Impact of a pharmacist-delivered discharge and follow-up intervention for patients with acute coronary syndromes in Qatar: a study protocol for a randomised controlled trial

Amani Zidan, Ahmed Awaisu, Nadir Kheir, Ziyad Mahfoud, Rasha Kaddoura, Sumaya AlYafei, Maguy Saffouh El Hajj, Amani Zidan, Ahmed Awaisu, Nadir Kheir, Ziyad Mahfoud, Rasha Kaddoura, Sumaya AlYafei, Maguy Saffouh El Hajj

Abstract

Introduction: Acute coronary syndrome (ACS) is one of the leading causes of morbidity and mortality worldwide. Secondary cardiovascular risk reduction therapy (consisting of an aspirin, a β-blocker, an ACE inhibitor or an angiotensin II receptor blocker and a statin) is needed for all patients with ACS. Less than 80% of patients with ACS in Qatar use this combination after discharge. This study is aimed to evaluate the effectiveness of clinical pharmacist-delivered intervention at discharge and tailored follow-up postdischarge on decreasing hospital readmissions, emergency department (ED) visits and mortality among patients with ACS.

Methods and analysis: A prospective, randomised controlled trial will be conducted at the Heart Hospital in Qatar. Patients are eligible for enrolment if they are at least 18 years of age and are discharged from any non-surgical cardiology service with ACS. Participants will be randomised into 1 of 3 arms: (1) 'control' arm which includes patients discharged during weekends or after hours; (2) 'clinical pharmacist delivered usual care at discharge' arm which includes patients receiving the usual care at discharge by clinical pharmacists; and (3) 'clinical pharmacist-delivered structured intervention at discharge and tailored follow-up postdischarge' arm which includes patients receiving intensive structured discharge interventions in addition to 2 follow-up sessions by intervention clinical pharmacists. Outcomes will be measured by blinded research assistants at 3, 6 and 12 months after discharge and will include: all-cause hospitalisations and cardiac-related hospital readmissions (primary outcome), all-cause mortality including cardiac-related mortality, ED visits including cardiac-related ED visits, adherence to medications and treatment burden. Percentage of readmissions between the 3 arms will be compared on intent-to-treat basis using χ2 test with Bonferroni's adjusted pairwise comparisons if needed.

Ethics and dissemination: The study was ethically approved by the Qatar University and the Hamad Medical Corporation Institutional Review Boards. The results shall be disseminated in international conferences and peer-reviewed publications.

Trials registration number: NCT02648243; pre-results.

Keywords: Acute Coronary Syndrome; Discharge; Intervention; Pharmacist; Qatar.

Conflict of interest statement

Conflicts of Interest: None declared.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
Participants flow during the study.

References

    1. WHO. Cardiovascular diseases. Secondary cardiovascular diseases 2013. (accessed 14 Oct 2014).
    1. Hiratzka LF, Eagle KA, Liang L et al. , Get With the Guidelines Steering Committee. Atherosclerosis secondary prevention performance measures after coronary bypass graft surgery compared with percutaneous catheter intervention and nonintervention patients in the Get With the Guidelines database. Circulation 2007;116(11 Suppl):I207–I12. 10.1161/CIRCULATIONAHA.106.681247
    1. Witt BJ, Brown RD, Jacobsen SJ et al. . A community-based study of stroke incidence after myocardial infarction. Ann Intern Med 2005;143:785–92.
    1. DiPiro JT, Robert L, Yee GC et al. . Pharmacotherapy: a pathophysiologic approach. McGraw-Hill Education, 2014.
    1. Smith SC, Allen J, Blair SN et al. . AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update: endorsed by the National Heart, Lung, and Blood Institute. J Am Coll Cardiol 2006;47:2130–9. 10.1016/j.jacc.2006.04.026
    1. Smith SC, Benjamin EJ, Bonow RO et al. . AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation endorsed by the World Heart Federation and the Preventive Cardiovascular Nurses Association. J Am Coll Cardiol 2011;58:2432–46. 10.1016/j.jacc.2011.10.824
    1. Bassand JP, Hamm CW, Ardissino D et al. . Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J 2007;28:1598–660. 10.1093/eurheartj/ehm161
    1. Van de Werf F, Bax J, Betriu A et al. . Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation. Eur Heart J 2008;29:2909–45. 10.1093/eurheartj/ehn416
    1. Jones K, Saxon L, Cunningham W et al. . Secondary prevention for patients after a myocardial infarction: summary of updated NICE guidance. BMJ 2013;347:f6544.
    1. Anderson JL, Adams CD, Antman EM et al. . ACC/AHA 2007 guidelines for the management of patients with unstable angina/non–ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 2002 guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol 2007;50:e1–e157. 10.1016/j.jacc.2007.02.013
    1. Kushner FG, Hand M, Smith SC et al. . 2009 focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2009;54:2205–4112. 10.1016/j.jacc.2009.10.015
    1. Mukherjee D, Fang J, Chetcuti S et al. . Impact of combination evidence-based medical therapy on mortality in patients with acute coronary syndromes. Circulation 2004;109:745–9. 10.1161/01.CIR.0000112577.69066.CB
    1. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001;285:2486–97.
    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. Kumbhani DJ, Fonarow GC, Cannon CP et al. . Predictors of adherence to performance measures in patients with acute myocardial infarction. Am J Med 2013;126:74.e1–9. 10.1016/j.amjmed.2012.02.025
    1. Yan AT, Yan RT, Tan M et al. . Optimal medical therapy at discharge in patients with acute coronary syndromes: temporal changes, characteristics, and 1-year outcome. Am Heart J 2007;154:1108–15. 10.1016/j.ahj.2007.07.040
    1. Naderi SH, Bestwick JP, Wald DS. Adherence to drugs that prevent cardiovascular disease: meta-analysis on 376,162 patients. Am J Med 2012;125:882–7.e1. 10.1016/j.amjmed.2011.12.013
    1. Bi Y, Gao R, Patel A et al. . Evidence-based medication use among Chinese patients with acute coronary syndromes at the time of hospital discharge and 1 year after hospitalization: results from the Clinical Pathways for Acute Coronary Syndromes in China (CPACS) study. Am Heart J 2009;157:509–16.e1. 10.1016/j.ahj.2008.09.026
    1. Abu Samaha RAS, Mohammed S, El Hajj M. Assessment of patient adherence to secondary preventive medications post acute coronary syndrome. Qatar. (Poster) Doha, Qatar: College of Pharmacy 4th Annual Research Forum. Qatar University, 2014.
    1. Wei L, Wang J, Thompson P et al. . Adherence to statin treatment and readmission of patients after myocardial infarction: a six year follow up study. Heart 2002;88:229–33.
    1. Wei L, Flynn R, Murray GD et al. . Use and adherence to beta-blockers for secondary prevention of myocardial infarction: who is not getting the treatment? Pharmacoepidemiol Drug Saf 2004;13:761–6. 10.1002/pds.963
    1. Ho PM, Spertus JA, Masoudi FA et al. . Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med 2006;166:1842–7. 10.1001/archinte.166.17.1842
    1. Spertus JA, Kettelkamp R, Vance C et al. . Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement results from the PREMIER registry. Circulation 2006;113:2803–9. 10.1161/CIRCULATIONAHA.106.618066
    1. Rublee DA, Chen SY, Mardekian J et al. . Evaluation of cardiovascular morbidity associated with adherence to atorvastatin therapy. Am J Ther 2012;19:24–32. 10.1097/MJT.0b013e3181ee707e
    1. Gehi AK, Ali S, Na B et al. . Self-reported medication adherence and cardiovascular events in patients with stable coronary heart disease: the heart and soul study. Arch Intern Med 2007;167:1798–803. 10.1001/archinte.167.16.1798
    1. Kumbhani DJ, Steg PG, Cannon CP et al. . Adherence to secondary prevention medications and four-year outcomes in outpatients with atherosclerosis. Am J Med 2013;126:693–700.e1. 10.1016/j.amjmed.2013.01.033
    1. Coleman EA, Berenson RA. Lost in transition: challenges and opportunities for improving the quality of transitional care. Ann Intern Med 2004;141:533–6.
    1. Makaryus AN, Friedman EA. Patients’ understanding of their treatment plans and diagnosis at discharge. Mayo Clin Proc 2005;80:991–4. 10.4065/80.8.991
    1. Forster AJ, Murff HJ, Peterson JF et al. . The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 2003;138:161–7.
    1. Halasyamani L, Kripalani S, Coleman E et al. . Transition of care for hospitalized elderly patients—development of a discharge checklist for hospitalists. J Hosp Med 2006;1:354–60. 10.1002/jhm.129
    1. Dudas V, Bookwalter T, Kerr KM et al. . The impact of follow-up telephone calls to patients after hospitalization. Am J Med 2001;111:26–30.
    1. Boockvar KS, Carlson LaCorte H, Giambanco V et al. . Medication reconciliation for reducing drug-discrepancy adverse events. Am J Geriatr Pharmacother 2006;4:236–43. 10.1016/j.amjopharm.2006.09.003
    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. Developing pharmacy practice: a focus on patient care. Secondary developing pharmacy practice: a focus on patient care 2006. (accessed 14 Mar 2016).
    1. Definition of Clinical Pharmacy. (accessed 14 Mar 2016).
    1. What is clinical pharmacy? (accessed 14 Mar 2016).
    1. Schnipper JL, Kirwin JL, Cotugno MC et al. . Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med 2006;166:565–71. 10.1001/archinte.166.5.565
    1. Crotty M, Rowett D, Spurling L et al. . Does the addition of a pharmacist transition coordinator improve evidence-based medication management and health outcomes in older adults moving from the hospital to a long-term care facility? Results of a randomized, controlled trial. Am J Geriatr Pharmacother 2004;2:257–64.
    1. Jack BW, Chetty VK, Anthony D et al. . A reengineered hospital discharge program to decrease rehospitalization: a randomized trial. Ann Intern Med 2009;150:178–87.
    1. Bailey TC, Noirot LA, Blickensderfer A et al. . An intervention to improve secondary prevention of coronary heart disease. Arch Intern Med 2007;167:586–90. 10.1001/archinte.167.6.586
    1. Ponniah A, Anderson B, Shakib S et al. . Pharmacists’ role in the post-discharge management of patients with heart failure: a literature review. J Clin Pharm Ther 2007;32:343–52. 10.1111/j.1365-2710.2007.00827.x
    1. Blenkinsopp A, Anderson C, Armstrong M. Systematic review of the effectiveness of community pharmacy-based interventions to reduce risk behaviours and risk factors for coronary heart disease. J Public Health 2003;25:144–53.
    1. Wiggins BS, Rodgers JE, DiDomenico RJ et al. . Discharge counseling for patients with heart failure or myocardial infarction: a best practices model developed by members of the American College of Clinical Pharmacy's Cardiology Practice and Research Network based on the Hospital to Home (H2H) Initiative. Pharmacotherapy 2013;33:558–80. 10.1002/phar.1231
    1. NCD country profile: Qatar 2014. (accessed 31 Mar 2016).
    1. El-Menyar A, Ahmed E, Albinali H et al. . Mortality trends in women and men presenting with acute coronary syndrome: insights from a 20-year registry. PLoS ONE 2013;8:e70066 10.1371/journal.pone.0070066
    1. Micromedex® Solutions, 2016. (accessed 31 Mar 2016).
    1. UpToDate, 2016. (accessed 31 Mar 2016).
    1. Kripalani S, Risser J, Gatti ME et al. . Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health 2009;12:118–23. 10.1111/j.1524-4733.2008.00400.x
    1. Horwitz RI, Viscoli CM, Donaldson R et al. . Treatment adherence and risk of death after a myocardial infarction. Lancet 1990;336:542–5.
    1. Tran VT, Harrington M, Montori VM et al. . Adaptation and validation of the Treatment Burden Questionnaire (TBQ) in English using an internet platform. BMC Med 2014;12:109 10.1186/1741-7015-12-109
    1. Sangu PV, Ranasinghe I, Aliprandi Costa B et al. . Trends and predictors of rehospitalisation following an acute coronary syndrome: report from the Australian and New Zealand population of the Global Registry of Acute Coronary Events (GRACE). Heart 2012;98:1728–31. 10.1136/heartjnl-2012-302532

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