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Clinical Trials/NCT02464618
NCT02464618CompletedNot Applicable

Improving Attendance to Outpatient Endoscopy Among Blacks

Howard University2 sites in 1 country812 target enrollmentStarted: June 26, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
812
Locations
2
Primary Endpoint
Compliance with appointment and colonoscopy

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Usual care

No Intervention

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

Social contact intervention

Active Comparator

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

Intervention: Social contact intervention (Behavioral)

Outcomes

Primary Outcomes

Compliance with appointment and colonoscopy

Time Frame: 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

Time Frame: Scheduled procedure time, an average of 8 weeks

For specialty subjects: Completing scheduled upper endoscopy or colonoscopy

Secondary Outcomes

  • Bowel preparation quality(At scheduled colonoscopy, an average of 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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