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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01371864
Other study ID # 10-1772
Secondary ID UNCDRE
Status Completed
Phase N/A
First received June 9, 2011
Last updated April 21, 2017
Start date August 2011
Est. completion date December 2011

Study information

Verified date March 2013
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Every day clinicians face challenges when attempting to negotiate their way through dialogues with families whose children require surgical intervention in the near future. The area of clinician-patient communication with pediatric families is under-researched and highlights a pressing clinical problem. There are several adult studies that describe the content and nature of patient-physician communications at the time of cardiac surgery. However, there are no studies that evaluate the communications between nursing, physicians, and pediatric patient's families at the time of cardiac surgery. Further knowledge in this area is valuable in that a disparity between the these groups can lead to medical error, damage the clinician-patient relationship and provide grounds for dissatisfaction, complaints, or claim. This research will provide insight into what patient's families value in their communications with the medical team and assist the medical community in better meeting our children's families needs.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Informed decisions Parental and provider assessment of the content and nature of communications in the peri-operative time period. Specifically, the family's ability to make informed decisions. 1 week
Secondary Trust in the medical team Parental and provider assessment of the content and nature of communications in the peri-operative time period. Specifically, the families trust in the medical team. 1 week
Secondary Desire for disclosure of peri-operative complications Parental and provider assessment of the content and nature of communications in the peri-operative time period. Specifically, families desire for disclosure of peri-operative complications. 1 week
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