Clinical trial NCT03999905: 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
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Atrial Fibrillation
Keywords: Patient counseling
Mystery patient
Oral anticoagulant
Pharmacist
Warfarin
Adverse drug reaction
Nigeria
Community pharmacists
Lead sponsor: University of Ibadan
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in the level of oral anticoagulant counseling
timeFrame: Baseline and at 2-weeks post intervention training
Secondary outcomes:
measure: Detection of adverse drug reaction due to warfarin
timeFrame: Baseline and 4 week post intervention training.
measure: Detection of drug interaction with warfarin
timeFrame: Baseline and 4 week post intervention training.
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: Community Pharmacies in Ibadan Metropolis
state: Oyo
Study officials:
affiliation: University of Ibadan
name: Segun J Showande, Ph.D
role: STUDY_DIRECTOR
References: