Cost-Effectiveness Study on Establishing a Warfarin Counseling Clinic for Egyptian Patients With Mitral Valve Prostheses

The outcome of poor adherence to medications can be life threatening with certain drugs like warfarin. For each 10% increase in non-adherence to warfarin, there was a 14% increase in the risk of under-anticoagulation with significantly higher rates of morbidity and mortality. Furthermore, warfarin therapy is fraught with several inherent problems. These include a wide variation in dose requirement, delayed onset of anticoagulant effect, prolonged continuation after cessation of therapy, serious interactions with a wide range of medications and food items, risk of major hemorrhage related to overdosing, unpredictable control in presence of co-morbidities such as hepatic and renal impairment.

There is ongoing evidence that better outcomes are achieved when anticoagulation is managed by a pharmacist with expertise in anticoagulation management rather than usual care by physicians. Pharmacists can contribute to positive outcomes of therapy by educating and counseling patients to prepare and motivate them to follow their therapeutic regimens and monitoring plans, which will result substantially in improving the quality of care, reducing complications, and lowering hospitalization rates. Thus, beneficial effects of the pharmacist-managed counseling clinic have been repeatedly reported in terms of cost-effectiveness, patients' adherence to and knowledge about pharmacotherapy, and the outcome of treatment.

The objective of this study is to evaluate the cost-effectiveness of establishing a Medication Counseling Clinic for outpatients with mitral valve prostheses taking warfarin therapy in an Egyptian Teaching Hospital setting. Availability of this information could be used to target further quality improvement efforts, which may significantly improve outcomes for patients and cost containment efforts in an era when cost-effectiveness is at the forefront of healthcare policy initiatives.

Study Overview

• Status: Completed
• Conditions: Cost Effectiveness
• Intervention / Treatment: Other: Education and counseling

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11211
    • Academy of CardioThoracic Surgery, Ain-Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients (18-70) years.
2. Post mitral valve surgery patients.
3. Patients with a prescription of warfarin.

Exclusion Criteria:

1. Pregnant patients.
2. Patients with double and aortic valve replacement surgery.
3. Patients with biological prostheses.
4. Patients with congenital blood disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinical pharmacist-provided services+standard care group; that receive clinical pharmacist-provided services at the Warfarin Counseling Clinic plus standard medical care	Other: Education and counseling; All patients or their caregivers will receive twenty minutes educational sessions for the first three visits according to patient ability to understand. At subsequent visits along the study duration, we will briefly review our educational material to refresh the patient's information. This will include: The objectives of treatment, disease progression process, risk factors, common symptoms of bleeding/thrombotic events and how to deal with this. Lifestyle modifications, including smoking cessation, blood pressure and diabetes control. Drug information: drug action, dose, indication, possible side effects, how to deal with the side effects, actions to take when missing the dose, storage conditions and when and how to administer. Possible interactions including drug-drug and drug-food interactions. Target INR and INR monitoring
No Intervention: Standard care group; that will receive standard medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality-adjusted life-years (QALYs)	The outcome of the two strategies will be measured in terms of quality-adjusted life-years (QALYs).This measurement weighs the length of life by the quality of life a patient experiences while in a specific health state. QALYs combine both morbidity and mortality into a single parameter.	1 year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Radwa Ahmed, Ain Shams University

Publications and helpful links

General Publications

• Batran RA, Sabri NA, Ali I, Fahmy SF. Cost-Effectiveness of the Pharmacist-Managed Warfarin Therapy vs. Standard Care for Patients With Mechanical Mitral Valve Prostheses: An Egyptian Healthcare Perspective. Front Cardiovasc Med. 2022 Jul 13;9:889197. doi: 10.3389/fcvm.2022.889197. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: May 24, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ENREC-ASU.2019-99

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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