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The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Specific pharmacist-led anticoagulation care |
|
| Control | No Intervention | The control group will receive usual care; no interventions will be administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anticoagulation care | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time in therapeutic range (TTR) | Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reactions | To measure the difference in number and types of adverse drug reactions between the intervention and the control group | 6 months |
| Time to adverse drug reaction | To measure the difference in time to adverse drug reactions between the intervention and the control group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Slaven Falamić, MPharm | Pharmacy Branka Marušić | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34754004 | Derived | Falamic S, Lucijanic M, Ortner-Hadziabdic M, Marusic S, Bacic-Vrca V. Pharmacists' interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial. Sci Rep. 2021 Nov 9;11(1):21897. doi: 10.1038/s41598-021-01394-0. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013927 | Thrombosis |
| D006333 | Heart Failure |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| 6 months |
| International randomised ratio | To measure the difference in patterns of the International randomised ratio between the intervention and the control group | 6 months |
| Adherence | To measure the difference in adherence between the intervention and the control group | 6 months |
| Quality of life | 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) | 6 months |
| Incidence and influence of clinically significant drug interactions | 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 | 6 months |
| Dietary intake of vitamin K | Changes of dietary intake of vitamin K | 6 months |
| Acceptance of pharmacist's intervention by the general practitioners | To measure the rate of acceptance of pharmacist's interventions by the general practitioners | 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |