Biliary ObstructionERCPNCT02127229
Cost Analysis for Endoscopic Retrograde Cholangiopancreatography (ERCP)
A study testing Endoscopist informed of cost per procedure in people with Biliary Obstruction, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of the study is to determine if endoscopist notification of accessory cost results in altered resource utilization related to the total cost and number of accessories used in ERCP. This study will be a prospective cost--analysis study. Only chart review of PHI removed records will be used. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biliary Obstruction
- What is being tested?
- Endoscopist informed of cost per procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Sep 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult receiving ERCP at Endoscopy diagnostic center.
Who cannot join
- No stent removal or replacement procedures. EUS can only be used for intubation of bile duct. No spyglass will added to total cost.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: The Impact of Cost Itemization on Resource Utilization With ERCP
The purpose of the study is to determine if endoscopist notification of accessory cost results in altered resource utilization related to the total cost and number of accessories used in ERCP.
This study will be a prospective cost--analysis study. Only chart review of PHI removed records will be used. The only intervention used is that endoscopists will be made aware of the cost of accessories used in the second phase of the study following each ERCP.
The investigators are in an era of increased medical cost consciousness. Medical education and post--graduate education incorporates cost savings and appropriate diagnostic test selection based on expense as one aspects of the decision process. This era now focuses on what is best for the patient with the understanding that the cost to the patient and cost to the overall health care system matters. Not only is this apart of postgraduate training but now being implemented as part of Medicare reimbursement to provide low cost and high quality care. Incidence of pancreatic and biliary disease is increasing. ERCP is a vital tool for therapeutic intervention. The costs of these procedures, to both patients and hospitals, have caused some to question the amount of accessories used as well as the poor reimbursement provided by Medicare and insurers. Studies have indicated that hospitals actually lose money with each ERCP used and their use is being limited many times to tertiary care centers.
Read the detailed description
This study is a prospective cost-identification analysis of accessories used during the ERCP. The study will be conducted in two phases. Each phase will include at least 71 ERCP procedures. All consecutive patients undergoing ERCP will be included. For the first phase of the study the physicians performing the procedure 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 manager after completion of each procedure about the total number of accessories used and the dollar value of the accessories used during the procedure.
During the study period, all gathered information will be deidentified but the procedure indication and whether it was successful or not will be collected. Only deidentified information will be collected. Endoscopists will not be aware of the study to avoid a Hawthorne effect. The endoscopists resource utilization is what is being studied. They will be debriefed at completion of protocol.
ERCP's requiring cholangioscopy (spyglass), stent removal alone, or just stent exchange will be excluded from the cost analysis, because of the atypical nature of the procedures and the number of accessories used during these procedures may not reflect the number of accessories used during a typical procedure. For both groups, if an endoscopic ultrasound is used for gaining biliary access it will be included in the cost analysis of this study. Both outpatient and inpatients will be included for both groups. All investigator patients will be excluded from the analysis.
- Conditions
- Biliary Obstruction
- Being tested
- Endoscopist informed of cost per procedure
- Keywords
- endoscopic retrograde cholangiopancreatography, disposable accessory cost, endoscopy cost analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopist informed of cost per procedureProcedure or surgery
Following each procedure, endoscopists will get a cost report regarding the amount spent on disposable accessories.
| Study group | Role | What they receive |
|---|---|---|
| Blinded observation of ERCP | No intervention | Blind observation of disposable accessories use. |
| Endoscopist informed of cost per procedure | Experimental | Endoscopists informed following each ERCP. Receives: Procedure: Endoscopist informed of cost per procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of total cost of disposable accessories used for individual ERCP procedures
Two arms in the study. One arm is observation of blinding endoscopists and calculating cost of disposable accessories used while performing ERCP. The other arm will be the intervention group. Before the intervention period begins, advanced endoscopists will be informed that there cost is being monitored for each ERCP and the cost of disposable accessories. Following each ERCP during the intervention group, the endoscopists will be informed of the cost of that individual procedure based on disposable accessories.
Measured: ERCP procedures will be observed for up to 3 months for each arms of study
Secondary outcomes (1)
Cost identification of disposable accessory use in ERCP
Two arms in the study. One arm is observation of blinding endoscopists and calculating cost of disposable accessories used while performing ERCP. The other arm will be the intervention group. Before the intervention period begins, advanced endoscopists will be informed that there cost is being monitored for each ERCP and the cost of disposable accessories. Following each ERCP during the intervention group, the endoscopists will be informed of the cost of that individual procedure based on disposable accessories.
Measured: ERCP procedures will be observed for up to 3 months for each arms of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Why it stopped: No participants enrolled; study inactivated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Tierney, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127229
- Sponsor's protocol ID
- 574462
- Acronym
- ERCP
- Status last verified
- Aug 2017
- First submitted
- 4 Mar 2014
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cost Itemization on Resource Utilization With ERCP
- ClinicalTrials.gov ID
- NCT02127229
- Acronym / sponsor ID
- ERCP / 574462
- Conditions
- Biliary Obstruction
- Keywords
- endoscopic retrograde cholangiopancreatography, disposable accessory cost, endoscopy cost analysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled; study inactivated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 30 Apr 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.
The purpose of the study is to determine if endoscopist notification of accessory cost results in altered resource utilization related to the total cost and number of accessories used in ERCP.
This study will be a prospective cost--analysis study. Only chart review of PHI removed records will be used. The only intervention used is that endoscopists will be made aware of the cost of accessories used in the second phase of the study following each ERCP.
The investigators are in an era of increased medical cost consciousness. Medical education and post--graduate education incorporates cost savings and appropriate diagnostic test selection based on expense as one aspects of the decision process. This era now focuses on what is best for the patient with the understanding that the cost to the patient and cost to the overall health care system matters. Not only is this apart of postgraduate training but now being implemented as part of Medicare reimbursement to provide low cost and high quality care. Incidence of pancreatic and biliary disease is increasing. ERCP is a vital tool for therapeutic intervention. The costs of these procedures, to both patients and hospitals, have caused some to question the amount of accessories used as well as the poor reimbursement provided by Medicare and insurers. Studies have indicated that hospitals actually lose money with each ERCP used and their use is being limited many times to tertiary care centers.
Detailed description
This study is a prospective cost-identification analysis of accessories used during the ERCP. The study will be conducted in two phases. Each phase will include at least 71 ERCP procedures. All consecutive patients undergoing ERCP will be included. For the first phase of the study the physicians performing the procedure 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 manager after completion of each procedure about the total number of accessories used and the dollar value of the accessories used during the procedure.
During the study period, all gathered information will be deidentified but the procedure indication and whether it was successful or not will be collected. Only deidentified information will be collected. Endoscopists will not be aware of the study to avoid a Hawthorne effect. The endoscopists resource utilization is what is being studied. They will be debriefed at completion of protocol.
ERCP's requiring cholangioscopy (spyglass), stent removal alone, or just stent exchange will be excluded from the cost analysis, because of the atypical nature of the procedures and the number of accessories used during these procedures may not reflect the number of accessories used during a typical procedure. For both groups, if an endoscopic ultrasound is used for gaining biliary access it will be included in the cost analysis of this study. Both outpatient and inpatients will be included for both groups. All investigator patients will be excluded from the analysis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded observation of ERCP | No intervention | –Blind observation of disposable accessories use. |
| Endoscopist informed of cost per procedure | Experimental | Procedure: Endoscopist informed of cost per procedureEndoscopists informed following each ERCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult receiving ERCP at Endoscopy diagnostic center.
Key exclusion criteria (1 listed)
- No stent removal or replacement procedures. EUS can only be used for intubation of bile duct. No spyglass will added to total cost.
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 |
|---|---|---|
| Endoscopist informed of cost per procedureFollowing each procedure, endoscopists will get a cost report regarding the amount spent on disposable accessories. | Procedure or surgery | Endoscopist informed of cost per procedure |
Primary outcome
Reduction of total cost of disposable accessories used for individual ERCP procedures
Time frame: ERCP procedures will be observed for up to 3 months for each arms of study
Two arms in the study. One arm is observation of blinding endoscopists and calculating cost of disposable accessories used while performing ERCP. The other arm will be the intervention group. Before the intervention period begins, advanced endoscopists will be informed that there cost is being monitored for each ERCP and the cost of disposable accessories. Following each ERCP during the intervention group, the endoscopists will be informed of the cost of that individual procedure based on disposable accessories.
1 secondary outcome
Cost identification of disposable accessory use in ERCP
Time frame: ERCP procedures will be observed for up to 3 months for each arms of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
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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 Endoscopist informed of cost per procedure in people with Biliary Obstruction, run by University of Oklahoma 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Aug 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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction of total cost of disposable accessories used for individual ERCP procedures (time frame: ERCP procedures will be observed for up to 3 months for each arms of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2017.