Improving Outcomes After PICU Admission: A Pilot Study

NCT01737021 | Completed Results

• 1 other identifier: CRO2015
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care;
2. 2.Evaluate the feasibility and acceptability of the study design and procedures;
3. 3.Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU;
4. 4.Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention;
5. 5.To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.

Conditions

Critical Illness

Keywords

PICU; Critical illness; Outcomes; Mental health; Education; Randomized Controlled Trial (RCT); Pilot; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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.

  3-6 months post discharge from PICU

Secondary Outcomes (2)

• Impact of Events Scale (IES)

  3-6 months post discharge from PICU

• Hospital Anxiety and Depression Scale (HADS)

  3-6 months post discharge from PICU

Study Arms (2)

Psycho-educational intervention

EXPERIMENTAL

Psycho-education

Other: Psycho-education

Treatment as usual

NO INTERVENTION

Interventions

Psycho-education OTHER

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.

Psycho-educational intervention

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Children of St Mary's Intensive Care: collaborator

Related Publications (1)

• 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.

  PMID: 26715482 DERIVED

MeSH Terms

Conditions

Critical Illness; Psychological Well-Being

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Results Point of Contact

• Title: Professor Elena Garralda
• Organization: Imperial College London

e.garralda@imperial.ac.uk

+44 (0)20 3312 6085

Study Officials

• Elena Garralda, M.D.

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 29, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 11, 2022
• Results First Posted: May 15, 2015

Record last verified: 2022-04