title: Appropriate prescribing in nursing homes demonstration project (APDP) study protocol: pragmatic, cluster-randomized trial and mixed methods process evaluation of an Ontario policy-maker initiative to improve appropriate prescribing of antipsychotics.
abstract: BACKGROUND
  Antipsychotic medications are routinely prescribed in nursing homes to address the behavioral and psychological symptoms of dementia. Unfortunately, inappropriate prescribing of antipsychotic medications is common and associated with increased morbidity, adverse drug events, and hospitalizations. Multifaceted interventions can achieve a 12-20 % reduction in antipsychotic prescribing levels in nursing homes. Effective interventions have featured educational outreach and ongoing performance feedback.
  
  
  METHODS
  This pragmatic, cluster-randomized control trial and embedded process evaluation seeks to determine the effect of adding academic detailing to audit and feedback on prescribing of antipsychotic medications in nursing homes, compared with audit and feedback alone. Nursing homes within pre-determined regions of Ontario, Canada, are eligible if they express an interest in the intervention. The academic detailing intervention will be delivered by registered health professionals following an intensive training program including relevant clinical issues and techniques to support health professional behavior change. Physicians in both groups will have the opportunity to access confidential reports summarizing their prescribing patterns for antipsychotics in comparison to the local and provincial average. Participating homes will be allocated to one of the two arms of the study (active/full intervention versus standard audit and feedback) in two waves, with a 2:1 allocation ratio. Homes will be randomized after stratifying for geography, baseline antipsychotic prescription rates, and size, to ensure a balance of characteristics. The primary outcome is antipsychotic dispensing in nursing homes, measured 6 months after allocation; secondary outcomes include clinical outcomes and healthcare utilization.
  
  
  CONCLUSIONS
  Policy-makers and the public have taken note that antipsychotics are used in nursing homes in Ontario far more than other jurisdictions. Academic detailing can be an effective technique to address challenges in appropriate prescribing in nursing homes, but effect sizes vary widely. This opportunistic, policy-driven evaluation, embedded within a government-initiated demonstration project, was designed to ensure policy-makers receive the best evidence possible regarding whether and how to scale up the intervention.
  
  
  BACKGROUND
  ClinicalTrials.gov NLM Identifier: NCT02604056 .
authors.affiliation: Women's College Research Institute and Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, Canada.
authors.forename: Laura
authors.initials: L
authors.lastname: Desveaux
authors.affiliation: Li Ka Shing Knowledge Institute, St. Michael's Hospital, 209 Victoria St, Toronto, ON, Canada.|Institute for Clinical Evaluative Sciences, 2075 Bayview Avenue, Toronto, ON, Canada.|Ontario Drug Policy Research Network, St. Michael's Hospital, 30 Bond St, Toronto, ON, Canada.
authors.forename: Tara
authors.initials: T
authors.lastname: Gomes
authors.affiliation: Ontario Drug Policy Research Network, St. Michael's Hospital, 30 Bond St, Toronto, ON, Canada.
authors.forename: Mina
authors.initials: M
authors.lastname: Tadrous
authors.affiliation: Li Ka Shing Knowledge Institute, St. Michael's Hospital, 209 Victoria St, Toronto, ON, Canada.
authors.forename: Lianne
authors.initials: L
authors.lastname: Jeffs
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Civic Campus, 1053 Carling Ave, Ottawa, ON, Canada.|School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, ON, Canada.
authors.forename: Monica
authors.initials: M
authors.lastname: Taljaard
authors.affiliation: Centre for Effective Practice, 203 College St, Toronto, ON, Canada.
authors.forename: Jess
authors.initials: J
authors.lastname: Rogers
authors.affiliation: Department of Medicine, Mount Sinai Hospital and University of Toronto, 600 University Ave, Toronto, ON, Canada.
authors.forename: Chaim M
authors.initials: CM
authors.lastname: Bell
authors.affiliation: Women's College Research Institute and Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville Ave, Toronto, ON, Canada. noah.ivers@utoronto.ca.|Institute for Clinical Evaluative Sciences, 2075 Bayview Avenue, Toronto, ON, Canada. noah.ivers@utoronto.ca.|Department of Family and Community Medicine, Women's College Hospital and University of Toronto, 76 Grenville Ave, Toronto, ON, Canada. noah.ivers@utoronto.ca.
authors.forename: Noah M
authors.identifier: http://orcid.org/0000-0003-2500-2435
authors.initials: NM
authors.lastname: Ivers
mesh_terms: D058633:Antipyretics / Q000008:administration & dosage*; D016000:Cluster Analysis; D016208:Databases, Factual; D057970:Inappropriate Prescribing / Q000517:prevention & control*; D009735:Nursing Homes; D009864:Ontario; D011050:Policy Making; D058996:Quality Improvement
chemical_list: D058633:Antipyretics
keywords: Academic detailing; Antipsychotic medication; Inappropriate prescribing; Nursing home; Randomized trials