Improving Outcomes After PICU Admission: A Pilot Study

NCT ID: NCT01737021

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-07-31

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Psycho-educational intervention

Psycho-education

Group Type: EXPERIMENTAL

Psycho-education

Intervention Type: 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.

Treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children of St Mary's Intensive Care

UNKNOWN

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Garralda, M.D.

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

References

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.

Reference Type: DERIVED

PMID: 26715482 (View on PubMed)

Other Identifiers

CRO2015

Identifier Type: -

Identifier Source: org_study_id