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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04109612

Acronym

SUN4P

Enrollment

913

Registered

2019-09-30

Start date

2019-07-17

Completion date

2022-01-13

Last updated

2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disorders

Keywords

stroke, stroke care, stroke units, value of stroke care

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Countries

Greece

Outcome results