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

NCT04109612 | Completed DMC

• 1 other identifier: 15117
• Study Type: observational
• Target: 913
• Locations: 1 country
• Sites: 10

Brief Summary

The main objectives of the proposed project are:

1. 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. 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. 3.To evaluate patients' and physicians' experiences and their impact on stroke management.
4. 4.To assess severe negative impact of stroke on the life of survivors including quality of life and disability
5. 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. 6.To evaluate the value of care focusing on health outcomes compared with total costs of achieving them

Conditions

Cerebrovascular Disorders

Keywords

stroke; stroke care; stroke units; value of stroke care

Outcome Measures

Primary Outcomes (12)

• Mortality

  Patient based stroke (inpatient and outpatient) mortality

  Through hospitalization completion, an average of 10 days

• Mortality

  Patient based stroke (inpatient and outpatient) mortality

  One month

• Mortality

  Patient based stroke (inpatient and outpatient) mortality

  Three months

• 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

• 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

• 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

• 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

• 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

• 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

• Cost

  Average cost per patient

  Through hospitalization completion, an average of 10 days

• Cost

  Average cost per patient

  One month

• Cost

  Average cost per patient

  Three months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Hellenic Foundation for Research and Innovation: collaborator
• General Secretariat for Research and Technology: collaborator
• Hellenic Stroke Organization: collaborator

Study Sites (10)

National and Kapodistrian University of Athens

Athens, 11527, Greece

Location

Aiginiteio Hospital of Athens

Athens, Greece

Location

General Hospital of Athens Alexandra

Athens, Greece

Location

Hellenic Stroke Organization

Athens, Greece

Location

Laiko General Hospital of Athens

Athens, Greece

Location

Chania General Hospital St George

Chania, Greece

Location

University General Hospital of Ioannina

Ioannina, Greece

Location

General University Hospital of Larisa

Larissa, Greece

Location

University General Hospital of Thessaloniki Ahepa

Thessaloniki, Greece

Location

General Hospital of Tripoli Evaggelistria

Tripoli, Greece

Location

Related Links

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

MeSH Terms

Conditions

Cerebrovascular Disorders; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• OLGA SISKOU, PhD

  Senior Researcher on Health and Nursing Economics and Management

  PRINCIPAL INVESTIGATOR

• GEORGE NTAIOS, PhD

  Head of Physicians /Nurses Team

  PRINCIPAL INVESTIGATOR

• GEORGE PAPASTEFANATOS, PhD

  Head of IT Team

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: September 30, 2019
• Study Start: July 17, 2019
• Primary Completion: October 30, 2021
• Study Completion: January 13, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

GR (10)