The Effect of Providing Free Samples of Generic Cardiovascular Medications to Physicians (SAMPLES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00761904
Recruitment Status : Unknown
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 30, 2008
Last Update Posted : May 5, 2010
Information provided by:
Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Behavioral: Free Generic Samples (hydrochlorothiazide, simvastatin) Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples
Study Start Date : December 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: receipt of free generic samples Behavioral: Free Generic Samples (hydrochlorothiazide, simvastatin)
Free samples of generic hydrochlorothiazide (12.5 mg tabs) and simvastatin (20 mg tabs)

No Intervention: usual prescribing

Primary Outcome Measures :
  1. Percentage of prescriptions filled for generic medications [ Time Frame: 6 months after receipt of samples ]
  2. Patient adherence - Amount of prescriptions actually filled (Proportion of Days Covered) within each class in the first year of use of an anti-hypertensive or lipid-lowering medication [ Time Frame: in the year subsequent to patient initiation of an anti-hypertensive or lipid-lowering medication ]

Secondary Outcome Measures :
  1. The sum of medication costs for all prescriptions used to treat either hypertension or hypercholesterolemia. [ Time Frame: The year before and the year after provision of samples ]
  2. Guideline adherence - Proportion of patients who received first-line anti-hypertensive medications suggested by JNC-VII when medications are initiated. [ Time Frame: In the 6 months after receipt of samples ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Primary care physicians receiving an existing academic detailing program in Pennsylvania

Exclusion Criteria:

  • Those with administrative policies stating they do not accept free samples

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00761904

Contact: William H Shrank, MD MSHS 617-278-0930
Contact: Amber Servi, BA 617-278-0930

United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02120
Contact: William H Shrank, MD MSHS    617-278-0930   
Principal Investigator: William H Shrank, MD MSHS         
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: William H Shrank, MD Brigham and Women's Hospital

Responsible Party: William H. Shrank MD MSHS, Instructor, Brigham and Women's Hospital Identifier: NCT00761904     History of Changes
Other Study ID Numbers: 08-001010
1K23HL090505-01 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: May 2010

Keywords provided by Brigham and Women's Hospital:
free generic samples

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators