Plain English Summary
Background and study aims
Antithrombotic drugs reduce the formation of blood clots. Many patients receive antithrombotic treatment because of an irregular heartbeat or recurrent blood clots. Traditional antithrombotic treatments (e.g. with coumarins or aspirin) may lead to severe or even lethal adverse events such as bleeding. The aim of this study is to investigate whether a best practice model that includes patient education and regular monitoring by a healthcare assistant can help to improve antithrombotic management in general practices by reducing the number of severe events.
Who can participate?
Adult patients who are expected to take antithrombotic tablets for the rest of their lives and who regularly visit their general practitioner.
What does the study involve?
Participating family practices are randomly assigned to either the intervention group or the standard care group. Patients in the intervention group receive a more intensive treatment program involving general practitioners, health care assistants and education. The healthcare assistants in particular regularly monitor patients by means of a structured checklist whenever they visit the practice. This is so the practice team can figure out certain problems with medication interaction immediately and can help to solve the problems at once. The standard care group continue to receive standard healthcare based on the provided guidelines.
What are the possible benefits and risks of participating?
We expect intensified antithrombotic care in the intervention group to lead to improved outcomes. As the study is not concerned with drug effectivness and the patients continue their assigned treatment, we do not expect participation to entail any additional risks.
Where is the study run from?
The study will be run by the Institute of General Practice and involve 46 practices in Germany.
When is the study starting and how long is it expected to run for?
May 2012 to April 2015.
Who is funding the study?
German Federal Ministry of Education and Research.
Who is the main contact?
Prof Andrea Siebenhofer-Kroitzsch
Johann Wolfgang Goethe University
+49 (0)69 6301 7296
PrImary Care management for optimized ANtithrombotic Treatment: a cluster-randomized controlled trial
We expect that a best practice model that applies major elements of case management, including patient education, can improve antithrombotic management in primary health care in terms of reducing major thromboembolic and bleeding events in the intervention versus the standard care group.
Department of Medicine, J.W. Goethe University Hospital, Frankfurt [Fachbereich Medizin, Klinikum der J.W. Goethe Universität Frankfurt], 14/11/2011, ref: E 191/11
Single-center cluster randomized controlled trial
Primary study design
Secondary study design
Cluster randomised trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Patients with long-term indication for antithrombotic treatment
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, as well as detect complications early, HCAs will be trained in case management and will regularly monitor patients by means of the Coagulation-Monitoring-List (Co-MoL). Practice routines will be improved. For patients the intervention will include patient information, treatment monitoring via the Co-MoL and motivation to perform self-management.
The control will consist of standard primary health care based on the provided guidelines without any case-management intervention and specific patient education.
Primary outcome measures
Combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications
Secondary outcome measures
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
Overall trial start date
Overall trial end date
Participant inclusion criteria
Trial sites (General practices):
1. Working as a general practitioner inclusive specialists in internal medicine
2. Doctors 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
Target number of participants
345 per group, 690 in total
Participant exclusion criteria
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)]
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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Johann Wolfgang Goethe University
Federal Ministry of Education and Research (Germany) ref: 01GY1145
Federal Ministry of Education and Research, BMBF
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25344288
Ulrich LR, Mergenthal K, Petersen JJ, Roehl I, Rauck S, Kemperdick B, Schulz-Rothe S, Berghold A, Siebenhofer A, Anticoagulant treatment in German family practices - screening results from a cluster randomized controlled trial., BMC Fam Pract, 2014, 15, 170, doi: 10.1186/s12875-014-0170-0.