Provision Of Psychological support to People in Intensive care (POPPI): feasibility study
| ISRCTN | ISRCTN61088114 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61088114 |
| Secondary identifying numbers | 16479 |
- Submission date
- 05/06/2014
- Registration date
- 05/06/2014
- Last edited
- 13/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom
| paul.mouncey@icnarc.org |
Study information
| Study design | Non-randomised; Both; Design type: Prevention, Screening, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI): a feasibility study |
| Study acronym | POPPI |
| Study objectives | 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(s) | NRES Committee South Central - Oxford B, 23/04/2014, ref: 14/SC/0149 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2014 |
| Completion date | 01/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 110; UK Sample Size: 110 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 11/06/2014 |
| Date of final enrolment | 30/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Bristol
BS2 8HW
United Kingdom
Gillingham
ME7 5NY
United Kingdom
Fitzrovia
London
NW1 2BU
United Kingdom
Watford
WD18 0HB
United Kingdom
Sponsor information
Research organisation
Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom
"ROR" |
https://ror.org/057b2ek35 |
|---|
Funders
Funder type
Government
Government organisation / National government
- 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
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/07/2018 | Yes | No | |
| Results article | results | 01/08/2019 | 13/09/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/09/2019: Publication reference added.
27/07/2018: Publication reference added.
10/12/2014: The overall trial end date was changed from 15/12/2014 to 01/06/2015.
