title: 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.
abstract: BACKGROUND
  Inappropriate 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.
  
  
  METHODS
  A 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  Netherlands Trial register: NTR4264.
authors.affiliation: NIVEL, Netherlands Institute for Health Services Research, Po, Box 1568, 3500 BN, Utrecht, The Netherlands. f.willeboordse@vumc.nl.
authors.forename: Floor
authors.initials: F
authors.lastname: Willeboordse
authors.forename: Jacqueline G
authors.initials: JG
authors.lastname: Hugtenburg
authors.forename: Liset
authors.initials: L
authors.lastname: van Dijk
authors.forename: Judith E
authors.initials: JE
authors.lastname: Bosmans
authors.forename: Oscar J
authors.initials: OJ
authors.lastname: de Vries
authors.forename: François G
authors.initials: FG
authors.lastname: Schellevis
authors.forename: Petra J M
authors.initials: PJ
authors.lastname: Elders
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D016000:Cluster Analysis; D003362:Cost-Benefit Analysis; D017723:Drug Utilization Review / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D058006:General Practice / Q000379:methods* / Q000706:statistics & numerical data; D006707:Homes for the Aged; D006801:Humans; D008297:Male; D009426:Netherlands; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D011788:Quality of Life; D012189:Retrospective Studies