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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03922971

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted September 15, 2020

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.

  • Condition or Disease:Infection
  • Intervention/Treatment: Other: Option 1: National comparison
    Other: Option 2: National comparison with benchmarking
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 190 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Care Provider)
  • Primary Purpose: Health Services Research
  • Official Title: Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Other: National comparison
Ability to view center's rate compared with all others
Other: Option 1: National comparison
Ability to view center's rate compared with all others.
Other: 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
Other: 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.
Outcome Measures
  • Primary Outcome Measures: 1. Change in the infection rate among centers with elevated infection rates [ Time Frame: Baseline, 12 months ]
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Facilities that bill to fee for service Medicare for gastrointestinal endoscopy

Exclusion Criteria:

-

Contacts and Locations
Contacts

Contact: Susan Hutfless 410-502-0194 shutfle1@jhmi.edu

Contact: Tony Kalloo 410-614-3530 akalloo@jhmi.edu

Locations

United States, Maryland
Johns Hopkins University
Baltimore

Sponsors and Collaborators

Johns Hopkins University

Medivators Cantel

Investigators

Principal Investigator: Susan Hutfless Johns Hopkins University

More Information
  • Responsible Party: Johns Hopkins University
  • ClinicalTrials.gov Identifier: NCT03922971 History of Changes
  • Other Study ID Numbers: IRB00203304
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: September 15, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Johns Hopkins University: colonoscopy
    EGD
    endoscopy
    ASC
    outpatient
    infection
    Endoscopic procedures
  • Additional relevant MeSH terms: Communicable Diseases Infection