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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

Impact of drug reconciliation at discharge and communication between hospital and community pharmacists on drug-related problems: study protocol for a randomized controlled trial

Authors: Xavier Pourrat, Clarisse Roux, Brigitte Bouzige, Valérie Garnier, Armelle Develay, Benoit Allenet, Martial Fraysse, Jean-Michel Halimi, Jacqueline Grassin, Bruno Giraudeau

Published in: Trials | Issue 1/2014

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Abstract

Background

Patients are at risk of drug-related problems (DRPs) at transition points during hospitalization. The community pharmacist (CP) is often the first healthcare professional patients visit after discharge. CPs lack sufficient information about the patient and so they may be unable to identify problems in medications, which may lead to dispensing the wrong drugs or dosage, and/or giving wrong information. We aim to assess the impact of a complex intervention comprising of medication reconciliation performed at discharge by a hospital pharmacist (HP) with communication between the HP and CP on DRPs during the seven days following discharge.

Methods/Design

The study is a cluster randomized crossover trial involving 46 care units (each unit corresponding to a cluster) in 22 French hospitals during two consecutive 14-day periods, randomly assigned as ‘experimental’ or ‘control’ (usual care) periods. We will recruit patients older than 18 years of age and visiting the same CP for at least three months. We will exclude patients with a hospital length of stay of more than 21 days, who do not return home or those in palliative care. During the experimental period, the HP will perform a medications reconciliation that will be communicated to the patient. The HP will inform the patient’s CP about the patient’s drug therapy (modification in home medication, acute drugs prescribed, nonprescription treatments, and/or lab results). The primary outcome will be a composite outcome of any kind of drug misuse during the seven days following discharge assessed at day seven (±2) post-discharge by a pharmacist in charge of the study who will contact both patients and CPs by phone. The secondary outcome will be unplanned hospitalizations assessed by phone contact at day 35 (±5) after discharge. We plan to recruit 1,176 patients.

Discussion

This study will assess the impact of a reconciliation of medications performed at patient discharge followed by communication between the HP and the patient’s CP. It will allow for identifying the type of patients in France for which the intervention is most relevant.

Trial registration

This study was registered with ClinicalTrials.gov (number: NCT02006797) on 5 December 2013.
Appendix
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Literature
1.
go back to reference Van Mil JW, Westerlund LO, Hersberger KE, Schaefer MA: Drug-related problem classification systems. Ann Pharmacother. 2004, 38: 859-867. 10.1345/aph.1D182.CrossRefPubMed Van Mil JW, Westerlund LO, Hersberger KE, Schaefer MA: Drug-related problem classification systems. Ann Pharmacother. 2004, 38: 859-867. 10.1345/aph.1D182.CrossRefPubMed
4.
go back to reference Corneau H, Dorval E, Rosset P, Hay N, Guegan F, Grassin J, Pourrat X: Exchange of patient’s data between hospital and community pharmacists: impact on admission drugs prescriptions. 39th ESCP European symposium on clinical pharmacy & 13th SFPC congress: octobre 2011. Int J Clin Pharmacol. 2011, 3: 285-497. Corneau H, Dorval E, Rosset P, Hay N, Guegan F, Grassin J, Pourrat X: Exchange of patient’s data between hospital and community pharmacists: impact on admission drugs prescriptions. 39th ESCP European symposium on clinical pharmacy & 13th SFPC congress: octobre 2011. Int J Clin Pharmacol. 2011, 3: 285-497.
5.
go back to reference Conciliation des traitements médicamenteux: détecter, intercepter et corriger les erreurs médicamenteuses à l'admission des patients hospitalisés [medication reconciliation: detect, intercept and correct the medication errors at admission]. Risques Qualité. 2011, 8: 130-138. Conciliation des traitements médicamenteux: détecter, intercepter et corriger les erreurs médicamenteuses à l'admission des patients hospitalisés [medication reconciliation: detect, intercept and correct the medication errors at admission]. Risques Qualité. 2011, 8: 130-138.
6.
go back to reference Pourrat X, Corneau H, Floch S, Kuzzay MP, Favard F, Rosset P, Hay N, Grassin J: Communication between community and hospital pharmacists: impact on medication reconciliation at admission. Int J Clin Pharmacol. 2013, 35: 656-663. 10.1007/s11096-013-9788-6.CrossRef Pourrat X, Corneau H, Floch S, Kuzzay MP, Favard F, Rosset P, Hay N, Grassin J: Communication between community and hospital pharmacists: impact on medication reconciliation at admission. Int J Clin Pharmacol. 2013, 35: 656-663. 10.1007/s11096-013-9788-6.CrossRef
7.
go back to reference Walker PC, Bernstein SJ, Jones JN, Piersma J, Kim HW, Regal RE, Kuhn L, Flanders SA: Impact of a pharmacist-facilitated hospital discharge program: a quasi-experimental study. Arch Intern Med. 2009, 169: 2003-2010. 10.1001/archinternmed.2009.398.CrossRefPubMed Walker PC, Bernstein SJ, Jones JN, Piersma J, Kim HW, Regal RE, Kuhn L, Flanders SA: Impact of a pharmacist-facilitated hospital discharge program: a quasi-experimental study. Arch Intern Med. 2009, 169: 2003-2010. 10.1001/archinternmed.2009.398.CrossRefPubMed
8.
go back to reference Brulebois A: Analyse des écarts de prescriptions médicamenteuses entre domicile, admission et sortie d’hospitalisation au centre hospitalier de Voiron: vers la conciliation des traitements médicamenteux. Thèse d’état Docteur en pharmacie consulté dernièrement le 30 décembre 2011 à l’URL. [http://dumas.ccsd.cnrs.fr/dumas-00592376/] Brulebois A: Analyse des écarts de prescriptions médicamenteuses entre domicile, admission et sortie d’hospitalisation au centre hospitalier de Voiron: vers la conciliation des traitements médicamenteux. Thèse d’état Docteur en pharmacie consulté dernièrement le 30 décembre 2011 à l’URL. [http://​dumas.​ccsd.​cnrs.​fr/​dumas-00592376/​]
9.
go back to reference Chevremont L, Blandin M, Corneau H, Perarnau J-M, Grassin J, Pourrat X: Prescription errors in orthopaedic surgery: are there more risks at admission? During hospitalization? At discharge?. 2011, Dublin: 40th ESCP European symposium on clinical pharmacy Chevremont L, Blandin M, Corneau H, Perarnau J-M, Grassin J, Pourrat X: Prescription errors in orthopaedic surgery: are there more risks at admission? During hospitalization? At discharge?. 2011, Dublin: 40th ESCP European symposium on clinical pharmacy
10.
go back to reference Boockvar KS, Carlson LaCorte H, Giambanco V, Fridman B, Siu A: Medication reconciliation for reducing drug-discrepancy adverse events. Am J Geriatr Pharmacother. 2006, 4: 236-243. 10.1016/j.amjopharm.2006.09.003.CrossRefPubMed Boockvar KS, Carlson LaCorte H, Giambanco V, Fridman B, Siu A: Medication reconciliation for reducing drug-discrepancy adverse events. Am J Geriatr Pharmacother. 2006, 4: 236-243. 10.1016/j.amjopharm.2006.09.003.CrossRefPubMed
11.
go back to reference Karapinar-Carkit F, Borgsteede SD, Zoer J, Smit HJ, Egberts AC, van den Bemt PM: Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009, 43: 1001-1010. 10.1345/aph.1L597.CrossRefPubMed Karapinar-Carkit F, Borgsteede SD, Zoer J, Smit HJ, Egberts AC, van den Bemt PM: Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009, 43: 1001-1010. 10.1345/aph.1L597.CrossRefPubMed
12.
go back to reference Climente-Martí M, García-Mañón ER, Artero-Mora A, Jiménez-Torres NV: Potential risk of medication discrepancies and reconciliation errors at admission and discharge from an inpatient medical service. Ann Pharmacother. 2010, 44: 1747-1754. 10.1345/aph.1P184.CrossRefPubMed Climente-Martí M, García-Mañón ER, Artero-Mora A, Jiménez-Torres NV: Potential risk of medication discrepancies and reconciliation errors at admission and discharge from an inpatient medical service. Ann Pharmacother. 2010, 44: 1747-1754. 10.1345/aph.1P184.CrossRefPubMed
13.
go back to reference Grimes TC, Duggan CA, Delaney TP, Graham IM, Conlon KC, Deasy E, Jago-Byrne MC, O’ Brien P: Medication details documented on hospital discharge: cross-sectional observational study of factors associated with medication non-reconciliation. Br J Clin Pharmacol. 2011, 71: 449-457. 10.1111/j.1365-2125.2010.03834.x.CrossRefPubMedPubMedCentral Grimes TC, Duggan CA, Delaney TP, Graham IM, Conlon KC, Deasy E, Jago-Byrne MC, O’ Brien P: Medication details documented on hospital discharge: cross-sectional observational study of factors associated with medication non-reconciliation. Br J Clin Pharmacol. 2011, 71: 449-457. 10.1111/j.1365-2125.2010.03834.x.CrossRefPubMedPubMedCentral
14.
go back to reference Eggink RN, Lenderink AW, Widdershoven JW, van den Bemt PM: The effect of a clinical pharmacist discharge service on medication discrepancies in patients with heart failure. Pharm World Sci. 2010, 32: 759-766. 10.1007/s11096-010-9433-6.CrossRefPubMedPubMedCentral Eggink RN, Lenderink AW, Widdershoven JW, van den Bemt PM: The effect of a clinical pharmacist discharge service on medication discrepancies in patients with heart failure. Pharm World Sci. 2010, 32: 759-766. 10.1007/s11096-010-9433-6.CrossRefPubMedPubMedCentral
15.
go back to reference Carter M, Allin D, Scott LA, Grauer D: Pharmacist-acquired medication histories in a university hospital emergency department. Am J Health Syst Pharm. 2006, 63: 2500-2503. 10.2146/ajhp060028.CrossRefPubMed Carter M, Allin D, Scott LA, Grauer D: Pharmacist-acquired medication histories in a university hospital emergency department. Am J Health Syst Pharm. 2006, 63: 2500-2503. 10.2146/ajhp060028.CrossRefPubMed
16.
go back to reference Nester T, Hale L: Effectiveness of a pharmacist-acquired medication history in promoting patient safety. Am J Health Syst Pharm. 2002, 59: 2221-2225.PubMed Nester T, Hale L: Effectiveness of a pharmacist-acquired medication history in promoting patient safety. Am J Health Syst Pharm. 2002, 59: 2221-2225.PubMed
17.
go back to reference Cohen J, Wilson C, Ward F: Improve drug history taking. Pharm Pract. 1998, 8: 13-14. 16 Cohen J, Wilson C, Ward F: Improve drug history taking. Pharm Pract. 1998, 8: 13-14. 16
18.
go back to reference Dawson P, Gray S: Clinical significance of pharmacist obtained drug histories. Pharm J. 1981, 227: 20- Dawson P, Gray S: Clinical significance of pharmacist obtained drug histories. Pharm J. 1981, 227: 20-
19.
go back to reference Durán-García E, Fernandez-Llamazares CM, Calleja-Hernández MA: Medication reconciliation: passing phase or real need?. Int J Clin Pharmacol. 2012, 34: 797-802. 10.1007/s11096-012-9707-2.CrossRef Durán-García E, Fernandez-Llamazares CM, Calleja-Hernández MA: Medication reconciliation: passing phase or real need?. Int J Clin Pharmacol. 2012, 34: 797-802. 10.1007/s11096-012-9707-2.CrossRef
22.
go back to reference Bolas H, Brookes K, Scott M: McElnay evaluation of a hospital-based community liaison pharmacy service in Northern Ireland. J Pharm World Sci. 2004, 26: 114-120.CrossRef Bolas H, Brookes K, Scott M: McElnay evaluation of a hospital-based community liaison pharmacy service in Northern Ireland. J Pharm World Sci. 2004, 26: 114-120.CrossRef
23.
go back to reference Hugtenburg JG, Borgsteede SD, Beckeringh J: Medication review and patient counselling at discharge from the hospital by community pharmacists. J Pharm World Sci. 2009, 31: 630-637. 10.1007/s11096-009-9314-z.CrossRef Hugtenburg JG, Borgsteede SD, Beckeringh J: Medication review and patient counselling at discharge from the hospital by community pharmacists. J Pharm World Sci. 2009, 31: 630-637. 10.1007/s11096-009-9314-z.CrossRef
24.
go back to reference Donner A, Klar N, Zou G: Methods for the statistical analysis of binary data in split-cluster designs. Biometrics. 2004, 60: 919-925. 10.1111/j.0006-341X.2004.00247.x.CrossRefPubMed Donner A, Klar N, Zou G: Methods for the statistical analysis of binary data in split-cluster designs. Biometrics. 2004, 60: 919-925. 10.1111/j.0006-341X.2004.00247.x.CrossRefPubMed
25.
go back to reference Bayliff C, Einarson T: Physician assessment of pharmacists’ interventions to correct prescribing errors. Can J Hosp. 1990, 4: 167-171. Bayliff C, Einarson T: Physician assessment of pharmacists’ interventions to correct prescribing errors. Can J Hosp. 1990, 4: 167-171.
26.
go back to reference Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P: Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med. 2007, 4: e61-10.1371/journal.pmed.0040061.CrossRefPubMedPubMedCentral Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P: Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med. 2007, 4: e61-10.1371/journal.pmed.0040061.CrossRefPubMedPubMedCentral
28.
go back to reference Giraudeau B, Ravaud P, Donner A: Sample size calculation for cluster randomized cross-over trials. Stat Med. 2008, 27: 5578-5585. 10.1002/sim.3383.CrossRefPubMed Giraudeau B, Ravaud P, Donner A: Sample size calculation for cluster randomized cross-over trials. Stat Med. 2008, 27: 5578-5585. 10.1002/sim.3383.CrossRefPubMed
29.
go back to reference Gulliford MC, Adams G, Ukoumunne OC, Latinovic R, Chinn S, Campbell MJ: Intraclass correlation coefficient and outcome prevalence are associated in clustered binary data. J Clin Epidemiol. 2005, 58: 246-251. 10.1016/j.jclinepi.2004.08.012.CrossRefPubMed Gulliford MC, Adams G, Ukoumunne OC, Latinovic R, Chinn S, Campbell MJ: Intraclass correlation coefficient and outcome prevalence are associated in clustered binary data. J Clin Epidemiol. 2005, 58: 246-251. 10.1016/j.jclinepi.2004.08.012.CrossRefPubMed
30.
go back to reference Turner RM, White IR, Croudace T, PIP Study Group: Analysis of cluster randomized cross-over trial data: a comparison of methods. Stat Med. 2007, 26: 274-289. 10.1002/sim.2537.CrossRefPubMed Turner RM, White IR, Croudace T, PIP Study Group: Analysis of cluster randomized cross-over trial data: a comparison of methods. Stat Med. 2007, 26: 274-289. 10.1002/sim.2537.CrossRefPubMed
31.
go back to reference French code of public heqlth about biomedical research and patient protection. Section R1121-3. Edict n°2006-477 from April 26th 2006 - art. 1 official Journal of the French republic April 27th 2006 French code of public heqlth about biomedical research and patient protection. Section R1121-3. Edict n°2006-477 from April 26th 2006 - art. 1 official Journal of the French republic April 27th 2006
Metadata
Title
Impact of drug reconciliation at discharge and communication between hospital and community pharmacists on drug-related problems: study protocol for a randomized controlled trial
Authors
Xavier Pourrat
Clarisse Roux
Brigitte Bouzige
Valérie Garnier
Armelle Develay
Benoit Allenet
Martial Fraysse
Jean-Michel Halimi
Jacqueline Grassin
Bruno Giraudeau
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-260

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