Improving Outcomes After PICU Admission: A Pilot Study

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Other: Psycho-education

• Registration Number: NCT01737021
• Lead Sponsor: Imperial College London

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-04-24
• Results First Submitted QC: 2015-04-24
• Results First Posted: 2015-05-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psycho-educational intervention	Psycho-education	Psycho-education

Primary Outcome Measures

Name	Time	Method
The Number of Feasibility Criteria Successfully Met	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: "\*" 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

Name	Time	Method
Impact of Events Scale (IES)	3-6 months post discharge from PICU	Validated measure of post-traumatic stress symptoms in the parent.
Hospital Anxiety and Depression Scale (HADS)	3-6 months post discharge from PICU	Validated measure of anxiety and depression in the parent.