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

September 13, 2018 updated by: Howard University

Improving Attendance to Outpatient Endoscopy Among Blacks

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

812

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
The social contact of patients in this arm will not be contacted
Active Comparator: 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
Behavioral: Social contact intervention
The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
Scheduled procedure time, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel preparation quality
Time Frame: At scheduled colonoscopy, an average of 8 weeks
Adequacy of bowel preparation with ratings of good to excellent on Aronchick scale
At scheduled colonoscopy, an average of 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social contact's activity
Time Frame: During the duration of the project, an average of 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Howard University

Investigators

  • Principal Investigator: Adeyinka O Laiyemo, MD, MPH, Howard University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2014

Primary Completion (Actual)

March 7, 2017

Study Completion (Actual)

March 7, 2017

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-14-MED-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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