Trial Outcomes & Findings for Effects of External Inspection on Sepsis Detection and Treatment (NCT NCT02747121)
NCT ID: NCT02747121
Last Updated: 2022-03-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7407 participants
Primary outcome timeframe
30 days
Results posted on
2022-03-24
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3594
|
3813
|
|
Overall Study
COMPLETED
|
3594
|
3813
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Before Intervention
n=3813 Participants
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.
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.
|
After Intervention (After Inspection)
n=3594 Participants
Patients included after intervention.
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.
|
Total
n=7407 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=3813 Participants
|
73 years
n=3594 Participants
|
72 years
n=7407 Participants
|
|
Sex: Female, Male
Female
|
1874 Participants
n=3813 Participants
|
1713 Participants
n=3594 Participants
|
3587 Participants
n=7407 Participants
|
|
Sex: Female, Male
Male
|
1939 Participants
n=3813 Participants
|
1881 Participants
n=3594 Participants
|
3820 Participants
n=7407 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 30 daysWe 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.
Outcome measures
| Measure |
Intervention
n=3594 Participants
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.
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.
|
Control Before Intervention
n=3813 Participants
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.
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.
|
|---|---|---|
|
Number of Sepsis Patients With 30 Days Mortality
Decesed Deceased within 30 days
|
377 Participants
|
424 Participants
|
|
Number of Sepsis Patients With 30 Days Mortality
Alive within 30 days
|
3217 Participants
|
3389 Participants
|
SECONDARY outcome
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.Mean time for hospital length of stay before and after inspections
Outcome measures
| Measure |
Intervention
n=3594 Participants
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.
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.
|
Control Before Intervention
n=3813 Participants
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.
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.
|
|---|---|---|
|
Hospital Length of Stay
|
6.2 days
Standard Deviation 6.1
|
7.1 days
Standard Deviation 7.8
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Before Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place