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

Sponsor
Howard University (Other)
Overall Status
Completed
CT.gov ID
NCT02464618
Collaborator
(none)
812
1
2
32.4
25.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Social contact intervention
N/A

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
Actual Enrollment :
812 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Improving Attendance to Outpatient Endoscopy Among Blacks
Actual Study Start Date :
Jun 26, 2014
Actual Primary Completion Date :
Mar 7, 2017
Actual Study Completion Date :
Mar 7, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Compliance with appointment and colonoscopy [6 months]

    For primary care subjects: Making appointment with Gastrointestinal endoscopist within 3 months and completing colonoscopy within 6 months of enrolment

  2. Compliance with scheduled upper endoscopy and colonoscopy [Scheduled procedure time, an average of 8 weeks]

    For specialty subjects: Completing scheduled upper endoscopy or colonoscopy

Secondary Outcome Measures

  1. Bowel preparation quality [At scheduled colonoscopy, an average of 8 weeks]

    Adequacy of bowel preparation with ratings of good to excellent on Aronchick scale

Other Outcome Measures

  1. Social contact's activity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Howard University Washington District of Columbia United States 20060

Sponsors and Collaborators

  • Howard University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Howard University
ClinicalTrials.gov Identifier:
NCT02464618
Other Study ID Numbers:
  • IRB-14-MED-11
First Posted:
Jun 8, 2015
Last Update Posted:
Sep 17, 2018
Last Verified:
Jun 1, 2018
Keywords provided by Howard University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 17, 2018