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

NCT ID: NCT04409613

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-03-01

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.

Conditions

Cost Effectiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Clinical pharmacist-provided services+standard care group

that receive clinical pharmacist-provided services at the Warfarin Counseling Clinic plus standard medical care

Group Type: ACTIVE_COMPARATOR

Education and counseling

Intervention Type: OTHER

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

Standard care group

that will receive standard medical care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Ahmed Batran

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Radwa Ahmed

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Academy of CardioThoracic Surgery, Ain-Shams University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 35911528 (View on PubMed)

Other Identifiers

ENREC-ASU.2019-99

Identifier Type: -

Identifier Source: org_study_id