Facilitators to Keeping Colonoscopy Appointments

ID: NCT00431327
Status: Completed
Phase: Early Phase 1
Start Date: February 01, 2005
First Submitted: February 01, 2007
Last Updated: February 02, 2007
Results: N/A
Sponsors & Collaborators: University of Pennsylvania
Location: United States
Conditions: Healthy
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Study Description

Brief Summary

To identify patients at risk for nonattendance to their first scheduled colonoscopy and to conduct a randomized trial of a theory-based, peer coach intervention on completing the scheduled colonoscopy.

Detailed Description

The potential to reduce the morbidity and mortality from colorectal cancer, the second most common cause of cancer death in the U.S. has been compromised because only about half of eligible patients have been appropriately screened. Patients contribute to inadequate colorectal cancer screening by failing to complete ordered tests. Several studies have reported low rates of attendance to scheduled sigmoidoscopy and colonoscopy studies. Because physicians offer limited counseling when ordering these tests, approaches are needed to address patient concerns and to promote adherence to scheduled colon studies. Therefore, we conducted a trial of a theory-based telephone intervention by patient ‘peer coach’ who was trained to address barriers to colonoscopy attendance versus a mailed professional brochure. The support was targeted to those at greatest risk of non-attendance.
Condition or disease Intervention/treatment Phase

Healthy

Behavioral: Peer coach phone call
Other Names
Early Phase 1

Tracking Information

First Submitted DateFebruary 01, 2007
Last Update Posted DateFebruary 02, 2007
Start DateFebruary 01, 2005
Completion DateOctober 01, 2006
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Attending the colonoscopy

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleFacilitators to Keeping Colonoscopy Appointments
Official TitlePeer Coach Intervention to Improve Attendance to Scheduled Colonoscopy
Brief Summary

To identify patients at risk for nonattendance to their first scheduled colonoscopy and to conduct a randomized trial of a theory-based, peer coach intervention on completing the scheduled colonoscopy.

Detailed Description

The potential to reduce the morbidity and mortality from colorectal cancer, the second most common cause of cancer death in the U.S. has been compromised because only about half of eligible patients have been appropriately screened. Patients contribute to inadequate colorectal cancer screening by failing to complete ordered tests. Several studies have reported low rates of attendance to scheduled sigmoidoscopy and colonoscopy studies. Because physicians offer limited counseling when ordering these tests, approaches are needed to address patient concerns and to promote adherence to scheduled colon studies. Therefore, we conducted a trial of a theory-based telephone intervention by patient ‘peer coach’ who was trained to address barriers to colonoscopy attendance versus a mailed professional brochure. The support was targeted to those at greatest risk of non-attendance.

Study TypeInterventional
Study PhaseEarly Phase 1
Estimated Enrollment
140
Allocation
Randomized
Interventional Model
Single Group Assignment
Masking
None
Primary Purpose
Prevention
Conditions
Healthy
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Behavioral: Peer coach phone call

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment140
Completion DateOctober 01, 2006
Eligibility Criteria: Inclusion Criteria:
- Age 50
- No prior colonoscopy in our health system records
- Patient in one of four primary care clinics within the University of Pennsylvania Health System
- Attended <75 of their primary care physicians visits within the past year

Exclusion Criteria:
- Colonoscopy not ordered by a primary care physician in a study clinic
- High readiness for the procedure
- A health care professional
- Had a prior colonoscopy outside of our health care system
GenderAll
Age50 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00431327
Other Study ID Numbers
705823
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyN/A
Study Sponsor
University of Pennsylvania
Collaborators
Not Available
Investigators
Principal Investigator
Barbara J Turner, MD
University of Pennsylvania