title: Preventing hospital admissions by reviewing medication (PHARM) in primary care: design of the cluster randomised, controlled, multi-centre PHARM-study.
abstract: BACKGROUND
  Medication can be effective but can also be harmful and even cause hospital admissions. Medication review or pharmacotherapy review has often been proposed as a solution to prevent these admissions and to improve the effectiveness and safety of pharmacotherapy. However, most published randomised controlled trials on pharmacotherapy reviews showed no or little effect on morbidity and mortality. Therefore we designed the PHARM (Preventing Hospital Admissions by Reviewing Medication)-study with the objective to study the effect of the total pharmaceutical care process on medication related hospital admissions and on adverse drug events, survival and quality of life.
  
  
  METHODS
  The PHARM-study is designed as a cluster randomised, controlled, multi-centre study in an integrated primary care setting. Patients with a high risk of a medication related hospital admission are included in the study with randomisation at GP (general practitioner) level. We aim to include 14200 patients, 7100 in each arm, from at least 142 pharmacy practices.The intervention consists of a patient-centred, structured, pharmaceutical care process. This process consists of several steps, is continuous and occurs over multiple encounters of patients and clinicians. The steps of this pharmaceutical care process are a pharmaceutical anamnesis, a review of the patient's pharmacotherapy, the formulation and execution of a pharmaceutical care plan combined with the monitoring and follow up evaluation of the care plan and pharmacotherapy. The patient's own pharmacist and GP carry out the intervention. The control group receives usual care.The primary outcome of the study is the frequency of hospital admissions related to medication within the study period of 12 months of each patient. The secondary outcomes are survival, quality of life, adverse drug events and severe adverse drug events. The outcomes will be analysed by using mixed-effects Cox models.
  
  
  CONCLUSIONS
  The PHARM-study is one of the largest controlled trials to study the effectiveness of the total pharmaceutical care process. The study should therefore provide evidence as to whether such a pharmaceutical care process should be implemented in the primary care setting.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  NTR 2647.
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology & Clinical Pharmacology, Faculty of Science, Utrecht University, Utrecht, the Netherlands.
authors.forename: Anne J
authors.initials: AJ
authors.lastname: Leendertse
authors.forename: Fred H P
authors.initials: FH
authors.lastname: de Koning
authors.forename: Alex N
authors.initials: AN
authors.lastname: Goudswaard
authors.forename: Andries R
authors.initials: AR
authors.lastname: Jonkhoff
authors.forename: Sander C A
authors.initials: SC
authors.lastname: van den Bogert
authors.forename: Han J
authors.initials: HJ
authors.lastname: de Gier
authors.forename: Toine C G
authors.initials: TC
authors.lastname: Egberts
authors.forename: Patricia M L A
authors.initials: PM
authors.lastname: van den Bemt
mesh_terms: D004358:Drug Therapy / Q000592:standards*; D006302:Health Services Research; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D008508:Medication Errors / Q000517:prevention & control*; D009426:Netherlands; D011320:Primary Health Care