Central Venous Access Study (CASCADE)

December 8, 2023 updated by: Hackensack Meridian Health

The CentrAl VenouS Catheter Access DocumEntation (CASCADE) Study

The aim of this study is to document clinicians variation in practice in comparison to standard guidelines by the Medical Center's approved Evidence-based Practice (EBP) guidelines, policies, and procedures for Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD catheters by way of a structured retrospective review of the Electronic Medical Record (EMR) system.

Study Overview

Status

Completed

Conditions

Detailed Description

This will be a single site retrospective (non-experimental) study utilizing the electronic medical record, both descriptive and correlational methods.

There will be two outcomes:

  1. The outcomes associated with the management of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter in adherence with hospital approved Evidence-based Practice guidelines for Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter.
  2. The mechanical/technical, thrombotic, and other adverse outcomes (Heparin induced coagulopathy) associated with central venous catheters due to variation in insertion and management practices of Central Venous Catheter(CVC), Peripherally Inserted Central Catheter (PICC), and Hemodialysis (HD) Catheter.

Study Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Three hundred patient electronic medical records will be reviewed from the Critical Care Units (Medical Intensive Care Unit, Coronary Care Unit, Cardiac Surgical Intensive Care Unit, Surgical Intensive Care Unit).

Description

Inclusion Criteria:

• Adult patients in Medical Intensive Care Unit (MICU), Coronary Care Unit (CCU), Cardiac Surgical Intensive Care Unit (CSICU), Surgical Intensive Care Unit (SICU) with either CVCs, PICCs, or HD catheters.

Exclusion Criteria:

• Pediatric (including neonates), obstetric and gynecology, medical-surgical, and oncology patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Clinical Guidelines for Catheter Interventions and Management
Time Frame: 1 year
Number of medical records with documented mechanical/technical, thrombotic, and other adverse outcomes associated with use of CVCs, PICCs, and Hemodialysis (HD) catheters.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Documented Catheter Complications
Time Frame: 1 year
Number of medical records with documented complications associated with the use of CVCs, PICCs, and Hemodialysis (HD) catheters
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Investigators

  • Principal Investigator: Claudia Douglas, DNP, Hackensack Meridian Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2017

Primary Completion (Actual)

April 7, 2022

Study Completion (Actual)

April 7, 2022

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PRO2016-0711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

. If the results of the trial are published, participants' identities will remain confidential. Publication resulting from this research will not contain any information that could potentially identify participants either directly or indirectly.

IPD Sharing Time Frame

6 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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