Trial Outcomes & Findings for Improving Outcomes After PICU Admission: A Pilot Study (NCT NCT01737021)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

3-6 months post discharge from PICU

Results posted on

2022-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Psycho-educational Intervention Psycho-education 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.	Treatment as Usual There is no existing standard follow up for parents of children discharged from PICU.
Overall Study STARTED	22	9
Overall Study COMPLETED	17	6
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Psycho-educational Intervention Psycho-education 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.	Treatment as Usual There is no existing standard follow up for parents of children discharged from PICU.
Overall Study Lost to Follow-up	5	3

Baseline Characteristics

Improving Outcomes After PICU Admission: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psycho-educational Intervention n=17 Participants Received psycho-educational intervention.	Treatment as Usual n=6 Participants There is no existing standard follow up for parents of children discharged from PICU.	Total n=23 Participants Total of all reporting groups
Age, Continuous	6.00 years n=5 Participants	9.00 years n=7 Participants	6.00 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=17 Participants There were six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation.	Study Design n=23 Participants There were also six feasibility criteria related to the study design, covering recruitment/ participation rate, acceptability of procedures, loss to follow-up rate, and the time-scale of data collection.
The Number of Feasibility Criteria Successfully Met	3 Number of criteria successfully met	1 Number of criteria successfully met

SECONDARY outcome

Timeframe: 3-6 months post discharge from PICU

Validated measure of post-traumatic stress symptoms in the parent.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3-6 months post discharge from PICU

Validated measure of anxiety and depression in the parent.

Outcome measures

Outcome data not reported

Adverse Events

Psycho-educational Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Elena Garralda

Imperial College London

Phone: +44 (0)20 3312 6085

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place