Anemia
Conditions
Brief summary
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.
Interventions
OTHERimplementation of recommendations
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.
Sponsors
University Hospital, Angers
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Length of stay in intensive care is ≥ 2 days * The patient has at least one organ failure lasting 24 hours or more (catecholamine infusion and/or mechanical ventilation (invasive or NIV \> 6 hours/day)) * No objection to data collection (patient or relative)
Exclusion criteria
* Terminally ill patient with limited active treatment options within 72 hours of admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate the impact of multifaceted support for STOP-A implementation on hospital mortality, taking into account the stepped wedge design structure. | Day 0 to Day 90 | in-hospital mortality, up to day 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the impact of implementation support on Hb levels | hospital discharge or day 28 | hemoglobin level in g/dl |
| Assess the impact of implementation support on recovery after ICU discharge. | Day 90 | number of days living in the previous place of residence prior to D90 |
| Evaluate impact of implementation support on longer-term mortality | 6 Months | all-cause mortality at 6 months |
| Assess the impact of implementation support on survival | 6 months | 6-month survival curves |
| Assess the impact of implementation support (STOP-A) on professional practices | From enrollment to the end of recruitment | 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 |
| Assess the impact of implementation support on transfusion use between the two phases. | From enrollment to the end of recruitment | Rate of transfused patients relative to the number of hospitalized patients in each phase |
| Assess impact of implementation support on transfusion use between the two phases. | From enrollment to the end of recruitment | transfusion index relative to the number of hospitalized patients in each phase |
| Analysis of the impact of compliance with recommendations on patient outcomes regardless of the study phase | day 90 | The primary endpoint (in-hospital mortality) and secondary endpoints will be analyzed in subgroups of patients with an IRR \>75% vs. \<20%; |
| Evaluate the impact of implementation support (STOP-A) in traumatized and non-traumatized patients. | Day 90 | — |
| Evaluate the impact of EPO treatment in patients with Hb<12 g/dL | Day 90 | — |
| Evaluate the impact of implementation support (STOP-A) on complications due to healthcare | hospital discharge or day 28 | thromboembolic events occurring in intensive care |
| Evaluate the efficiency of assistance in implementing RFEs (STOP-A) through a cost-effectiveness analysis. | day 180 | 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. |
Countries
France
Contacts
CONTACTSigismond LASOCKI, Professor
Outcome results
None listed