May 8. — View Citation

Laiyemo AO, Williams CD, Burnside C, Moghadam S, Sanasi-Bhola KD, Kwagyan J, Brim H, Ashktorab H, Scott VF, Smoot DT. Factors associated with attendance to scheduled outpatient endoscopy. Postgrad Med J. 2014 Oct;90(1068):571-5. doi: 10.1136/postgradmedj-2012-131650. Epub 2014 Sep 1. — View Citation

Laiyemo AO. In search of a perfect solution to ensure that "no colon is left behind". Dig Dis Sci. 2012 Feb;57(2):263-5. doi: 10.1007/s10620-011-2010-6. Epub 2011 Dec 20. — View Citation

Tammana VS, Laiyemo AO. Colorectal cancer disparities: issues, controversies and solutions. World J Gastroenterol. 2014 Jan 28;20(4):869-76. doi: 10.3748/wjg.v20.i4.869. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social contact's activity	Characteristics of participants and Lubbens social network scale correlation with other outcomes and activities of the social contact	During the duration of the project, an average of 6 months
Primary	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
Primary	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	Bowel preparation quality	Adequacy of bowel preparation with ratings of good to excellent on Aronchick scale	At scheduled colonoscopy, an average of 8 weeks