CHAPTER III METHODOLOGY
3.2 Phase 2: A Randomized Controlled Trial (RCT) study
3.2.11 Data collection procedure
3.2.11.1 The researcher was contacted with Mahosot Hospital to confirm the dates (during February to May, 2019).
3.2.11.2 When research met patients for the first time, patients were guided by nurses. When patient walk in, researcher identified the patient who was participant in the study following the inclusion and exclusion criteria.
3.2.11.3 Researcher was asked for patients who met the inclusion and exclusion criteria to be a participant on the research during February to May 2019.
Participant information forms were given to all participants (see Appendix K). All included patients had to sign an informed consent form (see Appendix J).
3.2.11.4 Patients were divided into two groups using a randomized table (permuted block). During baseline visit in February, researcher could invite 72 patients, 36 patients for each group.
3.2.11.5 A sticker was used to mark patients who is in trial. Patient individual codes were used to divide the control or intervention group.
Data collection procedure for patient in the pharmacist-managed warfarin therapy (intervention group):
- Patients were received usual care then following with the intervention led by researcher which was developed from phase 1.
- Each patient was met the researcher four times (take about 15 minutes for each visit).
First visit:
- Patients were asked for a patients’ data.
- Patients were asked a question following the questionnaire for warfarin therapy to be patients’ baseline knowledge.
- To give patients’ intervention by researcher and to take individual short note for each patient.
Second, third and fourth visit:
- Patients were asked for a patients’ data.
- Patients were asked a question following the questionnaire for warfarin therapy to assess patients’ knowledge.
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- To give patients’ intervention by researcher and to take individual short note for each patient.
Data collection procedure for patient in the usual care (control group):
- Patients were received usual care then following to answer a questionnaire with preparing by a researcher.
- Each patient was met the researcher four times (take about 5 minutes for each visit).
First visit:
- Patients were asked for a patients’ data.
- Patients were asked a question following the questionnaire for patients’ knowledge assessment to be patients’ baseline knowledge.
Second and third visit:
- Patients were asked for a patients’ data.
Fourth visit:
- Patients were asked for a patients’ data.
- Patients were asked a question following the questionnaire for patients’ knowledge assessment to assess patients’ knowledge.
3.2.11.6 In case of patients who do not come to follow were during the second visit, the researcher was called to ask for the reason. If patients were not available for a next visit, the patients were excluded from the study. A new case was randomly selected to compensate for patients who was cut.
3.2.11.7 In case of patients who do not come to follow-up during the third or fourth visit. That patients were cut from the study. A new case was not being randomly selected to compensate for patients who was cut.
3.2.11.8 Figure 2 was guide how the data collection procedure was being followed.
3.2.11.9 Table 5 was explained the workflow of the groups.
3.2.11.10 Outcomes measurement is in the table 6.
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Figure 2 Flowchart for data collection procedure for RCT phase
Patient receive usual care on warfarin therapy Patient receive usual care on
warfarin therapy 30 patients in control group
Patient receive pharmacists’
intervention call pharmacist- managed warfarin therapy Random 60 samples used permuted block randomization
Collect patients’ data and questionnaire for knowledge
assessments
Screen sample by inclusion and exclusion criteria
30 patients in intervention group
Collect patients’ data and questionnaire for knowledge
assessments
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Table 5 The workflow of the groups
Timing Usual care
(control group)
The pharmacist-managed warfarin therapy (intervention group) Month
0 (first visit)
- Receive usual care as following step:
1. Patient takes a blood test (INR test) at the laboratory room.
2. Patient registration, recipe the bill, a queue card.
3. A nurse was interviewed them about some patient
characteristics. To measure blood pressure and record it in to the patient’s book.
4. The doctor (cardiology specialist) was diagnosed, recommend to continues or change cardiovascular drugs including warfarin, provide a short counselling about the disease and the medication use to patient. So, the next follow up was up to the doctor appointment.
- After meeting with doctor, patient was met the
pharmacist (researcher) as following step:
1. Make an understanding to sign the informed-consent form.
2. Patient’s data collection.
3. Ask a questionnaire for patients’ knowledge assessment.
- Receive usual care.
- After meeting with doctor, patient was met the pharmacist (researcher) as following step:
1. Make an understanding to sign the informed-consent form.
2. Patient’s data collection.
3. Ask a questionnaire for patients’
knowledge assessment.
4. Medication review: DRPs.
5. Patient adherence checking.
6. In case of any DRPs, notify doctor and record the change in DRPs assessment form.
7. Patient education about warfarin therapy (see Appendix N).
Month 1 (second
visit)
- Receive the usual care.
- Meet the researcher for patient’s data collection.
- Receive usual care.
- After meeting with doctor, patient was meet the pharmacist (researcher) as following step:
1. Patient’s data collection.
2. Ask a questionnaire for patients’
knowledge assessment.
3. Medication review: DRPs.
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Table 5 (continued)
Timing Usual care
(control group)
The pharmacist-managed warfarin therapy (intervention group) 4. Patient adherence checking.
5. In case of any DRPs, notify doctor and record the change in DRPs assessment form.
6. Patient education about warfarin therapy (see Appendix N).
Month 2 (third visit)
- Receive the usual care.
- Meet the researcher for patient’s data collecting.
- Receive usual care.
- After meeting with doctor, patient was met the pharmacist (researcher) as following step:
1. Patient’s data collecting.
2. Ask a questionnaire for patients’
knowledge assessment.
3. Medication review: DRPs.
4. Patient adherence checking.
5. In case of any DRPs, notify doctor and record the change in DRPs assessment form.
6. Patient education about warfarin therapy (see Appendix N).
Month 3 (fourth
visit)
- Receive usual care.
- After meeting with doctor, patient was met the
pharmacist (researcher) as following step:
1. Patient’s data collecting.
2. Ask a questionnaire for patients’ knowledge assessment.
3. Medication review: DRPs.
4. Patient adherence checking.
5. In case of any DRPs, notify doctor and record the change.
Patient education about warfarin therapy.
- Receive usual care.
- After meeting with doctor, patient was met the pharmacist (researcher) as following step:
1. Patient’s data collecting.
2. Ask a questionnaire for patients’
knowledge assessment.
3. Medication review: DRPs.
4. Patient adherence checking.
5. In case of any DRPs, notify doctor and record the change in DRPs assessment form.
6. Patient education about warfarin therapy (see Appendix N).
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Table 6 Outcomes measurement
Control group Intervention group
1. Efficacy outcome:
- TTR - INR
- Knowledge scores - DRPs
- Thromboembolism events - Patients adherences 2. Safety outcome:
- ADRs
1. Efficacy outcome:
- TTR - INR
- Knowledge scores - DRPs
- Thromboembolism events - Patients adherences 2. Safety outcome:
- ADRs