Primary Focus of the Study is Cost-minimization AnalysisNCT02328001
Cost-Minimization Analysis After a Targeted Intervention for EGD and Colonoscopy
A study testing Debriefing endoscopists of the procedure accessory costs in people with Primary Focus of the Study is Cost-minimization Analysis, run by Sindhu R Kaitha, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Focus of the Study is Cost-minimization Analysis
- What is being tested?
- Debriefing endoscopists of the procedure accessory costs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 969 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pediatric population
- Diagnostic EGD and colonoscopy procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma University Physicians Building, OUPB, Endoscopy Unit
Oklahoma City, Oklahoma, 73014
About this study
Official title: 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.
Read the 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.
- Being tested
- Debriefing endoscopists of the procedure accessory costs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debriefing endoscopists of the procedure accessory costsBehavioural
Informing endoscopists of the number of accessories used and the dollar value of the accessories
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention phase/phase 1 | No intervention | No intervention will be applied in phase 1 |
| Post-intervention phase/phase 2 | Other | Intervention will be applied in phase 2 i.e; Debriefing endoscopists of the procedure accessory costs and pathology specimen costs Receives: Behavioral: Debriefing endoscopists of the procedure accessory costs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cost of accessory use and pathology specimen costs
The cost of accessory and pathology specimens would be assessed immediately post-procedure during phase 2
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary Focus of the Study is Cost-minimization AnalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 969 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sindhu R Kaitha, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sindhu R Kaitha, MD, University of Oklahoma
- Investigators
- William Tierney, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328001
- Sponsor's protocol ID
- 4667
- Status last verified
- Apr 2017
- First submitted
- 16 Dec 2014
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hogan RB, Santa-Cruz R, Weeks ES Jr, Alexander L, Hogan RB 3rd. Cost-minimization analysis of jumbo reusable forceps versus disposable forceps in a high-volume ambulatory endoscopy center. Gastrointest Endosc. 2009 Feb;69(2):284-8. doi: 10.1016/j.gie.2008.04.062. Epub 2008 Aug 23.
PubMed 18725156ASGE Technology Committee; Siddiqui UD, Banerjee S, Barth B, Chauhan SS, Gottlieb KT, Konda V, Maple JT, Murad FM, Pfau PR, Pleskow DK, Tokar JL, Wang A, Rodriguez SA. Tools for endoscopic stricture dilation. Gastrointest Endosc. 2013 Sep;78(3):391-404. doi: 10.1016/j.gie.2013.04.170. No abstract available.
PubMed 23948186Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.
PubMed 24042189Paspatis GA, Tribonias G, Konstantinidis K, Theodoropoulou A, Vardas E, Voudoukis E, Manolaraki MM, Chainaki I, Chlouverakis G. A prospective randomized comparison of cold vs hot snare polypectomy in the occurrence of postpolypectomy bleeding in small colonic polyps. Colorectal Dis. 2011 Oct;13(10):e345-8. doi: 10.1111/j.1463-1318.2011.02696.x.
PubMed 21689363Horiuchi 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.
PubMed 24125514Leighton 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.
PubMed 16564852
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Minimization Analysis and Its Impact on Resource Utilization After a Targeted Intervention for EGD and Colonoscopy
- ClinicalTrials.gov ID
- NCT02328001
- Acronym / sponsor ID
- 4667
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 969 participants (actual)
- Lead sponsor
- Sindhu R Kaitha, MDUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention phase/phase 1 | No intervention | –No intervention will be applied in phase 1 |
| Post-intervention phase/phase 2 | Other | Behavioral: Debriefing endoscopists of the procedure accessory costsIntervention will be applied in phase 2 i.e; Debriefing endoscopists of the procedure accessory costs and pathology specimen costs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pediatric population
- Diagnostic EGD and colonoscopy procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debriefing endoscopists of the procedure accessory costsInforming endoscopists of the number of accessories used and the dollar value of the accessories | Behavioural | Post-intervention phase/phase 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Background: PubMed 18725156Hogan RB, Santa-Cruz R, Weeks ES Jr, Alexander L, Hogan RB 3rd. Cost-minimization analysis of jumbo reusable forceps versus disposable forceps in a high-volume ambulatory endoscopy center. Gastrointest Endosc. 2009 Feb;69(2):284-8. doi: 10.1016/j.gie.2008.04.062. Epub 2008 Aug 23.
- Background: PubMed 23948186ASGE Technology Committee; Siddiqui UD, Banerjee S, Barth B, Chauhan SS, Gottlieb KT, Konda V, Maple JT, Murad FM, Pfau PR, Pleskow DK, Tokar JL, Wang A, Rodriguez SA. Tools for endoscopic stricture dilation. Gastrointest Endosc. 2013 Sep;78(3):391-404. doi: 10.1016/j.gie.2013.04.170. No abstract available.
- Background: PubMed 24042189Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.
- Background: PubMed 21689363Paspatis GA, Tribonias G, Konstantinidis K, Theodoropoulou A, Vardas E, Voudoukis E, Manolaraki MM, Chainaki I, Chlouverakis G. A prospective randomized comparison of cold vs hot snare polypectomy in the occurrence of postpolypectomy bleeding in small colonic polyps. Colorectal Dis. 2011 Oct;13(10):e345-8. doi: 10.1111/j.1463-1318.2011.02696.x.
- Background: PubMed 24125514Horiuchi 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.
- Background: PubMed 16564852Leighton 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Tierney, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debriefing endoscopists of the procedure accessory costs in people with Primary Focus of the Study is Cost-minimization Analysis, run by Sindhu R Kaitha, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cost of accessory use and pathology specimen costs (time frame: Up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328001, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.