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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01883739
Enrollment
200
Registered
2013-06-21
Start date
2013-06-30
Completion date
Unknown
Last updated
2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children's Safety, Parental Anxiety

Keywords

Parental anxiety, Children's safety, Family Centered Care, Bedside Transfer Rounds, Pediatric Cardiac Intensive Care

Brief summary

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.

Interventions

OTHERParental Presence at Handover Rounds

Sponsors

Canadian Medical Protective Association
CollaboratorOTHER
University of Alberta
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in parental STAI score2 to 4 hours post transferSpeilberger 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

MeasureTime frameDescription
Rate of unplanned changes in medication and nutrition management48 hours post transferMedication 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026