Discontinuing inappropriate medication in nursing home residents (DIM-NHR Study): protocol of a cluster randomised controlled trial

Hans Wouters, Elise H Quik, Froukje Boersma, Peder Nygård, Judith Bosman, Wendelien M Böttger, Hans Mulder, Jan-Gerard Maring, Linda Wijma-Vos, Tim Beerden, Jasperien van Doormaal, Maarten J Postma, Sytse U Zuidema, Katja Taxis, Hans Wouters, Elise H Quik, Froukje Boersma, Peder Nygård, Judith Bosman, Wendelien M Böttger, Hans Mulder, Jan-Gerard Maring, Linda Wijma-Vos, Tim Beerden, Jasperien van Doormaal, Maarten J Postma, Sytse U Zuidema, Katja Taxis

Abstract

Introduction: Nursing home residents often have a high number of comorbidities resulting in polypharmacy. Inappropriate prescribing is therefore likely to occur, which in turn is expected to worsen cognitive impairment, to increase the fall risk and to decrease residents' quality of life. The objective of the 'Discontinuing Inappropriate Medication in Nursing Home Residents' (DIM-NHR) study is to examine the efficacy and cost-effectiveness of the Multidisciplinary Multistep Medication Review (3MR) that is aimed at optimising prescribing and discontinuing inappropriate medication.

Methods: A cluster randomised controlled trial will be conducted. Elderly care physicians and their wards (clusters) will be randomised. Data will be collected at baseline and 4 months after the 3MR has taken place. Six hundred nursing home residents will be recruited of whom more than half are expected to suffer from dementia. The 3MR will be based on consensus criteria and the relevant literature and will be performed by the patient's elderly care physician in collaboration with a pharmacist.

Analysis: Primary outcomes-the difference in proportion of residents who successfully discontinued inappropriate medication between the intervention and control group at follow-up. Secondary outcomes-undertreatment, exposure to anticholinergic and sedative medicines, neuropsychiatric symptoms, cognitive function, falls, hospital admission, quality of life and cost-effectiveness.

Ethics and dissemination: Participant burden will be kept at a minimum. The elderly care physician will remain free to adjust medication when symptoms relapse or adverse events occur, rendering serious adverse events highly unlikely. Study findings will be published in peer-reviewed journals and a 3MR toolkit will be developed.

Trial registration number: This study has been registered at http://www.ClinicalTrials.gov (trial registration number: NCT01876095).

Keywords: CLINICAL PHARMACOLOGY; GERIATRIC MEDICINE; HEALTH ECONOMICS; MEDICAL EDUCATION & TRAINING.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
Flow chart of study phases (IC, informed consent).

References

    1. Gallagher P, Barry P, O'Mahony D. Inappropriate prescribing in the elderly. J Clin Pharm Ther 2007;32:113–21
    1. Ruggiero C, Dell'Aquila G, Gasperini B, et al. . Potentially inappropriate drug prescriptions and risk of hospitalisation among older, Italian, nursing home residents: the ULISSE project. Drugs Aging 2010;27:747–58
    1. Perri M, Menon AM, Deshpande AD, et al. . Adverse outcomes associated with inappropriate drug use in nursing homes. Ann Pharmacother 2005;39:405–11
    1. Jano E, Aparasu RR. Healthcare outcomes associated with Beers’ criteria: a systematic review. Ann Pharmacother 2007;41:438–47
    1. Bergh S, Selbaek G, Engedal K. Discontinuation of antidepressants in people with dementia and neuropsychiatric symptoms (DESEP study): double blind, randomised, parallel group, placebo controlled trial. BMJ 2012;344:e1566.
    1. Iyer S, Naganathan V, McLachlan AJ, et al. . Medication withdrawal trials in people aged 65 years and older: a systematic review. Drugs Aging 2008;25:1021–31
    1. Molander L, Lovheim H, Norman T, et al. . Lower systolic blood pressure is associated with greater mortality in people aged 85 and older. J Am Geriatr Soc 2008;56:1853–9
    1. Ballard C, Margallo-Lana M, Juszczak E, et al. . Quetiapine and rivastigmine and cognitive decline in Alzheimer's disease: randomised double blind placebo controlled trial. BMJ 2005;330:874.
    1. Seitz DP, Gill SS, Herrmann N, et al. . Pharmacological treatments for neuropsychiatric symptoms of dementia in long-term care: a systematic review. Int Psychogeriatr 2013;25:185–203
    1. Ballard C, Lana MM, Theodoulou M, et al. . A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (the DART-AD trial). PLoS Med 2008;5:e76.
    1. Devanand DP, Mintzer J, Schultz SK, et al. . Relapse risk after discontinuation of risperidone in Alzheimer's disease. N Engl J Med 2012;367:1497–507
    1. Garfinkel D, Zur-Gil S, Ben-Israel J. The war against polypharmacy: a new cost-effective geriatric-palliative approach for improving drug therapy in disabled elderly people. Isr Med Assoc J 2007;9:430–4
    1. Christensen D, Trygstad T, Sullivan R, et al. . A pharmacy management intervention for optimizing drug therapy for nursing home patients. Am J Geriatr Pharmacother 2004;2:248–56
    1. Patterson SM, Hughes CM, Crealey G, et al. . An evaluation of an adapted U.S. model of pharmaceutical care to improve psychoactive prescribing for nursing home residents in Northern Ireland (Fleetwood Northern Ireland study). J Am Geriatr Soc 2010;58:44–53
    1. Patterson SM, Hughes CM, Cardwell C, et al. . A cluster randomised controlled trial of an adapted U.S. model of pharmaceutical care for nursing home residents in Northern Ireland (Fleetwood Northern Ireland study): a cost- effectiveness analysis. J Am Geriatr Soc 2011;59:586–93
    1. Loganathan M, Singh S, Franklin BD, et al. . Interventions to optimise prescribing in care homes: systematic review. Age Ageing 2011;40:150–62
    1. Forsetlund L, Eike MC, Gjerberg E, et al. . Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials. BMC Geriatr 2011;11:1–18
    1. Wilson NM, Hilmer SN, March LM, et al. . Associations between drug burden index and falls in older people in residential aged care. J Am Geriatr Soc 2011;59:875–80
    1. Cornege-Blokland E, Kleijer BC, Hertogh CM, et al. . Reasons to prescribe antipsychotics for the behavioural symptoms of dementia: a survey in Dutch nursing homes among physicians, nurses, and family caregivers. J Am Med Dir Assoc 2012;13:80.e1,80.e6
    1. Wetzels RB, Zuidema SU, de Jonghe JF, et al. . Prescribing pattern of psychotropic drugs in nursing home residents with dementia. Int Psychogeriatr 2011;23:1249–59
    1. Hughes CM, Goldie R. “I just take what I am given”: adherence and resident involvement in decision making on medicines in nursing homes for older people: a qualitative survey. Drugs Aging 2009;26:505–17
    1. Garfinkel D, Mangin D. Feasibility study of a systematic approach for discontinuation of multiple medications in older adults: addressing polypharmacy. Arch Intern Med 2010;170:1648–54
    1. Zuidema SU, de Jonghe JF, Verhey FR, et al. . Psychotropic drug prescription in nursing home patients with dementia: influence of environmental correlates and staff distress on physicians’ prescription behaviour. Int Psychogeriatr 2011;23:1632–9
    1. Gallagher P, Baeyens JP, Topinkova E, et al. . Inter-rater reliability of STOPP (screening tool of older persons’ prescriptions) and START (screening tool to alert doctors to right treatment) criteria amongst physicians in six European countries. Age Ageing 2009; 38:603–6
    1. Gallagher P, Ryan C, Byrne S, et al. . STOPP (Screening Tool of Older Person's Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment). Consensus validation. Int J Clin Pharmacol Ther 2008;46:72–83
    1. American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American geriatrics society updated beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc 2012;60:616–31
    1. Finkers F, Maring JG, Boersma F, et al. . A study of medication reviews to identify drug-related problems of polypharmacy patients in the Dutch nursing home setting. J Clin Pharm Ther 2007;32:469–76
    1. Bain KT, Holmes HM, Beers MH, et al. . Discontinuing medications: a novel approach for revising the prescribing stage of the medication-use process. J Am Geriatr Soc 2008;56:1946–52
    1. Spinewine A, Schmader KE, Barber N, et al. . Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet 2007;370:173–84
    1. Zermansky AG, Alldred DP, Petty DR, et al. . Clinical medication review by a pharmacist of elderly people living in care homes—randomised controlled trial. Age Ageing 2006;35:586–91
    1. Schölzel-Dorenbos CJ, Arons AM, Wammes JJ, et al. . Validation study of the prototype of a disease-specific index measure for health-related quality of life in dementia. Health Qual Life Outcomes 2012;10:1–11
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L). Qual Life Res 2011;20:1727–36
    1. Saxton J, Kastango KB, Hugonot-Diener L, et al. . Development of a short form of the severe impairment battery. Am J Geriatr Psychiatry 2005;13:999–1005
    1. De Jonghe JF, Wetzels RB, Mulders A, et al. . Validity of the severe impairment battery short version. J Neurol Neurosurg Psychiatry 2009;80:954–9
    1. Folstein MF, Folstein SE, McHugh PR. Mini-mental state: a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975;12:189–98
    1. Cummings JL, Mega M, Gray K, et al. . The neuropsychiatric inventory: comprehensive assessment of psychopathology in dementia. Neurology 1994;44:2308–14
    1. Kat MG, de Jonghe JF, Aalten P, et al. . Neuropsychiatric symptoms of dementia: psychometric aspects of the Dutch neuropsychiatric inventory (NPI). Tijdschr Gerontol Geriatr 2002;33:150–5
    1. Quan H, Li B, Couris CM, et al. . Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol 2011;173:676–82
    1. Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet 2002;359:515–19

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