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

NCT ID: NCT02328001

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 969 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-10-31

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.

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.

Conditions

Primary Focus of the Study is Cost-minimization Analysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Pre-intervention phase/phase 1

No intervention will be applied in phase 1

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: OTHER

Debriefing endoscopists of the procedure accessory costs

Intervention Type: BEHAVIORAL

Informing endoscopists of the number of accessories used and the dollar value of the accessories

Interventions

Debriefing endoscopists of the procedure accessory costs

Informing endoscopists of the number of accessories used and the dollar value of the accessories

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sindhu R Kaitha, MD

OTHER

Sponsor Role: lead

Responsible Party

Sindhu R Kaitha, MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

William Tierney, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Oklahoma University Physicians Building, OUPB, Endoscopy Unit

Oklahoma City, Oklahoma, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 23948186 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24042189 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 21689363 (View on PubMed)

Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.

Reference Type: BACKGROUND

PMID: 24125514 (View on PubMed)

Leighton JA, Shen B, Baron TH, Adler DG, Davila R, Egan JV, Faigel DO, Gan SI, Hirota WK, Lichtenstein D, Qureshi WA, Rajan E, Zuckerman MJ, VanGuilder T, Fanelli RD; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. ASGE guideline: endoscopy in the diagnosis and treatment of inflammatory bowel disease. Gastrointest Endosc. 2006 Apr;63(4):558-65. doi: 10.1016/j.gie.2006.02.005. No abstract available.

Reference Type: BACKGROUND

PMID: 16564852 (View on PubMed)

Other Identifiers

4667

Identifier Type: -

Identifier Source: org_study_id