Effects of External Inspection on Sepsis Detection and Treatment

NCT02747121 | Completed Results

• 1 other identifier: 2015/2195 REK number
• Study Type: interventional
• Target: 7,407
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

External inspections

Outcome Measures

Primary Outcomes (1)

• Number of Sepsis Patients With 30 Days Mortality

  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 Outcomes (1)

• Hospital Length of Stay

  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.

Study Arms (2)

Control before intervention

OTHER

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

Intervention

EXPERIMENTAL

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

Interventions

External inspection of health services BEHAVIORAL

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.

Control before intervention; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian Board of Health Supervision: lead
• University of Bergen: collaborator
• Norwegian Institute of Public Health: collaborator

Study Sites (1)

Haukeland hospital

Bergen, Hordaland, 5021, Norway

Location

Related Publications (21)

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  PMID: 33082187 DERIVED

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  PMID: 28877944 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Einar Hovlid
• Organization: Helsetilsynet

eho@helsetilsynet.no

+4721529900

Study Officials

• Jan Fredrik Andresen, MD

  Head of Norwegian Board of Health Supervision

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 21, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 24, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)