PrImary Care management for optimized ANtithrombotic Treatment: a cluster-randomized controlled trial

Federal Ministry of Education and Research (Germany)0 个研究点目标入组 736 人开始时间: 2012年4月13日最近更新: 2020年7月6日

试验速览

•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
•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

•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

发起方

Federal Ministry of Education and Research (Germany)