Opti-Med: the effectiveness of optimised clinical medication reviews in older people with ‘geriatric giants’ in general practice; study protocol of a cluster randomised controlled trial

BackgroundInappropriate drug use has been identified as one of the most important problems affecting the quality of care in older people. Inappropriate drug use may increase the risk of the occurrence of ‘geriatric giants’ such as immobility, instability, incontinence and cognitive impairment. There are indications that clinical medication reviews (CMR) can reduce inappropriate drug use. However, CMRs have not yet been implemented at a large scale in primary care. An innovative medication review program in primary care will be developed which tackles the most important obstacles for a large scale implementation of CMRs. The aim of this study is to assess whether this CMR program is (cost-) effective compared with usual general practice care for older patients with geriatric symptoms with regard to quality of life and geriatric symptoms.MethodsA cluster randomised controlled trial will be performed in 20 Dutch general practices including 500 patients. Patients of 65 years and older are eligible if they newly present with pre-specified geriatric symptoms in general practice and chronic use of at least one prescribed drug. GP practices will be stratified by practice size and randomly allocated to control (n = 10) or intervention group (n = 10). The intervention consists of CMRs which will be facilitated and prepared by an expert team consisting of a GP and a pharmacist. Primary outcome measures are patient’s quality of life and the presence of self-reported geriatric symptoms during a follow-up period of 6 months. Secondary outcomes are costs of healthcare utilisation, feasibility, number of drug related problems, medication adherence and satisfaction with medication.DiscussionThis study is expected to add evidence on the (cost-) effectiveness of an optimally facilitated, prepared and structured CMR in comparison with usual care in older patients who present a geriatric symptom to their GP. The strength of this study is that it will be conducted in daily clinical practice. This improves the possibilities to implement the CMRs in the primary care setting on a large scale.Trial registrationNetherlands Trial register: NTR4264

[1]  J. Wood,et al.  Nursing home care. , 1986, Clinics in geriatric medicine.

[2]  A Simon Pickard,et al.  Proxy Evaluation of Health-Related Quality of Life: A Conceptual Framework for Understanding Multiple Proxy Perspectives , 2005, Medical care.

[3]  N. Wit,et al.  Multidisciplinaire richtlijn Polyfarmacie bij ouderen , 2013, Huisarts en wetenschap.

[4]  P. Stolee,et al.  Illness presentation in elderly patients. , 1995, Archives of internal medicine.

[5]  L. French,et al.  Urinary problems in women. , 2009, Primary care.

[6]  N. Jones,et al.  Testing the validity of the Euroqol and comparing it with the SF-36 health survey questionnaire , 1993, Quality of Life Research.

[7]  E. Roughead,et al.  Australia and New Zealand Health Policy Open Access Medication Safety in Acute Care in Australia: Where Are We Now? Part 1: a Review of the Extent and Causes of Medication Problems 2002– 2008 , 2022 .

[8]  S. Folstein,et al.  "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. , 1975, Journal of psychiatric research.

[9]  Giel Nijpels,et al.  Identification of drug-related problems of elderly patients discharged from hospital , 2014, Patient preference and adherence.

[10]  H. Melhus,et al.  A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. , 2009, Archives of internal medicine.

[11]  D. Revicki,et al.  Psychometric evaluation of the Medication Satisfaction Questionnaire (MSQ) to assess satisfaction with antipsychotic medication among schizophrenia patients , 2010, Schizophrenia Research.

[12]  R. Garrick,et al.  Frequency of and Risk Factors for Preventable Medication-Related Hospital Admissions in the Netherlands , 2009 .

[13]  M. Vernooij-Dassen,et al.  NHG-Standaard Dementie (derde herziening)+ , 2012 .

[14]  W. Clyne,et al.  A guide to medication review , 2008 .

[15]  Y. Loke,et al.  Does pharmacist-led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta-analysis. , 2008, British journal of clinical pharmacology.

[16]  R. Wallace,et al.  Risk Factors for Adverse Drug Events in Older Adults with Mobility Limitations in the Community Setting , 2007, Journal of the American Geriatrics Society.

[17]  Patrick Royston,et al.  Multiple imputation using chained equations: Issues and guidance for practice , 2011, Statistics in medicine.

[18]  R. Fitzpatrick,et al.  Older people specific health status and quality of life: a structured review of self-assessed instruments. , 2005, Journal of evaluation in clinical practice.

[19]  R. Brooks.  EuroQol: the current state of play. , 1996, Health policy.

[20]  Henks Lamberts,et al.  ICPC : international classification of primary care , 1987 .

[21]  A. Williams.  EuroQol : a new facility for the measurement of health-related quality of life , 1990 .

[22]  Sjaak Brinkkemper,et al.  General practitioners’ attitudes towards decision-supported prescribing: An analysis of the Dutch primary care sector , 2013, Health Informatics J..

[23]  Paul F. M. Krabbe,et al.  Kwaliteit van leven meten in economische evaluaties: het Nederlands EQ-5D-tarief , 2005 .

[24]  M. Griffin,et al.  Medication-Related Admissions in Older People , 2009, Drugs & aging.

[25]  S. D. de Rooij,et al.  RELIABILITY AND VALIDITY OF THE VISUAL ANALOGUE SCALE FOR FEAR OF FALLING IN OLDER PERSONS , 2010, Journal of the American Geriatrics Society.

[26]  B. Pollock,et al.  Drugs with anticholinergic properties: a current perspective on use and safety , 2011, Expert opinion on drug safety.

[27]  Allen Huang,et al.  The challenge of managing drug interactions in elderly people , 2007, The Lancet.

[28]  L. Welschen,et al.  Effect of medication review and cognitive behaviour treatment by community pharmacists of patients discharged from the hospital on drug related problems and compliance: design of a randomized controlled trial , 2010, BMC public health.

[29]  P. Scheltens,et al.  The cost-effectiveness of a family meetings intervention to prevent depression and anxiety in family caregivers of patients with dementia: a randomized trial , 2013, Trials.

[30]  G. D. Spoelhof,et al.  Nursing home care: part II. Clinical aspects. , 2010, American family physician.

[31]  Wanzhu Tu,et al.  Pharmacist Intervention to Improve Medication Adherence in Heart Failure , 2007, Annals of Internal Medicine.

[32]  N. Aaronson,et al.  Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. , 1998, Journal of clinical epidemiology.

[33]  B. Thiers,et al.  Appropriate prescribing in elderly people: how well can it be measured and optimised? , 2008 .

[34]  J. Ware,et al.  Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. , 1998, Journal of clinical epidemiology.

[35]  Marc A. Koopmanschap,et al.  Handleiding iMTA Medical Cost Questionnaire (iMCQ) , 2013 .

[36]  J. Ware,et al.  A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. , 1996, Medical care.

[37]  N. Kerse,et al.  Interventions to improve the appropriate use of polypharmacy for older people. , 2018, The Cochrane database of systematic reviews.

[38]  P. Stalmeier,et al.  [Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff]. , 2005, Nederlands tijdschrift voor geneeskunde.

[39]  R. Marum,et al.  Detectie van ongeschikt medicatiegebruik bij ouderen Worden de STOPP- en START-criteri a de nie uwe st and aard ? , 2012 .

[40]  J. Beijnen,et al.  Evaluation of Pharmacotherapy in Geriatric Patients after Performing Complete Geriatric Assessment at a Diagnostic Day Clinic , 2006, Clinical drug investigation.

[41]  W. F. Ossenfort.  An Introduction to Geriatrics. , 1966 .

[42]  J. Hanlon,et al.  Impact of Inappropriate Drug Use on Mortality and Functional Status in Representative Community Dwelling Elders , 2002, Medical care.

[43]  Karim M Khan,et al.  Meta-analysis of the impact of 9 medication classes on falls in elderly persons. , 2009, Archives of internal medicine.

[44]  Lisa Bero,et al.  Effect of outpatient pharmacists' non-dispensing roles on patient outcomes and prescribing patterns. , 2010, The Cochrane database of systematic reviews.

[45]  John E. Brazier,et al.  Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D , 2005, Quality of Life Research.

[46]  Gregory M. Peterson,et al.  DOCUMENT: a system for classifying drug-related problems in community pharmacy , 2012, International Journal of Clinical Pharmacy.

[47]  S. McPhail,et al.  Two Perspectives of Proxy Reporting of Health-Related Quality of Life Using the Euroqol-5D, An Investigation of Agreement , 2008, Medical care.

[48]  J. Westbrook,et al.  Impact of Medication Reconciliation and Review on Clinical Outcomes , 2014, The Annals of pharmacotherapy.

[49]  F. Schellevis,et al.  Information on actual medication use and drug-related problems in older patients: questionnaire or interview? , 2016, International Journal of Clinical Pharmacy.

[50]  T. Rajji,et al.  Sensitivity to Antipsychotic Drugs in Older Adults , 2010, Current psychiatry reports.

[51]  G. Piaggio,et al.  Consort 2010 statement: extension to cluster randomised trials , 2012, BMJ : British Medical Journal.

[52]  P. Jansen,et al.  Clinical Pharmacology in Old Persons , 2012, Scientifica.

[53]  K. Kulich,et al.  A literature review to explore the link between treatment satisfaction and adherence, compliance, and persistence , 2012, Patient preference and adherence.

[54]  J. Dartigues,et al.  BMC Geriatrics BioMed Central , 2009 .

[55]  S. van Buuren.  Multiple imputation of discrete and continuous data by fully conditional specification , 2007, Statistical methods in medical research.