STOP-A is a prospective, multicenter data study aimed at demonstrating the impact of multifaceted support for the implementation of recommendations on the prevention and management of anemia in intensive care, compared to previous practices, on hospital mortality in adult patients hospitalized in intensive care for ≥2 days. The timing of implementation in each center is determined randomly by stepped-wedge randomization. As such, this is a pragmatic study that meets the international PRECIS-2 criteria.
Study Type
OBSERVATIONAL
Enrollment
5,760
The study will be organized into three periods: * a pre-implementation phase, with no changes to usual care; * a period of implementation of the recommendations; * a post-implementation phase.
réanimation médicale CHU ANGERS
Angers, France
Ch Victor Dupouy
Argenteuil, France
CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation chirurgicale
Brest, France
CHRU BREST SITE HOPITAL CAVALE BLANCHE, réanimation médicale
Brest, France
Ch Chartres Louis Pasteur-Le Coudray
Chartres, France
Ch de Cholet
Cholet, France
HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Médico-Chrirugicale
Clermont-Ferrand, France
HOPITAL GABRIEL MONTPIED - CHU63, Réanimation Neurochirurgicale
Clermont-Ferrand, France
CHU Grenoble-HOPITAL SUD - CHU38
Grenoble, France
CH de LAVAL
Laval, France
...and 17 more locations
evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure.
in-hospital mortality, up to day 90
Time frame: Day 0 to Day 90
Evaluate the impact of implementation support on Hb levels
hemoglobin level in g/dl
Time frame: hospital discharge or day 28
Assess the impact of implementation support on recovery after ICU discharge.
number of days living in the previous place of residence prior to D90
Time frame: Day 90
Evaluate impact of implementation support on longer-term mortality
all-cause mortality at 6 months
Time frame: 6 Months
Assess the impact of implementation support on survival
6-month survival curves
Time frame: 6 months
Assess the impact of implementation support (STOP-A) on professional practices
RFE compliance rate (calculation of an RFE compliance index, IRR, comprising 6 items and scored out of 8 points) between the pre-implementation and post-implementation phases
Time frame: From enrollment to the end of recruitment
Assess the impact of implementation support on transfusion use between the two phases.
Rate of transfused patients relative to the number of hospitalized patients in each phase
Time frame: From enrollment to the end of recruitment
Assess impact of implementation support on transfusion use between the two phases.
transfusion index relative to the number of hospitalized patients in each phase
Time frame: From enrollment to the end of recruitment
Assess the impact of implementation support on transfusion use between the two phases.
the number of red blood cell units relative to the number of hospitalized patients
Time frame: From enrollment to the end of recruitment
Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase
The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed in subgroups of patients with an IRR \>75% vs. \<20%;
Time frame: day 90
Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase
The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed according to IRR quartiles.
Time frame: day 90
Evaluate the impact of implementation support (STOP-A) in traumatized and non-traumatized patients.
Time frame: Day 90
Evaluate the impact of EPO treatment in patients with Hb<12 g/dL
Time frame: Day 90
Evaluate the impact of implementation support (STOP-A) on complications due to healthcare
thromboembolic events occurring in intensive care
Time frame: hospital discharge or day 28
Evaluate the impact of implementation support (STOP-A) on complications due to healthcare
transfusion-related adverse events
Time frame: hospital discharge or day 28
Evaluate the efficiency of assistance in implementing RFEs (STOP-A) through a cost-effectiveness analysis.
Differential cost-effectiveness ratio, expressed as cost per life year gained at 3 and 6 months after admission to intensive care, from the perspective of the French healthcare system and from the hospital perspective.
Time frame: day 180
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