Effects of External Inspection on Sepsis Detection and Treatment

January 24, 2022 updated by: Norwegian Board of Health Supervision
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7407

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Haukeland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control before intervention
External inspection of health services. The intervention is external inspection of sepsis detection and treatment. The intervention is delivered on the organizational Level. Patient are not assigned to the intervention. The intervention is rolled out sequentially to 24 hospitals. We collect data at base line, before the inspections and 8 and 14 month after the inspections. The first arm is the Control period before the inspections.
Behavioral: External inspection of health services
The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole.
Experimental: Intervention
External inspection of health services. We compare the effect measures before and after the inspection. The intervention arm is data after the hospitals have received the inspection.
Behavioral: External inspection of health services
The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Sepsis Patients With 30 Days Mortality
Time Frame: 30 days
We will still use 30-day mortality rate as our outcome measure. The new international sepsis definition will over time affect coding practice and we can therefore not use routine data from the National Patient Register to calculate the mortality rate. We will calculate the mortality rate based on the patient population we include in the study. We will compare mortality rates before and after the inspections.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: 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.
Mean time for hospital length of stay before and after inspections
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Board of Health Supervision

Collaborators

Norwegian Institute of Public Health
University of Bergen

Investigators

  • Study Chair: Jan Fredrik Andresen, MD, Head of Norwegian Board of Health Supervision

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/2195 REK number

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In line with the ethical approval data is not to be shared outside the research group

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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