Patients with long-term indication for antithrombotic treatment Circulatory System
Conditions
Interventions
The trial interventions will be a multifaceted intervention involving general practitioners (GPs), health care assistants (HCA) and patients. To assess adherence to medication and symptoms in patients
Sponsors
Federal Ministry of Education and Research (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Trial sites (General practices): 1. Working as a general practitioner inclusive specialists in internal medicine 2. Doctor?s agreement that health care assistants (HCAs) from the practice are allowed to participate in a structured educational course and perform specific case management duties afterwards 3. Practice provides health services to persons with German statutory health insurance 4. Practice software with the facility to detect eligible patients requiring antithrombotic treatment 5. Investigating physician agrees to the contractual obligations of the trial Patient 1. All patients (age =18 years) 2. Long term indication for oral anticoagulation: atrial fibrillation, recurrent venous thromboembolism, pulmonary embolism, mechanical heart prosthesis and others such as; hereditary coagulopathy, intracardial thrombosis 3. Given indication for coumarins, antiplatelet therapies or the new antithrombotic agents rivaroxaban and dabigatran 4. Patient is capable to give a free and written informed consent to participate in the trial, to fill in questionnaires and to participate in telephone interviews. 5. Care is provided by a general practitioner (GP) working at a trial site (at least one contact in the last 12 months) 6. Patient is legally competent to sign any documents
Exclusion criteria
Exclusion criteria: Patients: 1. Lack of German language skills 2. Diseases causing life expectancy of < 6 months 3. Dementia (GPs assessment) [less than score 26 in Mini Mental State Examination (MMSE)] 4. Psychosis 5. Severe sight disorder or auditory defect 6. Alcohol-or drug abuse 7. Dementia (less than score 26 in MMSE) 8. Residence in institutions e.g. nursing homes or residential care home 9. Visits at the practice of the GP not possible, home visits required 10. Alcohol-or drug abuse 11. Participation in a clinical trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality 2. Frequency and duration of hospitalization 3. Number of recurrent strokes, major bleeding and thromboembolic complications 4. Treatment-related quality of life analysis (EQ 5 D;The EuroQol Group. Health Policy 1990 Dec;16(3):199-208) 5. Number of treatment interactions 6. Number of adverse events 7. Quality of anticoagulation control (Siebenhofer A, Rakovac I, Kleespies C, Piso B, Didjurgeit U. 8. Self-management of oral anticoagulation reduces major outcomes in the elderly. A randomized controlled trial. Thromb Haemost 2008; 100(6):1089-1098) 9. Cost effectiveness evaluations (Drummond et al Methods for the Economic Evaluation of Health care Programmes. 3rd edition, Oxford University Press 2005) 10. Qualitative study analysis to describe the experience of study participants (patients, HCA, GPs) on the basis of semi-structured interviews | — |
Countries
Germany
Outcome results
None listed