Pediatric Cardiac Surgery Pre-operative Counselling Study
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): STAGES-Booklet
Intervention type(s): Other
Intervention description(s): STAGES-booklet was designed by the investigators focussing on guiding parents through the pre-operative and operative admission period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: congenital; surgery; peri-operative; counselling