Multiprofessional intervention to improve adherence to medication in stroke patients: a study protocol for a randomised controlled trial (ADMED AVC study)

Sophie Khettar, Sophie Jacquin Courtois, Jacques Luaute, Evelyne Decullier, Sylvie Bin, Marine Dupuis, Laurent Derex, Laura Mechtouff, Norbert Nighoghossian, Claude Dussart, Gilles Rode, Audrey Janoly-Dumenil, Sophie Khettar, Sophie Jacquin Courtois, Jacques Luaute, Evelyne Decullier, Sylvie Bin, Marine Dupuis, Laurent Derex, Laura Mechtouff, Norbert Nighoghossian, Claude Dussart, Gilles Rode, Audrey Janoly-Dumenil

Abstract

Introduction: Adherence to secondary preventive medications is often suboptimal in patients with stroke, exposing them to an increased risk of recurrent cerebral and/or cardiovascular events. Effective actions in the long term to improve adherence to medication are needed. The study will evaluate the efficacy of a collaborative multiprofessional patient-centred intervention conducted by a pharmacist on adherence to secondary preventive medication in stroke survivors.

Methods and analysis: This is a multicentre cluster-randomised controlled trial. Two groups of 91 patients (intervention vs standard care) will be recruited. The clinical pharmacist intervention targeting secondary preventive medication will consist of three parts over 1 year: (1) an individual semi-structured interview at hospital discharge; (2) follow-up telephone interviews at 3, 6 and 9 months after discharge; and (3) a final individual semi-structured interview 1 year after discharge. Information on patient follow-up will be shared with the general practitioner and the community pharmacist by sending a report of each interview. The primary outcome is adherence to medication during the 12 months after hospital discharge, assessed using a composite endpoint: the medication possession ratio associated with a self-administered questionnaire.

Ethics and dissemination: The local ethics committee, the national committee for use of personal data in medical research and the national data protection agency approved the study. The sponsor has no role in study design; collection, analysis and interpretation of data; or report writing.

Discussion: This pharmacist-led educational programme has the potential to significantly improve adherence to medication in stroke survivors which could lead to a decrease in recurrent cerebral and/or cardiovascular events.

Trial registration number: NCT02611440.

Keywords: education; hospital; pharmacy; pharmacy service; physical and rehabilitation medicine; randomized controlled trial; stroke.

Conflict of interest statement

Competing interests: None declared.

© European Association of Hospital Pharmacists 2022. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.

Figures

Figure 1
Figure 1
Flowchart of trial design. GP, general practitioner.

References

    1. Hautes Autorité de Santé . Recommandations de bonnes pratiques. Prévention vasculaire après un infarctus cérébral ou un accident ischémique transitoire – Actualisation, 2014. Available: [Accessed 4 Jul 2018].
    1. Burke JP, Sander S, Shah H, et al. . Impact of persistence with antiplatelet therapy on recurrent ischemic stroke and predictors of nonpersistence among ischemic stroke survivors. Curr Med Res Opin 2010;26:1023–30. 10.1185/03007991003670563
    1. Bailey JE, Wan JY, Tang J, et al. . Antihypertensive medication adherence, ambulatory visits, and risk of stroke and death. J Gen Intern Med 2010;25:495–503. 10.1007/s11606-009-1240-1
    1. Lewis SJ, Robinson JG, Fox KM, et al. . Underutilisation of cardiovascular medications among at-risk individuals. Int J Clin Pract 2010;64:604–10. 10.1111/j.1742-1241.2009.02258.x
    1. Rijkmans M, de Jong G, van den Berg JSP. Non-persistence in ischaemic stroke: risk of recurrent vascular events. Acta Neurol Scand 2018;137:288–92. 10.1111/ane.12813
    1. Lee HJ, Jang S-I, Park E-C. Effect of adherence to antihypertensive medication on stroke incidence in patients with hypertension: a population-based retrospective cohort study. BMJ Open 2017;7:e014486. 10.1136/bmjopen-2016-014486
    1. Sabaté E. Adherence to long-term therapies: evidence for action. Geneva: World Health Organization, 2003.
    1. Glader E-L, Sjölander M, Eriksson M, et al. . Persistent use of secondary preventive drugs declines rapidly during the first 2 years after stroke. Stroke 2010;41:397–401. 10.1161/STROKEAHA.109.566950
    1. Perreault S, Yu AYX, Côté R, et al. . Adherence to antihypertensive agents after ischemic stroke and risk of cardiovascular outcomes. Neurology 2012;79:2037–43. 10.1212/WNL.0b013e3182749e56
    1. Bushnell CD, Olson DM, Zhao X, et al. . Secondary preventive medication persistence and adherence 1 year after stroke. Neurology 2011;77:1182–90. 10.1212/WNL.0b013e31822f0423
    1. O'Carroll RE, Chambers JA, Dennis M, et al. . Improving adherence to medication in stroke survivors: a pilot randomised controlled trial. Ann Behav Med 2013;46:358–68. 10.1007/s12160-013-9515-5
    1. Barker-Collo S, Krishnamurthi R, Witt E, et al. . Improving adherence to secondary stroke prevention strategies through motivational interviewing: randomized controlled trial. Stroke 2015;46:3451–8. 10.1161/STROKEAHA.115.011003
    1. Kamal AK, Shaikh Q, Pasha O, et al. . A randomized controlled behavioral intervention trial to improve medication adherence in adult stroke patients with prescription tailored Short Messaging Service (SMS)-SMS4Stroke study. BMC Neurol 2015;15:212. 10.1186/s12883-015-0471-5
    1. Hornnes N, Larsen K, Boysen G. Blood pressure 1 year after stroke: the need to optimize secondary prevention. J Stroke Cerebrovasc Dis 2011;20:16–23. 10.1016/j.jstrokecerebrovasdis.2009.10.002
    1. Wan L-H, Zhang X-P, Mo M-M, et al. . Effectiveness of goal-setting telephone follow-up on health behaviors of patients with ischemic stroke: a randomized controlled trial. J Stroke Cerebrovasc Dis 2016;25:2259–70. 10.1016/j.jstrokecerebrovasdis.2016.05.010
    1. Menard MM, Smith DB, Taormina C. A program to improve secondary stroke prevention: the Colorado Neurological Institute stroke preventing recurrence of thromboembolic events through coordinated treatment program. J Neurosci Nurs 2011;43:199–204.
    1. McManus JA, Craig A, McAlpine C, et al. . Does behaviour modification affect post-stroke risk factor control? Three-year follow-up of a randomized controlled trial. Clin Rehabil 2009;23:99–105. 10.1177/0269215508095874
    1. Ireland S, MacKenzie G, Gould L, et al. . Nurse case management to improve risk reduction outcomes in a stroke prevention clinic. Can J Neurosci Nurs 2010;32:7–13.
    1. Sit JWH, Yip VYB, Ko SKK, et al. . A quasi-experimental study on a community-based stroke prevention programme for clients with minor stroke. J Clin Nurs 2007;16:272–81. 10.1111/j.1365-2702.2005.01522.x
    1. Mackenzie G, Ireland S, Moore S, et al. . Tailored interventions to improve hypertension management after stroke or TIA--phase II (TIMS II). Can J Neurosci Nurs 2013;35:27–34.
    1. Lummis HL, Sketris IS, Gubitz GJ, et al. . Medication persistence rates and factors associated with persistence in patients following stroke: a cohort study. BMC Neurol 2008;8:25. 10.1186/1471-2377-8-25
    1. Hedegaard U, Kjeldsen LJ, Pottegård A, et al. . Multifaceted intervention including motivational interviewing to support medication adherence after stroke/transient ischemic attack: a randomized trial. Cerebrovasc Dis Extra 2014;4:221–34. 10.1159/000369380
    1. McAlister FA, Majumdar SR, Padwal RS, et al. . Case management for blood pressure and lipid level control after minor stroke: prevention randomized controlled trial. CMAJ 2014;186:577–84. 10.1503/cmaj.140053
    1. Clifford S, Barber N, Elliott R, et al. . Patient-centred advice is effective in improving adherence to medicines. Pharm World Sci 2006;28:165–70. 10.1007/s11096-006-9026-6
    1. Vrijens B, Belmans A, Matthys K, et al. . Effect of intervention through a pharmaceutical care program on patient adherence with prescribed once-daily atorvastatin. Pharmacoepidemiol Drug Saf 2006;15:115–21. 10.1002/pds.1198
    1. Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA 2006;296:2563–71. 10.1001/jama.296.21.joc60162
    1. Santschi V, Chiolero A, Burnand B, et al. . Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Arch Intern Med 2011;171:1441–53. 10.1001/archinternmed.2011.399
    1. Machado M, Bajcar J, Guzzo GC, et al. . Sensitivity of patient outcomes to pharmacist interventions. Part II: Systematic review and meta-analysis in hypertension management. Ann Pharmacother 2007;41:1770–81. 10.1345/aph.1K311
    1. Machado M, Nassor N, Bajcar JM, et al. . Sensitivity of patient outcomes to pharmacist interventions. Part III: Systematic review and meta-analysis in hyperlipidemia management. Ann Pharmacother 2008;42:1195–207. 10.1345/aph.1K618
    1. Santschi V, Chiolero A, Colosimo AL, et al. . Improving blood pressure control through pharmacist interventions: a meta-analysis of randomized controlled trials. J Am Heart Assoc 2014;3:e000718. 10.1161/JAHA.113.000718
    1. Hohmann C, Klotz JM, Radziwill R, et al. . Pharmaceutical care for patients with ischemic stroke: improving the patients quality of life. Pharm World Sci 2009;31:550–8. 10.1007/s11096-009-9315-y
    1. Andres J, Ruchalski C, Katz P, et al. . Drug therapy management in a pharmacist-run stroke prevention clinic. Am J Health Syst Pharm 2016;73:1388–90. 10.2146/ajhp150773
    1. Bergeron J, Laprise R, Mallet L. Pharmacy discharge plan for continuity in patient care. Can Pharm J 1998;131:21–3.
    1. Peterson AM, Nau DP, Cramer JA, et al. . A checklist for medication compliance and persistence studies using retrospective databases. Value Health 2007;10:3–12. 10.1111/j.1524-4733.2006.00139.x
    1. Anderson C, Laubscher S, Burns R. Validation of the Short Form 36 (SF-36) Health Survey questionnaire among stroke patients. Stroke 1996;27:1812–6. 10.1161/01.STR.27.10.1812
    1. Broadbent E, Petrie KJ, Main J, et al. . The brief illness perception questionnaire. J Psychosom Res 2006;60:631–7. 10.1016/j.jpsychores.2005.10.020
    1. Ruiz MA, Pardo A, Rejas J, et al. . Development and validation of the "Treatment Satisfaction with Medicines Questionnaire" (SATMED-Q). Value Health 2008;11:913–26. 10.1111/j.1524-4733.2008.00323.x
    1. Manger Bouger . Programme National Nutrition Santé [Internet]. Paris: Santé publique France. Guides et documents; [about 3 screens]. Available: [Accessed 4 Jul 2018].
    1. Bauler S, Jacquin-Courtois S, Haesebaert J, et al. . Barriers and facilitators for medication adherence in stroke patients: a qualitative study conducted in French neurological rehabilitation units. Eur Neurol 2014;72:262–70. 10.1159/000362718
    1. Souter C, Kinnear A, Kinnear M, et al. . Optimisation of secondary prevention of stroke: a qualitative study of stroke patients' beliefs, concerns and difficulties with their medicines. Int J Pharm Pract 2014;22:424–32. 10.1111/ijpp.12104
    1. Kronish IM, Diefenbach MA, Edmondson DE, et al. . Key barriers to medication adherence in survivors of strokes and transient ischemic attacks. J Gen Intern Med 2013;28:675–82. 10.1007/s11606-012-2308-x
    1. Arif H, Aijaz B, Islam M, et al. . Drug compliance after stroke and myocardial infarction: a comparative study. Neurol India 2007;55:130–5. 10.4103/0028-3886.32783
    1. Chambers JA, O'Carroll RE, Hamilton B, et al. . Adherence to medication in stroke survivors: a qualitative comparison of low and high adherers. Br J Health Psychol 2011;16:592–609. 10.1348/2044-8287.002000
    1. Sjölander M, Eriksson M, Glader E-L. The association between patients' beliefs about medicines and adherence to drug treatment after stroke: a cross-sectional questionnaire survey. BMJ Open 2013;3:e003551. 10.1136/bmjopen-2013-003551
    1. Lehmann A, Aslani P, Ahmed R, et al. . Assessing medication adherence: options to consider. Int J Clin Pharm 2014;36:55–69. 10.1007/s11096-013-9865-x

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