CommunicationNCT01371864
Families and Pediatric Cardiac Surgery Multidisciplinary Teams: How Well Do We Communicate
An observational study of Communication, run by University of North Carolina, Chapel Hill at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Families and Pediatric Cardiac Surgery Multidisciplinary Teams: How Well Do We Communicate?
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.
Read the detailed 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.
- Conditions
- Communication
- Keywords
- Congenital cardiac disease, Teamwork, Communication, Peri-operative
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (3)
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.
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cherissa C Hanson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371864
- Sponsor's protocol ID
- 10-1772
- Other IDs
- UNCDRE
- Status last verified
- Mar 2013
- First submitted
- 9 Jun 2011
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families and Pediatric Cardiac Surgery Multidisciplinary Teams: How Well Do We Communicate?
- ClinicalTrials.gov ID
- NCT01371864
- Acronym / sponsor ID
- 10-1772
- Conditions
- Communication
- Keywords
- Congenital cardiac disease, Teamwork, Communication, Peri-operative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peri-operative risk information
Time frame: 1 week
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.
3 secondary outcomes
Informed decisions
Time frame: 1 week
Trust in the medical team
Time frame: 1 week
Desire for disclosure of peri-operative complications
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cherissa C Hanson, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Communication, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-operative risk information (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.