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

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ClinicalTrials.gov Identifier: NCT03922971
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
Medivators Cantel
Information provided by (Responsible Party):
Johns Hopkins University

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 Intervention/treatment Phase
Infection Other: Option 1: National comparison Other: Option 2: National comparison with benchmarking Not Applicable

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : October 13, 2020
Estimated Study Completion Date : October 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Change in the infection rate among centers with elevated infection rates [ Time Frame: Baseline, 12 months ]


Information from the National Library of Medicine

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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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922971


Contacts
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Contact: Susan Hutfless 410-502-0194 shutfle1@jhmi.edu
Contact: Tony Kalloo 410-614-3530 akalloo@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Enrolling by invitation
Baltimore, Maryland, United States, 212187
Sponsors and Collaborators
Johns Hopkins University
Medivators Cantel
Investigators
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Principal Investigator: Susan Hutfless Johns Hopkins University

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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: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Infection
Communicable Diseases