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

Not Applicable

Completed

• Conditions: Cost Effectiveness
• Interventions: Other: Education and counseling

• Registration Number: NCT04409613
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-05-24
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-06-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical pharmacist-provided services+standard care group	Education and counseling	that receive clinical pharmacist-provided services at the Warfarin Counseling Clinic plus standard medical care

Primary Outcome Measures

Name	Time	Method
Quality-adjusted life-years (QALYs)	1 year	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.

Trial Locations

Locations (1)

Academy of CardioThoracic Surgery, Ain-Shams University; 🇪🇬 Cairo, Egypt