Condition category
Mental and Behavioural Disorders
Date applied
05/06/2014
Date assigned
05/06/2014
Last edited
08/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We know that patients may suffer from stress and panic in intensive care. Many patients become fearful and some even see or hear things that are not really happening (hallucinations). Doctors believe these frightening effects are caused by illness, medicine or stressful treatments in intensive care. Research shows that these worries and fears may increase the time it takes for patients to get better. The stress could also lead to future problems like flashbacks or nightmares. Our idea is to give intensive care staff special training to help patients who are worried or distressed. All the staff will learn how to make intensive care a calmer, less stressful place. Some nurses will also have training to give patients extra support to help lower their stress. We believe this will improve patientsÂ’ well-being after leaving intensive care.

Who can participate?
Adult patients receiving treatment in the intensive care can take part.

What does the study involve?
This study consists of two separate parts. Part one is to check that patients are happy to take part and complete a short questionnaire. If we show that patients are happy to do this, we will move on to part two. Part two of the study will test whether training intensive care staff to give stress support can improve patients' future well-being. Patients taking part in part one of the study will receive a short questionnaire 5 months after their stay in intensive care by email or post. Patients taking part in part two of the study will be given a short questionnaire about stress and mood in intensive care. It only takes a few minutes to answer the questions. If the stress score is low, they will continue to receive normal care from the intensive care staff. If they have a high score, one of our specially trained nurses will offer three sessions of stress support. These sessions are to discuss any worries they may have and to help them cope with being in intensive care. They will also receive music and relaxation tapes, and a booklet.

What are the possible benefits and risks of participating?
We cannot promise the study will help patients right now. They will be part of an important study aiming to improve the well-being of intensive care patients. If nurses like the training and patients find the stress support helpful, the study will be held in another 24 hospitals.

Where is the study run from?
The study is being run at four sites in the UK: Bristol Royal Infirmary, Medway Maritime Hospital, University College Hospital, and Watford General Hospital.

When is the study starting and how long is it expected to run for?
The study starts in June 2014 and runs until June 2015.

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

Who is the main contact?
Mr Paul Mouncey
paul.mouncey@icnarc.org

Trial website

Contact information

Type

Scientific

Primary contact

Mr Paul Mouncey

ORCID ID

Contact details

Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom
-
paul.mouncey@icnarc.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16479

Study information

Scientific title

Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI): feasibility study

Acronym

POPPI

Study hypothesis

The overall aim of the study is to develop and test the feasibility of a complex psychological intervention and to test the feasibility of the processes and procedures for the POPPI cluster randomised controlled trial.

On 10/12/2014 the overall trial end date was changed from 15/12/2014 to 01/06/2015.

Ethics approval

NRES Committee South Central - Oxford B; 23/04/2014; 14/SC/0149

Study design

Non-randomised; Both; Design type: Prevention, Screening, Treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

The intervention to be assessed is a complex psychological intervention comprising four related elements:
1. An education package (two training courses and associated materials) to train critical care unit staff to carry out elements 2-4
2. Creating a therapeutic environment to promote calm and minimise stress in critical care (all critical care staff)
3. Screening for acute psychological stress and psychosis-like symptoms in critical care patients using the IPAT (all critical care staff)
4. Carrying out three, one-to-one CBT-inspired stress support sessions, for patients screened as distressed and at high risk of psychological morbidity (delivered by specially trained POPPI nurses)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The main outcomes of the Intervention Feasibility Study will be the feasibility and acceptability of the intervention for the POPPI nurses and for patients, which will be assessed quantitatively and qualitatively. The main outcomes of the RCT Processes Feasibility Pilot Study are feasibility of estimated recruitment and retention rates.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2014

Overall trial end date

01/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years or greater
2. Receipt of Level 2 or Level 3 critical care for 48 hours or more
3. Between +1 and -1 on the Richmond Agitation Sedation Scale
4. English-speaking and ability to communicate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 110; UK Sample Size: 110

Participant exclusion criteria

1. Glasgow Coma Score of less than 15
2. Pre-existing chronic cognitive impairment, such as dementia
3. Pre-existing psychotic illness
4. Pre-existing chronic PTSD
5. Terminal illness/receiving end-of-life care

Recruitment start date

01/06/2014

Recruitment end date

30/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Infirmary
Upper Maudlin St
Bristol
BS2 8HW
United Kingdom

Trial participating centre

Medway Maritime Hospital
Windmill Rd
Gillingham
ME7 5NY
United Kingdom

Trial participating centre

University College Hospital
235 Euston Rd Fitzrovia
London
NW1 2BU
United Kingdom

Trial participating centre

Watford General Hospital
Vicarage Rd
Watford
WD18 0HB
United Kingdom

Sponsor information

Organisation

Intensive Care National Audit & Research Centre (UK)

Sponsor details

Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

NIHR Health Services and Delivery Research (UK); Grant Codes: 12/64/124

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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