Central Venous Access Study (CASCADE)

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 CVCs, PICCs and HD catheters by way of a structured retrospective review of the Electronic Medical Record (EMR) system.

Study Overview

• Status: Active, not recruiting
• Conditions: Central Line Catheters

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): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

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
1. Clinicians Interventions and Management in adherence and not in adherence with Hospital Approved EBP guidelines for CVCs, PICCs, and HD catheters	To document number of mechanical/technical, thrombotic, and other adverse outcomes associated with CVCs, PICCs and HD catheters	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2. Number of variation in practices in clinical management of CVCs PICCS, and HD catheters associated with Catheter Complication	To document number of variation in practices in clinician management of CVCs, PICCs, and HD catheters associated with CVCs, PICCs and HD catheters	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 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): April 4, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

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; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No