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

Primary Purpose

Compliance, Colon Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Social contact intervention

About this trial

This is an interventional health services research trial for Compliance focused on measuring Colonoscopy, Upper endoscopy, Adherence, Disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Howard University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual care

Social contact intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Compliance with scheduled upper endoscopy and colonoscopy

For specialty subjects: Completing scheduled upper endoscopy or colonoscopy

Secondary Outcome Measures

Bowel preparation quality

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

Full Information

NCT ID

NCT02464618

First Posted

June 2, 2015

Last Updated

September 13, 2018

Sponsor

Howard University

1. Study Identification

Unique Protocol Identification Number

NCT02464618

Brief Title

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

Official Title

Improving Attendance to Outpatient Endoscopy Among Blacks

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

June 26, 2014 (Actual)

Primary Completion Date

March 7, 2017 (Actual)

Study Completion Date

March 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Howard University

4. Oversight

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Compliance, Colon Cancer

Keywords

Colonoscopy, Upper endoscopy, Adherence, Disparities

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

812 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

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

Arm Title

Social contact intervention

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Social contact intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Compliance with appointment and colonoscopy

Description

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

Time Frame

6 months

Title

Compliance with scheduled upper endoscopy and colonoscopy

Description

For specialty subjects: Completing scheduled upper endoscopy or colonoscopy

Time Frame

Scheduled procedure time, an average of 8 weeks

Secondary Outcome Measure Information:

Title

Bowel preparation quality

Description

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

Time Frame

At scheduled colonoscopy, an average of 8 weeks

Other Pre-specified Outcome Measures:

Title

Social contact's activity

Description

Characteristics of participants and Lubbens social network scale correlation with other outcomes and activities of the social contact

Time Frame

During the duration of the project, an average of 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adeyinka O Laiyemo, MD, MPH

Organizational Affiliation

Howard University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Howard University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20060

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25180285

Citation

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.

Results Reference

background

PubMed Identifier

24574761

Citation

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.

Results Reference

background

PubMed Identifier

22571991

Citation

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.

Results Reference

background

PubMed Identifier

22183821

Citation

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.

Results Reference

background

PubMed Identifier

31478919

Citation

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.

Results Reference

derived

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

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