ICD-10-GM-2024: Acute ischemic or hemorrhagic stroke (I60-I64) or transient ischemic attack (G45)
Conditions
Interventions
Group 1: Intervention group: Patients with navigator support i.e., navigated patients, for 12 months.
Group 2: Control group: Patients without navigator support i.e., non-navigated patients, for 12 mo
Sponsors
Stiftung Deutsche Schlaganfall-Hilfe
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Stroke navigators • Patients with confirmed stroke, ICD codes I60 - I64 and G45 (TIA) • Continuous membership with a health insurance company participating in the LEX LOTSEN OWL project (consortium partner and cooperation partner health insurance companies). • Written informed consent • Patient's residence within the catchment area of the responsible patient navigator provider • No existing care level or existing care level 0, 1, 2, 3, or 4 before the current stroke, or care level 5 initiated by a stroke • Good German language skills or the guarantee of language support available for the duration of the intervention in order to understand and give informed consent to the declaration of consent 2) Cardio navigators • Patients with confirmed diagnoses of ICD codes I20 - I25, I47 - I49, I50 • Continuous membership with a health insurance company participating in the LEX LOTSEN OWL project (consortium partner and cooperation partner health insurance companies) • Written informed consent • Patient's residence within the catchment area of the responsible patient navigator provider • No existing care level or existing care levels 0, 1, 2, 3, or 4 • Good German language skills or the guarantee of language support available for the duration of the intervention in order to understand and give informed consent to the declaration of consent
Exclusion criteria
Exclusion criteria: 1) Stroke navigators • Insured persons under the age of 18 • Insured persons residing outside the catchment area • Existing care level 5 before the initial stroke • Existing long-term inpatient care or long-term inpatient therapy prior to the current stroke • Navigator level 0 (determined by navigators as part of the screening) • Navigator levels 1-3, but with overlapping secondary diagnoses that require focus on another indication-specific field of network activity (determined by navigators as part of the screening), e.g., oncology, palliative care, dementia, psychiatry, geriatrics 2) Cardio navigators • Insured persons under the age of 18 • Insured persons residing outside the catchment area • Existing care level 5 • Existing long-term inpatient care or long-term inpatient therapy prior to the current cardiac event • Navigator level 0 (determined by navigators as part of the screening) • Navigator levels 1-3, but with overlapping secondary diagnoses that require focus on another indication-specific field of network activity (determined by navigators as part of the screening), e.g., oncology, palliative care, dementia, psychiatry, geriatrics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two primary endpoints are examined: a patient-related and a navigator-related endpoint. 1) Patient-related primary endpoint: Experienced quality of care, measured using the Patient Experience of Integrated Care Scale (PEICS) questionnaire by Joober et al. (2018). Data collection points are at baseline (t0), after six months (t1), and after 12 months (t2); cross-sectional comparison. 2) Navigator-related primary endpoint: Relational coordination (i.e., coordination and networking of service providers and network partners of integrated care); measured with the construct of relational coordination according to Gittel (2008, 2011, and 2016). Data collection points are at baseline (t0), after six months (t1), after 12 months (t2), after 18 months (t3) and after 24 months (t4); longitudinal comparison. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Health-related quality of life, measured using EQ-5D-5L; data collection points are at baseline (t0), after six months (t1), and after 12 months (t2); cross-sectional comparison. 2) (Re-)hospitalizations are directly captured through a self-constructed survey of patients or their relatives. A distinction is made between all hospitalizations and outpatient-sensitive hospital admissions. Data collection points are after six months (t1) and after 12 months (t2); cross-sectional comparison. 3) Mortality of patients is directly captured through a self-constructed survey of their relatives. Data collection points are after six months (t1) and after 12 months (t2); cross-sectional comparison. 4) Patient self-management: The Patient Activation Measure (PAM-13) by Hibbard et al. (2005) is used to assess active patient participation. Data collection points are after six months (t1) and after 12 months (t2); cross-sectional comparison. 5) Self-efficacy of family caregivers, measured using the Caregiver Self-Efficacy Scale (CSES-8) by Ritter et al. (2022). Data collection points are after six months (t1) and after 12 months (t2); cross-sectional comparison. | — |
Countries
Germany
Outcome results
None listed