Notification of international normalized ratio test in atrial fibrillation patient with warfarin via short message service
Studys treated protocol for a randomized controlled trial
Keywords:
Stroke, Atrial fibrillation, Warfarin, Hemorrhage, Short Message Service, International Normalized Ratio, MortalityAbstract
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.
References
Hendriks, J. L., Nieuwlaat, R., Vrijhoef, H. J., de Wit, R. ,Crijns, H. J., Tieleman, R. G., Atrial fibrillation
pathophysiology. Circulation, 2011. 124(20): 2264-74. doi: 10.1161/CIRCULATIONAHA.111.019893,
PMid: 22083148
January, Craig T, Wann, L Samuel, Alpert, Joseph S, Calkins, Hugh, Cigarroa, Joaquin E, Cleveland,
Joseph C, et al., 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation.
Circulation, 2014. 130(23): e199-e267. doi: 10.1161/CIR.0000000000000041, PMid: 24682347, PMCid:
PMC4676081
Hylek, E. M., Evans-Molina, C., Shea, C., Henault, L. E., Regan, S., Major hemorrhage and tolerability of
warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation, 2007.
(21): 2689-96. doi: 10.1161/CIRCULATIONAHA.106.653048, PMid: 17515465
Camm, A. J., Lip, G. Y., De Caterina, R., Savelieva, I., Atar, D., Hohnloser, S. H., et al., 2012 focused
update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J, 2012: ehs253.
Vallerand, A.H., C.A. Sanoski, and J.H. Deglin, Davis's Canadian Drug Guide for Nurses. 2016: FA Davis.
Baker, W. L., Cios, D. A., Sander, S. D., Coleman, C. I., Meta-analysis to assess the quality of warfarin
control in artial fibrillation patients in the United States. Journal of Managed Care Pharmacy, 2009. 15(3):
-52. doi: 10.18553/jmcp.2009.15.3.244, PMid: 19326955
Jones, M., McEwan, P., Morgan, C. L., Peters, J. R., Goodfellow, J., Currie, C. J., Evaluation of the pattern
of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non- valvar atrial fibrillation: a record linkage study in a large British population. Heart, 2005. 91(4): 472-7. doi:
1136/hrt.2004.042465, PMid: 15772203, PMCid: PMC1768813
Ageno, W., Gallus, A. S., Wittkowsky, A., Crowther, M., Hylek, E. M., Palareti, G., Oral anticoagulant
therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest
Physicians Evidence-Based Clinical Practice Guidelines. Chest, 2012. 141(2 Suppl): e44S-88S.
Kim, J. H., Song, Y. B., Shin, D. H., Kim, J. S., Choi, J. O., On, Y. K., et al., How well does the target INR
level maintain in warfarin-treated patients with non-valvular atrial fibrillation? Yonsei Med J, 2009. 50(1):
-8. doi: 10.3349/ymj.2009.50.1.83, PMid: 19259353, PMCid: PMC2649856
Ludlow, H., J. Hurley, and S. Dolwani, Using email and text messaging to improve patient compliance with
blood monitoring. Nurs Times, 2009. 105(28): 26-8.
Prasad, S. and R. Anand, Use of mobile telephone short message service as a reminder: the effect on patient
attendance. Int Dent J, 2012. 62(1): 21-6. doi: 10.1111/j.1875-595X.2011.00081.x, PMid: 22251033
Nuti L, Turkcan A, Lawley MA, Zhang L, Sands L, McComb S, The impact of interventions on
appointment and clinical outcomes for individuals with diabetes: a systematic review. BMC Health Serv
Res, 2015. 15: 355. doi: 10.1186/s12913-015-0938-5, PMid: 26330299, PMCid: PMC4557865
Liu Q, Abba K, Alejandria MM, Sinclair D, Balanag VM, Lansang MA., Reminder systems to improve
patient adherence to tuberculosis clinic appointments for diagnosis and treatment. Cochrane Database Syst
Rev, 2014. 11: CD006594. doi: 10.1002/14651858.cd006594.pub3
Henderson, R., Encouraging attendance at outpatient appointments: can we do more? Scottish medical
journal, 2008. 53(1): 9-12. doi: 10.1258/rsmsmj.53.1.9, PMid: 18422203
Rohman L, Maruswezki D, Boyce Cam N, The impact of short message service text messages sent as
appointment reminders to patients' cell phones at outpatient clinics in Sao Paulo, Brazil. Int J Med Inform,
79(1): 65-70. doi: 10.1016/j.ijmedinf.2009.09.001, PMid: 19783204
Martin, C., T. Perfect, and G. Mantle, Non-attendance in primary care: the views of patients and practices
on its causes, impact and solutions. Fam Pract, 2005. 22(6): 638-43. doi: 10.1093/fampra/cmi076, PMid:
Wike, R. and R. Oates, Emerging nations embrace internet, mobile technology: cell phones nearly
ubiquitous in many countries. Pew Research Center, Washington DC.
Kannisto, K.A., M.H. Koivunen, and M.A. Valimaki, Use of mobile phone text message reminders in
health care services: a narrative literature review. J Med Internet Res, 2014. 16(10): e222.
Guy R, Hocking J, Wand H, Stott S, Ali H, Kaldor J., How effective are short message service reminders at
increasing clinic attendance? A meta-analysis and systematic review. Health Serv Res, 2012. 47(2): 614-32.
doi: 10.1111/j.1475-6773.2011.01342.x, PMid: 22091980, PMCid: PMC3419880
Chen ZW, Fang LZ, Chen LY, Dai HL, Comparison of an SMS text messaging and phone reminder to
improve attendance at a health promotion center: a randomized controlled trial. Journal of Zhejiang
University Science B, 2008. 9(1): 34-8. doi: 10.1631/jzus.B071464, PMid: 18196610, PMCid:
PMC2170466
Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ, Refining clinical risk stratification for predicting
stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart
survey on atrial fibrillation. Chest, 2010. 137(2): 263-72. doi: 10.1378/chest.09-1584, PMid: 19762550
Min, J. and M.U. Farooq, Detecting nonvalvular atrial fibrillation and anticoagulant therapy in
cardioembolic ischemic stroke. Postgrad Med, 2016. 128(6): 620-8. doi: 10.1080/00325481.2016.1195236,
PMid: 27263867
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., et al., 2016 ESC Guidelines for
the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl
Ed), 2017. 70(1): 50.
Suresh, K., An overview of randomization techniques: An unbiased assessment of outcome in clinical
research. J Hum Reprod Sci, 2011. 4(1): 8-11. doi: 10.4103/0974-1208.82352, PMid: 21772732. PMCid:
PMC3136079
Nieuwlaat R, Connolly SJ, Mackay JA, Weise-Kelly L, Navarro T, Wilczynski NL, et al., Computerized
clinical decision support systems for therapeutic drug monitoring and dosing: a decision-maker-researcher
partnership systematic review. Implementation Science, 2011. 6(1): 90.
Harrison, J., J.P. Shaw, and J.E. Harrison, Anticoagulation management by community pharmacists in New
Zealand: an evaluation of a collaborative model in primary care. Int J Pharm Pract, 2015. 23(3): 173-81.
doi: 10.1111/ijpp.12148, PMid: 25250655
Schulz, K.F., D.G. Altman, and D. Moher, CONSORT 2010 statement: updated guidelines for reporting
parallel group randomised trials. BMC medicine, 2010. 8(1): 18. doi: 10.1186/1741-7015-8-18, PMid:
, PMCid: PMC2860339
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