title: Decreasing the load? Is a Multidisciplinary Multistep Medication Review in older people an effective intervention to reduce a patient's Drug Burden Index? Protocol of a randomised controlled trial.
abstract: BACKGROUND
  Older people often use medications with anticholinergic or sedative side effects which increase the risk of falling and worsen cognitive impairment. The Drug Burden Index (DBI) is a measure of the burden of anticholinergic and sedative medications. Medication reviews are typically done by a pharmacist in collaboration with a general practitioner to optimise the medication use and reduce these adverse drug events. We will evaluate whether a Multidisciplinary Multistep Medication Review (3MR) is an effective intervention to reduce a patient's DBI.
  
  
  METHODS
  A randomised controlled trial including 160 patients from 15 community pharmacies will be conducted. Per pharmacy, 1 pharmacist will perform a structured 3MR in close collaboration with the general practitioner, including the objective to reduce the DBI.
  
  
  METHODS
  Primary outcome--the difference in proportion of patients having a decrease in DBI ≥ 0.5 in the intervention and control groups at follow-up. Secondary outcomes--anticholinergic and sedative side effects, falls, cognitive function, activities of daily living, quality of life, hospital admission, and mortality.
  
  
  BACKGROUND
  The burden of patients will be kept at a minimum. The 3MR can be considered as usual care by the pharmacist and general practitioner. Medical specialists will be consulted, if necessary. The intervention is specifically aimed at older community-dwelling patients in an attempt to optimise prescribing, in particular, to reduce medication with anticholinergic and sedative properties. Study results will be published in peer-reviewed journals and will be distributed through information channels targeting professionals.
  
  
  BACKGROUND
  NCT02317666; Pre-results.
authors.affiliation: Department of Pharmacy, Section of Pharmacotherapy and Pharmaceutical Care, Groningen Research Institute of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen, Groningen, The Netherlands.
authors.forename: Helene G
authors.initials: HG
authors.lastname: van der Meer
authors.affiliation: Department of Pharmacy, Section of Pharmacotherapy and Pharmaceutical Care, Groningen Research Institute of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen, Groningen, The Netherlands.
authors.forename: Hans
authors.initials: H
authors.lastname: Wouters
authors.affiliation: Department of Pharmacy, Section of Pharmacotherapy and Pharmaceutical Care, Groningen Research Institute of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen, Groningen, The Netherlands.
authors.forename: Rolf
authors.initials: R
authors.lastname: van Hulten
authors.affiliation: Department of Pharmacy, Section of Pharmacotherapy and Pharmaceutical Care, Groningen Research Institute of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen, Groningen, The Netherlands.
authors.forename: Niesko
authors.initials: N
authors.lastname: Pras
authors.affiliation: Department of Pharmacy, Section of Pharmacotherapy and Pharmaceutical Care, Groningen Research Institute of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen, Groningen, The Netherlands.
authors.forename: Katja
authors.initials: K
authors.lastname: Taxis
mesh_terms: D000058:Accidental Falls; D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D018680:Cholinergic Antagonists / Q000009:adverse effects*; D017723:Drug Utilization Review; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D005260:Female; D058005:General Practitioners; D006760:Hospitalization; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects*; D008297:Male; D010595:Pharmacists; D000067561:Potentially Inappropriate Medication List; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method
chemical_list: D018680:Cholinergic Antagonists; D006993:Hypnotics and Sedatives
keywords: aged; drug burden index; medication review; muscarinic antagonists; polypharmacy