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

NCT ID: NCT02464618

Last Updated: 2018-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

812 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-26

Study Completion Date

2017-03-07

Brief Summary

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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

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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

Conditions

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Compliance Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual care

The social contact of patients in this arm will not be contacted

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Social contact intervention

Intervention Type BEHAVIORAL

The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy

Interventions

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Social contact intervention

The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Howard University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adeyinka O Laiyemo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Howard University

Locations

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Howard University

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25180285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24574761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22571991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22183821 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31478919 (View on PubMed)

Other Identifiers

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IRB-14-MED-11

Identifier Type: -

Identifier Source: org_study_id

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