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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

Primary Purpose

Parental Anxiety, Children's Safety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Parental Presence at Handover Rounds
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parental Anxiety focused on measuring Parental anxiety, Children's safety, Family Centered Care, Bedside Transfer Rounds, Pediatric Cardiac Intensive Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pediatric Cardiac ICU, Stollery Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parental Presence at Handover Rounds

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 17, 2013
Last Updated
December 17, 2014
Sponsor
University of Alberta
Collaborators
Canadian Medical Protective Association
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1. Study Identification

Unique Protocol Identification Number
NCT01883739
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Canadian Medical Protective Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parental Anxiety, Children's Safety
Keywords
Parental anxiety, Children's safety, Family Centered Care, Bedside Transfer Rounds, Pediatric Cardiac Intensive Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parental Presence at Handover Rounds
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Parental Presence at Handover Rounds
Primary Outcome Measure Information:
Title
Change from baseline in parental STAI score
Description
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.
Time Frame
2 to 4 hours post transfer
Secondary Outcome Measure Information:
Title
Rate of unplanned changes in medication and nutrition management
Description
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.
Time Frame
48 hours post transfer

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Adatia, MBChB, MRCP, FRCP(C)
Organizational Affiliation
Stollery Children's Hospital, University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Cardiac ICU, Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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