The Effect of Providing Free Samples of Generic Cardiovascular Medications to Physicians

Hypertension Clinical Trial

— SAMPLES  

Official title:

A Study Assessing the Effect of Cardiovascular Medications Provided as Low-cost, Evidence-based Generic Samples

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00761904
• Other study ID #: 08-001010
• Secondary ID: 1K23HL090505-01
• Status: Not yet recruiting
• Phase: N/A
• First received: September 26, 2008
• Last updated: May 3, 2010
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2010
• Source: Brigham and Women's Hospital
• Contact: William H Shrank, MD MSHS
• Phone: 617-278-0930
• Email: wshrank[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 660
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Behavioral:
• Free Generic Samples (hydrochlorothiazide, simvastatin)
Free samples of generic hydrochlorothiazide (12.5 mg tabs) and simvastatin (20 mg tabs)

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of prescriptions filled for generic medications		6 months after receipt of samples	No
Primary	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		in the year subsequent to patient initiation of an anti-hypertensive or lipid-lowering medication	No
Secondary	The sum of medication costs for all prescriptions used to treat either hypertension or hypercholesterolemia.		The year before and the year after provision of samples	No
Secondary	Guideline adherence - Proportion of patients who received first-line anti-hypertensive medications suggested by JNC-VII when medications are initiated.		In the 6 months after receipt of samples	Yes