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Effects of External Inspection on Sepsis Detection and Treatment

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ClinicalTrials.gov Identifier: NCT02747121
Recruitment Status : Recruiting
First Posted : April 21, 2016
Last Update Posted : March 3, 2020
Sponsor:
Collaborators:
University of Bergen
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Norwegian Board of Health Supervision

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.

Condition or disease Intervention/treatment Phase
Sepsis Behavioral: External inspection of health services Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2376 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effects of External Inspection on Sepsis Detection and Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in process measures of care delivery [ Time Frame: Up to 24 months ]

    Ratio of patients receiving care in line with recommendations in guideline for sepsis treatment.

    For investigating the effects of intervention on the various outcome measures we will use logistic regression model for binary outcomes, Poisson regression models for count outcomes, and linear regression models for continuous outcomes.



Secondary Outcome Measures :
  1. 30 days mortality rate for sepsis patients [ Time Frame: Up to 36 month ]
    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.

  2. Change in time as to when care is delivered [ Time Frame: Up to 24 months ]
    1. Mean time to triage (minutes)
    2. Mean time to initial assessment by doctor (minutes)

  3. Hospital length of stay [ Time Frame: Up to 24 months ]
    Mean time for hospital length of stay before and after inspections



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747121


Contacts
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Contact: Einar Hovlid, PhD +4721529900 fmsfeho@fylkesmannen.no
Contact: Signe Romuld +4721529900 ser@helsetilsynet.no

Locations
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Norway
Haukeland hospital Recruiting
Bergen, Hordaland, Norway, 5021
Sponsors and Collaborators
Norwegian Board of Health Supervision
University of Bergen
Norwegian Institute of Public Health
Investigators
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Study Chair: Jan Fredrik Andresen, MD Head of Norwegian Board of Health Supervision
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Norwegian Board of Health Supervision
ClinicalTrials.gov Identifier: NCT02747121    
Other Study ID Numbers: 2015/2195 REK number
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In line with the ethical approval data is not to be shared outside the research group
Keywords provided by Norwegian Board of Health Supervision:
External inspections
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes