Pediatric Cardiac Surgery Pre-operative Counselling Study

June 11, 2016 updated by: Dr. David Horne, University of Manitoba

We have developed a pre-operative educational / counselling booklet with the focus on informing parents / patients about the different stages before, during, and after cardiac surgery that they will encounter; both chronologically and emotionally. With this approach and study our objectives are:

1. To provide anticipatory guidance for parents to decrease parental stress and improve parental experience and preparedness, thus involving the parent as a partner in caring for their child.

We hypothesize that this additional tool will improve parental satisfaction in regards to being prepared for their child's heart surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Our study objectives are to provide anticipatory guidance for parents to decrease parental stress and improve parental experience and preparedness, thus involving the parent as a partner in caring for their child.

A Case-control trial comparing family satisfaction between families that did and did not receive the STAGES-booklet.

Primary endpoints are Family satisfaction score and Family stress score. Secondary endpoints are Percentage of families that would recommend the STAGES-booklet as routine pre-operative educational tool, as well as Family Stress score during each stage as outlined in the STAGES-booklet

The Study period either 1 year or once 100 participants enrolled have completed their post-operative survey

Methods Group allocation: The first 50 families will be assigned to the STAGES-post group, and the last 50 to the STAGES-pre group. In both groups participants will be blinded to their timing of exposure to the intervention. This randomization in an attempt to minimize educator bias of possibly giving the STAGES-post group information pertaining to the intervention proposed.

Time points: Routinely after the cardiologist informs families that their child has a cardiac condition needing intervention, the Variety Children's Heart Centre clinical resource nurses, meet with families to help them navigate through upcoming events, do pre-operative counselling and supply them with educational material. At this point parents will be asked in a sensitive manner, whether they would consent to taking part in this study (see consent form). The first 50 will be informed that they will receive a booklet (not disclosing the STAGES-booklet) post-operatively to evaluate and a survey to complete post-operatively. The subsequent 50 families will be given the STAGES-booklet (not disclosing that STAGES is the interventional tool being investigated) together with the other routine educational material, and be counselled according to the STAGES-philosophy. Before leaving the province for cardiac surgery, the RN's will in addition to logistical matters, repeat the STAGES-booklet review and teaching with the STAGES-pre group.During the routine post-operative visit at 6-12 weeks, families will be warned that their visit will be approximately 20-30 minutes longer to complete the post-operative evaluation-survey. The STAGES-post group will be given the STAGES-booklet and informed of the STAGES-philosophy before completing the post-operative survey.In both groups, parents will receive condition specific teaching that is part of routine care currently.

Data collection : Surveys will contain only the family's study number in order to remain anonymous. Data will be analyzed collectively at the end of the study.

Survey responses will be aggregated and appropriate statistical analysis performed by the CHARM statistician.

Expected outcomes:Mean Family satisfaction scores will be 10-20% higher, and mean emotional stress scores 10-20% lower in the STAGES-pre group compared to the STAGES-post group. More than 80% of families in each group will recommend the STAGES-booklet and/or philosophy to be used as a routine pre-operative tool.

Results will be published in a respectable influential journal, submitted to national and international conferences, with the goal to promote the use of STAGES, across Canada and internationally.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Variety Children's Heart Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. All consented families of children <18 years that will be sent out of province for cardiac surgery from the Variety Children's Heart Centre

Exclusion Criteria:

1. Families that can't read or write english

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: STAGES PRE-GROUP
INTERVENTION: this group will receive our "STAGES" booklet PRE-operatively
Other: STAGES-Booklet
STAGES-booklet was designed by the investigators focussing on guiding parents through the pre-operative and operative admission period.
Placebo Comparator: STAGES POST-GROUP
INTERVENTION: This arm will only receive the STAGES-booklet POST-operatively
Other: STAGES-Booklet
STAGES-booklet was designed by the investigators focussing on guiding parents through the pre-operative and operative admission period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Family satisfaction and stress score
Time Frame: up to 6 weeks post-operatively
At post-operative visit families will complete a study questionnaire evaluating their satisfaction of pre-operative preparation and their stress levels during the surgical period
up to 6 weeks post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of families that would recommend the STAGES-booklet as routine pre-operative educational tool.
Time Frame: 1 day (At post-operative visit)
1 day (At post-operative visit)
Family Stress score during each stage as outlined in the STAGES-booklet
Time Frame: 1 day (At post-operative visit)
1 day (At post-operative visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Horne, MD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H2013:117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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