Effects of external inspection on sepsis detection and treatment: a study protocol for a quasiexperimental study with a stepped-wedge design

Abstract

IntroductionInspections are widely used in health care as a means to improve the health services delivered to patients. Despite their widespread use, there is little evidence of their effect. The mechanisms for how inspections can promote change are poorly understood. In this study, we use a national inspection campaign of sepsis detection and initial treatment in hospitals as case to: (1) Explore how inspections affect the involved organizations. (2) Evaluate what effect external inspections have on the process of delivering care to patients, measured by change in indicators reflecting how sepsis detection and treatment is carried out. (3) Evaluate whether external inspections affect patient outcomes, measured as change in the 30-day mortality rate and length of hospital stay.Methods and analysisThe intervention that we study is inspections of sepsis detection and treatment in hospitals. The intervention will be rolled out sequentially during 12 months to 24 hospitals. Our effect measures are change on indicators related to the detection and treatment of sepsis, the 30-day mortality rate and length of hospital stay. We collect data from patient records at baseline, before the inspections, and at 8 and 14 months after the inspections. We use logistic regression models and linear regression models to compare the various effect measurements between the intervention and control periods. All the models will include time as a covariate to adjust for potential secular changes in the effect measurements during the study period. We collect qualitative data before and after the inspections, and we will conduct a thematic content analysis to explore how inspections affect the involved organisations.Ethics and disseminationThe study has obtained ethical approval by the Regional Ethics Committee of Norway Nord and the Norwegian Data Protection Authority. It is registered at www.clinicaltrials.gov (Identifier: NCT02747121). Results will be reported in international peer-reviewed journals.Trial RegistrationNCT02747121; Pre-results.

Early diagnosis of sepsis in emergency departments, time to treatment, and association with mortality: An observational study

“…The project was initiated in 2015 by the Norwegian Board of Health Supervision, which is the body delegated with the overall responsibility for external inspections of health care in Norway. The protocol for this project has been published previously [15]. In the present article, we report the results of the first part of the study, establishing baseline levels of compliance with sepsis guidelines, and assessing the associations between delayed diagnostic procedures and time to treatment and between time to treatment and mortality.…”

“…was arrived at through power calculations to detect changes between the baseline measurements (which is the study sample used for this study) and post-inspection measurements. The power calculations are explained in detail in the study protocol [15]. Six regional inspection teams from the County Governors, who carry out inspections on behalf of the Norwegian Board of Health Supervision, were tasked with assessing eligibility and collecting data.…”

“…The sequence of inspections was randomized to facilitate comparison of outcomes before and after the inspections. The details of and rationale for the study design are described in the published study protocol [15].…”

Effects of external inspections on sepsis detection and treatment: a stepped-wedge study with cluster-level randomisation

“…We have previously published the full protocol of the study, including the rationale for the use of the stepped-wedge design. 25 We based inclusion into the study on the standard definition of sepsis in use when the study was developed. 26 Accordingly, the criteria were clinically suspected infection on presentation to the emergency department and at least two systemic inflammatory response syndrome Inspection team announces inspection and requests the hospital to submit information 2…”

“…Due to the preconditions and constraints provided by doing the study in a real-world setting, it was not possible to conduct a randomised controlled trial. 25 As with any observational study, there was an inherent risk of confounding from unknown factors. A limitation of our study is that we did not have data on severity of sepsis in the form of commonly used severity scores like SAPS 2 (simplified acute physiology score) or APACHE II (acute physiology and chronic health evaluation), or a detailed organ failure assessment score like SOFA (sequential organ failure assessment).…”