search
Back to results

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

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Follow up Clinic for High risk participants
Sponsored by
University Hospitals Bristol and Weston NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post Traumatic Stress Disorder focused on measuring PICU, Follow up, PTSD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Bristol Royal Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Follow up Clinic

Control

Arm 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.

Participants will not receive an offer of a follow up clinic

Outcomes

Primary Outcome Measures

The Impact of Event Scale-Revised (IES-R)
Widely used self-report measure of responses to trauma
Hospital Anxiety & Depression Scale (HADS)
Widely used self-report measure of anxiety and depression

Secondary Outcome Measures

Feedback Questionnaire
Questionnaire to elicit feelings about taking part in the study including questions about acceptability of completing screening measures and some people being excluded from clinic due to being low risk. Clinic attenders will be asked if they found it a useful experience and how it could be improved.

Full Information

First Posted
June 21, 2012
Last Updated
November 24, 2020
Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT01628263
Brief Title
Does a Follow-up Appointment Help Parents of Children on PICU?
Acronym
PICUfu
Official Title
Does Screening Parents Allow Targeting of a Paediatric Intensive Care Follow-up Clinic? A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Bristol and Weston NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
PICU, Follow up, PTSD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Follow up Clinic
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will not receive an offer of a follow up clinic
Intervention Type
Other
Intervention Name(s)
Follow up Clinic for High risk participants
Intervention Description
Families where either or both parents are screened to be at risk of PTSD or depression are randomised in a 1:1 ratio to the intervention or control arm. Those in the intervention arm 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. Those in the control arm will not be offered a follow up clinic.
Primary Outcome Measure Information:
Title
The Impact of Event Scale-Revised (IES-R)
Description
Widely used self-report measure of responses to trauma
Time Frame
5 months post discharge
Title
Hospital Anxiety & Depression Scale (HADS)
Description
Widely used self-report measure of anxiety and depression
Time Frame
5 months post discharge
Secondary Outcome Measure Information:
Title
Feedback Questionnaire
Description
Questionnaire to elicit feelings about taking part in the study including questions about acceptability of completing screening measures and some people being excluded from clinic due to being low risk. Clinic attenders will be asked if they found it a useful experience and how it could be improved.
Time Frame
6 months post discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Goodwin
Organizational Affiliation
University Hospitals Bristol and Weston NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria Samuel
Organizational Affiliation
University Hospitals Bristol and Weston NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Bristol Royal Hospital for Children
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs