Impact of Pharmacists' Training on Oral Anticoagulant Counseling
Primary Purpose
Deep Vein Thrombosis, Pulmonary Embolism, Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Counseling training
Sponsored by
About this trial
This is an interventional health services research trial for Deep Vein Thrombosis focused on measuring Patient counseling, Mystery patient, Oral anticoagulant, Pharmacist, Warfarin, Adverse drug reaction, Nigeria, Community pharmacists
Eligibility Criteria
Inclusion Criteria:
- Community Pharmacists with at least one-year practice experience
- Community pharmacies that stock and dispense warfarin
Exclusion Criteria:
- Community pharmacists working in order sectors
Sites / Locations
- Community Pharmacies in Ibadan Metropolis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm
Control Arm
Arm Description
Online training on Oral anticoagulant counseling.
No counseling training
Outcomes
Primary Outcome Measures
Change in the level of oral anticoagulant counseling
Level of counseling is determined by the mnemonic WARFARINISED median score. W - When to take warfarin, A - Alcohol consumption effect, R - Risk of bleeding explanation, F - Follow-up appointments, A - Aspirin and other drugs affect the action of warfarin, R - Reason for taking warfarin, I - Interactions with food and drinks, N - Notify health professional of the medication, I - International Normalised Ration measurement, S - Skipped doses, what to do, E - End of treatment, D - Dose of warfarin
Each of the counseling points will be scored 1 point. The minimum score will be 0 point and the maximum will be 12 points.
Higher values indicate better counseling provided by the pharmacist while lower value indicate poor counseling .
Secondary Outcome Measures
Detection of adverse drug reaction due to warfarin
Identification and counseling on detected adverse drug reaction resulting from the use of warfarin
Detection of drug interaction with warfarin
Identification and counseling drug interaction with warfarin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03999905
Brief Title
Impact of Pharmacists' Training on Oral Anticoagulant Counseling
Official Title
Impact of Pharmacists' Training on Oral Anticoagulant Counseling: a Randomized Control Trial Using Mystery Patient Model.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ibadan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the impact of community pharmacists' educational training on the nature and adequacy of counseling provided to patients on warfarin, an oral anticoagulant. Half of the community pharmacists participating in the study will receive a two-week educational training on how to adequately counsel patients on warfarin while the other half of community pharmacists will receive the same training after the study. A mystery patient model will be used in this intervention study where six different trained and standardized individuals will act as patients. Each of these mystery patients will supposedly have pulmonary embolism, deep vein thrombosis, or atrial fibrillation. The mystery patient will visit each pharmacy to buy warfarin or complain about adverse drug reaction been experienced. It is expected that pharmacists will provide relevant information and counseling to these patients on the use of the medication warfarin and how to handle the adverse drug reactions.
Detailed Description
Although direct oral anticoagulants also have their limitations (such as the risk of gastrointestinal bleeding) they are not as prominent as that of warfarin but still important to consider before prescribing to patients. These limitations associated with the use of oral anticoagulants prove that there is need for special counseling of patients placed on oral anticoagulants. Counseling, as an important aspect of drug therapy management, is somewhat technical and requires a peculiar way of providing vital information on drug therapy within the shortest possible time. Pharmacists, who are key members of the healthcare team, are tasked with this role more than others and as such this area is of optimum importance.
Proper and adequate counseling on oral anticoagulants is essential for optimal use of the drug and to reduce the number of incidence of adverse drug reactions. Adequate counseling cannot be achieved without proper training. This aspect is seen to be lacking due to the suboptimal performance discovered in research among healthcare professionals including pharmacists with regards to counseling of patients on oral anticoagulant use Mystery patients in pharmacy practice research are a very reliable means of obtaining unbiased data on pharmacists with regards to counseling. This study, therefore, is aimed at providing counseling training to community pharmacists and evaluating the impact of the training on patients indirectly using the mystery patient model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Pulmonary Embolism, Atrial Fibrillation
Keywords
Patient counseling, Mystery patient, Oral anticoagulant, Pharmacist, Warfarin, Adverse drug reaction, Nigeria, Community pharmacists
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned into either arm of the study randomly. Participants in the intervention arm will receive educational training after baseline assessment while participants in the control group will receive the same training after the study had been completed.
Masking
Care ProviderInvestigator
Masking Description
Participants were randomized into the intervention and control arm through computer-generated random numbers. the randomization was done by a neutral person. The investigators and the mystery patients were unaware of the members of the intervention arm or the control arm.
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Online training on Oral anticoagulant counseling.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
No counseling training
Intervention Type
Behavioral
Intervention Name(s)
Counseling training
Intervention Description
Online training using Moodle.
Primary Outcome Measure Information:
Title
Change in the level of oral anticoagulant counseling
Description
Level of counseling is determined by the mnemonic WARFARINISED median score. W - When to take warfarin, A - Alcohol consumption effect, R - Risk of bleeding explanation, F - Follow-up appointments, A - Aspirin and other drugs affect the action of warfarin, R - Reason for taking warfarin, I - Interactions with food and drinks, N - Notify health professional of the medication, I - International Normalised Ration measurement, S - Skipped doses, what to do, E - End of treatment, D - Dose of warfarin
Each of the counseling points will be scored 1 point. The minimum score will be 0 point and the maximum will be 12 points.
Higher values indicate better counseling provided by the pharmacist while lower value indicate poor counseling .
Time Frame
Baseline and at 2-weeks post intervention training
Secondary Outcome Measure Information:
Title
Detection of adverse drug reaction due to warfarin
Description
Identification and counseling on detected adverse drug reaction resulting from the use of warfarin
Time Frame
Baseline and 4 week post intervention training.
Title
Detection of drug interaction with warfarin
Description
Identification and counseling drug interaction with warfarin
Time Frame
Baseline and 4 week post intervention training.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Community Pharmacists with at least one-year practice experience
Community pharmacies that stock and dispense warfarin
Exclusion Criteria:
Community pharmacists working in order sectors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Segun J Showande, Ph.D
Organizational Affiliation
University of Ibadan
Official's Role
Study Director
Facility Information:
Facility Name
Community Pharmacies in Ibadan Metropolis
City
Ibadan
State/Province
Oyo
ZIP/Postal Code
200284
Country
Nigeria
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participants data will be made available online.
IPD Sharing Time Frame
Data will be available on the Mendeley database repository six months after the completion of the study.
IPD Sharing Access Criteria
Once the data is uploaded on the Mendeley database repository, it can be accessed easily.
IPD Sharing URL
https://data.mendeley.com/drafts/
Learn more about this trial
Impact of Pharmacists' Training on Oral Anticoagulant Counseling
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