Impact of Pharmacists' Training on Oral Anticoagulant Counseling

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Deep Vein Thrombosis; Pulmonary Embolism
• Intervention / Treatment: Behavioral: Counseling training

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Oyo
    • Ibadan, Oyo, Nigeria, 200284
      • Community Pharmacies in Ibadan Metropolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Online training on Oral anticoagulant counseling.	Behavioral: Counseling training; Online training using Moodle.
No Intervention: Control Arm; No counseling training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Detection of drug interaction with warfarin	Identification and counseling drug interaction with warfarin	Baseline and 4 week post intervention training.

Collaborators and Investigators

• Sponsor: University of Ibadan
• Investigators: Study Director: Segun J Showande, Ph.D, University of Ibadan

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 5, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Warfarin; Pharmacist; Nigeria; Patient counseling; Mystery patient; Oral anticoagulant; Adverse drug reaction; Community pharmacists
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Embolism; Atrial Fibrillation; Thrombosis; Venous Thrombosis; Pulmonary Embolism
• Other Study ID Numbers: PharmImpact001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No