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

NCT ID: NCT00761904

Last Updated: 2010-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Hyperlipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

receipt of free generic samples

Group Type EXPERIMENTAL

Free Generic Samples (hydrochlorothiazide, simvastatin)

Intervention Type BEHAVIORAL

Free samples of generic hydrochlorothiazide (12.5 mg tabs) and simvastatin (20 mg tabs)

usual prescribing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Free Generic Samples (hydrochlorothiazide, simvastatin)

Free samples of generic hydrochlorothiazide (12.5 mg tabs) and simvastatin (20 mg tabs)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brigham and Women's Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William H Shrank, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

William H Shrank, MD MSHS

Role: CONTACT

617-278-0930

Amber Servi, BA

Role: CONTACT

617-278-0930

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

William H Shrank, MD MSHS

Role: primary

617-278-0930

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1K23HL090505-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-001010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MinMed: Do Older Adults do Better With Less Medication
NCT05307666 ENROLLING_BY_INVITATION PHASE4