Condition category
Mental and Behavioural Disorders
Date applied
15/07/2015
Date assigned
16/07/2015
Last edited
20/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many patients suffer distress whilst in an intensive care unit (ICU) and can have a poor psychological recovery after leaving hospital. This could include suffering from frightening flashbacks to intensive care, a symptom of post-traumatic stress disorder (PTSD). POPPI investigates whether a nurse-led psychological intervention (program) can improve patients’ psychological recovery after a stay in an ICU and see if this approach is cost-effective.

Who can participate?
Adult patients from ICUs having spent over 48 hours in critical care.

What does the study involve?
ICUs taking part in the study are allocated randomly into one of two groups. Patients attending ICUs in group 1 receive the intervention. Patients attending ICUs in group 2 receive usual care.For the first five months, all sites deliver usual care. The intervention group then undergo training before delivering the intervention for the remaining six months. The control group continues to deliver usual care for the entire study period (11 months). At the end of the study, the psychological recovery of patients in the two groups (intervention and control) are compared by measuring patient-reported PTSD symptom severity six months after recruitment onto the study. The costs of the intervention and patients’ quality of life are also compared to measure the cost-effectiveness.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Intensive Care National Audit & Research Centre (UK)

When is the study starting and how long is it expected to run for?
September 2015 to July 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mr Paul Mouncey

Trial website

Contact information

Type

Public

Primary contact

Mr Paul Mouncey

ORCID ID

Contact details

Intensive Care National Audit & Research Centre
Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18940

Study information

Scientific title

Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) cluster-randomised controlled trial

Acronym

POPPI

Study hypothesis

Many patients suffer distress whilst in an intensive care unit (ICU) and can have a poor psychological recovery after leaving hospital. This could include suffering from frightening flashbacks to intensive care, a symptom of post traumatic stress disorder (PTSD). POPPI aims to assess whether implementing a nurse-led psychological intervention can improve patients’ psychological recovery after a stay in an ICU and see if this approach is cost-effective.

Ethics approval

NRES Committee South Central - Oxford B, 15/05/2015, ref: 15/SC/0287

Study design

Randomised; Interventional; Design type: Screening, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Mental Health, Critical care; Subtopic: Anxiety, Critical care; Disease: Anxiety, All Critical care

Intervention

1. An education package (two training courses and associated materials) to train critical care unit staff to carry out parts 2-4 below
2. Creating a less stressful environment in the ICU
3. Assessing patients’ psychological distress in the ICU using the Intensive care Psychological Assessment Tool; and
4. Carrying out three stress support sessions for very distressed patients (delivered by specially trained POPPI nurses).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

PTSD symptom severity measured using the PTSD Symptom Scale (Self-report version) (PSS-SR) Timepoint(s): Six months

Secondary outcome measures

1. Cost-effectiveness; Timepoint(s): Six months
2. Days alive and free from sedation; Timepoint(s): Day 30
3. Depression measured using the Hospital Anxiety and Depresion Scale (HADS); Timepoint(s): six months
4. Duration of critical care unit stay; Timepoint(s): End of critical care unit stay
5. Health Related Quality of Life; Timepoint(s): six months
6. PTSD Symptom Scale (Self-Report version) (PSS-SR) >18; Timepoint(s): six months
7. Anxiety measured using the HADS; Timepoint(s): six months (added 04/04/2016)

Overall trial start date

01/09/2015

Overall trial end date

31/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or greater
2. Greater than 48 hours in critical care
3. Receipt of Level 3 critical care (for any period of time) during first 48 hours
4. Between +1 and 1 on the Richmond Agitation Sedation Scale
5. Glasgow Coma Scale score of 15
6. Englishspeaking and ability to communicate orally; Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Target accrual: 1,378 patients. During recruitment, in consultation with the TSC and DMEC, a review of assumptions underlying the pre-trial power calculation once outcome data were available for patients recruited during the five-month baseline period in both intervention group and control group sites. This review, undertaken using data available on 9 August 2016, established that the planned design had an anticipated 78% power under the observed parameter estimates (allowing for uncertainty in the between-site variation, between 73% and 85% power). Consequently, the decision was taken to extend recruitment in all sites to the end of planned recruitment in the third group of sites (November 2016). With this extension to recruitment, the planned design had an anticipated 85% power (allowing for uncertainty in the between-site variation, between 79% and 91% power). It was anticipated that, with this extension to recruitment, the estimated total number of patients recruited would be 1,378. Recruitment continued to be monitored to ensure 1,378 or more patients were recruited. A final decision to extend recruitment by an additional two months (until end-January 2017) in all sites was taken to ensure this minimum number was achieved.

Participant exclusion criteria

1. Pre-existing chronic cognitive impairment, such as dementia
2. Pre-existing psychotic illness, such as schizophrenia
3. Pre-existing chronic PTSD
4. Receiving end-of-life-care
5. Previously recruited into POPPI

Recruitment start date

01/09/2015

Recruitment end date

31/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Intensive Care National Audit & Research Centre
Napier House 24 High Holborn
London
WC1V 6AZ
United Kingdom

Sponsor information

Organisation

Intensive Care National Audit & Research Centre

Sponsor details

Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

https://www.icnarc.org/Our-Research/Studies/Poppi

Funders

Funder type

Government

Funder name

National Institute for Health Research, Health Services and Delivery Research (HS&DR) Programme

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/02/2017: The target number of participants has been updated from 1914 to 1378. 12/01/2017: The correct date of ethics approval has been added. 19/12/2016: The overall trial end date has been corrected from 30/11/2016 to 31/07/2017 and the recruitment end date has been updated from 30/11/2016 to 31/01/2017. 04/04/2016: Number of participants changed from 2904 to 1914. A secondary outcome measure added to relevant field. Overall study and recruitment start date changed from 01/08/2015 to 01/09/2015. Overall study and recruitment end date changed from 01/10/2016 to 30/11/2016.