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      Notification of international normalized ratio test in atrial fibrillation patients treated with warfarin via short message service: Study protocol for a randomized controlled trial

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          Abstract

          Background

          Atrial Fibrillation (AF) is the most common abnormal heart rhythm. AF patients usually use warfarin therapy. Safety and efficacy of warfarin are dependent on maintaining the International Normalized Ratio (INR) within the therapeutic range.

          Objective

          We will use a Short Message Service (SMS) to evaluate the effect of a reminder on carrying out the INR laboratory test in a timely manner.

          Methods

          This study (a Randomized Controlled Trial) will be done in Loghman hospital Tehran, Iran. Convenience sampling will be done and 400 AF patients that have inclusion criteria will be randomized equally to an intervention or control group. Patients in the intervention group will receive an SMS that will remind them of the INR test date. The SMS will be sent at 6 PM on the day before and 8 AM on the scheduled date but the patients of the control group will receive usual care without any SMS reminders. We will evaluate the effect of reminders on carrying out the INR test in a timely manner and maintaining the INR in the therapeutic range. Patients’ follow-up will be done via telephone conversation to identify thromboembolic events, bleeding and mortality. The data will be analyzed by IBM SPSS version 24. We will use independent samples t-test or Mann–Whitney and Chi-square tests for the analyses of outcomes.

          Discussion

          This protocol describes the randomized control trial to study the effects of the SMS reminder system on adherence to the timing of INR test in AF patients treated with warfarin. The research will also form the basis for future decision support systems for monitoring of patients who receive oral anticoagulants.

          Trial registration

          Iranian Registry of Clinical Trials ( http://www.irct.ir) was used to register the trial and IRCT ID was IRCT2016052528070N1.

          Funding

          This research was supported by Mashhad University of Medical Sciences.

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          Most cited references19

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          Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation.

          Elaine Hylek, Carmella Evans-Molina, Carol Shea … (2007)
          Warfarin is effective in the prevention of stroke in atrial fibrillation but is under used in clinical care. Concerns exist that published rates of hemorrhage may not reflect real-world practice. Few patients > or = 80 years of age were enrolled in trials, and studies of prevalent use largely reflect a warfarin-tolerant subset. We sought to define the tolerability of warfarin among an elderly inception cohort with atrial fibrillation. Consecutive patients who started warfarin were identified from January 2001 to June 2003 and followed for 1 year. Patients had to be > or = 65 years of age, have established care at the study institution, and have their warfarin managed on-site. Outcomes included major hemorrhage, time to termination of warfarin, and reason for discontinuation. Of 472 patients, 32% were > or = 80 years of age, and 91% had > or = 1 stroke risk factor. The cumulative incidence of major hemorrhage for patients > or = 80 years of age was 13.1 per 100 person-years and 4.7 for those or = 80 years, and international normalized ratio (INR) > or = 4.0 were associated with increased risk despite trial-level anticoagulation control. Within the first year, 26% of patients > or = 80 years of age stopped taking warfarin. Perceived safety issues accounted for 81% of them. Rates of major hemorrhage and warfarin termination were highest among patients with CHADS2 scores (an acronym for congestive heart failure, hypertension, age > or = 75, diabetes mellitus, and prior stroke or transient ischemic attack) of > or = 3. Rates of hemorrhage derived from younger noninception cohorts underestimate the bleeding that occurs in practice. This finding coupled with the short-term tolerability of warfarin likely contributes to its underutilization. Stroke prevention among elderly patients with atrial fibrillation remains a challenging and pressing health concern.
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            2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS

            Paulus Kirchhof, Stefano Benussi, Dipak Kotecha … (2016)
            Kardiologia Polska, 1359-1469
            Article 0 comments Cited 126 times – based on 0 reviews     Review now
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              How effective are short message service reminders at increasing clinic attendance? A meta-analysis and systematic review.

              Handan Wand, Harriet Rosenthal-Stott, Hammad Ali … (2012)
              In the last few years there has been a steady uptake of mobile phone short message service (SMS) reminders to increase medical attendance rates. We undertook a review of studies that assessed the effectiveness of SMS reminders at increasing the uptake of appointments in health care settings. We reviewed studies which involved a comparison of appointment attendance rates between patients who did and did not receive SMS reminders published prior to June 2010. We used meta-analysis methods to calculate the overall effect on attendance rates, stratified by study design and clinic type. The review criteria were met by 18 reports, made up of eight randomized controlled trials (RCTs) and 10 controlled observational studies. Across all studies, there was significant heterogeneity in the estimated effect measure of the relationship between use of SMS reminders and clinic attendance (I(2)  = 90 percent; p < .01), so a summary effect estimate was not calculated. Stratification by study design showed that the heterogeneity was due to the observational studies. The summary effect from the RCTs was 1.48 (95% CI: 1.23-1.72) with no significant subgroup differences by clinic type (primary care clinics, hospital outpatient clinics), message timing (24, 48, and 72+ hours before the scheduled appointment), and target age group (pediatric, older). Short message service reminders in health care settings substantially increase the likelihood of attending clinic appointments. SMS reminders appear to be a simple and efficient option for health services to use to improve service delivery, as well as resulting in health benefits for the patients who receive the reminders. © Health Research and Educational Trust.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Electron Physician
                Journal ID (iso-abbrev): Electron Physician
                Journal ID (publisher-id): Electronic physician
                Title: Electronic Physician
                Publisher: Electronic physician
                ISSN (Electronic): 2008-5842
                Publication date Collection: July 2017
                Publication date (Electronic): 25 July 2017
                Volume: 9
                Issue: 7
                Pages: 4732-4736
                Affiliations
                [1 ]Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
                [2 ]Clinical Research Development Center of Loghman Hakim Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran
                Author notes
                Corresponding author: Dr. Saeid Eslami, Pharmaceutical Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. Tel/Fax: +98.5138827048, Email: EslamiS@ 123456mums.ac.ir
                Article
                Publisher ID: epj-09-4732
                DOI: 10.19082/4732
                PMC ID: 5586986
                SO-VID: e4daecd9-485b-41e6-9978-b1c730d2f493
                Copyright © © 2017 The Authors
                License:

                This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

                History
                Date received : 02 February 2017
                Date accepted : 28 April 2017
                Categories
                Subject: Study Protocol

                Keywords: stroke,atrial fibrillation,warfarin,hemorrhage,short message service,international normalized ratio,mortality
                Data availability:
                Keywords: stroke, atrial fibrillation, warfarin, hemorrhage, short message service, international normalized ratio, mortality

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