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

NCT01883739 | Completed

• 1 other identifier: Pro 00037475
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Parental Anxiety; Children's Safety

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of unplanned changes in medication and nutrition management

  48 hours post transfer

Study Arms (1)

Parental Presence at Handover Rounds

EXPERIMENTAL

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

Interventions

Parental Presence at Handover Rounds OTHER

Parental Presence at Handover Rounds

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Medical Protective Association: collaborator

Study Sites (1)

Pediatric Cardiac ICU, Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Study Officials

• Ian Adatia, MBChB, MRCP, FRCP(C)

  Stollery Children's Hospital, University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

CA (1)