IATROREF III: a Multifaceted Program for Improving Quality of Care in Critically Ill Patients

Design and methods Definition of adverse events

1. Error in insulin administration Insulin not given exactly as prescribed (including in the written protocol used in the ICU). The error may be a planning error or an implementation error regarding the nature of the insulin, dosage, preparation modalities, or administration modalities. Insulin therapy requires monitoring of capillary blood glucose levels.
2. Error in anticoagulant prescription Non respect of the recommendations about indications, dosages, administration modalities, contraindications, drug-drug interactions, and laboratory monitoring using the VIDAL (French Drug Compendium), learned societies, ICU protocols, and local drug committees. Either unfractionated heparin or low-molecular-weight heparin may be involved
3. Error in anticoagulant administration Anticoagulant not given exactly as prescribed. The error may be a planning error or an implementation error regarding the nature of the anticoagulant, dosage, preparation modalities, administration modalities, dosing times, or dosing intervals. Either unfractionated heparin or low-molecular-weight heparin may be involved.
4. Unplanned catheter removal Unplanned complete removal of a central venous catheter by the patient or by staff while caring for the patient.
5. Unplanned extubation Extubation not planned by the physicians. Unplanned extubations can be categorized as self-extubation by the patient, or accidental extubation for technical reasons (porosity, section of the balloon, poorly secured tube), and during patient care (bathing, taking radiographs, transportation, care).

Randomization procedure We will use a multicenter cluster randomized design to assess the effectiveness of a multifaceted intervention. Our statistician will randomly assign each unit to compliance with ICU guidelines as usual or implementation of the multifaceted intervention to prevent one of the AEs. Randomization will occur at the ICU level. Units that do not use the intervention program will serve as controls. The randomization procedure will be repeated every 2 1/2 months for a total of four 21/2-month periods in 2007-2008. During the month of January, the study will be prepared at each site, where a clinical research assistant will be trained in the use of RheaTM data collection software (http://outcomerea.org/rhea/install).

In the Iatroref II study, anticoagulant prescription or administration errors occurred in 59/1377 (about 6%) patients, insulin administration errors in more than 20% of patients, and unplanned catheter or endotracheal tube removal in 4% of patients. For this study, we collapsed unplanned catheter removal and unplanned extubation into a single group and administration error and prescription error of anticiagulant in another single group. Assuming that more than 2400 patients will be admitted to the four study ICUs during the study period, the study would have greater than 80% power for detecting a 4% absolute decrease in anticoagulant errors, a 3% absolute decrease in unplanned catheter or endotracheal tube removal, and a 10% absolute decrease in insulin treatment errors. We will use the two-sided score test for comparisons (Farrington and Manning). P levels ≤0.05 will be considered statistically significant.

Interventions In each study ICU, a physician trained in clinical research and a a clinical research assistant will prepare the study during the two weeks preceding randomization. The intervention for each AEs will include three components: meeting with the ICU nurses and physicians, distribution of educational materials including a pocket card showing the recommendations about prevention of each AE, and quality improvement sessions twice a month. At each site, the physician trained in clinical research and the clinical research assistant will lead feedback meetings with the ICU staff every 2 weeks 1) to provide feedback about AEs that occurred in the last 2 weeks, 2) to review compliance with recommendations on the pocket card, and 3) to analyze the causes of AEs and suggest practice changes if appropriate. A report on each meeting will be drafted.