Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON): study protocol of a cluster controlled trial

Pauline Anrys, Goedele Strauven, Benoit Boland, Olivia Dalleur, Anja Declercq, Jean-Marie Degryse, Jan De Lepeleire, Séverine Henrard, Valérie Lacour, Steven Simoens, Niko Speybroeck, Kris Vanhaecht, Anne Spinewine, Veerle Foulon, Pauline Anrys, Goedele Strauven, Benoit Boland, Olivia Dalleur, Anja Declercq, Jean-Marie Degryse, Jan De Lepeleire, Séverine Henrard, Valérie Lacour, Steven Simoens, Niko Speybroeck, Kris Vanhaecht, Anne Spinewine, Veerle Foulon

Abstract

Background: Ageing has become a worldwide reality and presents new challenges for the health-care system. Research has shown that potentially inappropriate prescribing, both potentially inappropriate medications and potentially prescribing omissions, is highly prevalent in older people, especially in the nursing home setting. The presence of potentially inappropriate medications/potentially prescribing omissions is associated with adverse drug events, hospitalisations, mortality and health-care costs. The Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON) study aims to evaluate the effect of a complex, multifaceted intervention, including interdisciplinary case conferences, on the appropriateness of prescribing of medicines for older people in Belgian nursing homes.

Methods/design: A multicentre cluster-controlled trial is set up in 63 Belgian nursing homes (30 intervention; 33 control). In each of these nursing homes, 35 residents (≥65 years) are selected for participation. The complex, multifaceted intervention comprises (i) health-care professional education and training, (ii) local concertation (discussion on the appropriate use of at least one medication class at the level of the nursing home) and (iii) repeated interdisciplinary case conferences between general practitioner, nurse and pharmacist to perform medication review for each included nursing home resident. The control group works as usual. The study period lasts 15 months. The primary outcome measures relate to the appropriateness of prescribing and are defined as (1) among residents who had at least one potentially inappropriate medication/potentially prescribing omission at baseline, the proportion of them for whom there is a decrease of at least one of these potentially inappropriate medications/potentially prescribing omissions at the end of study, and (2) among all residents, the proportion of them for whom at least one new potentially inappropriate medication/potentially prescribing omission is present at the end of the study, compared to baseline. The secondary outcome measures include individual components of appropriateness of prescribing, medication use, outcomes of the case conferences, clinical outcomes and costs. A process evaluation (focusing on implementation, causal mechanisms and contextual factors) will be conducted alongside the study.

Discussion: The COME-ON study will contribute to a growing body of knowledge concerning the effect of complex interventions on the use of medicines in the nursing home setting, and on factors influencing their effect. The results will inform policymakers on strategies to implement in the near future.

Trial registration: Current Controlled Trials ISRCTN66138978.

Keywords: Aged; Complex intervention; Drug-related problems; Inappropriate prescribing; Interdisciplinary case conferences; Medication review; Medication use; Patient care team; Residential facilities.

Figures

Fig. 1
Fig. 1
COME-ON study flowchart
Fig. 2
Fig. 2
Timeline of COME-ON intervention

References

    1. Rechel B, Grundy E, Robine JM, Cylus J, Mackenbach JP, Knai C, et al. Ageing in the European Union. Lancet. 2013;381(9874):1312–1322. doi: 10.1016/S0140-6736(12)62087-X.
    1. Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, et al. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007;370(9582):173–184. doi: 10.1016/S0140-6736(07)61091-5.
    1. Conejos Miquel MD, Sánchez Cuervo M, Delgado Silveira E, Sevilla Machuca I, González-Blazquez S, Montero Errasquin B, et al. Potentially inappropriate drug prescription in older subjects across health care settings. Eur Geriatr Med. 2010;1(1):9–14. doi: 10.1016/j.eurger.2009.12.002.
    1. Cullinan S, O’Mahony D, Fleming A, Byrne S. A meta-synthesis of potentially inappropriate prescribing in older patients. Drugs Aging. 2014;31(8):631–638. doi: 10.1007/s40266-014-0190-4.
    1. Hill-Taylor B, Sketris I, Hayden J, Byrne S, O’Sullivan D, Christie R. Application of the STOPP/START criteria: a systematic review of the prevalence of potentially inappropriate prescribing in older adults, and evidence of clinical, humanistic and economic impact. J Clin Pharm Ther. 2013;38(5):360–372. doi: 10.1111/jcpt.12059.
    1. Jano E, Aparasu RR. Healthcare outcomes associated with beers’ criteria: a systematic review. Ann Pharmacother. 2007;41(3):438–447. doi: 10.1345/aph.1H473.
    1. Lau DT, Kasper JD, Potter DE, Lyles A, Bennett RG. Hospitalization and death associated with potentially inappropriate medication prescriptions among elderly nursing home residents. Arch Intern Med. 2005;165(1):68–74. doi: 10.1001/archinte.165.1.68.
    1. Albert SM, Colombi A, Hanlon J. Potentially inappropriate medications and risk of hospitalization in retirees: analysis of a US retiree health claims database. Drugs Aging. 2010;27(5):407–415. doi: 10.2165/11315990-000000000-00000.
    1. Klarin I, Wimo A, Fastbom J. The association of inappropriate drug use with hospitalisation and mortality: a population-based study of the very old. Drugs Aging. 2005;22(1):69–82. doi: 10.2165/00002512-200522010-00005.
    1. Dalleur O, Spinewine A, Henrard S, Losseau C, Speybroeck N, Boland B. Inappropriate prescribing and related hospital admissions in frail older persons according to the STOPP and START criteria. Drugs Aging. 2012;29(10):829–837. doi: 10.1007/s40266-012-0016-1.
    1. O’Mahony D, O’Sullivan D, Byrne S, O’Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015;44(2):213–218. doi: 10.1093/ageing/afu145.
    1. By the American Geriatrics Society Beers Criteria Update Expert P. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society. 2015. doi:10.1111/jgs.13702.
    1. Da Silva DT, Santos AP, Aguiar PM, Da Silva WB, De Lyra DP., Jr Analysis of research quality regarding pharmaceutical intervention in elderly residents of long-term care facilities: a systematic review. J Am Geriatr Soc. 2010;58(7):1404–1406. doi: 10.1111/j.1532-5415.2010.02932.x.
    1. Marcum ZA, Handler SM, Wright R, Hanlon JT. Interventions to improve suboptimal prescribing in nursing homes: a narrative review. Am J Geriatr Pharmacother. 2010;8(3):183–200. doi: 10.1016/j.amjopharm.2010.05.004.
    1. Loganathan M, Singh S, Franklin BD, Bottle A, Majeed A. Interventions to optimise prescribing in care homes: systematic review. Age Ageing. 2011;40(2):150–162. doi: 10.1093/ageing/afq161.
    1. Verrue CL, Petrovic M, Mehuys E, Remon JP, Vander Stichele R. Pharmacists’ interventions for optimization of medication use in nursing homes: a systematic review. Drugs Aging. 2009;26(1):37–49. doi: 10.2165/0002512-200926010-00003.
    1. Alldred DP, Raynor DK, Hughes C, Barber N, Chen TF, Spoor P. Interventions to optimise prescribing for older people in care homes. Cochrane Database Syst Rev. 2013;2
    1. Forsetlund L, Eike MC, Gjerberg E, Vist GE. Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials. BMC Geriatr. 2011;11:16. doi: 10.1186/1471-2318-11-16.
    1. Kaur S, Mitchell G, Vitetta L, Roberts MS. Interventions that can reduce inappropriate prescribing in the elderly: a systematic review. Drugs Aging. 2009;26(12):1013–1028. doi: 10.2165/11318890-000000000-00000.
    1. Sanford AM, Orrell M, Tolson D, Abbatecola AM, Arai H, Bauer JM, et al. An international definition for “nursing home”. J Am Med Dir Assoc. 2015;16(3):181–184. doi: 10.1016/j.jamda.2014.12.013.
    1. KCE . La performance du système de santé Belge - Rapport 2015 (KCE report 259B) 2015.
    1. KCE . L’utilisation des médicaments dans les maisons de repos et les maisons de repos et de soins belges (KCE reports vol. 47B) 2006.
    1. Verrue C, Mehuys E, Boussery K, Adriaens E, Remon JP, Petrovic M. A pharmacist-conducted medication review in nursing home residents: impact on the appropriateness of prescribing. Acta Clin Belg. 2012;67(6):423–429.
    1. Hughes CM, Roughead E, Kerse N. Improving use of medicines for older people in long-term care: contrasting the policy approach of four countries. Healthc Policy. 2008;3(3):e154–e167.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655.
    1. Parsons C, Alldred D, Daiello L, Hughes C. Prescribing for older people in nursing homes: strategies to improve prescribing and medicines use in nursing homes. Int J Older People Nursing. 2011;6(1):55–62. doi: 10.1111/j.1748-3743.2010.00263.x.
    1. Campbell MK, Piaggio G, Elbourne DR, Altman DG, Group C. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345 doi: 10.1136/bmj.e5661.
    1. Basger BJ, Moles RJ, Chen TF. Development of an aggregated system for classifying causes of drug-related problems. Ann Pharmacother. 2015
    1. P.C.N.E. Classification for drug related problems V6.2. . Accessed 4 Jan 2016.
    1. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258. doi: 10.1136/bmj.h1258.
    1. Campbell MK, Thomson S, Ramsay CR, MacLennan GS, Grimshaw JM. Sample size calculator for cluster randomized trials. Comput Biol Med. 2004;34(2):113–125. doi: 10.1016/S0010-4825(03)00039-8.
    1. KCE . Belgische richtlijnen voor economische evaluaties en budget impact analyses: tweede editie (KCE report 183A) 2012.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する