Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes-

Completed

• Conditions: Cerebrovascular Disorders

• Registration Number: NCT04109612
• Lead Sponsor: National and Kapodistrian University of Athens

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.

Study Timeline

• Study Start: 2019-07-17
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Primary Completion: 2021-10-30
• Study Completion: 2022-01-13
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 913

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS) score	Three months	mRS measures the degree of disability or dependence in the daily activities of patients after a stroke or other causes of neurological disability (0: no symptoms at all - 6: Dead)
National Institutes of Health Stroke Scale (NIHSS) score	Three months	NIHSS is a method for assessing the severity of a stroke experienced by a patient (0: No Stroke Symptoms, 42: Severe Stroke)
Mortality	Three months	Patient based stroke (inpatient and outpatient) mortality
Cost	Three months	Average cost per patient

Trial Locations

Locations (10)

National and Kapodistrian University of Athens; 🇬🇷 Athens, Greece

Aiginiteio Hospital of Athens; 🇬🇷 Athens, Greece

General Hospital of Athens Alexandra; 🇬🇷 Athens, Greece

Chania General Hospital St George; 🇬🇷 Chania, Greece

University General Hospital of Ioannina; 🇬🇷 Ioannina, Greece

General University Hospital of Larisa; 🇬🇷 Larisa, Greece

University General Hospital of Thessaloniki Ahepa; 🇬🇷 Thessaloniki, Greece

General Hospital of Tripoli Evaggelistria; 🇬🇷 Tripoli, Greece

Laiko General Hospital of Athens; 🇬🇷 Athens, Greece

Hellenic Stroke Organization; 🇬🇷 Athens, Greece