NCT02127229

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

5 months

First QC Date

March 4, 2014

Last Update Submit

August 25, 2017

Conditions

Keywords

endoscopic retrograde cholangiopancreatographydisposable accessory costendoscopy cost analysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    ERCP procedures will be observed for up to 3 months for each arms of study

Study Arms (2)

Blinded observation of ERCP

NO INTERVENTION

Blind observation of disposable accessories use.

Endoscopist informed of cost per procedure

EXPERIMENTAL

Endoscopists informed following each ERCP.

Procedure: Endoscopist informed of cost per procedure

Interventions

Following each procedure, endoscopists will get a cost report regarding the amount spent on disposable accessories.

Endoscopist informed of cost per procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult receiving ERCP at Endoscopy diagnostic center.

You may not qualify if:

  • No stent removal or replacement procedures. EUS can only be used for intubation of bile duct. No spyglass will added to total cost.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

  • William Tierney, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

April 30, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations