title: Rationale and design of the Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples (SAMPLES) trial.
abstract: BACKGROUND
  Highly effective generic cardiovascular medications are frequently underused, leading to greater overall drug costs and cost-related nonadherence.
  
  
  OBJECTIVE
  We sought to assess an intervention to stimulate appropriate generic cardiovascular drug use without creating administrative or financial barriers that may impede essential medication use.
  
  
  METHODS
  The SAMPLES (Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples) trial is a clustered, randomized controlled trial of the effect of providing physicians with free generic samples of hydrochlorothiazide for hypertensive patients and simvastatin for patients with hyperlipidemia. We will randomize 660 primary care physicians in Pennsylvania, clustered by physician practice, to receive free samples for both conditions or to receive no samples. We will use data on filled prescriptions obtained from a state-sponsored prescription drug assistance program to perform an intention-to-treat evaluation of the impact of the intervention on physician prescribing behavior (proportion of prescriptions that are generic) and patient adherence. Secondary outcomes will include physician adherence to established guidelines and overall prescription drug costs.
  
  
  CONCLUSIONS
  This trial will define the potential role of an innovative approach to stimulate clinically appropriate cost-effective prescribing. We will determine whether free generic samples can reduce overall drug costs as well as out-of-pocket costs to the patient without sacrificing efficacy and whether this approach results in improved adherence to essential cardiovascular medications. This intervention may also improve adherence to practice guidelines and improve the quality of care received. If effective, this strategy could be used broadly by private insurers or government payers aiming to stimulate more cost-effective and higher-quality care.
authors.affiliation: Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. wshrank@partners.org
authors.forename: William H
authors.initials: WH
authors.lastname: Shrank
authors.forename: Niteesh K
authors.initials: NK
authors.lastname: Choudhry
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Solomon
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Snedden
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Lee
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Glynn
authors.forename: Theresa V
authors.initials: TV
authors.lastname: Brown
authors.forename: Caitlin
authors.initials: C
authors.lastname: Jolda
authors.forename: Michelle
authors.initials: M
authors.lastname: Spetman
authors.forename: Maurice Alan
authors.initials: MA
authors.lastname: Brookhart
authors.forename: Sebastian
authors.initials: S
authors.lastname: Schneeweiss
authors.forename: Jerry
authors.initials: J
authors.lastname: Avorn