Clinical trial NCT04159324: StroCare - Optimised Cross-sectoral,Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement
Official title: StroCare - Optimised Cross-sectoral, Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Patient-reported outcomes (PROs)
Cross-sectoral care
Stroke aftercare
Aftercare coordination
Post-rehabilitation support
Evidence based treatment
Patient-centred care
Quality of life
Morbidity
Mortality
Functional status
Feasibility
Acceptance
Process evaluation
Health economics
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Albertinen Krankenhaus
name: Elbe Kliniken Stade-Buxtehude GmbH
name: Reha Centrum Hamburg GmbH
name: Klinikum Bad Bramstedt GmbH
name: MediClin Klinikum Soltau GmbH
name: VAMED Klinik Geesthacht
name: VAMED Rehaklinik Damp
name: BARMER Krankenkasse
name: Lohmann und Birkner medizinisches ServiceCenter GmbH
name: Forcare GmbH
First posted: 2019-11-12
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: For a 12-months period patients undergoing aftercare treatment as usual are enrolled as an active control group. Subsequently, the intervention is implemented (StroCare treatment) and enrolment of the intervention group takes place for another 12 months. 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), routine data provided by the collaborating BARMER health insurance agency (for the intervention and control group and additionally for a historic control).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported physical QoL: PROMIS-10
timeFrame: 1 year after index ischemic event
Secondary outcomes:
measure: Patient-reported mental QoL
timeFrame: 1 year after index ischemic event
measure: Patient-reported mental health status
timeFrame: 1 year after index ischemic event
measure: Functional Status modified Rankin Scale questionnaire (smRSq)
timeFrame: 1 year after index ischemic event
measure: Overall survival
timeFrame: 1 year after index ischemic event
measure: Stroke recurrence
timeFrame: 1 year after index ischemic event
measure: Utilisation of health care Services
timeFrame: 1 year after index ischemic event
measure: Patient' s waiting time between Treatment phases (Transition) to the ambulant neurological Rehabilitation Treatment)
timeFrame: 1 year after index ischemic event
measure: Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): blood pressure
timeFrame: 1 year after index ischemic event
measure: Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): LDL-cholesterol
timeFrame: 1 year after index ischemic event
measure: Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): HbA1c
timeFrame: 1 year after index ischemic event
measure: Costs
timeFrame: 1 year after index ischemic event
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Centre Hamburg-Eppendorf
name: Götz Thomalla, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rimmele DL, Schrage T, Brettschneider C, Engels A, Gerloff C, Harter M, Rosenkranz M, Schmidt H, Kriston L, Thomalla G. Rationale and design of an interventional study of cross-sectoral, coordinated treatment of stroke patients with patient-orientated outcome measurement (StroCare). Neurol Res Pract. 2021 Feb 2;3(1):7. doi: 10.1186/s42466-021-00107-2.