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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00761904
First received: September 26, 2008
Last updated: May 3, 2010
Last verified: May 2010
  Purpose

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 Intervention
Hypertension
Hyperlipidemia
Behavioral: Free Generic Samples (hydrochlorothiazide, simvastatin)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Percentage of prescriptions filled for generic medications [ Time Frame: 6 months after receipt of samples ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 660
Study Start Date: December 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761904

Contacts
Contact: William H Shrank, MD MSHS 617-278-0930 wshrank@partners.org
Contact: Amber Servi, BA 617-278-0930 aservi@partners.org

Locations
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    wshrank@partners.org   
Principal Investigator: William H Shrank, MD MSHS         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: William H Shrank, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: William H. Shrank MD MSHS, Instructor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00761904     History of Changes
Other Study ID Numbers: 08-001010, 1K23HL090505 - 01
Study First Received: September 26, 2008
Last Updated: May 3, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents
Hydrochlorothiazide
Simvastatin
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014