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

NCT ID: NCT03922971

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-07

Study Completion Date

2023-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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National comparison

Ability to view center's rate compared with all others

Group Type OTHER

Option 1: National comparison

Intervention Type OTHER

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

Group Type OTHER

Option 2: National comparison with benchmarking

Intervention Type OTHER

Ability to view center's rate compared with the others with a similar patient comorbidity profile and in addition to viewing option 1.

Interventions

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Option 1: National comparison

Ability to view center's rate compared with all others.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medivators Cantel

UNKNOWN

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Hutfless

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00203304

Identifier Type: -

Identifier Source: org_study_id

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