title: Cooperation between geriatricians and general practitioners for improved pharmacotherapy in home-dwelling elderly people receiving polypharmacy - the COOP Study: study protocol for a cluster randomised controlled trial.
abstract: Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are limited by the use of surrogate outcomes or suboptimal design. Thus, the potential for clinically significant improvements from different interventions is still unclear. The main objective of this study is therefore to evaluate the effect upon patient-relevant endpoints of a cooperation between geriatricians and general practitioners on complex drug regimens in home-dwelling elderly people.
  
  
  
  This is a cluster randomised, single-blind, controlled trial where general practitioners are invited to participate with patients from their lists. The patients must be 70 years or older, use at least seven different medications and have their medications administered by the home nursing service. We plan to recruit 200 patients, with randomisation at physician level. The intervention consists of three main parts: (1) clinical geriatric assessment of the patient, combined with a thorough review of their medications; (2) a meeting between the geriatrician and general practitioner, where the two physicians combine their competence and knowledge and discuss the drug list systematically; (3) clinical follow-up, depending on the medication changes that have been done. The study period is 24 weeks, and the patients are assessed at baseline, 16 and 24 weeks. The primary outcome measure is health-related quality of life according to the 15D instrument. Secondary outcome measures include physical and cognitive functioning, medication appropriateness, falls, carer burden, use of health services (hospital or nursing home admissions, use of home nursing services) and mortality.
  
  
  
  Our choice of patient-relevant outcome measures will hopefully provide new knowledge on the potential for clinical improvements after performing comprehensive medication reviews in home-dwelling elderly people receiving polypharmacy.
  
  
  
  ClinicalTrials.gov, NCT02379455 . Registered on 27 February 2015.
authors.affiliation: Department of Geriatric medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway. ritulf@gmail.com.
authors.forename: Rita
authors.identifier: 0000-0002-3251-6349
authors.initials: R
authors.lastname: Romskaug
authors.affiliation: School of Pharmacy, University of Oslo, Oslo, Norway.|Center for Psychopharmacology, Diakonhjemmet Hospital, Oslo, Norway.
authors.forename: Espen
authors.initials: E
authors.lastname: Molden
authors.affiliation: Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.
authors.forename: Jørund
authors.initials: J
authors.lastname: Straand
authors.affiliation: School of Pharmacy, University of Oslo, Oslo, Norway.|Department of Research and Development, Telemark Hospital Trust, Tønsberg, Norway.|Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway.
authors.forename: Hege
authors.initials: H
authors.lastname: Kersten
authors.affiliation: Department of Public Health and General Practice, NTNU, Trondheim, Norway.|Mental and Physical Health, Norwegian Institute of Public Health, Oslo, Norway.
authors.forename: Eva
authors.initials: E
authors.lastname: Skovlund
authors.affiliation: Department of General Practice, University of Helsinki, Helsinki, Finland.|Unit of Primary Health Care, Helsinki University Hospital, Helsinki, Finland.
authors.forename: Kaisu H
authors.initials: KH
authors.lastname: Pitkala
authors.affiliation: Department of Geriatric medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.|Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.
authors.forename: Torgeir Bruun
authors.initials: TB
authors.lastname: Wyller
mesh_terms: D000367:Age Factors; D000368:Aged; D000375:Aging / Q000523:psychology; D001291:Attitude of Health Personnel; D003299:Cooperative Behavior; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D005260:Female; D058005:General Practitioners / Q000523:psychology*; D000072219:Geriatricians / Q000523:psychology*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D057970:Inappropriate Prescribing / Q000517:prevention & control; D057187:Independent Living; D033183:Interdisciplinary Communication; D008297:Male; D054539:Medication Therapy Management; D009664:Norway; D010348:Patient Care Team; D019338:Polypharmacy; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors
keywords: Elderly; Geriatrics; Home-dwelling; Inappropriate drug use; Medication review; Polypharmacy