Parental Feelings About Their Child Needing a Central Line

The goal of this research project is to determine if different communication techniques during the consent process impact parental anxiety and comfort providing consent.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Stress; Children, Only
• Intervention / Treatment: Behavioral: Communication Technique 2

Detailed Description

The parents of children in the pediatric intensive care units (PICUs) at Columbia University may be asked if they are interested in participating in this study if their child needs a central venous line (CVL) or peripherally inserted central catheter (PICC) placed.

If the parents are interested in participating, they will be randomly assigned to a communication technique group while they are discussing the procedure and giving consent with a medical team member. After they provide consent, they will be asked to complete surveys about their thoughts and feelings. The study should take about 15 minutes.

After data is collected, the researchers will compare survey answers between the two communication styles used with parents.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Spence, MD; Phone Number: 646-825-1336; Email: ms6290@cumc.columbia.edu
• Study Contact Backup: Name: Jeffrey Edwards, MD, MA, MS

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University New York-Presbyterian Morgan Stanley Children's Hospital
      • Contact: Matthew Spence, MD; Phone Number: 646-825-1336; Email: ms6290@cumc.columbia.edu
      • Principal Investigator: Jeffrey Edwards, MD, MA, MS
      • Sub-Investigator: Matthew Spence, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parent or guardian of a child admitted to the pediatric intensive care units (PICUs) at Columbia University
• The child needs a central venous line (CVL) or peripherally inserted central catheter (PICC) placed in the PICU
• The parent or guardian speaks English or Spanish

Exclusion Criteria:

• Parents or guardians who speak languages other than English or Spanish
• Parents or guardians of children who need a CVL or PICC placed during an emergency without consent
• Parents or guardians who are unable to be physically present and provide consent over the phone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Communication Technique 1; A standard communication technique will be used in this group.
Experimental: Communication Technique 2; A new communication technique will be used in this group.	Behavioral: Communication Technique 2; A new communication technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Anxiety	The parental anxiety survey is a tool used to measure levels of parental anxiety at the time of consent. Scores range from 7 to 28 with lower scores representing lower levels of anxiety.	15 minutes
Parental Comfort Providing Consent	The parental comfort providing consent survey score is a tool used to measure parental comfort in providing consent. Scores range from 0 to 24 with lower scores representing higher levels of comfort.	15 minutes

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Jeffrey Edwards, MD, MA, MS, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Peripherally Inserted Central Catheter (PICC); Central Venous Line (CVL)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: AAAU3577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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