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

Parental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883739
• Other study ID #: Pro 00037475
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: December 17, 2014
• Start date: June 2013

Study information

• Verified date: December 2014
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorders
• Children's Safety
• Parental Anxiety

Intervention

Other:
• Parental Presence at Handover Rounds

Locations

Country	Name	City	State
Canada	Pediatric Cardiac ICU, Stollery Children's Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Medical Protective Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes