Improving care of patients with sepsis: Analysis of care pathways, experiences, and needs of patients with and after sepsis
- Conditions
- R65.1R57.2Systemic Inflammatory Response Syndrome of infectious origin with organ failureSeptic shock
- Registration Number
- DRKS00031302
- Lead Sponsor
- Institut für Infektionsmedizin und Krankenhaushygiene, Universitätsklinikum Jena
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500000
Subproject A: AOK-insured hospital-treated patients with sepsis, coded as primary or secondary diagnosis, in the years 2016-2020, whereby the hospital case is referred to as index hospitalization in the following. The insured persons have to be continuously insured with the AOK (max. 5 days of absence per quarter) in the pre- and post-observation period (12 months before and 24 months after the index hospitalization, respectively) or died in the post-observation period (quarter of death, max. 5 days of absence between the day of death and the beginning of the quarter).
Inclusion criteria for 2016-2019:
- R57.2 (Septic shock) OR
- R65.1 (severe sepsis) OR
- Explicit sepsis code and ICD/OPS code for organ dysfunction.
Inclusion criteria for 2020:
- R57.2 (Septic shock) OR
- Explicit sepsis code AND R65.1 (SIRS with ODF) OR
- Explicit sepsis code AND (ICD/OPS code for organ dysfunction) OR
- (Code for covid OR influenza) AND (ICD/OPS code for organ dysfunction)
Subproject B: Patients for whom (at least) one EMS provision in Bavaria and Baden-Württemberg has been documented by the cooperating EMS-providers in the period 2017-2021 (and can thus be further linked to claims data of the AOK Bavaria or Baden-Württemberg).
Subproject C: For the survey study with focus on provider perspective, the following inclusion criteria apply: 1. medical professionals who care for and treat patients with or after sepsis and/or septic shock, 2. at least 1 year of professional experience, 3. age = 18, 4. informed consent to participate in the substudy. The following inclusion criteria are used for the survey study with a focus on the patient and relative perspective: 1. The sepsis illness must not have occurred more than 5 years ago, 2. Age = 18, 3. Declaration of consent for participation in the substudy
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Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subproject A: Analysis of patient pathways to acute care (outpatient and inpatient treatment, anti-infective therapies and diagnostics), acute inpatient care including interhospital transfers, post-acute rehabilitative, outpatient and inpatient follow-up, new morbidity, health care utilization classes, mortality up to 24 months after hospital discharge from index stay with sepsis<br>Subproject B: Analysis of preclinical, clinical and post-acute care pathways of patients before, with and after sepsis; proportion of patients who come to inpatient treatment with community-acquired sepsis via EMS; proportion of patients for whom the suspected diagnosis of sepsis or severe infection or infection-associated organ dysfunction is already documented by EMS or which alternative suspected diagnoses are coded; which therapies are already initiated by EMS.<br>Subproject C: Patient/family and provider satisfaction with acute care/aftercare, needs, perceived deficits and potentials
- Secondary Outcome Measures
Name Time Method Subproject A: infection-related pre-sepsis treatments and rehospitalization, rehospitalization with ambulatory-care sensitive hospital discharge diagnoses.<br>Subproject B: Subgroups of sepsis patients stratified by age, sepsis severity, pathogen (e.g. influenza, SARS-CoV2), specific pre-existing conditions (e.g. cognitive impairment) and need for care/nursing home stay; examination of the extent to which pre-hospital care by EMS or correct initial assessment of sepsis associated with the acute and long-term mortality of patients); does temporal latency between outpatient infection-associated treatment and inpatient admission (e.g. treatment with anti-infectives, ICD diagnosis) increase the risk of mortality<br>Subproject C: provider perspective – subjective possible solutions to improve the deficits discussed<br>Patient/relatives perspective - subjective solutions to improve the discussed care needs and deficits of patients and relatives