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Completed

NCT Number: NCT03999905

Impact of Pharmacists' Training on Oral Anticoagulant Counseling

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.

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Key information

Conditions

Deep Vein Thrombosis Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Embolism Embolism and Thrombosis Heart Diseases Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Pharmacies in Ibadan Metropolis

Ibadan, Oyo State, 200284, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling training

Behavioral

Online training using Moodle.

Primary outcomes

  1. Change in the level of oral anticoagulant counseling

    Time frame: Baseline and at 2-weeks post intervention training

    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 outcomes

  1. Detection of adverse drug reaction due to warfarin

    Time frame: Baseline and 4 week post intervention training.

    Identification and counseling on detected adverse drug reaction resulting from the use of warfarin

  2. Detection of drug interaction with warfarin

    Time frame: Baseline and 4 week post intervention training.

    Identification and counseling drug interaction with warfarin

Sponsors and collaborators

Lead sponsor

University of Ibadan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2019
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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