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Improving Outcomes After PICU Admission: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737021
First Posted: November 29, 2012
Last Update Posted: May 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children of St Mary's Intensive Care
Information provided by (Responsible Party):
Imperial College London
  Purpose
  1. Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care;
  2. Evaluate the feasibility and acceptability of the study design and procedures;
  3. Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU;
  4. Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention;
  5. To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.

Condition Intervention
Critical Illness Other: Psycho-education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • The Number of Feasibility Criteria Successfully Met [ Time Frame: 3-6 months post discharge from PICU ]

    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:

    1. 0-2/6 criteria met - Stop; intervention and/or study design not feasible.
    2. 3-4/6 criteria met - Continue with modifications; feasible intervention and/or study design with modifications.
    3. 5/6 criteria met - Continue without modifications, but monitor closely; feasible intervention and/or study design with close monitoring.
    4. 6/6 criteria met - Continue without modifications; feasible intervention and/or study design as is.


Secondary Outcome Measures:
  • Impact of Events Scale (IES) [ Time Frame: 3-6 months post discharge from PICU ]
    Validated measure of post-traumatic stress symptoms in the parent.

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3-6 months post discharge from PICU ]
    Validated measure of anxiety and depression in the parent.


Enrollment: 31
Study Start Date: November 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psycho-educational intervention
Psycho-education
Other: Psycho-education
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.
No Intervention: Treatment as usual

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737021


Sponsors and Collaborators
Imperial College London
Children of St Mary's Intensive Care
Investigators
Principal Investigator: Elena Garralda, M.D. Imperial College London
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01737021     History of Changes
Other Study ID Numbers: CRO2015
First Submitted: November 1, 2012
First Posted: November 29, 2012
Results First Submitted: April 24, 2015
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015
Last Verified: April 2015

Keywords provided by Imperial College London:
PICU
Critical illness
Outcomes
Mental health
Education
Randomized Controlled Trial (RCT)
Pilot
Feasibility

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes