Atrial Fibrillation, Cardiac Failure, Hemorrhage, Thrombosis
Conditions
Keywords
pharmacist interventions, warfarin, elderly rural patients
Brief summary
The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.
Interventions
OTHERanticoagulation care
Patients in the intervention group will: 1) have a repeated pharmacist-led education on all aspects of warfarin treatment; 2) receive enhanced medication instructions and a care and follow up plan; 3) receive a pill box 4) be refered to the GP with proposal for dose change when outside the therapeutic range or therapy modification to avoid drug interactions with warfarin
Sponsors
Slaven Falamić
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥65 years * Living site of participant outside the city eg. rural site * Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before
Exclusion criteria
* Hospitalization * Vegetarianism * Patients not able to provide an informed consent * The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in therapeutic range (TTR) | 6 months | Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to adverse drug reaction | 6 months | To measure the difference in time to adverse drug reactions between the intervention and the control group |
| International randomised ratio | 6 months | To measure the difference in patterns of the International randomised ratio between the intervention and the control group |
| Adherence | 6 months | To measure the difference in adherence between the intervention and the control group |
| Adverse drug reactions | 6 months | To measure the difference in number and types of adverse drug reactions between the intervention and the control group |
| Incidence and influence of clinically significant drug interactions | 6 months | To measure the incidence of clinically significant drug interactions (defined by the Lexicomp-interact base as degree C and D of clinical significance) and influence of drug interactions on the effectiveness and safety of treatment between the intervention and the control group |
| Dietary intake of vitamin K | 6 months | Changes of dietary intake of vitamin K |
| Acceptance of pharmacist's intervention by the general practitioners | 6 months | To measure the rate of acceptance of pharmacist's interventions by the general practitioners |
| Quality of life | 6 months | To measure the difference of the quality of life in the intervention and the control group at the beginning and the end of the study (validated Croatian version of DUKE - Duke anticoagulation satisfaction scale questionaire) |
Outcome results
None listed