Clinical trial NCT02464618: Using Patients' Social Contact to Improve Out-Patient Endoscopy Among Blacks
Official title: Improving Attendance to Outpatient Endoscopy Among Blacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance
Colon Cancer
Keywords: Colonoscopy
Upper endoscopy
Adherence
Disparities
Lead sponsor: Howard University
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: Compliance with appointment and colonoscopy
timeFrame: 6 months
measure: Compliance with scheduled upper endoscopy and colonoscopy
timeFrame: Scheduled procedure time, an average of 8 weeks
Secondary outcomes:
measure: Bowel preparation quality
timeFrame: At scheduled colonoscopy, an average of 8 weeks
Other outcomes:
measure: Social contact's activity
timeFrame: During the duration of the project, an average of 6 months
Locations:
city: Washington
country: United States
facility: Howard University
state: District of Columbia
Study officials:
affiliation: Howard University
name: Adeyinka O Laiyemo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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. No abstract available.
citation: Laiyemo AO, Kwagyan J, Williams CD, Rogers J, Kibreab A, Jack MA, Lee EE, Brim H, Ashktorab H, Howell CD, Smoot DT, Platz EA. Using Patients' Social Network to Improve Compliance to Outpatient Screening Colonoscopy Appointments Among Blacks: A Randomized Clinical Trial. Am J Gastroenterol. 2019 Oct;114(10):1671-1677. doi: 10.14309/ajg.0000000000000387.