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Utility Analysis of an Endoscopy Follow-up System

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ClinicalTrials.gov Identifier: NCT01172080
Recruitment Status : Completed
First Posted : July 29, 2010
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Leffler, Beth Israel Deaconess Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colonoscopy Adherence Other: protocol of reminders regarding due colonoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Utility Analysis of an Endoscopy Follow-up System
Study Start Date : January 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: control
Participants in this group are monitored for adherence to colonoscopy recommendations.
Experimental: intervention
Participants to receive a protocol of reminder letters and a phone call regarding due follow up colonoscopy
 Other: 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


Outcome Measures
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Primary Outcome Measures :
  1. percentage of individuals scheduling colonoscopy [ Time Frame: within three months of due date ]

Eligibility Criteria
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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172080


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Daniel Leffler, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01172080     History of Changes
Other Study ID Numbers: 2010P000113
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Daniel Leffler, Beth Israel Deaconess Medical Center:
colonoscopy
adherence
reminders
quality