Randomised Controlled Trial to Investigate the Effect of Parental Presence at Intensive Care Unit to Ward Transfer Bedside Rounds on Parental Anxiety and Children's Safety

Study Overview
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Brief Summary
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The investigators shall conduct a randomized controlled trial to investigate the effect of parental presence at transfer rounds on parental anxiety and patient safety following transfer from the Pediatric Cardiac Intensive Care Unit (PCICU) to the ward. The investigators plan to test the hypothesis that parental involvement in the child's transfer, with the option of peer support, will result in measurable reductions in medication errors, unplanned nutritional and feeding management, and parental anxiety after transfer as compared to the control group. The investigators goal is to improve continuity of care by implementing multidisciplinary transfer rounds at the child's bedside in which patients and family share in the control of the management plan when a cardiac child is discharged from PCICU to the ward.

Official Title
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Randomised Controlled Trial to Investigate the Effect of Parental Presence at Intensive Care Unit to Ward Transfer Bedside Rounds on Parental Anxiety and Children's Safety

Conditions
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Parental Anxiety, Children's Safety

Intervention / Treatment
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* Other: Parental Presence at Handover Rounds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of cardiac children aged 1 day to 17 years admitted to PCICU Written informed consent and assent when appropriate Planned discharge from the PCICU to the ward. Exclusion Criteria: Parents with less than grade 6 reading skills as they will not be able to independently take the Spielberger's State -Trait Anxiety Inventory (STAI). Parents who are not willing to be randomized to the control group in which they cannot be present for transfer rounds. Neonates being discharged from PCICU to NICU or neonates being discharged from NICU to wards.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parental Presence at Handover Rounds<br>Subjects will receive an educational document prior to transfer rounds introducing the concept of Patient and Family Centered Care and the role of a parent in transfer rounds. These parents will have the option of meeting with a parental peer support person for a coaching or training session prior to their participation in transfer rounds. During the transfer rounds parents will be actively included in discussion of their child's medical management plan upon discharge to the wards. | Other: Parental Presence at Handover Rounds<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in parental STAI score | Speilberger State-Trait Anxiety Inventory will be administered to participating parents both prior to and post transfer of their child out of the pediatric cardiac ICU. | 2 to 4 hours post transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of unplanned changes in medication and nutrition management | Medication and nutritional order reconciliation will occur 48 hours after transfer from the PCICU. The pharmacist, dietician and physician who review the patient charts and order sheets will be blinded to the randomization. Differences between pre and post transfer orders will be discussed to detect omissions and/or deviation from standard of care. | 48 hours post transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parental anxiety, Children's safety, Family Centered Care, Bedside Transfer Rounds, Pediatric Cardiac Intensive Care