Nurse-led Warfarin Therapy Guide for Improving Patient Safety After Mechanical Valve Replacement - A Randomized Control Trial

Physical or Informational Materials Used • Educational Booklets: A Warfarin Therapy Guide for Patient Safety after Mechanical Valve Replacement will be used. This guide includes information on warfarin therapy, medication adherence, and International Normalized Ratio (INR) stability. This guide is a study-specific resource, developed for the purpose of this intervention to ensure consistency and relevance to the patient group. Procedures, Activities, and Processes Used 1. Initial Assessment and Patient Enrollment o Baseline International Normalized Ratio (INR) levels, medical history, and patient readiness for anticoagulation therapy will be assessed prior to enrollment. 2. Individualized Patient Education o A 30-minute one-on-one education session will be delivered by trained nurses using the study-specific Warfarin Therapy Guide. This session will occur prior to the initiation of warfarin therapy. 3. Weekly INR Testing o INR testing will be conducted weekly, with immediate review of results and adjustments to warfarin doses as necessary. 4. Dose Adjustment o Dose modifications will be made by nurses, following standardized, evidence-based protocols approved by supervising physicians. 5. Proactive Follow-Ups o Weekly INR check-ins will be performed either in-person or virtually to monitor patient progress and medication adherence. Who Will Deliver the Intervention? • The intervention will be delivered by trained nursing staff who are part of the study team. The nurses will be responsible for patient education, INR monitoring, and warfarin dose adjustment under physician oversight. Training for Nurses • All participating nurses will receive two hours of face-to-face training on the use of the Warfarin Therapy Guide, the INR monitoring protocol, and the dose adjustment checklist. • Training will be delivered by a clinical pharmacist and a supervising cardiologist involved in the study. • This training will occur three weeks prior to the enrollment of the first participant. Mode of Delivery • The intervention will be delivered via a combination of in-person and virtual formats: o In-person INR testing and education sessions at the Pakistan Institute of Cardiology o Telephonic and video call consultations based on patient preference and availability Frequency and Duration • Duration: 6 months per patient, starting immediately post mechanical valve replacement • Frequency: o Weekly sessions for the first 4 months o Bi-weekly or monthly follow-ups for the final 2 months based on INR stability Location/Setting • All in-person activities will take place at the Outpatient Department of Pakistan Institute of Cardiology. Strategies to Assess or Monitor Adherence and Fidelity 1. Patient Logs o Patients will maintain daily logs to record warfarin doses, missed doses, and any symptoms. 2. INR Trends o Ongoing monitoring of INR levels to detect patterns in adherence and dose adjustments. 3. Protocol Checklists o Nurses will use standardized checklists during dose adjustment to ensure protocol adherence. 4. Random Audits o Regular audits of educational materials, patient logs, and adherence documentation will be conducted to ensure consistency with the intervention protocol.