Using Patients' Social Contact to Improve Out-Patient Endoscopy Among Blacks
Improving Attendance to Outpatient Endoscopy Among Blacks
1 other identifier
interventional
812
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2014
CompletedFirst Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2017
CompletedSeptember 17, 2018
June 1, 2018
2.7 years
June 2, 2015
September 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Bowel preparation quality
At scheduled colonoscopy, an average of 8 weeks
Other Outcomes (1)
Social contact's activity
During the duration of the project, an average of 6 months
Study Arms (2)
Usual care
NO INTERVENTIONThe social contact of patients in this arm will not be contacted
Social contact intervention
ACTIVE COMPARATORThe social contact of patients in this arm will be contacted and asked to facilitate the endoscopy care plan of the patient
Interventions
The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy
Eligibility Criteria
You may qualify if:
- Patients referred for out-patient colonoscopy by primary care physicians
- Patients scheduled for out-patient screening colonoscopy
- Patients scheduled for out-patient upper endoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Howard University
Washington D.C., District of Columbia, 20060, United States
Related Publications (5)
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.
PMID: 25180285BACKGROUNDTammana 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.
PMID: 24574761BACKGROUNDBadurdeen 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.
PMID: 22571991BACKGROUNDLaiyemo 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.
PMID: 22183821BACKGROUNDLaiyemo 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.
PMID: 31478919DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adeyinka O Laiyemo, MD, MPH
Howard University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 8, 2015
Study Start
June 26, 2014
Primary Completion
March 7, 2017
Study Completion
March 7, 2017
Last Updated
September 17, 2018
Record last verified: 2018-06