Clinical trial NCT04109612: Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes-
Official title: Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes- Stroke Units Necessity for Patients (SUN4P)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Disorders
Keywords: stroke
stroke care
stroke units
value of stroke care
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Hellenic Foundation for Research and Innovation
name: General Secretariat for Research and Technology
name: Hellenic Stroke Organization
First posted: 2019-09-30
Enrollment: 913
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: About 1,000 first ever stroke patients (2% of all new cases/annually) will be recruited from six urban and semi-urban areas with 5.5 mil people (50% of Greek population), reporting 25,000 discharged stroke cases annually. All patients will be followed for three months.

Brief summary: The main objectives of the proposed project are:

1. To provide essential data on acute stroke management (quality indicators) incorporating hard clinical outcomes that will contribute to an ongoing process of quality improvement
2. To develop an interactive multichannel platform, for collecting, cleansing and curating high quality in-hospital and follow up data, applying multidimensional quality assessment analysis, providing statistical and analytic reports, monitoring behavioral changes and supporting overall project's management.
3. To evaluate patients' and physicians' experiences and their impact on stroke management.
4. To assess severe negative impact of stroke on the life of survivors including quality of life and disability
5. To measure health related and non- health (loss of productivity, informal care) related national expenditure for stroke care using a bottom up approach
6. To evaluate the value of care focusing on health outcomes compared with total costs of achieving them

Detailed description: A prospective cohort multicenter study of patients with first ever acute stroke, hemorrhagic and ischemic, (ICD-10 codes: I61, I63 and I64) admitted within 48 hours of symptoms onset to seven NHS and University hospitals will be conducted. About 1,000 patients (2% of all new cases/annually) will be recruited from six urban and semi-urban areas with 5.5 mil people (50% of Greek population), reporting 25,000 discharged stroke cases annually (53% of all stroke discharges), according to data derived from Hellenic Statistical Authority. All patients will be followed for three months. Moreover, a sub-group of the 300 firstly recruited patients will be followed for a year to obtain data on post hospital health and social needs, health services utilization (medication, rehabilitation, outpatient visits) and productivity loss . Patient enrolment and follow up is estimated to last 18 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of hemorrhagic or ischemic stroke (ICD-10: I61, I63 and I64)
* Patients with First ever acute stroke

Primary outcomes:
measure: Mortality
timeFrame: Through hospitalization completion, an average of 10 days
measure: Mortality
timeFrame: One month
measure: Mortality
timeFrame: Three months
measure: Modified Rankin Scale (mRS) score
timeFrame: Through hospitalization completion, an average of 10 days
measure: Modified Rankin Scale (mRS) score
timeFrame: One month
measure: Modified Rankin Scale (mRS) score
timeFrame: Three months
measure: National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: Through hospitalization completion, an average of 10 days
measure: National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: One month
measure: National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: Three months
measure: Cost
timeFrame: Through hospitalization completion, an average of 10 days
measure: Cost
timeFrame: One month
measure: Cost
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
city: Athens
country: Greece
facility: Aiginiteio Hospital of Athens
city: Athens
country: Greece
facility: General Hospital of Athens Alexandra
city: Athens
country: Greece
facility: Hellenic Stroke Organization
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Chania
country: Greece
facility: Chania General Hospital St George
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Larisa
country: Greece
facility: General University Hospital of Larisa
city: Thessaloniki
country: Greece
facility: University General Hospital of Thessaloniki Ahepa
city: Tripoli
country: Greece
facility: General Hospital of Tripoli Evaggelistria
Study officials:
affiliation: Senior Researcher on Health and Nursing Economics and Management
name: OLGA SISKOU, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Physicians /Nurses Team
name: GEORGE NTAIOS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of IT Team
name: GEORGE PAPASTEFANATOS, PhD
role: PRINCIPAL_INVESTIGATOR
References: