Impact of Pharmacists' Training on Oral Anticoagulant Counseling

Atrial Fibrillation Clinical Trial

Official title:

Impact of Pharmacists' Training on Oral Anticoagulant Counseling: a Randomized Control Trial Using Mystery Patient Model.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999905
• Other study ID #: PharmImpact001
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: October 10, 2019

Study information

• Verified date: April 2020
• Source: University of Ibadan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 10, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Behavioral:
• Counseling training
Online training using Moodle.

Locations

Country	Name	City	State
Nigeria	Community Pharmacies in Ibadan Metropolis	Ibadan	Oyo

Sponsors (1)

Lead Sponsor	Collaborator
University of Ibadan

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	Baseline and at 2-weeks post intervention training
Secondary	Detection of adverse drug reaction due to warfarin	Identification and counseling on detected adverse drug reaction resulting from the use of warfarin	Baseline and 4 week post intervention training.
Secondary	Detection of drug interaction with warfarin	Identification and counseling drug interaction with warfarin	Baseline and 4 week post intervention training.