StroCare - Optimised Cross-sectoral,Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Stroke

Treatments: Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT04159324

01NVF18022

Details and patient eligibility

About

The Trial is a multi-centred controlled interventional study with a pre-post design. The primary aim of the study is the evaluation of the effectiveness and cost-effectiveness of the StroCare treatment.

Full description

Stroke is the second most common cause of death in Germany and the most common cause for life-long disability in adulthood. After stroke, patients often experience incisive changes in their health, daily routine and quality of life. The developed model of care (StroCare treatment) forms a cross--sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation. It aims to optimize the transition from acute inpatient treatment after an acute stroke to the ambulant neurological rehabilitation treatment. This is done firstly by creating an electronic portal solution for a safe and coordinated transmission of clinical data between the three participating hospitals and five stroke-specialized ambulant rehabilitation clinics and secondly by introducing a case-manager provided by the participating health insurance agency for patient support and aftercare coordination. The presented study is a multi-centred controlled interventional study with a pre-post design. Stroke patients in both groups are assessed after the index ischemic event and 12 months thereafter. Further sources of information are the medical record, the electronic portal (only intervention group), and routine data provided by the collaborating BARMER health insurance agency (for the Intervention and control group and additionally for a historic control). The main hypotheses are : (1) The StroCare treatment is more effective than the routine aftercare treatment (primary outcome: patient-reported physical quality of life) and (2) the StroCare treatment reduces costs for care and in the inpatient sector by providing more coordinated and thorough rehabilitation and outpatient aftercare.

Enrollment: 409 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in inpatient care in the stroke unit of one of the participating acute clinics who are insured at the BARMER health insurance agency with the following diagnosis (ICD-10):
• Ischemic attack (I63)
• Transient ischemic attack and related syndromes (G45)
• Intracerebral haermorrhage (I64)
• Written informed consent
• Sufficient mastery of German language

Exclusion criteria

• Substantially impaired communication capacity due to aphasia or dementia
• Patients with artificial Respiration
• Insufficient adherence
• Premorbid score of mRS≥4
• Patients with artificial Respiration (Z99.1)
• Dementia (F00.x., F01.x. or G30.x) or aphasia (R47)
• Death during inpatient Treatment or the Admission to a nursing home following the acute treatment

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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409 participants in 2 patient groups

StroCare treatment group

Experimental group

Description:

Optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation

Treatment:

Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation

control group

No Intervention group

Description:

routine aftercare stroke treatment