NCT00761904

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
660

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 5, 2010

Status Verified

May 1, 2010

Enrollment Period

4 months

First QC Date

September 26, 2008

Last Update Submit

May 3, 2010

Conditions

Keywords

hypertensionhyperlipidemiafree generic samples

Outcome Measures

Primary Outcomes (2)

  • Percentage of prescriptions filled for generic medications

    6 months after receipt of samples

  • 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

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (2)

receipt of free generic samples

EXPERIMENTAL
Behavioral: Free Generic Samples (hydrochlorothiazide, simvastatin)

usual prescribing

NO INTERVENTION

Interventions

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

receipt of free generic samples

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

HydrochlorothiazideSimvastatin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • William H Shrank, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William H Shrank, MD MSHS

CONTACT

Amber Servi, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

December 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 5, 2010

Record last verified: 2010-05

Locations