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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328001
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Sindhu R Kaitha, MD, University of Oklahoma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Focus of the Study is Cost-minimization Analysis Behavioral: Debriefing endoscopists of the procedure accessory costs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 969 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: Cost-Minimization Analysis and Its Impact on Resource Utilization After a Targeted Intervention for EGD and Colonoscopy
Study Start Date : December 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
No Intervention: Pre-intervention phase/phase 1
No intervention will be applied in phase 1
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02328001


Locations
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United States, Oklahoma
Oklahoma University Physicians Building, OUPB, Endoscopy Unit
Oklahoma city, Oklahoma, United States, 73014
Sponsors and Collaborators
Sindhu R Kaitha, MD
Investigators
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Principal Investigator: William Tierney, MD University of Oklahoma
Publications:

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Responsible Party: Sindhu R Kaitha, MD, MD, University of Oklahoma
ClinicalTrials.gov Identifier: NCT02328001    
Other Study ID Numbers: 4667
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017