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NCT03075813 · ClinicalTrials.gov registry record · NA

Early Recognition and Response to Increases in Surgical Site Infections Using Optimized Statistical Process Control Charts: The Early 2RIS Study

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
29
Enrollment target

NCT03075813 is a NA study that has completed, run by Duke University. The registered enrollment target is 29 participants.

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The verdict

NCT03075813, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
29 participants
Enrollment target

Study Summary

The purpose of this quality improvement study is to measure the effectiveness of surveillance using optimized statistical process control (SPC) methods and feedback on rates of surgical site infection (SSI) compared to traditional surveillance and feedback. The primary objective is to determine if hospital clusters randomized to receive feedback from optimized SPC surveillance methods collectively have lower rates of SSI compared to hospital clusters randomized to receiving feedback from traditional surveillance methods. Secondary objectives are 1) to estimate and compare the number of signals identified using optimized SPC methods and traditional surveillance methods; 2) to estimate and compare the time and effort required to investigate signals generated using optimized SPC methods and traditional surveillance methods; and 3) to estimate the number and proportion of false-positive signals identified using optimized SPC methods and traditional surveillance methods. The Early 2RIS study will be a prospective, multicenter cluster randomized controlled trial using stepped wedge design. The active component of the quality improvement study will be performed in 29 DICON hospitals over three years, from March 2017 through February 2020. Clusters randomized to intervention will receive feedback on increasing rates of SSI identified through optimized SPC methods. This intervention is expected to decrease the subsequent rate of SSIs by closing the feedback loop on SSI outcomes. Participating study hospitals will all be members of DICON, a network of 43 community hospitals in North Carolina, South Carolina, Georgia, Florida, and Virginia that provides community hospitals access to consultative services from infection prevention experts, data analyses and benchmarking, and educational materials designed by faculty from Duke. This study is considered part of routine quality improvement measures and a part of previously established agreements between DICON and the community

Interventions

  • OTHER Intervention Cluster

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2017-03-06
Est. Completion 2020-02-29
Phase NA

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT03075813

The ClinicalTrials.gov registry entry for NCT03075813 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Intervention Cluster is the first listed.

NCT03075813 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03075813 about?

NCT03075813 is a clinical study titled "Early Recognition and Response to Increases in Surgical Site Infections Using Optimized Statistical Process Control Charts: The Early 2RIS Study". The purpose of this quality improvement study is to measure the effectiveness of surveillance using optimized statistical process control (SPC) methods and feedback on rates of surgical site infection (SSI) compared to traditional surveillance and feedback. The primary objective is to determine if ...

What is the current status of trial NCT03075813?

This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2017-03-06. Estimated completion is 2020-02-29.

What interventions are being tested in trial NCT03075813?

The interventions under investigation include: Intervention Cluster (OTHER).

Who is sponsoring clinical trial NCT03075813?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.