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Completed

NCT Number: NCT01883739

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

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.

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Key information

Conditions

Parental Anxiety Children's Safety

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Cardiac ICU, Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parental Presence at Handover Rounds

Other

Primary outcomes

  1. Change from baseline in parental STAI score

    Time frame: 2 to 4 hours post transfer

    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.

Secondary outcomes

  1. Rate of unplanned changes in medication and nutrition management

    Time frame: 48 hours post transfer

    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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Medical Protective Association

Registry information

Important dates

Study start
2013
Primary completion
2014
First posted
Jun 21, 2013
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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