Plain English Summary
Background and study aims
It is known 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. The idea of this study 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. The trialists 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 it is shown that patients are happy to do this, they move on to part two. Part two of the study tests whether training intensive care staff to give stress support can improve patients' future well-being. Patients taking part in part one of the study 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 are 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 continue to receive normal care from the intensive care staff. If they have a high score, a specially trained nurse offers 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 also receive music and relaxation tapes, and a booklet.
What are the possible benefits and risks of participating?
The trialists 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?
June 2014 to 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): a 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.
Ethics approval
NRES Committee South Central - Oxford B, 23/04/2014, ref: 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 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
11/06/2014
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
Funders
Funder type
Government
Funder name
Health Services and Delivery Research Programme (Grant Codes: 12/64/124)
Alternative name(s)
Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research Programme, HS&DR Programme, HS&DR
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