Resource use and outcome in intensive care units
| ISRCTN | ISRCTN12457206 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12457206 |
- Submission date
- 26/01/2021
- Registration date
- 31/01/2021
- Last edited
- 16/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Intensive care prevents death and disability caused by critical illness and it consumes large amounts of health care resources. The severity of illness influences both the risk of death and the amount of resources needed to achieve survivors. Both the ability to achieve survivors and the resources needed to achieve survivors at a specific severity of illness may vary widely between intensive care units internationally and within a country. The aim of this study is to evaluate variation in resources needed and the ability achieve survivors in intensive care units over time, using methods that take into account the severity of illness in resource use and mortality. This study attempts to find factors possibly related to such variations, for example, structural and organizational characteristics of the intensive care units in Finland, Estonia, and Switzerland.
Who can participate?
Patients treated in participating intensive care units from 1/1/2008 - 31/12/2017
What does the study involve?
The study uses routinely collected information of severity of illness and resource use during admissions to intensive care units. The data has been collected as part of standard care in a registry and will be analyzed in fully anonymized form, i.e. so that no patients can be recognized based on the data available for the study.
What are the benefits and risks of participating?
None for the individual patients. Potential benefits for society and health care may help to better allocate health care resources in the future.
Where is the study run from?
The study is run from the Department of Intensive Care Medicine, Bern University Hospital and University of Bern, Bern, Switzerland.
When is the study starting and how long is it expected to run for?
August 2017 to April 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Professor (Emeritus) Jukka Takala, jukka.takala@med.unibe.ch
Contact information
Scientific
Department of Intensive Care Medicine
Bern University Hospital
Freiburgstrasse 18
Bern
3010
Switzerland
| Phone | +41 316323938 |
|---|---|
| jukka.takala@med.unibe.ch |
Study information
| Study design | Retrospective analysis |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cost-benefit analysis |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Variation in severity-adjusted resource utilization and outcome in intensive care units |
| Study hypothesis | This health economic study evaluates variation in resource use and mortality, both standardized for the severity of illness, in intensive care units over time, assesses factors related to the variation, and evaluates the cost structure and ICU organization in participating intensive units in Finland, Estonia, and Switzerland. |
| Ethics approval(s) | According to the national regulations in Finland, Estonia, and Switzerland, no ethics committee approval is needed for health economic studies using anonymized data from existing health care registry. The study protocol, database contents and process of data management were approved by the National Institute of Health and Welfare, Finland (Decision THL/1524/5.05.00/2017 and THL/1173/05.00/2018) |
| Condition | Resource use and hospital outcome standardized for severity of illness in patients admitted to intensive care units |
| Intervention | Registry data from all admissions in 21 intensive care units from 2008-2017 will be used. Severity of illness and resource use data, collected prospectively in a quality registry, are retrospectively analyzed for severity adjusted, standardized resource use ratio (SRUR) and standardized mortality ratio (SMR). The variation over time and association between SRUR and SMR and their association with predefined structural and organizational variables will be analyzed. |
| Intervention type | Other |
| Primary outcome measure | Resource use is measured from the retrospectively collected records using: 1. Length of intensive care unit stay 2. Daily collected data on therapeutic interventions (TISS-score) 3. Severity of illness measured during the first 24 hrs of intensive unit stay 4. Mortality measured at hospital discharge |
| Secondary outcome measures | Characteristics of treatment centres measured from the retrospectively collected records using: 1. ICU-category (University, small/large non-University) 2. Cardiac surgery in hospital (yes/no) 3. Neurosurgery in hospital (yes/no) 4. Nurses/bed 5. Nurses/bed to physician/bed ratio 6. Total number of beds 7. Readmissions/total admissions 8. Admissions/bed 9. Specialist availability 24/7 (yes/no) 10. Medical emergency team (yes/no) 11. Physician full time equivalents(FTE)/bed, 12. Organization type (independent or not) 13. Median SAPS category 14. SMR |
| Overall study start date | 22/08/2017 |
| Overall study end date | 30/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 207953 |
| Total final enrolment | 207953 |
| Participant inclusion criteria | All patients admitted to the participating intensive care units 2008-2017 |
| Participant exclusion criteria | 1. Data collection error 2. Missing admission number 3. Missing severity score 4. Missing diagnosis |
| Recruitment start date | 01/01/2008 |
| Recruitment end date | 31/12/2017 |
Locations
Countries of recruitment
- Estonia
- Finland
- Switzerland
Study participating centre
Inselspital
Freiburgstrasse 18
Bern
3010
Switzerland
Sponsor information
Hospital/treatment centre
Department of Intensive Care Medicine
Inselspital
Freiburgstrasse 18
Bern
3010
Switzerland
| Phone | +41 316323938 |
|---|---|
| kim.backoffice@insel.ch | |
| Website | http://www.insel.ch/en/ |
"ROR" |
https://ror.org/01q9sj412 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 29/01/2021 | 03/02/2021 | No | No | |
| Results article | 18/10/2021 | 19/10/2021 | Yes | No | |
| Protocol file | 22/08/2017 | 16/08/2022 | No | No |
Additional files
- ISRCTN12457206_SAP_29Jan21.pdf
- Uploaded 03/02/2021
- 39352 Protocol 22Aug2017.pdf
Editorial Notes
16/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
19/10/2021: Publication reference added.
18/03/2021: The overall trial end date has been changed from 31/03/2021 to 30/04/2021 and the plain English summary has been updated accordingly.
03/02/2021: The overall trial end date was changed from 31/01/2021 to 31/03/2021. Uploaded statistical analysis plan.
28/01/2021: Trial’s existence confirmed by National Institute of Health and Welfare, Finland.
