Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS): study protocol for a randomized controlled trial

Mary A De Vera, Mohsen Sadatsafavi, Nicole W Tsao, Larry D Lynd, Richard Lester, Louise Gastonguay, Jessica Galo, J Mark FitzGerald, Penelope Brasher, Carlo A Marra, Mary A De Vera, Mohsen Sadatsafavi, Nicole W Tsao, Larry D Lynd, Richard Lester, Louise Gastonguay, Jessica Galo, J Mark FitzGerald, Penelope Brasher, Carlo A Marra

Abstract

Background: Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients. Pharmacists are suited to impact medication adherence given their training, skills, and frequent contact with patients. The Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS) trial involves an intervention leveraging mobile health (mHealth) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma.

Methods/design: This study is a pragmatic pharmacy-based, cluster, randomized controlled trial with 12 months of intervention delivery and follow-up. Pharmacies (the clusters) will be randomized at a 1:1 ratio to provide intervention or usual care. The EmPhAsIS intervention consists of patient asthma education, short message service (SMS)-based monthly assessment of adherence, and follow-up of non-adherent individuals by community pharmacists. There are no inclusion or exclusion criteria for pharmacies. Patients are eligible if they: are 14 years of age or older, fill a prescription for inhaled corticosteroid (either monotherapy or in a combination inhaler with long-acting beta-agonists), have been diagnosed with asthma, possess a mobile phone with SMS capabilities, and have no communication difficulties such as inability to communicate in English, or significant impairment in vision, hearing, or speech. The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio, the ratio of the days of medication supplied to days in a given time interval. This study will also evaluate secondary outcomes including: asthma control, asthma-related quality of life, asthma-related hospital admissions, and use of reliever medications during the follow-up period. A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a 10-year time horizon.

Discussion: Considering the prevalence of asthma, the extent of the non-adherence problem in this disease, and the availability of effective treatments, there is a tremendous potential to reduce the burden of asthma through improving adherence. This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management.

Trial registration: ClinicalTrials.gov identifier: NCT02170883; date of registration: 19 June 2014.

Figures

Figure 1
Figure 1
Schematic of transmission of short message service (SMS) assessment of adherence (pillar two) and follow-up of non-adherent patients by community pharmacist (pillar three) of the EmPhAsIS intervention. AAAQ: Adult Asthma Adherence Questionnaire; ACT: Asthma Control Test.
Figure 2
Figure 2
EmPhAsIS trial design and schematic of data collection and outcomes. ICS: inhaled corticosteroids.
Figure 3
Figure 3
Schematic illustration of the asthma Markov model.

References

    1. Kim H, Mazza J. Asthma. Allergy Asthma Clin Immun. 2011;10:S2. doi: 10.1186/1710-1492-7-S1-S2.
    1. Braman SS. The global burden of asthma. Chest. 2006;130(Suppl 1):4S–12S. doi: 10.1378/chest.130.1_suppl.4S.
    1. Masoli M, Fabian D, Holt S, Beasley R, Global Initiative for Asthma P The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004;59:469–478. doi: 10.1111/j.1398-9995.2004.00526.x.
    1. Bahadori K, Doyle-Waters MM, Marra C, Lynd L, Alasaly K, Swiston J, FitzGerald JM. Economic burden of asthma: a systematic review. BMC Pulm Med. 2009;9:24. doi: 10.1186/1471-2466-9-24.
    1. Statistics Canada: Asthma, by Sex, Provinces and Territories. Available from:
    1. Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O’Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008;31:143–178. doi: 10.1183/09031936.00138707.
    1. Accordini S, Bugiani M, Arossa W, Gerzeli S, Marinoni A, Olivieri M, Pirina P, Carrozzi L, Dallari R, De Togni A, de Marco R. Poor control increases the economic cost of asthma. A multicentre population-based study. Int Arch Allergy Immunol. 2006;141:189–198. doi: 10.1159/000094898.
    1. The National Asthma Education Prevention Program (NAEPP II) Guidelines for the Treatment of Asthma: Implications for the Pharmacist. St. Louis, Missouri: St. Louis College of Pharmacy; 2000.
    1. Stempel DA, Stoloff SW, Carranza Rosenzweig JR, Stanford RH, Ryskina KL, Legorreta AP. Adherence to asthma controller medication regimens. Respir Med. 2005;99:1263–1267. doi: 10.1016/j.rmed.2005.03.002.
    1. Apter AJ, Reisine ST, Affleck G, Barrows E, ZuWallack RL. Adherence with twice-daily dosing of inhaled steroids. Socioeconomic and health-belief differences. Am J Respir Crit Care Med. 1998;157:1810–1817. doi: 10.1164/ajrccm.157.6.9712007.
    1. Bender BG, Pedan A, Varasteh LT. Adherence and persistence with fluticasone propionate/salmeterol combination therapy. J Allergy Clin Immunol. 2006;118:899–904. doi: 10.1016/j.jaci.2006.07.002.
    1. Gamble J, Stevenson M, McClean E, Heaney LG. The prevalence of nonadherence in difficult asthma. Am J Respir Crit Care Med. 2009;180:817–822. doi: 10.1164/rccm.200902-0166OC.
    1. Murphy AC, Proeschal A, Brightling CE, Wardlaw AJ, Pavord I, Bradding P, Green RH. The relationship between clinical outcomes and medication adherence in difficult-to-control asthma. Thorax. 2012;67:751–753. doi: 10.1136/thoraxjnl-2011-201096.
    1. Williams LK, Joseph CL, Peterson EL, Wells K, Wang M, Chowdhry VK, Walsh M, Campbell J, Rand CS, Apter AJ, Lanfear DE, Tunceli K, Pladevall M. Patients with asthma who do not fill their inhaled corticosteroids: a study of primary nonadherence. J Allergy Clin Immunol. 2007;120:1153–1159. doi: 10.1016/j.jaci.2007.08.020.
    1. Williams LK, Peterson EL, Wells K, Ahmedani BK, Kumar R, Burchard EG, Chowdhry VK, Favro D, Lanfear DE, Pladevall M. Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence. J Allergy Clin Immunol. 2011;128:1185–1191. doi: 10.1016/j.jaci.2011.09.011.
    1. Williams LK, Pladevall M, Xi H, Peterson EL, Joseph C, Lafata JE, Ownby DR, Johnson CC. Relationship between adherence to inhaled corticosteroids and poor outcomes among adults with asthma. J Allergy Clin Immunol. 2004;114:1288–1293. doi: 10.1016/j.jaci.2004.09.028.
    1. Rand CS, Wise RA. Measuring adherence to asthma medication regimens. Am J Respir Crit Care Med. 1994;149:S69–S76. doi: 10.1164/ajrccm/149.2_Pt_2.S69.
    1. Bender BG, Rand C. Medication non-adherence and asthma treatment cost. Curr Opin Allergy Clin Immunol. 2004;4:191–195. doi: 10.1097/00130832-200406000-00009.
    1. Boulet LP, Vervloet D, Magar Y, Foster JM. Adherence: the goal to control asthma. Clin Chest Med. 2012;33:405–417. doi: 10.1016/j.ccm.2012.06.002.
    1. Blais L, Suissa S, Boivin JF, Ernst P. First treatment with inhaled corticosteroids and the prevention of admissions to hospital for asthma. Thorax. 1998;53:1025–1029. doi: 10.1136/thx.53.12.1025.
    1. Ernst P, Spitzer WO, Suissa S, Cockcroft D, Habbick B, Horwitz RI, Boivin JF, Mcnutt M, Buist AS. Risk of fatal and near-fatal asthma in relation to inhaled corticosteroid use. Jama-J Am Med Assoc. 1992;268:3462–3464. doi: 10.1001/jama.1992.03490240070039.
    1. Suissa S, Ernst P. Inhaled corticosteroids: impact on asthma morbidity and mortality. J Allergy Clin Immunol. 2001;107:937–944. doi: 10.1067/mai.2001.115653.
    1. Suissa S, Ernst P, Kezouh A. Regular use of inhaled corticosteroids and the long term prevention of hospitalisation for asthma. Thorax. 2002;57:880–884. doi: 10.1136/thorax.57.10.880.
    1. Knapp KK, Paavola FG, Maine LL, Sorofman B, Politzer RM. Availability of primary care providers and pharmacists in the United States. J Am Pharm Assoc. 1999;39:127–135.
    1. Garcia-Cardenas V, Sabater-Hernandez D, Kenny P, Martinez-Martinez F, Faus MJ, Benrimoj SI. Effect of a pharmacist intervention on asthma control. A cluster randomised trial. Respir Med. 2013;107:1346–1355. doi: 10.1016/j.rmed.2013.05.014.
    1. Armour C, Bosnic-Anticevich S, Brillant M, Burton D, Emmerton L, Krass I, Saini B, Smith L, Stewart K. Pharmacy Asthma Care Program (PACP) improves outcomes for patients in the community. Thorax. 2007;62:496–502. doi: 10.1136/thx.2006.064709.
    1. McLean W, Gillis J, Waller R. The BC community pharmacy asthma study: a study of clinical, economic and holistic outcomes influenced by an asthma care protocol provided by specially trained community pharmacists in British Columbia. Can Respir J. 2003;10:195–202.
    1. International Telecommunication Union . Key Global Telecom Indicators for the World Telecommunication Service Sector. 2010.
    1. Kay M. mHealth: New Horizons for Health Through Mobile Technologies. Geneva, Switzerland: World Health Organization; 2011.
    1. Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009;36:165–173. doi: 10.1016/j.amepre.2008.09.040.
    1. Aggleton P. Behavior change communication strategies. AIDS Educ Prev. 1997;9:111–123.
    1. Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010;376:1838–1845. doi: 10.1016/S0140-6736(10)61997-6.
    1. Bender B, Milgrom H, Apter A. Adherence intervention research: what have we learned and what do we do next? J Allergy Clin Immunol. 2003;112:489–494. doi: 10.1016/S0091-6749(03)01718-4.
    1. Pinnock H, Bawden R, Proctor S, Wolfe S, Scullion J, Price D, Sheikh A. Accessibility, acceptability, and effectiveness in primary care of routine telephone review of asthma: pragmatic, randomised controlled trial. BMJ. 2003;326:477–479. doi: 10.1136/bmj.326.7387.477.
    1. Ryan D, Price D, Musgrave SD, Malhotra S, Lee AJ, Ayansina D, Sheikh A, Tarassenko L, Pagliari C, Pinnock H. Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial. BMJ. 2012;344:e1756. doi: 10.1136/bmj.e1756.
    1. Pocket Guide for Asthma Management and PreventionDocuments/ResourcesGINA Available from:
    1. Price D, Musgrave SD, Shepstone L, Hillyer EV, Sims EJ, Gilbert RFT, Juniper EF, Ayres JG, Kemp L, Blyth A, Wilson ECF, Wolfe S, Freeman D, Mugford HM, Murdoch J, Harvey I. Leukotriene antagonists as first-line or add-on asthma-controller therapy. New Engl J Med. 2011;364:1695–1707. doi: 10.1056/NEJMoa1010846.
    1. Marra CA, Cibere J, Grubisic M, Grindrod KA, Gastonguay L, Thomas JM, Embley P, Colley L, Tsuyuki RT, Khan KM, Esdaile JM. Pharmacist-initiated intervention trial in osteoarthritis: a multidisciplinary intervention for knee osteoarthritis. Arthritis Care Res. 2012;64:1837–1845. doi: 10.1002/acr.21763.
    1. Marra CA, Cibere J, Tsuyuki RT, Soon JA, Esdaile JM, Gastonguay L, Oteng B, Embley P, Colley L, Enenajor G, Kok R. Improving osteoarthritis detection in the community: pharmacist identification of new, diagnostically confirmed osteoarthritis. Arthritis Rheum. 2007;57:1238–1244. doi: 10.1002/art.23019.
    1. Tsao NW, Marra CA, Lynd LD, Thomas JM, Ferreira E. Community pharmacist surveillance of hypertension in pregnancy: are we ready for prime time? Can Pharm J. 2014;147:307–315. doi: 10.1177/1715163514543898.
    1. Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113:59–65. doi: 10.1016/j.jaci.2003.09.008.
    1. Schatz M, Zeiger RS, Yang SJ, Weinstein AG, Chen W, Saris-Baglama RN, Turner-Bowker DM. Development and preliminary validation of the adult asthma adherence questionnaire. J Allergy Clin Immunol Pract. 2013;1:280–288. doi: 10.1016/j.jaip.2013.03.001.
    1. Hahn SR, Park J, Skinner EP, Yu-Isenberg KS, Weaver MB, Crawford B, Flowers PW. Development of the ASK-20 adherence barrier survey. Curr Med Res Opin. 2008;24:2127–2138. doi: 10.1185/03007990802174769.
    1. McHorney CA, Victor Spain C, Alexander CM, Simmons J. Validity of the adherence estimator in the prediction of 9-month persistence with medications prescribed for chronic diseases: a prospective analysis of data from pharmacy claims. Clin Ther. 2009;31:2584–2607. doi: 10.1016/j.clinthera.2009.11.030.
    1. British Columbia Ministry of Health . PharmaNet. What is PharmaNet? 2014.
    1. Population Data BC. Population Data BC. 2014.
    1. Hess LM, Raebel MA, Conner DA, Malone DC. Measurement of adherence in pharmacy administrative databases: a proposal for standard definitions and preferred measures. Ann Pharmacother. 2006;40:1280–1288. doi: 10.1345/aph.1H018.
    1. Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK. Evaluation of impairment of health related quality-of-life in asthma - development of a questionnaire for use in clinical-trials. Thorax. 1992;47:76–83. doi: 10.1136/thx.47.2.76.
    1. Campbell MK, Thomson S, Ramsay CR, MacLennan GS, Grimshaw JM. Sample size calculator for cluster randomized trials. Comput Biol Med. 2004;34:113–125. doi: 10.1016/S0010-4825(03)00039-8.
    1. Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. London: Arnold; 2000.
    1. Evans CD, Eurich DT, Lamb DA, Taylor JG, Jorgenson DJ, Semchuk WM, Mansell KD, Blackburn DF. Retrospective observational assessment of statin adherence among subjects patronizing different types of community pharmacies in Canada. J Manage Care Pharm. 2009;15:476–484.
    1. Qureshi NN, Hatcher J, Chaturvedi N, Jafar TH, Hypertension RG. Effect of general practitioner education on adherence to antihypertensive drugs: cluster randomised controlled trial. BMJ. 2007;335:1030. doi: 10.1136/.
    1. Smeeth L, Ng ES. Intraclass correlation coefficients for cluster randomized trials in primary care: data from the MRC trial of the assessment and management of older people in the community. Control Clin Trials. 2002;23:409–421. doi: 10.1016/S0197-2456(02)00208-8.
    1. Cosby RH, Howard M, Kaczorowski J, Willan AR, Sellors JW. Randomizing patients by family practice: sample size estimation, intracluster correlation and data analysis. Fam Pract. 2003;20:77–82. doi: 10.1093/fampra/20.1.77.
    1. Heisler M, Hofer TP, Klamerus ML, Schmittdiel J, Selby J, Hogan MM, Bosworth HB, Tremblay A, Kerr EA. Study protocol: the Adherence and Intensification of Medications (AIM) study–a cluster randomized controlled effectiveness study. Trials. 2010;11:95. doi: 10.1186/1745-6215-11-95.
    1. Pladevall M, Brotons C, Gabriel R, Arnau A, Suarez C, de la Figuera M, Marquez E, Coca A, Sobrino J, Divine G, Heisler M, Williams LK, COM99 Study Group Multicenter cluster-randomized trial of a multifactorial intervention to improve antihypertensive medication adherence and blood pressure control among patients at high cardiovascular risk (The COM99 Study) Circulation. 2010;122:1183–U81. doi: 10.1161/CIRCULATIONAHA.109.892778.
    1. Omran D, Guirguis LM, Simpson SH. Systematic review of pharmacist interventions to improve adherence to oral antidiabetic medications in people with type 2 diabetes. Can J Diab. 2012;36:292–299. doi: 10.1016/j.jcjd.2012.07.002.
    1. Zafari Z, Sadatsafavi M, FitzGerald M, Lynd L, Marra C. The humanistic and economic impact of following evidence-based asthma controller therapy: a simulation study. Value Health. 2013;16:A235. doi: 10.1016/j.jval.2013.03.1195.
    1. Newell DJ. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol. 1992;21:837–841. doi: 10.1093/ije/21.5.837.
    1. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637–639. doi: 10.1001/jama.1996.03540080059030.
    1. Wu AC, Paltiel AD, Kuntz KM, Weiss ST, Fuhlbrigge AL. Cost-effectiveness of omalizumab in adults with severe asthma: results from the Asthma Policy Model. J Allergy Clin Immunol. 2007;120:1146–1152. doi: 10.1016/j.jaci.2007.07.055.
    1. Zafari Z, Lynd LD, FitzGerald JM, Sadatsafavi M. Economic and health effect of full adherence to controller therapy in adults with uncontrolled asthma: a simulation study. J Allergy Clin Immunol. 2014;134:908–915. doi: 10.1016/j.jaci.2014.04.009.
    1. Urquhart J. The electronic medication event monitor. Lessons for pharmacotherapy. Clin Pharmacokinet. 1997;32:345–356. doi: 10.2165/00003088-199732050-00001.
    1. Catwell L, Sheikh A. Evaluating eHealth interventions: the need for continuous systemic evaluation. PLoS Med. 2009;6:e1000126. doi: 10.1371/journal.pmed.1000126.

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