NCT01371864

Brief Summary

Purpose:

  • To evaluate the peri-operative communication between families and the pediatric cardiac surgery team. Method:
  • In this study the investigators plan to utilize structured interview and survey of parents/legal guardians and health care providers of children undergoing cardiac surgery in the United States of America.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 25, 2017

Status Verified

March 1, 2013

Enrollment Period

4 months

First QC Date

June 9, 2011

Last Update Submit

April 21, 2017

Conditions

Keywords

Congenital cardiac diseaseTeamworkCommunicationPeri-operative

Outcome Measures

Primary Outcomes (1)

  • Peri-operative risk information

    Parental and provider assessment of the content and nature of communications in the peri-operative time period. Specifically, the quantity and type of risk information required before consenting for surgery.

    1 week

Secondary Outcomes (3)

  • Informed decisions

    1 week

  • Trust in the medical team

    1 week

  • Desire for disclosure of peri-operative complications

    1 week

Study Arms (4)

Pediatric Cardiothoracic Team

This group consists of members of the cardiothoracic surgery team: The attending physician, the fellow physician, the nurses, and the physician assistants.

Critical Care Team

This group consists of the nurses and physicians who work in the pediatric intensive care unit and the neonatal intensive care unit caring for patients who require cardiothoracic surgery.

Subspecialty Team

This group consists of physicians and nurses from pediatric cardiology and pediatric anesthesiology who care for children who require cardiothoracic surgery.

Parent

This group consists of the parent or legal guardian of the pediatric patient who requires cardiothoracic surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be selected from a tertiary care academic children's hospital including: * Inpatient population within the pediatric critical care unit, neonatal critical care unit, and the cardiac intermediate care unit. * Outpatient population including the pediatric cardiothoracic surgery clinic patients. * Hospital personnel

You may qualify if:

  • Primary language is English
  • \> 18 years age
  • Nurse, physician, physician assistant, or parent / legal guardian of a pediatric patient who requires cardiothoracic surgery at the North Carolina Children's Hospital.

You may not qualify if:

  • Primary language is not English. The interviewers all speak English as their primary language. People whose primary language is other than English will only be excluded if they do not have the ability to converse in English with the interviewers.
  • \<18 years of age. The parent / legal guardian must be of age to be the primary caregiver able to make decisions for their child.
  • People with an intellectual or mental impairment that prohibits their capacity to make medical decisions for their child. Our research aims to investigate the relationship between the parent / legal guardians of pediatric cardiac surgery patients who interact with the pediatric cardiac surgery multidisciplinary team. These individuals must have sufficient mental capacity to be able to provide consent for their child to undergo surgery. Individuals with intellectual or mental impairment that prohibits their ability to give consent are therefore excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Cherissa C Hanson, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 13, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 25, 2017

Record last verified: 2013-03

Locations