A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study

Charity D Evans, Dean T Eurich, Jeff G Taylor, Alfred J Remillard, Yvonne M Shevchuk, David F Blackburn, Charity D Evans, Dean T Eurich, Jeff G Taylor, Alfred J Remillard, Yvonne M Shevchuk, David F Blackburn

Abstract

Background: Traditional randomized controlled trials are considered the gold standard for evaluating the efficacy of a treatment. However, in adherence research, limitations to this study design exist, especially when evaluating real-world applicability of an intervention. Although adherence interventions by community pharmacists have been tested, problems with internal and external validity have limited the usefulness of these studies, and further well-designed and well-conducted research is needed. We aimed to determine the real-world effectiveness of a community pharmacy adherence intervention using a robust study design. This novel design integrates cluster randomization and an outcome evaluation of medication adherence using a population-based administrative data source in the province of Saskatchewan, Canada.

Methods/design: Community pharmacies from across the province of Saskatchewan, Canada were randomized to deliver an adherence intervention to their patients or usual care. Intervention pharmacies were trained to employ a practical adherence strategy targeted at new users of statin medications. While randomization and implementation of the intervention occurred at the community pharmacy level, the outcome analysis will occur at the level of the individual subjects. The primary outcome is the mean statin adherence among all eligible new users of statin medications. Secondary outcomes include the proportion of new statin users who exhibit adherence>or=80%, and persistence with statin use.

Discussion: This novel study design was developed to combine the rigor of a randomized trial with a pragmatic approach to implementing and capturing the results in a real-world fashion. We believe this approach can serve as an example for future study designs evaluating practice-based adherence interventions.

Trial registration: ClinicalTrials.gov no. NCT00971412.

References

    1. Moher D, Jadad A, Nichol G, Penman M, Tugwell P, Walsh S. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Controlled Clinical Trials. 1995;16:62–73. doi: 10.1016/0197-2456(94)00031-W.
    1. McDonald H, Garg A, Haynes RB. Interventions to enhance patient adherence to medication prescriptions. JAMA. 2002;288:2868–2879. doi: 10.1001/jama.288.22.2868.
    1. Van Wijk B, Klungel O, Heerdink E, de Boer A. Effectiveness of interventions by community pharmacists to improve patient adherence to chronic medication: a systematic review. Ann Pharmacother. 2005;39:319–328. doi: 10.1345/aph.1E027.
    1. Bouvy M, Heerdink E, Urquart J, Grobbee D, Hoe A, Leufkens H. Effect of a pharmacist-led intervention on diuretic compliance in heart failure patients: a randomized controlled study. J Card Failure. 2003;9:404–411. doi: 10.1054/S1071-9164(03)00130-1.
    1. Park J, Kelly P, Carter B, Burgess P. Comprehensive pharmaceutical care in the chain setting. J Am Pharm Assoc. 1996;NS36:443–451.
    1. Lee L, Grace K, Taylor A. Effect of a pharmacy care program on medication adherence and persistence blood pressure and low-density lipoprotein cholesterol. A randomized controlled trial. JAMA. 2006;296:2563–2571. doi: 10.1001/jama.296.21.joc60162.
    1. Charrois T, Durec T, Tsuyuki R. Systematic reviews of pharmacy practice research: methodological issues in searching evaluating, interpreting and disseminating results. Ann Pharmacother. 2009;43:118–122. doi: 10.1345/aph.1L302.
    1. Simpson S, Johnson J, Biggs C, Biggs R, Kuntz A, Semchuk W, Taylor J, Farris K, Tsuyuki R. Practice-based research: lessons from community pharmacist participants. Pharmacotherapy. 2001;21:731–739. doi: 10.1592/phco.21.7.731.34570.
    1. Farris K, Schopflocher D. Between intention and behaviour: an application of community pharmacists' assessment of pharmaceutical care. Social Science & Medicine. 1999;49:55–66.
    1. Armour C, Brillant M, Krass I. Pharmacists' views on involvement in pharmacy practice research: strategies for facilitating participation. Pharmacy Practice. 2007;5:59–66.
    1. Saini B, Brillant M, Filipovska J, Gelgor L, Mitchell B, Rose G, Smith L. Factors influencing Australian community pharmacists' willingness to participate in research projects - an exploratory study. Int J Pharm Pract. 2006;14:179–188. doi: 10.1211/ijpp.14.3.0004.
    1. Blackburn D, Dobson R, Blackburn J, Wilson T, Stang MR, Semchuk W. Adherence to statins beta-blockers and angiotensin-converting enzyme inhibitors following a first cardiovascular event: A retrospective cohort study. Can J Cardiol. 2005;21:485–488.
    1. Jackevicius C, Mamdani M, Tu J. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002;288:462–467. doi: 10.1001/jama.288.4.462.
    1. Pedan A, Laleh V, Schneeweiss S. Analysis of factors associated with statin adherence in a hierarchical model considering physician pharmacy, patient and prescription characteristics. J Manag Care Pharm. 2007;13:487–496.
    1. Lamb D, Eurich D, McAlister F, Tsuyuki R, Semchuk W, Wilson T, Blackburn D. Changes in adherence to evidence-based medications in the first year after intial hospitalization for heart failure. Observational cohort study from 1994-2003. Circ Cardiovasc Qual Outcomes. 2009;2:228–235. doi: 10.1161/CIRCOUTCOMES.108.813600.
    1. McAlister F, Eurich D, Majumdar S, Johnson J. The risk of heart failure in patients with type 2 diabetes treated with oral agent monotherapy. Eur J Heart Failure. 2008;10:703–708. doi: 10.1016/j.ejheart.2008.05.013.
    1. Blackburn D, Dobson R, Blackburn J, Wilson T. Cardiovascular morbidity associated with nonadherence to statin therapy. Pharmacotherapy. 2005;25:1035–1043. doi: 10.1592/phco.2005.25.8.1035.
    1. Downey W, Stang MR, Beck P, Osei W, Nichol J. In: Pharamcoepidemiology. 4. Strom B, editor. Philadelphia: John Wiley & Sons Ltd; 2005. Health Services Databases in Saskatchewan.
    1. Karve S, Cleves M, Helm M, Hudson T, West D, Martin B. An Empirical Basis for Standardizing Adherence Measures Derived From Administrative Claims Data Among Diabetic Patients. Med Care. 2008;46:1125–1133. doi: 10.1097/MLR.0b013e31817924d2.
    1. Ho M, Magid D, Shetterly S, Olson K, Maddox T, Peterson P, Masoudi F, Rumsfeld J. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. Am Heart J. 2008;155:772–779. doi: 10.1016/j.ahj.2007.12.011.
    1. Evans C, Eurich D, Lamb D, Taylor J, Jorgenson D, Semchuk W, Mansell K, Blackburn D. Retrospective observational assessment of statin adherence among subjects patronizing different types of community pharmacies in Canada. JMCP. 2009;15:476–484.
    1. Larsen J, Andersen M, Kragstrup J, Gram L. High persistence of statin use in a Danish population: Compliance study 1993-1998. Br J Clin Pharmacol. 2002;53:375–378. doi: 10.1046/j.1365-2125.2002.01563.x.
    1. Foody J, Joyce A, Rudolph A, Lui L, Benner J. Persistence of atorvastatin and simvastatin among patients with and without prior cardiovascular diseases: a US managed care study. Curr Med Res Opin. 2005;24:1987–2000. doi: 10.1185/03007990802203279.
    1. Smith D, Kramer J, Perrin N, Platt R, Roblin D, Lane K, Goodman M, Nelson W, Yang X, Soumerai S. A randomized trial of direct-to-patient communication to enhance adherence to B-blocker therapy following myocardial infarction. Arch Intern Med. 2008;168:477–483. doi: 10.1001/archinternmed.2007.132.
    1. Qureshi A, Suri F, Kirmani J, Divani A. The relative impact of inadequate primary and secondary prevention on cardiovascular mortality in the united states. Stroke. 2004;35:2346–2350. doi: 10.1161/01.STR.0000141417.66620.09.
    1. Hayes R, Moulton L. Cluster Randomised Trials. Boca Raton: Chapman & Hall/CRC; 2009. Regression analysis based on individual-level data; pp. 199–231. full_text.
    1. Donner A, Piaggio G, Villar J, Pinol A, al-Mazrou Y, Ba'aqeel H, Bakketeig L, Belizán JM, Berendes H, Carroli G, Farnot U, Lumbiganon P. Methodological considerations in the design of the WHO Antenatal Care Randomised Controlled Trial. Paediatric & Perinatal Epidemiology. 1998;12:59–74.
    1. Adherence to long-term therapies - evidence for action.
    1. Osterberg L, Blaschke T. Adherence to medication. NEJM. 2005;353:487–497. doi: 10.1056/NEJMra050100.
    1. Simpson S, Eurich D, Majumdar S, Padwal R, Tsuyuki R, Varnery J, Johnson J. A meta-analysis of the association between adherence to drug therapy and mortality. BMJ. 2006. doi:10.1136/bmj.38875.675486.55.
    1. Meichembaum D, Turk D. Facilitating treatment adherence: a practitioner's guidebook. New York: Plenum; 1987.
    1. Lewsey J. Comparing completely and stratified randomized designs in cluster randomized trials when the stratifying factor is cluster size: a simulation study. Stat Med. 2004;23:897–905. doi: 10.1002/sim.1665.
    1. McCarney R, Warner J, Iliffe S, van Haselen R, Griffin M, Fisher P. The Hawthorne effect: a randomised controlled trial. BMC Health Services Research. 2009. doi:101186/1471-2288-7-30 2007.
    1. Campbell M, Elbourne D, Altman D. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328:702–708. doi: 10.1136/bmj.328.7441.702.
    1. The Canadian Enhancement of ICD-10 (International Statistical Classification of Diseases and Related Health Problems Tenth Revision)
    1. Canadian Classification of Health Interventions (CCI)
    1. Von Korff M, Wagner E, Saunders K. A chronic disease score from automated pharmacy data. J Clin Epidmiol. 1992;45:197–203. doi: 10.1016/0895-4356(92)90016-G.
    1. Community Pharmacy in Canada: Executive Summary.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit