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

Cerebrovascular Disorders Clinical Trial

— SUN4P  

Official title:

Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes- Stroke Units Necessity for Patients (SUN4P)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109612
• Other study ID #: 15117
• Status: Completed
• Start date: July 17, 2019
• Est. completion date: January 13, 2022

Study information

• Verified date: April 2022
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 913
• Est. completion date: January 13, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of hemorrhagic or ischemic stroke (ICD-10: I61, I63 and I64)

• Patients with First ever acute stroke

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Stroke

Locations

Country	Name	City	State
Greece	Aiginiteio Hospital of Athens	Athens
Greece	General Hospital of Athens Alexandra	Athens
Greece	Hellenic Stroke Organization	Athens
Greece	Laiko General Hospital of Athens	Athens
Greece	National and Kapodistrian University of Athens	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

Sponsors (4)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	General Secretariat for Research and Technology, Hellenic Foundation for Research and Innovation, Hellenic Stroke Organization

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Patient based stroke (inpatient and outpatient) mortality	Through hospitalization completion, an average of 10 days
Primary	Mortality	Patient based stroke (inpatient and outpatient) mortality	One month
Primary	Mortality	Patient based stroke (inpatient and outpatient) mortality	Three months
Primary	Modified Rankin Scale (mRS) score	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)	Through hospitalization completion, an average of 10 days
Primary	Modified Rankin Scale (mRS) score	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)	One month
Primary	Modified Rankin Scale (mRS) score	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)	Three months
Primary	National Institutes of Health Stroke Scale (NIHSS) score	NIHSS is a method for assessing the severity of a stroke experienced by a patient (0: No Stroke Symptoms, 42:Severe Stroke)	Through hospitalization completion, an average of 10 days
Primary	National Institutes of Health Stroke Scale (NIHSS) score	NIHSS is a method for assessing the severity of a stroke experienced by a patient (0: No Stroke Symptoms, 42: Severe Stroke)	One month
Primary	National Institutes of Health Stroke Scale (NIHSS) score	NIHSS is a method for assessing the severity of a stroke experienced by a patient (0: No Stroke Symptoms, 42: Severe Stroke)	Three months
Primary	Cost	Average cost per patient	Through hospitalization completion, an average of 10 days
Primary	Cost	Average cost per patient	One month
Primary	Cost	Average cost per patient	Three months

External Links

•   Paper entitled: Developing Patients' Experiences Database After Hospital Discharge: Another Step In Improving Stroke Care
•   Paper entitled: Inpatient Cost of Stroke Care in Greece: Preliminary Results of the Web-Based "SUN4P" Registry
•   Paper entitled: Stroke Units Necessity for Patients, Web-Based "SUN4P" Registry: Descriptive Characteristics of the Population
•   Paper entitled: Sun4Patients Web Platform: Facilitating Long-Term Monitoring of Stroke Patients
•   Paper entitled:Access of Stroke Patients' to Optimal Healthcare Technology in Greece: Messages to Policy Makers
•   Paper entitled:Assessing Staff's and Stroke Patients' Experiences in 8 Hospitals in Greece: Results from a Prospective Multi-Center Study ("SUN4Patients")
•   Project site