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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 409
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: StroCare treatment group; Optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation	Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation; the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions
No Intervention: control group; routine aftercare stroke treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported physical QoL: PROMIS-10	Patient-reported physical Quality of Life measured with Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10); one of two provided global scores: Global Physcial Health with scores ranging from 0-20 and higher scores indicating better health state.	1 year after index ischemic event

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported mental health status	Patient reported mental health Status measured with the Patient health questionnaire (PHQ-4); the questionnaire provides two sub-scores measuring anxiety and depression with scores ranging from 0-6 each with higher scores indiciating more symptoms of anxiety or depression, respectively	1 year after index ischemic event
Functional Status modified Rankin Scale questionnaire (smRSq)	Functional Status measured with the modified Rankin Scale (mRS); the nRS ranges from 0 (no disability) to 6 (death)	1 year after index ischemic event
Overall survival	Overall survival measured with the ICHOM Standard set	1 year after index ischemic event
Stroke recurrence	Stroke recurrence measured with the ICHOM Standard set	1 year after index ischemic event
Utilisation of health care Services	Utilisation of health care Services extracted from the medical record and the electronic Portal (only Intervention Group), i.e., number of admissions to hospital, number of outpatient contacts, weekly hours of physiotherapy, speech therapy, occupational therapy	1 year after index ischemic event
Patient' s waiting time between Treatment phases (Transition) to the ambulant neurological Rehabilitation Treatment)	Waiting time extracted from the medical record and the electronic Portal (only Intervention Group)	1 year after index ischemic event
Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): blood pressure	Current values Blood Pressure will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation	1 year after index ischemic event
Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): LDL-cholesterol	Current values of LDL-cholesterol will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation	1 year after index ischemic event
Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): HbA1c	Current values of HbA1c will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation	1 year after index ischemic event
Costs	Routine data	1 year after index ischemic event
Patient-reported mental QoL	Patient-reported mental Quality of Life measured with Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10); one of two provided global scores: Global Mental Health with scores ranging from 0-20 and higher scores indicating better health state.	1 year after index ischemic event

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Albertinen Krankenhaus gGmbH; Elbe Kliniken Stade-Buxtehude GmbH; Reha Centrum Hamburg GmbH; Klinikum Bad Bramstedt GmbH; MediClin Klinikum Soltau GmbH; VAMED Klinik Geesthacht; VAMED Rehaklinik Damp; BARMER Krankenkasse; Lohmann und Birkner medizinisches ServiceCenter GmbH; Forcare GmbH
• Investigators: Principal Investigator: Götz Thomalla, Prof. Dr., University Medical Centre Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Feasibility; Quality of life; Morbidity; Mortality; Functional status; Health economics; Patient-centred care; Process evaluation; Acceptance; Patient-reported outcomes (PROs); Cross-sectoral care; Stroke aftercare; Aftercare coordination; Post-rehabilitation support; Evidence based treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 01NVF18022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No