Impact of medication review via tele-expertise on unplanned hospitalizations at 3 months of nursing homes patients (TEM-EHPAD): study protocol for a randomized controlled trial

F Correard, M Montaleytang, M Costa, M Astolfi, K Baumstarck, S Loubière, K Amichi, P Auquier, P Verger, P Villani, S Honore, A Daumas, F Correard, M Montaleytang, M Costa, M Astolfi, K Baumstarck, S Loubière, K Amichi, P Auquier, P Verger, P Villani, S Honore, A Daumas

Abstract

Background: Inappropriate drug prescribing causes preventable drug-related adverse events that result in increased morbidity and mortality, additional costs and diminished quality of life. Numerous initiatives have been launched to improve the quality of drug prescribing and safeguard the security of drug administration processes in nursing homes. Against the backdrop of implementation of telemedicine services, the focus of the present work is to evaluate the impact of a telemedication review carried out by a hospital physician and pharmacist as part of the telemedicine offer.

Methods: The present study is a randomized controlled clinical trial. A total of 364 patients will be randomized into two groups: (1) an experimental group (182 patients) benefiting from a telemedication review using tele-expertise and (2) a control group (182 patients) receiving standard care. The primary endpoint will be rate of all-cause unplanned hospital admissions occurring within 3 months of randomization. The secondary endpoints will be rate of unplanned admissions at 6 months, patient quality of life, incidence of behavioral disturbances, number of falls, number of residents prescribed at least one inappropriate medication, nursing staff satisfaction, proposed medication reviews and their acceptability rate, characteristics of patients whose general practitioners have taken account of tele-expertise, efficacy of tele-expertise as compared to standard prescription and acceptability and satisfaction surveys of participating caregivers.

Discussion: In the literature, various studies have investigated the utility of structured medication review processes, but outcome measures are heterogeneous, and results vary widely. Medication review can detect medication-related problems in many patients, but evidence of clinical impact is scant. Incremental cost-effectiveness ratios will be used to compare the cost and effectiveness of the experimental strategy and that of standard care. Our approach, involving the combination of an acceptability survey and a mixed-method (qualitative and quantitative) satisfaction survey, is particularly innovative. The results of this randomized trial are expected to confirm that medication review using tele-expertise has potential as a worthwhile care management strategy for nursing home residents.

Trial registration: Clinicaltrials.gov NCT03640845; registered August 21, 2018 (Clinicaltrials.gov NCT03640845).

Keywords: Drug; Elderly; Iatrogenic; Inappropriate medication; Tele-expertise; Telemedicine.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of the study protocol

References

    1. Liew TM, Lee CS, Goh Shawn KL, Chang ZY. Potentially inappropriate prescribing among older persons: a meta-analysis of observational studies. Ann Fam Med. 2019;17:257–266. doi: 10.1370/afm.2373.
    1. Heider D, Matschinger H, Meid AD, Quinzler R, Adler JB, Günster C, et al. Health service use, costs, and adverse events associated with potentially inappropriate medication in old age in Germany: retrospective matched cohort study. Drugs Aging. 2017;34:289–301. doi: 10.1007/s40266-017-0441-2.
    1. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365:2002–2012. doi: 10.1056/NEJMsa1103053.
    1. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004;329:15–19. doi: 10.1136/bmj.329.7456.15.
    1. Maher RL, Hanlon J, Hajjar ER. Clinical consequences of polypharmacy in elderly. Expert Opin Drug Saf. 2014;13:57–65. doi: 10.1517/14740338.2013.827660.
    1. Haute Autorité de Santé. Comment améliorer la qualité et la sécurité des prescriptions de médicaments chez la personne âgée ? Accessed 04 Sept 2019.
    1. Ankri J. Le risque iatrogène médicamenteux chez le sujet âgé. Gérontologie et société. 2002;25:93–106. doi: 10.3917/gs.103.0093.
    1. Ministère des Solidarités et de la Santé. La politique du médicament en EHPAD – Rapport 2013. Accessed 04 Sept 2019.
    1. Rousseau A, Rybarczyk-Vigouret MC, Vogel T, Lang PO, Michel B. Inappropriate prescription and administration of medications in 10 nursing homes in Alsace, France. Rev Epidemiol Sante Publique. 2016;64:95–101. doi: 10.1016/j.respe.2015.12.016.
    1. Morin L, Laroche ML, Texier G, Johnell K. Prevalence of Potentially Inappropriate Medication Use in Older Adults Living in Nursing Homes: A Systematic Review. J Am Med Dir Assoc. 2016;17:862.e1–862.e9. doi: 10.1016/j.jamda.2016.06.011.
    1. Agence française de sécurité sanitaire des produits de santé. Prévenir la iatrogénèse médicamenteuse chez le sujet âgé. Accessed 04 Sept 2019.
    1. Haute Autorité de Santé. Prescription médicamenteuse chez le sujet âgé (1) - Médecin traitant. Accessed 04 Sept 2019.
    1. Agence Nationale de l'Evaluation et de la qualité des Etablissements et Services sociaux et Médico-sociaux. Prise en charge médicamenteuse en EHPAD. Accessed 04 Sept 2019.
    1. Desnoyer A, Guignard B, Lang PO, Desmeules J, Vogt-Ferrier N, Bonnabry P. Prescriptions médicamenteuses potentiellement inappropriées en gériatrie : quels outils utiliser pour les détecter ? Presse Med. 2016;45:957–970. doi: 10.1016/j.lpm.2016.06.033.
    1. Boudon A, Riat F, Rassam-Hasso Y, Lang PO. Polymorbidité et polypharmacie. Comment optimiser la prise en charge des patients âgés complexes ? Forum Med Suisse. 2017;17:306–312. doi: 10.4414/fms.2017.02899.
    1. Flodgren G, Rachas A, Farmer AJ, Inzitari M, Shepperd S. Interactive telemedicine: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2015;2015:CD002098.
    1. Zulfiqar AA, Hajjam A, Talha S, Hajjam M, Hajjam J, Ervé S, et al. Telemedicine and geriatrics in France: inventory of experiments. Curr Gerontol Geriatr Res. 2018;2018:1–10. doi: 10.1155/2018/9042180.
    1. De Luca R, Bramanti A, De Cola MC, Trifiletti A, Tomasello P, Torrisi M, et al. Tele-health-care in the elderly living in nursing home: the first Sicilian multimodal approach. Aging Clin Exp Res. 2016;28:753–759. doi: 10.1007/s40520-015-0463-8.
    1. Hanlon P, Daines L, Campbell C, McKinstry B, Weller D, Pinnock H. Telehealth interventions to support self-Management of Long-Term Conditions: a systematic Metareview of diabetes, heart failure, asthma, chronic obstructive pulmonary disease, and cancer. J Med Internet Res. 2017;19:e172.
    1. Bashi N, Karunanithi M, Fatehi F, Ding H, Walters D. Remote monitoring of patients with heart failure: an overview of systematic reviews. J Med Internet Res. 2017;19:1–14. doi: 10.2196/jmir.6571.
    1. Trivalle C, Cartier T, Verny C, Mathieu AM, Davrinche P, Agostini H, et al. IMEPAG GROUP Identifying and preventing adverse drug events in elderly hospitalised patients: a randomised trial of a program to reduce adverse drug effects. J Nutr Health Aging. 2010;14:57–61. doi: 10.1007/s12603-010-0010-4.
    1. Chapman KR, Bing-Canar H, Alosco ML, Steinberg EG, Martin B, Chaisson C, et al. Mini mental state examination and logical memory scores for entry into Alzheimer’s disease trials. Alzheimers Res Ther. 2016;8:9. doi: 10.1186/s13195-016-0176-z.
    1. Rolland Y, Andrieu S, Hein C, Vellas B. Rates of admissions and discharges of nursing home residents in France: results of the pleiad study. La Revue de gériatrie. 2012;37:543–548.
    1. Crotty M, Rowett D, Spurling L, Giles LC, Phillips PA. 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;2:257–264. doi: 10.1016/j.amjopharm.2005.01.001.
    1. Haute Autorité de Santé. Mettre en œuvre la conciliation des traitements médicamenteux en établissement de santé. Accessed 04 Sept 2019.
    1. Luo N, Li M, Chevalier J, Lloyd A, Herdman M. A comparison of the scaling properties of the English, Spanish, French, and Chinese EQ-5D descriptive systems. Qual Life Res. 2013;22:2237–2243. doi: 10.1007/s11136-012-0342-0.
    1. Olssson IN, Runnamo R, Engfeldt P. Medication quality and quality of life in the elderly, a cohort study. Health Qual Life Outcomes. 2011;9:95. doi: 10.1186/1477-7525-9-95.
    1. Diguer L, Turmel V, Brin J, Lapointe T, Chrétien S, Marcoux L.-A, Mathieu V, Da Silva Luis R. Translation and validation in French of the Pathological Narcissism Inventory. Can J Behav Sci. 2019; doi :10.1037/cbs0000140..
    1. Hanlon JT, Schmader KE. The Medication Appropriateness Index at 20: where it started, where it has been and where it may be going. Drugs Aging. 2013;30:10. doi: 10.1007/s40266-013-0118-4.
    1. Haute Autorité de Santé, guide «Choices in Methods for Economic Evaluation». Accessed 04 Sept 2019.
    1. Briggs AH. Statistical approaches to handling uncertainty in health economic evaluation. Eur J Gastroenterol Hepatol. 2004;16:551–561. doi: 10.1097/00042737-200406000-00007.
    1. Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2001;10:779–787. doi: 10.1002/hec.635.
    1. Creswell J, Plano CV. Designing and conducting mixed methods research. 2e ed. Thousand Oaks: Sage Publications; 2011.
    1. Kaur M. Application of mixed method approach in public Health Research. Indian J Community Med. 2016;41:93–97. doi: 10.4103/0970-0218.173495.
    1. Santé O mondiale de la. Rapport mondial sur le vieillissement et la santé [Internet]. Organisation mondiale de la Santé; 2016. Disponible sur: . Accessed 19 Nov 2019.
    1. La politique du médicament. Rapport Pierre Verger. . Accessed 19 Nov 2019.
    1. Lehnbom EC, Stewart MJ, Manias E, Westbrook JI. Impact of medication reconciliation and review on clinical outcomes. Ann Pharmacother. 2014;48:1298–1312. doi: 10.1177/1060028014543485.
    1. Crotty M, Halbert J, Rowett D, Giles L, Birks R, Williams H, et al. An outreach geriatric medication advisory service in residential aged care: a randomised controlled trial of case conferencing. Age Ageing. 2004;33:612–617. doi: 10.1093/ageing/afh213.
    1. Zermansky AG, Alldred DP, Petty DR, Raynor DK, Freemantle N, Eastaugh J, et al. Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial. Age Ageing. 2006;35:586–591. doi: 10.1093/ageing/afl075.
    1. Olsson IN, Curman B, Engfeldt P. Patient focused drug surveillance of elderly patients in nursing homes. Pharmacoepidemiol Drug Saf. 2010;19:150–157. doi: 10.1002/pds.1891.
    1. Mahlknecht A, Nestler N, Bauer U, Schüßler N, Schuler J, Scharer S, et al. Effect of training and structured medication review on medication appropriateness in nursing home residents and on cooperation between health care professionals: the InTherAKT study protocol. BMC Geriatr. 2017;17:24. doi: 10.1186/s12877-017-0418-3.
    1. Krause O, Wiese B, Doyle IM, Kirsch C, Thürmann P, Wilm S, et al. HIOPP-3-iTBX study group. Multidisciplinary intervention to improve medication safety in nursing home residents: protocol of a cluster randomised controlled trial (HIOPP-3-iTBX study) BMC Geriatr. 2019;19:2. doi: 10.1186/s12877-019-1027-0.
    1. Mestres Gonzalvo C, de Wit HA, van Oijen BP, Hurkens KP, Janknegt R, Schols JM, et al. Supporting clinical rules engine in the adjustment of medication (SCREAM): protocol of a multicentre, prospective, randomised study. BMC Geriatr. 2017;17:35. doi: 10.1186/s12877-017-0426-3.
    1. Maidment ID, Damery S, Campbell N, Seare N, Fox C, Iliffe S, et al. Medication review plus person-centred care: a feasibility study of a pharmacy-health psychology dual intervention to improve care for people living with dementia. BMC Psychiatry. 2018;18.
    1. Cardwell K, Clyne B, Moriarty F, Wallace E, Fahey T, Boland F, et al. Supporting prescribing in Irish primary care: protocol for a non-randomised pilot study of a general practice pharmacist (GPP) intervention to optimise prescribing in primary care. Pilot Feasibility Stud. 2018;4:122. doi: 10.1186/s40814-018-0311-7.
    1. Wilchesky M, Mueller G, Morin M, Marcotte M, Voyer P, Aubin M, et al. The OptimaMed intervention to reduce inappropriate medications in nursing home residents with severe dementia: results from a quasi-experimental feasibility pilot study. BMC Geriatr. 2018;18:204. doi: 10.1186/s12877-018-0895-z.
    1. Desveaux L, Saragosa M, Rogers J, Bevan L, Loshak H, Moser A, et al. Improving the appropriateness of antipsychotic prescribing in nursing homes: amixed-methods process evaluation of an academic detailing intervention. Implement Sci. 2017;12:71.
    1. Organization WH. Ethical issues related to study design for trials on therapeutics for Ebola Virus Disease: WHO Ethics Working Group meeting 20–21 October, summary of discussion. ().
    1. van Dijk KN, van Asselt DZ, Vogel D, van der Hooft CS, Van Roon EN, Brouwers JR. Effects of a structured medication review by geriatrician and clinical pharmacologist on appropriateness of pharmacotherapy in frail elderly inpatients. Tijdschr Gerontol Geriatr. 2009;40:72–78.
    1. Kaur S, Mitchell G, Vitetta L, Roberts MS. Interventions that can reduce inappropriate prescribing in the elderly: a systematic review. Drugs Aging. 2009;26:1013–1028. doi: 10.2165/11318890-000000000-00000.
    1. Gillespie RJ, Harrison L, Mullan J. Deprescribing medications for older adults in the primary care context: a mixed studies review. Health Sci Rep. 2018;1:e45. doi: 10.1002/hsr2.45.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj