Using novel Canadian resources to improve medication reconciliation at discharge: study protocol for a randomized controlled trial

Trials

Kristen E Reidel⁴  Kiyuri Naicker⁴  André Jacques³  David Buckeridge⁴  Tewodros Eguale⁴  Alan Forster²  Christian Rochefort¹  Nancy E Winslade¹  Ari N Meguerditchian¹  Allen R Huang¹  Robyn Tamblyn¹ 

[1] Department of Medicine, Royal Victoria Hospital, McGill University, 687 Pine Avenue West, Room A3.09, Montreal, QC, H3A 1A1, Canada;Ottawa Hospital Research Institute, 725 Parkdale Avenue, Ottawa, ON, K1Y 4E9, Canada;Collège des Médecins du Québec, 2170 Réné-Lévesque Boulevard West, Montreal, QC, H3H 2T8, Canada;Clinical and Health Informatics Research Group, McGill University, 1140 Pine Avenue West, Montreal, QC, H3A 1A3, Canada

关键词: Transitions in care;    Medication reconciliation;    Adverse events;   

Others  :  1095377
DOI  :  10.1186/1745-6215-13-150

 received in 2011-12-14, accepted in 2012-08-07,  发布年份 2012

【 摘 要 】

Background

Adverse drug events are responsible for up to 7% of all admissions to acute care hospitals. At least 58% of these are preventable, resulting from incomplete drug information, prescribing or dispensing errors, and overuse or underuse of medications. Effective implementation of medication reconciliation is considered essential to reduce preventable adverse drug events occurring at transitions between community and hospital care. An electronically enabled discharge reconciliation process represents an innovative approach to this problem.

Methods/Design

Participants will be recruited in Quebec and are eligible for inclusion if they are using prescription medication at admission, covered by the Quebec drug insurance plan, admitted from the community, 18 years or older, admitted to a general or intensive care medical or surgical unit, and discharged alive. A sample size of 3,714 will be required to detect a 5% reduction in adverse drug events. The intervention will comprise electronic retrieval of the community drug list, combined with an electronic discharge reconciliation module and an electronic discharge communication module. The primary outcomes will be adverse drug events occurring 30 days post-discharge, identified by a combination of patient self-report and chart abstraction. All emergency room visits and hospital readmission during this period will be measured as secondary outcomes. A cluster randomization approach will be used to allocate 16 medical and 10 surgical units to electronic discharge reconciliation and communication versus usual care. An intention-to-treat approach will be used to analyse data. Logistic regression will be undertaken within a generalized estimating equation framework to account for clustering within units.

Discussion

The goal of this prospective trial is to determine if electronically enabled discharge reconciliation will reduce the risk of adverse drug events, emergency room visits and readmissions 30 days post-discharge compared with usual care. We expect that this intervention will improve adherence to medication reconciliation at discharge, the accuracy of the community-based drug history and effective communication of hospital-based treatment changes to community care providers. The results may support policy-directed investments in computerizing and training of hospital staff, generate key requirements for future hospital accreditation standards, and highlight functional requirements for software vendors.

Trial registration

NCT01179867

【 授权许可】

   
2012 Tamblyn et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, Laffel G, Sweitzer BJ, Shea BF, Hallisey R, Vander Vliet M, Nemeskal R, Leape LL, Hojnowski-Diaz P, Petrycki S, Cotugno M, Patterson H, Hickey M, Kleefield S, Cooper J, Cullen DJ, Kinneally E, Demonaco HJ, Dempsey Clapp M, Gallivan T, Ives J, Porter K, Thompson T, Hackman R, Edmonson A: Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA 1995, 274:29-34.
• [2]Lazarou J, Pomeranz BH, Corey PN: Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998, 279:1200-1205.
• [3]Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA: The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA 1997, 307:307-311.
• [4]Forster AJ, Clark HD, Menard A, Dupuis N, Chernish R, Chandok N, Khan A, van Walraven C: Adverse events among medical patients after discharge from hospital. CMAJ 2004, 170:345-349.
• [5]Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW: The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 2003, 138:161-167.
• [6]Coleman EA, Smith JD, Raha D, Min SJ: Posthospital medication discrepancies: prevalence and contributing factors. Arch Intern Med 2005, 165:1842-1847.
• [7]Leape LL, Bates DW, Cullen DJ, Cooper J, Demonaco HJ, Gallivan T, Hallisey R, Ives J, Laird N, Laffel G, Nemeskal R, Petersen LA, Porter K, Servi D, Shea BF, Small SD, Sweitzer BJ, Thompson T, Vander Vliet M, Hojnowski-Diaz P, Petrycki S, Cotugno M, Patterson H, Hickey M, Kleefield S, Kinneally E, Dempsey Clapp M, Hackman R, Edmonson A: Systems analysis of adverse drug events. ADE Prevention Study Group. JAMA 1995, 274:35-43.
• [8]Bell CM, Bajcar J, Bierman AS, Li P, Mamdani MM, Urbach DR: Potentially unintended discontinuation of long-term medication use after elective surgical procedures. Arch Intern Med 2006, 166:2525-2531.
• [9]Bell CM, Brener SS, Gunraj N, Huo C, Bierman AS, Scales DC, Bajcar J, Zwarenstein M, Urbach DR: Association of ICU or hospital admission with unintentional discontinuation of medications for chronic diseases. JAMA 2011, 306:840-847.
• [10]Paparella S: Medication reconciliation: doing what’s right for safe patient care. J Emerg Nurs 2006, 32:516-520.
• [11]Using medication reconciliation to prevent errors Jt Comm J Qual Patient Saf 2006, 32:230-232.
• [12]Saufl NM: Reconciliation of medications. J Perianesth Nurs 2006, 21:126-127.
• [13]Manno MS, Hayes DD: Best-practice interventions: how medication reconciliation saves lives. Nursing 2006, 36:63-64.
• [14]Vira T, Colquhoun M, Etchells E: Reconcilable differences: correcting medication errors at hospital admission and discharge. Qual Saf Health Care 2006, 15:122-126.
• [15]Barker KN, Flynn EA, Pepper GA, Bates DW, Mikeal RL: Medication errors observed in 36 health care facilities. Arch Intern Med 2002, 162:1897-1903.
• [16]Kemp LO, Narula P, McPherson ML, Zuckerman I: Medication reconciliation in hospice: a pilot study. Am J Hosp Palliat Care 2009, 26:193-199.
• [17]Ledger S, Choma G: Medication reconciliation in hemodialysis patients. CANNT J 2008, 18:41-43.
• [18]Gleason KM, Groszek JM, Sullivan C, Rooney D, Barnard C, Noskin GA: Reconciliation of discrepancies in medication histories and admission orders of newly hospitalized patients. Am J Health Syst Pharm 2004, 61:1689-1695.
• [19]Vigoda MM, Gencorelli FJ, Lubarsky DA: Discrepancies in medication entries between anesthetic and pharmacy records using electronic databases. Anesth Analg 2007, 105:1061-1065.
• [20]Weingart SN, Cleary A, Seger A, Eng TK, Saadeh M, Gross A, Shulman LN: Medication reconciliation in ambulatory oncology. Jt Comm J Qual Patient Saf 2007, 33:750-757.
• [21]Groeschen H: Electronic system improves medication reconciliation rates. Am J Health Syst Pharm 1894, 2007:64.
• [22]What’s expected for med reconciliation? OR Manager 2008, 24(3):21-23.
• [23]Rozich JD, Howard RJ, Justeson JM, Macken PD, Lindsay ME, Resar RK: Standardization as a mechanism to improve safety in health care. Jt Comm J Qual Saf 2004, 30:5-14.
• [24]Bridgeman PJ, Rynn KO: Medication reconciliation in the emergency department. Am J Health Syst Pharm 2008, 65(24):2325-2326.
• [25]Meds reconciliation summit promises more clarification: Meds reconciliation summit promises more clarification. ED Manag 2008, 20(2):suppl 3-4.
• [26]Agrawal A, Wu WY: Reducing medication errors and improving systems reliability using an electronic medication reconciliation system. Jt Comm J Qual Patient Saf 2009, 35:106-114.
• [27]Lesselroth BJ, Felder RS, Adams SM, Cauthers PD, Dorr DA, Wong GJ, Douglas DM: Design and implementation of a medication reconciliation kiosk: the Automated Patient History Intake Device (APHID). J Am Med Inform Assoc 2009, 16(3):300-304.
• [28]Akwagyriam I, Goodyer LI, Harding L, Khakoo S, Millington H: Drug history taking and the identification of drug related problems in an accident and emergency department. J Accid Emerg Med 1996, 13:166-168.
• [29]Lau HS, Florax C, Porsius AJ, De BA: The completeness of medication histories in hospital medical records of patients admitted to general internal medicine wards. Br J Clin Pharmacol 2000, 49:597-603.
• [30]Poon EG, Blumenfeld B, Hamann C, Turchin A, Graydon-Baker E, McCarthy PC, Poikonen J, Mar P, Schnipper JL, Hallisey RK, Smith S, McCormack C, Paterno M, Coley CM, Karson A, Chueh HC, Van Putten C, Millar SG, Clapp M, Bhan I, Meyer GS, Gandhi TK, Broverman CA: Design and implementation of an application and associated services to support interdisciplinary medication reconciliation efforts at an integrated healthcare delivery network. J Am Med Inform Assoc 2006, 13:581-592.
• [31]Turchin A, Hamann C, Schnipper JL, Graydon-Baker E, Millar SG, McCarthy PC, Coley CM, Gandhi TK, Broverman CA: Evaluation of an inpatient computerized medication reconciliation system. J Am Med Inform Assoc 2008, 15:449-452.
• [32]Clay BJ, Halasyamani L, Stucky ER, Greenwald JL, Williams MV: Results of a medication reconciliation survey from the 2006 Society of Hospital Medicine national meeting. J Hosp Med 2008, 3:465-472.
• [33]Tam VC, Knowles SR, Cornish PL, Fine N, Marchesano R, Etchells EE: Frequency, type and clinical importance of medication history errors at admission to hospital: a systematic review. CMAJ 2005, 173:510-515.
• [34]Cornish PL, Knowles SR, Marchesano R, Tam V, Shadowitz S, Juurlink DN, Juurlink DN, Etchells EE: Unintended medication discrepancies at the time of hospital admission. Arch Intern Med 2005, 165:424-429.
• [35]LaPointe NM, Jollis JG: Medication errors in hospitalized cardiovascular patients. Arch Intern Med 2003, 163:1461-1466.
• [36]Pippins JR, Gandhi TK, Hamann C, Ndumele CD, Labonville SA, Diedrichsen EK, Carty MG, Karson AS, Bhan I, Coley CM, Liang CL, Turchin A, McCarthy PC, Schnipper JL: Classifying and predicting errors of inpatient medication reconciliation. J Gen Intern Med 2008, 23:1414-1422.
• [37]Mersfelder TL, Bickel RJ: Inpatient medication history verification by pharmacy students. Am J Health Syst Pharm 2008, 65:2273-2275.
• [38]Miller SL, Miller S, Balon J, Helling TS: Medication reconciliation in a rural trauma population. Ann Emerg Med 2008, 52:483-491.
• [39]van den Bemt PM, van den BS, van Nunen AK, Harbers JB, Lenderink AW: Medication reconciliation performed by pharmacy technicians at the time of preoperative screening. Ann Pharmacother 2009, 43:868-874.
• [40]Lubowski TJ, Cronin LM, Pavelka RW, Briscoe-Dwyer LA, Briceland LL, Hamilton RA: Effectiveness of a medication reconciliation project conducted by PharmD students. Am J Pharm Educ 2007, 71:94.
• [41]Schwarz M, Wyskiel R: Medication reconciliation: developing and implementing a program. Crit Care Nurs Clin North Am 2006, 18:503-507.
• [42]Haig K: Medication reconciliation. Am J Med Qual 2006, 21:299-303.
• [43]Bayley KB, Savitz LA, Maddalone T, Stoner SE, Hunt JS, Wells R: Evaluation of patient care interventions and recommendations by a transitional care pharmacist. Ther Clin Risk Manag 2007, 3:695-703.
• [44]Varkey P, Resar RK: Medication reconciliation implementation in an academic center. Am J Med Qual 2006, 21:293-295.
• [45]Kramer JS, Hopkins PJ, Rosendale JC, Garrelts JC, Hale LS, Nester TM, Cochran P, Eidem LA, Haneke RD: Implementation of an electronic system for medication reconciliation. Am J Health Syst Pharm 2007, 64:404-422.
• [46]Isaac LM, Tamblyn RM, McGill Calgary Drug Research Team: Compliance and cognitive function: a methodological approach to measuring unintentional errors in medication compliance in the elderly. Gerontologist 1993, 33(6):772-781.
• [47]Karnon J, Campbell F, Czoski-Murray C: Model-based cost-effectiveness analysis of interventions aimed at preventing medication error at hospital admission (medicines reconciliation). J Eval Clin Pract 2009, 15:299-306.
• [48]Orrico KB: Sources and types of discrepancies between electronic medical records and actual outpatient medication use. J Manag Care Pharm 2008, 14:626-631.
• [49]Fulford MD, Berger BA, Newton DS: The relationship between computerization and profitability in independent community pharmacies. J Pharm Mark Manage 1988, 3:75-98.
• [50]Sikka R, Xia F, Aubert RE: Estimating medication persistency using administrative claims data. Am J Manag Care 2005, 11:449-457.
• [51]Steiner JF, Prochazka AV: The assessment of refill compliance using pharmacy records: methods, validity, and applications. J Clin Epidemiol 1997, 50:105-116.
• [52]Choo PW, Rand CS, Inui TS, Lee ML, Cain E, Cordeiro-Breault M, Canning C, Platt R: Validation of patient reports, automated pharmacy records, and pill counts with electronic monitoring of adherence to antihypertensive therapy. Med Care 1999, 37:846-857.
• [53]Bails D, Clayton K, Roy K, Cantor MN: Implementing online medication reconciliation at a large academic medical center. Jt Comm J Qual Patient Saf 2008, 34:499-508.
• [54]Schenkel S: The unexpected challenges of accurate medication reconciliation. Ann Emerg Med 2008, 52:493-495.
• [55]Aarts J, Koppel R: Implementation of computerized physician order entry in seven countries. Health Aff 2009, 28(2):404-414.
• [56]Weingart SN, Toth M, Sands DZ, Aronson MD, Davis RB, Phillips RS: Physicians’ decisions to override computerized drug alerts in primary care. Arch Intern Med 2003, 163:2625-2631.
• [57]Tamblyn R, Huang A, Taylor L, Kawasumi Y, Bartlett G, Grad R, Jacques A, Dawes M, Abrahamowicz M, Perreault R, Winslade N, Poissant L, Pinsonneault A: A randomized trial of the effectiveness of on-demand versus computer-triggered drug decision support in primary care. J Am Med Inform Assoc 2008, 15:430-438.
• [58]Beers MH, Dang J, Hasegawa J, Tamai IY: Influence of hospitalization on drug therapy in the elderly. J Am Geriatr Soc 1989, 37:679-683.
• [59]Jackevicius CA, Paterson JM, Naglie G: Concordance between discharge prescriptions and insurance claims in post-myocardial infarction patients. Pharmacoepidemiol Drug Saf 2007, 16:207-215.
• [60]Jack BW, Chetty VK, Anthony D, Greenwald JL, Sanchez GM, Johnson AE, Forsythe SR, O’Donnell JK, Paasche-Orlow MK, Manasseh C, Martin S, Culpepper L: A reengineered hospital discharge program to decrease rehospitalization. Ann Intern Med 2009, 150:178-187.
• [61]Tamblyn RM, McLeod P, Abrahamowicz M, Berkson L, Dauphinee D, Gayton D, et al.: Multi-Physician Involvement and Questionable High Risk Prescribing in the Elderly. Toronto: The Canadian Pharmacoepidemiology Forum; 1993.
• [62]Tamblyn RM: Improving patient safety through computerized drug management: The devil is in the details. HealthCare Papers 2004, 5:52-68.
• [63]Kanjanarat P, Winterstein AG, Johns TE, Hatton RC, Gonzalez-Rothi R, Segal R: Nature of preventable adverse drug events in hospitals: a literature review. Am J Health Syst Pharm 2003, 60:1750-1759.
• [64]Agrawal A, Aronson JK, Britten N, Ferner RE, de Smet PA, Fialova D, Fitzgerald RJ, Likić R, Maxwell SR, Meyboom RH, Minuz P, Onder G, Schachter M, Velo G, Members of EMERGE Erice Medication Errors Research Group: Medication errors: problems and recommendations from a consensus meeting. Br J Clin Pharmacol 2009, 67:592-598.
• [65]Eguale T, Tamblyn R, Winslade N, Buckeridge D: Detection of adverse drug events and other treatment outcomes using an electronic prescribing system. Drug Saf 2008, 31:1005-1016.
• [66]Kawasumi Y, Tamblyn R, Platt R, Ernst P, Abrahamowicz M, Taylor L: Evaluation of the use of an integrated drug information system by primary care physicians for vulnerable population. Int J Med Inform 2008, 77:98-106.
• [67]Taylor LK, Kawasumi Y, Bartlett G, Tamblyn R: Inappropriate prescribing practices: the challenge and opportunity for patient safety. Healthc Q 2005, 8:81-85.
• [68]Tamblyn R, Huang A, Kawasumi Y, Bartlett-Esquilant G, Grad R, Jacques A, Dawes M, Abrahamowicz M, Perreault R, Taylor L, Winslade N, Poissant L, Pinsonneault A: The development and evaluation of an integrated electronic prescribing and drug management system for primary care. J Am Med Inform Assoc 2006, 13:148-159.
• [69]Tamblyn R, Huang A, Perreault R, Jacques A, Roy D, Hanley J, McLeod P, Laprise R: The medical office of the 21st century (MOXXI): effectiveness of computerized decision-making support in reducing inappropriate prescribing in primary care. CMAJ 2003, 169:549-556.
• [70]Bartlett G, Blais R, Tamblyn R, Clermont RJ, MacGibbon B: Impact of patient communication problems on the risk of preventable adverse events in acute care settings. CMAJ 2008, 178:1555-1562.
• [71]Interagency Advisory Panel on Research Ethics: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa: Interagency Secretariat on Research Ethics; 2008:1-154.
• [72]Tamblyn RM, Lavoie G, Petrella L, Monette J: The use of prescription claims databases in pharmacoepidemiological research: the accuracy and comprehensiveness of the prescription claims database in Quebec. J Clin Epidemiol 1995, 48(8):999-1009.
• [73]Kawasumi Y, Abrahamowicz M, Ernst P, Tamblyn R: Development and validation of a predictive algorithm to identify adult asthmatics from medical services and pharmacy claims databases. Health Serv Res 2011, 46:939-963.
• [74]Nebeker JR, Barach P, Samore MH: Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. Ann Intern Med 2004, 140:795-801.
• [75]Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ: A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981, 30:239-245.
• [76]Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, Seger DL, Shu K, Federico F, Leape LL, Bates DW: Adverse drug events in ambulatory care. N Engl J Med 2003, 348:1556-1564.
• [77]Mitchell AS, Henry DA, Hennrikus D, O’Connel DL: Adverse drug reactions: can consumers provide early warning? Pharmacoepidemiol Drug Saf 1994, 3:257-264.
• [78]Kelly WN: The quality of published adverse drug event reports. Ann Pharmacother 2003, 37:1774-1778.
• [79]Regie de l’assurance-maladie du Quebec: Statistiques Annuelles. Quebec: Regie de l'assurance-maladie du Quebec; 2000:46-48.
• [80]Charlson ME, Pompei P, Ales KL, MacKenzie CR: A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987, 40(5):373-383.
• [81]Campbell MK, Elbourne DR, Altman DG: CONSORT statement: extension to cluster randomised trials. Br Med J 2004, 328:702-708.
• [82]Zeger SL, Liang KY, Albert PS: Models for longitudinal data: a generalized estimating equation approach. Biometrics 1988, 44:1049-1060.
• [83]Bates DW, Kuperman GJ, Wang S, Gandhi T, Kittler A, Volk L, Spurr C, Khorasani R, Tanasijevic M, Middleton B: Ten commandments for effective clinical decision support: making the practice of evidence-based medicine a reality. J Am Med Inform Assoc 2003, 10:523-530.