Clinical trial NCT02747121: Effects of External Inspection on Sepsis Detection and Treatment
Official title: Effects of External Inspection on Sepsis Detection and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: External inspections
Lead sponsor: Norwegian Board of Health Supervision
Sponsor class: OTHER_GOV
Collaborators: name: University of Bergen
name: Norwegian Institute of Public Health
First posted: 2016-04-21
Enrollment: 7407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The intervention will be rolled out sequentially during 12 months to 24 hospitals, with six clusters of four geographically close hospitals. We collect data before and after the inspections.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: External inspections are widely used as means to improve the quality of care. Despite their widespread use, there is limited knowledge about whether and how they affect the quality of care. This study uses inspection with detection and treatment of sepsis in hospitals as a case to evaluate the effect of inspections on the quality of care and to explore how inspections affect the hospitals.

Detailed description: The aim of this study is to assess what effect external inspections have on the quality of care provided to sepsis patients admitted to hospital and to explore how external inspections affect the involved organizations.

External inspections are widely used as a means to improve the quality of care, and it is a core element of regulatory regimes and certification and accreditation processes. The activity of assessing a health care organization's performance according to an externally defined standard has been described by partly overlapping terms such as external inspection, external review, supervision, and audit. The project uses the term external inspection implying that the inspection is initiated and controlled by an organization external to the one being inspected; and define it as: "a system, process or arrangement in which some dimensions or characteristics of a healthcare provider organisation and its activities are assessed or analysed against a framework of ideas, knowledge, or measures derived or developed outside that organisation".

In line with this definition the investigator intend to study how external inspection affect the quality of care provided on an organizational level. The project does not intend to study how external inspections can affect individuals in the organization nor individual professional development. The investigator takes the perspective that quality of care can be considered a system property, being dependent on how the organization providing care performs as a whole. Accordingly, improving the quality of care is dependent on changing the performance of the organization, which in turn implies change in organizational behavior and the way clinicians mutually interact and perform their clinical processes. Change in organizational behavior is a complex social process that involves a number of different practices on different organizational levels. If external inspection has the ability to contribute to improve the quality of care on an organizational level, it need to affect the practices involved in organizational change.

The effect of external inspection systems on the quality of care remains unclear and the evidence is contradictory. Studies have demonstrated a positive association between accreditation and the ability to promote change, professional development, quality systems, and clinical leadership. There is evidence to support an association between inspections and different quality outcomes e.g. reduced incidence of pressure ulcer and suicide. There are however also studies reporting that inspections have no impact on the quality of care. Inspection systems are widely used and much resources are spent on such systems worldwide. More knowledge about how and whether external inspections can effect the quality of care is needed.

The inspection process can be considered a complex intervention consisting of a set of activities that are introduced into varying organizational contexts. The inspection itself does not have a direct impact on the quality of care. If the inspection encounters non-compliant behavior, the inspected organization is responsible for implementing necessary changes. The way the inspection process affects the involved organization will thus influence how the inspected organizations pursue the following change process. The way external inspections affect the involved organization, is currently poorly understood. A better understanding of the underlying mechanisms for how inspection systems might contribute to improve the quality of care is needed. Such knowledge can improve the understanding of why effects of external inspections seem to vary, which in turn can facilitate the development of more effective ways of conducting inspections.

The study uses external inspections of sepsis detection and treatment in hospitals as a case to explore how inspections affect the involved organizations and to evaluate their effect on the quality of care. Sepsis is a prevalent disease and one of the main causes of death among hospitalized patients internationally and in Norway. Former external inspections of Norwegian hospitals have showed that insufficient governance of clinical process in the emergency room could have severe consequences for patients admitted to hospital with undiagnosed sepsis. During recent years, the Norwegian Board of Health Supervision has investigated a number of cases in which the hospitals had not provided care in line with the recommended guidelines for sepsis treatment. On this background, the Norwegian Board of Health Supervision has decided to conduct a nationwide inspection campaign with sepsis detection and treatment in acute hospitals during 2016-2017.

Early treatment with antibiotics along with compliance to treatment guidelines is associated with reduced mortality for sepsis patients. International studies have shown that compliance with treatment guidelines varies, and that improved compliance can improve patient outcomes. External inspection can identify sub-optimal compliance with treatment guidelines. Improved compliance with treatment guidelines is dependent on change in organizational practice. Such changes in organizational practice can be measured using process indicators that are indicative and sensitive for changes in the key areas identified during the inspection. The study uses process measures to assess how external inspections affect guideline adherence. Because improved guideline adherence has been demonstrated to improve the quality of care in terms of reduced mortality, it can be argued that this is an expedient case for evaluating how external inspections can affect the quality of care.

Eligibility criteria: Inclusion Criteria:

* Suspected infection and minimum 2 SIRS criteria. If high leucocytes are one of the two criteria, then 3 SIRS criteria are needed.

Exclusion Criteria:

* Patients below the age of 18 years.
* Patients who do not pass through the emergency room.

Primary outcomes:
measure: Number of Sepsis Patients With 30 Days Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Exact number of days for the length of stay was collected from the National Patient Registry. Since the outcome measure is length of stay, the time frame varies between patients. Time frame for observation periode was at least 12 months for each patient.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland hospital
state: Hordaland
Study officials:
affiliation: Head of Norwegian Board of Health Supervision
name: Jan Fredrik Andresen, MD
role: STUDY_CHAIR
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