Utility Analysis of an Endoscopy Follow-up System

NCT ID: NCT01172080

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 830 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-10-31

Brief Summary

Although systems are in place to ensure results of tests are communicated to patients, there is currently no generalized accepted strategy to ensure that patients undergo recommended follow-up testing. When follow-up tests are recommended months to years into the future, there is a high likelihood that the test will either be delayed or not performed resulting in the potential for poor outcomes and litigation. For this reason, there is a clear need for systems to be developed which automatically trigger patient communication when the date of a recommended follow-up test is approaching. The investigators propose to design a protocol for ensuring that patients are reminded to schedule follow-up tests and that this communication is documented in the online medical record. This work will provide the foundation for the creation of systems that significantly improve patient care, and can be easily adapted for use in many clinical departments and institutions.

Aim 1. To use patient focus groups to help design a system for improving adherence to endoscopy follow up recommendations

Aim 2. To develop a prototype endoscopy follow up system and test the effectiveness of the system on a cohort of patients due for a surveillance colonoscopy.

Conditions

Colonoscopy Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

control

Participants in this group are monitored for adherence to colonoscopy recommendations.

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention

Participants to receive a protocol of reminder letters and a phone call regarding due follow up colonoscopy

Group Type: EXPERIMENTAL

protocol of reminders regarding due colonoscopy

Intervention Type: OTHER

Participants receive two standardized letters followed by a phone call if they have not scheduled or completed their upcoming due colonoscopy

Interventions

protocol of reminders regarding due colonoscopy

Participants receive two standardized letters followed by a phone call if they have not scheduled or completed their upcoming due colonoscopy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• due for a repeat surveillance colonoscopy for follow up of polyps during the study time period

Exclusion Criteria

• not due for a repeat surveillance colonoscopy for follow up of polyps during the study time period

• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Daniel Leffler

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Leffler DA, Neeman N, Rabb JM, Shin JY, Landon BE, Pallav K, Falchuk ZM, Aronson MD. An alerting system improves adherence to follow-up recommendations from colonoscopy examinations. Gastroenterology. 2011 Apr;140(4):1166-1173.e1-3. doi: 10.1053/j.gastro.2011.01.003. Epub 2011 Jan 13.

Reference Type: DERIVED

PMID: 21237167 (View on PubMed)

Other Identifiers

2010P000113

Identifier Type: -

Identifier Source: org_study_id