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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03922971
Other study ID # IRB00203304
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 7, 2019
Est. completion date June 15, 2023

Study information

Verified date February 2023
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 303
Est. completion date June 15, 2023
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Facilities that bill to fee for service Medicare for gastrointestinal endoscopy Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Option 1: National comparison
Ability to view center's rate compared with all others.
Option 2: National comparison with benchmarking
Ability to view center's rate compared with the others with a similar patient comorbidity profile and in addition to viewing option 1.

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Medivators Cantel

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the infection rate among centers with elevated infection rates Baseline, 12 months
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