Does a Follow-up Appointment Help Parents of Children on PICU? (PICUfu)

University Hospitals Bristol and Weston NHS Foundation Trust

Status: Completed

Conditions: Post Traumatic Stress Disorder

Treatments: Other: Follow up Clinic for High risk participants

Study type: Interventional

Funder types: Other

Identifiers

NCT01628263

CH/2011/3827

Details and patient eligibility

About

The aim of our study is to determine the feasibility of carrying out a randomized controlled trial (RCT) to investigate whether screening parents of children admitted to pediatric intensive care unit (PICU) so as to target follow-up at those most at risk of developing posttraumatic stress disorder (PTSD), is effective at reducing adverse psychological sequelae.

Full description

The study will assess the feasibility of offering a follow up clinic to parents identified to be vulnerable for future psychological difficulties after their child's admission to the Paediatric Intensive Care Unit (PICU) at Bristol Children's Hospital. Both mothers and fathers of children admitted to PICY for a duration of at least 12 hours will be invited to participate in this study. Screening measures will be used to identify vulnerability to future post-traumatic stress disorder (PTSD) and depression. Where one or both of the parents has been scored as high risk they will be randomised to receive the intervention or the control arm of the study (ratio 1:1). The intervention involves a follow-up clinic two months pots admission, staffed by the unit Clinical Psychologist, a PICU doctor and PICU nurse. In the control arm no follow-up clinic will be offered (i.e. current standard care).

Objectives:

i) To investigate the recruitment rates, clinic attendance and follow-up rates in order to perform an accurate sample size calculation for a larger study.

ii) To carry out initial statistical analysis to estimate the odds ratio and 95% confidence interval of developing PTSD, anxiety and depression after being offered the follow-up intervention as opposed to not being offered it.

iii) To assess the acceptability of providing targeted follow-up both to those who receive it and those who are excluded due to low risk.

The study is of importance to the public because not only does PTSD negatively affect quality of life, it is also associated with increased use of health care services and resources.

Enrollment: 127 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All parents of children admitted to paediatric intensive care for over 12 hours.

Exclusion criteria

• Parents deemed unsuitable for the study by the responsible consultant. This will include families where a child's condition is suspected to result from non-accidental injury or where withdrawal of care is being discussed due to a child's critical condition. Families will be excluded if their child died during or after admission, as these families are already followed up routinely.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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127 participants in 2 patient groups

Follow up Clinic

Experimental group

Description:

Participants will receive an offer of a follow up clinic two months post discharge, staffed by the unit Clinical Psychologist, a PICU doctor and PICU nurse.

Treatment:

Other: Follow up Clinic for High risk participants

Control

No Intervention group

Description:

Participants will not receive an offer of a follow up clinic