Provision of psychological support to people in intensive care (v1.0)
| ISRCTN | ISRCTN53448131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53448131 |
| Secondary identifying numbers | 18940 |
- Submission date
- 15/07/2015
- Registration date
- 16/07/2015
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 6 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
Contact information
Public
Intensive Care National Audit & Research Centre
Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom
Study information
| Study design | Randomized; Interventional; Design type: Screening, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) cluster-randomised controlled trial |
| Study 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(s) | NRES Committee South Central - Oxford B, 15/05/2015, ref: 15/SC/0287 |
| 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 |
| Primary outcome measure | PTSD symptom severity measured using the PTSD Symptom Scale (Self-report version) (PSS-SR) Timepoint(s): 6 months |
| Secondary outcome measures | 1. Cost-effectiveness; Timepoint(s): 6 months 2. Days alive and free from sedation; Timepoint(s): Day 30 3. Depression measured using the Hospital Anxiety and Depression Scale (HADS); Timepoint(s): 6 months 4. Duration of critical care unit stay; Timepoint(s): End of critical care unit stay 5. Health-Related Quality of Life; Timepoint(s): 6 months 6. PTSD Symptom Scale (Self-Report version) (PSS-SR) >18; Timepoint(s): 6 months 7. Anxiety measured using the HADS; Timepoint(s): 6 months (added 04/04/2016) |
| Overall study start date | 01/09/2015 |
| Overall study end date | 29/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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 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 the 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 |
| 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 | 03/02/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
24 High Holborn
London
WC1V 6AZ
United Kingdom
Sponsor information
Hospital/treatment centre
Napier House
24 High Holborn
London
WC1V 6AZ
England
United Kingdom
| Website | https://www.icnarc.org/Our-Research/Studies/Poppi |
|---|---|
"ROR" |
https://ror.org/057b2ek35 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/02/2018 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 01/11/2018 | No | No | |
| Results article | 6-month follow-up results | 19/02/2019 | 25/02/2019 | Yes | No |
| Results article | results | 01/08/2019 | 13/09/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | 17/03/2020 | 18/08/2023 | Yes | No |
Editorial Notes
18/08/2023: Publication reference added.
13/09/2019: Publication reference added.
25/02/2019: Publication reference added.
06/07/2018: Publication reference added.
20/06/2018: The following changes have been made:
1. The overall trial end date has been changed from 31/07/2017 to 29/12/2017.
2. The recruitment end date has been changed from 31/01/2017 to 03/02/2017.
3. Publication reference added.
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.
