search
Back to results

Improving Outcomes After PICU Admission: A Pilot Study

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psycho-education
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring PICU, Critical illness, Outcomes, Mental health, Education, Randomized Controlled Trial (RCT), Pilot, Feasibility

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unplanned emergency admissions to PICU for at least 12 hours
  • Parent or primary carer speaks and can read English

Exclusion Criteria:

  • Child dies whilst on ward
  • Child discharged with a terminal illness
  • Child has had multiple PICU admission in the past
  • Staff feel it is inappropriate to approach family
  • Family live overseas

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Psycho-educational intervention

    Treatment as usual

    Arm Description

    Psycho-education

    Outcomes

    Primary Outcome Measures

    The Number of Feasibility Criteria Successfully Met
    Feasibility success criteria have been defined a priori for the intervention and study design. There are six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation. There are also six feasibility criteria related to the study design, covering recruitment rate; participation rate; acceptability of procedures; attrition rate; and the time-scale of data collection. Dependent on the number of criteria successfully met, the following classification will be used: "*" 0-2/6 criteria met - Stop; intervention and/or study design not feasible. "*" 3-4/6 criteria met - Continue with modifications; feasible intervention and/or study design with modifications. "*" 5/6 criteria met - Continue without modifications, but monitor closely; feasible intervention and/or study design with close monitoring. "*" 6/6 criteria met - Continue without modifications; feasible intervention and/or study design as is.

    Secondary Outcome Measures

    Impact of Events Scale (IES)
    Validated measure of post-traumatic stress symptoms in the parent.
    Hospital Anxiety and Depression Scale (HADS)
    Validated measure of anxiety and depression in the parent.

    Full Information

    First Posted
    November 1, 2012
    Last Updated
    April 11, 2022
    Sponsor
    Imperial College London
    Collaborators
    Children of St Mary's Intensive Care
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01737021
    Brief Title
    Improving Outcomes After PICU Admission: A Pilot Study
    Official Title
    A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imperial College London
    Collaborators
    Children of St Mary's Intensive Care

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care; Evaluate the feasibility and acceptability of the study design and procedures; Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU; Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention; To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.
    Detailed Description
    Most children are now expected to make a complete medical recovery following admission to PICU. However, research suggests that some children will go on to develop psychological difficulties, such as problems with emotions, behaviour, and learning. In addition, parents themselves may suffer with emotional difficulties. Although the follow-up of survivors is recommended, there are currently no specific guidelines in place. Intervention in the early stages of recovery could help families pull through without long lasting after-effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness
    Keywords
    PICU, Critical illness, Outcomes, Mental health, Education, Randomized Controlled Trial (RCT), Pilot, Feasibility

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psycho-educational intervention
    Arm Type
    Experimental
    Arm Description
    Psycho-education
    Arm Title
    Treatment as usual
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Psycho-education
    Intervention Description
    The information given to parents will cover expected reactions that follow a PICU admission; how parents can help their child cope with these reactions; how to recognise warning signs; and sign-posting of appropriate follow-up services (if relevant). There will also be a follow-up telephone call to reinforce the information and to support parents in putting it in to practice, if appropriate.
    Primary Outcome Measure Information:
    Title
    The Number of Feasibility Criteria Successfully Met
    Description
    Feasibility success criteria have been defined a priori for the intervention and study design. There are six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation. There are also six feasibility criteria related to the study design, covering recruitment rate; participation rate; acceptability of procedures; attrition rate; and the time-scale of data collection. Dependent on the number of criteria successfully met, the following classification will be used: "*" 0-2/6 criteria met - Stop; intervention and/or study design not feasible. "*" 3-4/6 criteria met - Continue with modifications; feasible intervention and/or study design with modifications. "*" 5/6 criteria met - Continue without modifications, but monitor closely; feasible intervention and/or study design with close monitoring. "*" 6/6 criteria met - Continue without modifications; feasible intervention and/or study design as is.
    Time Frame
    3-6 months post discharge from PICU
    Secondary Outcome Measure Information:
    Title
    Impact of Events Scale (IES)
    Description
    Validated measure of post-traumatic stress symptoms in the parent.
    Time Frame
    3-6 months post discharge from PICU
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Description
    Validated measure of anxiety and depression in the parent.
    Time Frame
    3-6 months post discharge from PICU

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Unplanned emergency admissions to PICU for at least 12 hours Parent or primary carer speaks and can read English Exclusion Criteria: Child dies whilst on ward Child discharged with a terminal illness Child has had multiple PICU admission in the past Staff feel it is inappropriate to approach family Family live overseas
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elena Garralda, M.D.
    Organizational Affiliation
    Imperial College London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26715482
    Citation
    Als LC, Nadel S, Cooper M, Vickers B, Garralda ME. A supported psychoeducational intervention to improve family mental health following discharge from paediatric intensive care: feasibility and pilot randomised controlled trial. BMJ Open. 2015 Dec 29;5(12):e009581. doi: 10.1136/bmjopen-2015-009581.
    Results Reference
    derived

    Learn more about this trial

    Improving Outcomes After PICU Admission: A Pilot Study

    We'll reach out to this number within 24 hrs