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Health services research
Protocol
Effects of external inspection on sepsis detection and treatment: a study protocol for a quasiexperimental study with a stepped-wedge design
  1. Einar Hovlid1,
  2. Jan C Frich2,
  3. Kieran Walshe3,
  4. Roy M Nilsen4,
  5. Hans Kristian Flaatten5,
  6. Geir Sverre Braut6,
  7. Jon Helgeland7,
  8. Inger Lise Teig8,
  9. Stig Harthug9
  1. 1 Department of Social Science, Western Norway University of Applied Sciences, Sogndal and Norwegian Board of Health Supervision, Oslo, Norway
  2. 2 Institute of Health and Society, University of Oslo, Oslo, Norway
  3. 3 Health Management Group, Alliance Manchester Business School, University of Manchester, Manchester, UK
  4. 4 Department of Health and Social Sciences, Department of Research and Development, Western Norway University of Applied Sciences, Haukeland University Hospital, Bergen, Norway
  5. 5 Department of Anaesthesia and Intensive Care, Department of Clinical Medicine, Haukeland University Hospital, University of Bergen, Bergen, Norway
  6. 6 Department of research, Stavanger University Hospital, Stavanger; Norwegian Board of Health Supervision, Oslo, Norway
  7. 7 Quality Measurement Unit, Norwegian Institute of Public Health, Oslo, Norway
  8. 8 Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway
  9. 9 Department of Research and Development, Department of Clinical Science, Faculty of Medicine and Dentistry, Haukeland University Hospital, University of Bergen, Bergen, Norway
  1. Correspondence to Dr Einar Hovlid; einar.hovlid{at}hvl.no

Abstract

Introduction Inspections 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 analysis The 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 dissemination The 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 Registration NCT02747121; Pre-results.

  • external inspection
  • sepsis
  • stepped wedge design
  • effect
  • regulation

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-016213

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    Footnotes

    • Contributors EH led the development of the overall study design and drafted the manuscript. JCF, KW, GSB and SH participated in development of the overall study design and methods for collecting the data and analysis. HKF provided advice on designing substudy two and on how to search the National Patient Register to identify eligible patients. RMN provided statistical advice for the study design, developed the analysis plan and carried out the power calculations for substudy 2. ILT provided advice on developing substudy 1. JCH provided advice on the design, data collection and analysis for substudy 2. All authors contributed to writing and revising the manuscript.

    • Funding The Norwegian Board of Health Supervision funds expenses for the clinical experts on the inspection teams and part of the costs related to data collection. The members of inspection teams are employed by the county governors in Norway. EH and GSB are part-time employees at the Norwegian Board of Health Supervision. The management of the funders do not participate in analysis of the research data. Western Norway University of Applied Sciences funds a PhD student who will participate in collecting qualitative data and in data analysis.

    • Competing interests None declared.

    • Patient consent Obtained. The Regional Ethics Committee of Norway ruled that individual consent from all patients was not necessary.

    • Ethics approval The Regional Ethics Committee of Norway (REC) and The Norwegian Data Protection Authority.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement There is no data available for sharing now.