Cost-Minimization Analysis After a Targeted Intervention for EGD and Colonoscopy

April 6, 2017 updated by: Sindhu R Kaitha, MD

Cost-Minimization Analysis and Its Impact on Resource Utilization After a Targeted Intervention for EGD and Colonoscopy

This study performs a single intervention of informing endoscopists how much the disposable accessories cost following each procedure. Following this single and simple intervention, prospective analysis of EGD and colonoscopy accessory use and pathology specimen costs will be compared to the same resource costs during a control period where endoscopists are blinded to their observation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective cost-identification and cost-minimization analysis of accessories used during the EGD and colonoscopy procedures. The endoscopists will be the participants under study and not the patients. The study will be conducted in two phases - pre and post-intervention phases. Each phase will include a minimum of 337 combined EGD and colonoscopy procedures and a total of upto a minimum 674 and a maximum of 1200 procedures for both phases. All consecutive patients undergoing EGD and colonoscopy will be included. For the first phase of the study, the endoscopist will not be made aware of the study and also will not be briefed at the end of the procedure with the number of accessories used during the procedure and the dollar value of the accessories. For the second phase of the study, endoscopist will be briefed by the endoscopy nursing staff after completion of each procedure about the total number of accessories used and the dollar value of the accessories used during the procedure. Once the study is completed, endoscopists will be debriefed about the study and outcomes.

Study Type

Interventional

Enrollment (Actual)

969

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma city, Oklahoma, United States, 73014
        • Oklahoma University Physicians Building, OUPB, Endoscopy Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults with age of 18 or greater
  • All races
  • Indication for therapeutic EGD or colonoscopy
  • Outpatient procedures done at OU Physicians Building endoscopy unit
  • Procedure is performed by one of the observed endoscopists

Exclusion Criteria:

  • Pediatric population
  • Diagnostic EGD and colonoscopy procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-intervention phase/phase 1
No intervention will be applied in phase 1
Other: Post-intervention phase/phase 2
Intervention will be applied in phase 2 i.e; Debriefing endoscopists of the procedure accessory costs and pathology specimen costs
Behavioral: Debriefing endoscopists of the procedure accessory costs
Informing endoscopists of the number of accessories used and the dollar value of the accessories

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cost of accessory use and pathology specimen costs
Time Frame: Up to 5 months
The cost of accessory and pathology specimens would be assessed immediately post-procedure during phase 2
Up to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sindhu R Kaitha, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

December 25, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 4667

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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