Hypertension Clinical Trial
Official title:
A Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples
In this randomized controlled trial, we will provide primary care physicians with free samples of highly effective generic cardiovascular medications. We will test whether this intervention will stimulate cost-effective prescribing, reducing drug costs and improving adherence to essential cardiovascular medications.
Highly-effective generic cardiovascular medications are frequently underused, leading to
greater overall drug costs and cost-related non-adherence. Interventions are needed to
stimulate appropriate generic drug use without creating administrative or financial barriers
to branded medications that may impede essential medication use.
The 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 pharmacy claims of their patient population
enrolled in a state-sponsored prescription drug assistance program to evaluate outcomes of
interest. The primary outcomes are physician prescribing behavior (proportion of
prescriptions that are generic), and patient adherence to chronic therapy. Secondary
outcomes will include physician adherence to established guidelines (for anti-hypertensive
regimens) and overall prescription drug costs. Primary analyses will be based on
intention-to-treat principles.
This trial highlights a new and innovative approach to stimulate cost-effective prescribing.
Free generic samples can reduce overall drug costs as well as out-of-pocket costs to the
patient without sacrificing efficacy, and may result in improved adherence to essential
cardiovascular medications. This intervention may also improve adherence to practice
guidelines and improve the quality of care received. If found to be effective, this strategy
could be utilized broadly by private insurers or government payers aiming to stimulate more
cost-effective and higher-quality care.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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