Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care

Infection Clinical Trial

Official title:

Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922971
• Other study ID #: IRB00203304
• Status: Completed
• Phase: N/A
• 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
• 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:

-

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections

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