Back to resultsPost-Endoscopic Infection Rate Notifications to Improve the Delivery of Care
Primary Purpose
Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Option 1: National comparison
Option 2: National comparison with benchmarking
Sponsored by
About this trial
This is an interventional health services research trial for Infection focused on measuring colonoscopy, EGD, endoscopy, ASC, outpatient, infection, Endoscopic procedures
Eligibility Criteria
Inclusion Criteria:
- Facilities that bill to fee for service Medicare for gastrointestinal endoscopy
Exclusion Criteria:
-
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
National comparison
National comparison with benchmarking
Arm Description
Ability to view center's rate compared with all others
Ability to view center's rate compared with the others with a similar patient comorbidity profile and in addition to viewing option 1
Outcomes
Primary Outcome Measures
Change in the infection rate among centers with elevated infection rates
Secondary Outcome Measures
Full Information
NCT ID
NCT03922971
First Posted
April 17, 2019
Last Updated
June 21, 2023
Sponsor
Johns Hopkins University
Collaborators
Medivators Cantel
1. Study Identification
Unique Protocol Identification Number
NCT03922971
Brief Title
Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care
Official Title
Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Medivators Cantel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project will notify centers of center's post-endoscopic infection rates and evaluate the effectiveness of this notification system to decrease infection rates. The investigators aim to notify centers of the number of patients and center's risk-adjusted rates of hospitalizations for infections after colonoscopy and esophagogastroduodenoscopy (EGD) procedures performed between January 2015 and September 2018. The investigators will randomize centers to two notification groups: (1) Ability to view center's rate compared with all other centers (ASCs and outpatient centers notified and compared separately) or (2) Ability to view center's rate compared with the other centers with a similar patient comorbidity profile and in addition to viewing option 1. Facilities will answer questions about center's infection control practices. The investigators hypothesize that centers with high rates of post-procedural infections will (1) be more likely to report that the center took action to investigate the center's infection control practices after the first notification and (2) observe a decrease in infections after the notification. The investigators anticipate that centers with high rates of post-procedural infections that are randomized to group 2 will have greater change. The investigators anticipate no change in rates of infection in the facilities that had zero or very low (n=1) event rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
colonoscopy, EGD, endoscopy, ASC, outpatient, infection, Endoscopic procedures
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
National comparison
Arm Type
Other
Arm Description
Ability to view center's rate compared with all others
Arm Title
National comparison with benchmarking
Arm Type
Other
Arm Description
Ability to view center's rate compared with the others with a similar patient comorbidity profile and in addition to viewing option 1
Intervention Type
Other
Intervention Name(s)
Option 1: National comparison
Intervention Description
Ability to view center's rate compared with all others.
Intervention Type
Other
Intervention Name(s)
Option 2: National comparison with benchmarking
Intervention Description
Ability to view center's rate compared with the others with a similar patient comorbidity profile and in addition to viewing option 1.
Primary Outcome Measure Information:
Title
Change in the infection rate among centers with elevated infection rates
Time Frame
Baseline, 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Facilities that bill to fee for service Medicare for gastrointestinal endoscopy
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Hutfless
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212187
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care
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