| Title |
Designing and conducting a cluster-randomized trial of ICU admission for the elderly patients: the ICE-CUB 2 study
|
|---|---|
| Published in |
Annals of Intensive Care, July 2016
|
| DOI | 10.1186/s13613-016-0161-5 |
| Pubmed ID | |
| Authors |
Ariane Boumendil, Maguy Woimant, Jean-Pierre Quenot, François-Xavier Rooryck, Foued Makhlouf, Youri Yordanov, Samuel Delerme, Khalil Takun, Patrick Ray, Marie-Clément Kouka, Claire Poly, Maité Garrouste-Orgeas, Caroline Thomas, Tabasome Simon, Sylvie Azerad, Guillaume Leblanc, Dominique Pateron, Bertrand Guidet, on behalf of the ICE-CUB 2 study network |
| Abstract |
The benefit of ICU admission for elderly patients remains controversial. This report highlights the methodology, the feasibility of and the ethical and logistical constraints in designing and conducting a cluster-randomized trial of intensive care unit (ICU) admission for critically ill elderly patients. We designed an interventional open-label cluster-randomized controlled trial in 24 centres in France. Clusters were healthcare centres with at least one emergency department (ED) and one ICU. Healthcare centres were randomly assigned either to recommend a systematic ICU admission (intervention group) or to follow standard practices regarding ICU admission (control group). Clusters were stratified by the number of ED annual visits (<44,616 or >44,616 visits), the presence or absence of a geriatric ward and the geographical area (Paris area vs other regions in France). All elderly patients (≥75 years of age) who got to the ED were assessed for eligibility. Patients were included if they had one of the pre-established critical conditions, a preserved functional status as assessed by an ADL scale ≥4 (0 = very dependent, 6 = independent), a preserved nutritional status (subjectively assessed by physicians) and without active cancer. Exclusion criteria were an ED stay >24 h, a secondary referral to the ED and refusal to participate. The primary outcome was the mortality at 6 months calculated at the individual patient level. Secondary outcomes were ICU and hospital mortality, as well as ADL scale and quality of life (as assessed by the SF-12 Health Survey) at 6 months. Between January 2012 and April 2015, 3036 patients were included in the trial, 1518 patients in 11 clusters allocated to intervention group and 1518 patients in 13 clusters allocated to standard care. There were 51 protocol violations. The ICE-CUB 2 trial was deemed feasible and ethically acceptable. The ICE-CUB 2 trial will be the first cluster-randomized trial to assess the benefits of ICU admission for selected elderly patients on long-term mortality. Trial registration Clinical trials.gov identifier: NCT01508819. |
X Demographics
The data shown below were collected from the profiles of 5 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 3 | 60% |
| Spain | 1 | 20% |
| Unknown | 1 | 20% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Practitioners (doctors, other healthcare professionals) | 2 | 40% |
| Members of the public | 2 | 40% |
| Scientists | 1 | 20% |
Mendeley readers
The data shown below were compiled from readership statistics for 48 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 48 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 10 | 21% |
| Other | 6 | 13% |
| Student > Doctoral Student | 5 | 10% |
| Student > Master | 5 | 10% |
| Librarian | 3 | 6% |
| Other | 6 | 13% |
| Unknown | 13 | 27% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 19 | 40% |
| Nursing and Health Professions | 5 | 10% |
| Psychology | 3 | 6% |
| Pharmacology, Toxicology and Pharmaceutical Science | 1 | 2% |
| Biochemistry, Genetics and Molecular Biology | 1 | 2% |
| Other | 4 | 8% |
| Unknown | 15 | 31% |
Attention Score in Context
This research output has an Altmetric Attention Score of 3. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 27 September 2017.
All research outputs
#12,962,877
of 22,881,964 outputs
Outputs from Annals of Intensive Care
#679
of 1,046 outputs
Outputs of similar age
#190,068
of 365,421 outputs
Outputs of similar age from Annals of Intensive Care
#17
of 31 outputs
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