Impact of Pharmacists' Training on Oral Anticoagulant Counseling

NCT03999905 | Completed

• 1 other identifier: PharmImpact001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Vein Thrombosis; Pulmonary Embolism; Atrial Fibrillation

Keywords

Patient counseling; Mystery patient; Oral anticoagulant; Pharmacist; Warfarin; Adverse drug reaction; Nigeria; Community pharmacists

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Detection of adverse drug reaction due to warfarin

  Baseline and 4 week post intervention training.

• Detection of drug interaction with warfarin

  Baseline and 4 week post intervention training.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Online training on Oral anticoagulant counseling.

Behavioral: Counseling training

Control Arm

NO INTERVENTION

No counseling training

Interventions

Counseling training BEHAVIORAL

Online training using Moodle.

Intervention Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community Pharmacists with at least one-year practice experience
• Community pharmacies that stock and dispense warfarin

You may not qualify if:

• Community pharmacists working in order sectors

Sponsors & Collaborators

• University of Ibadan: lead

Study Sites (1)

Community Pharmacies in Ibadan Metropolis

Ibadan, Oyo State, 200284, Nigeria

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Atrial Fibrillation; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Officials

• Segun J Showande, Ph.D

  University of Ibadan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 27, 2019
• Study Start: April 24, 2019
• Primary Completion: September 30, 2019
• Study Completion: October 10, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available on the Mendeley database repository six months after the completion of the study.
• Access Criteria: Once the data is uploaded on the Mendeley database repository, it can be accessed easily.

Locations

NG (1)