Cardiovascular Diseases Clinical Trial
— TEPOfficial title:
An Open Cluster-randomized, 18 Month Trial to Compare the Effectiveness of Educational Outreach Visits With Usual Guideline Dissemination to Improve Family Physician Prescribing
Verified date | November 2014 |
Source | Universidade Nova de Lisboa |
Contact | n/a |
Is FDA regulated | No |
Health authority | Portugal: Health Ethic Committee |
Study type | Interventional |
Background: The Portuguese National Health Directorate has issued clinical practice
guidelines on prescription of anti-inflammatory drugs and COX-2 inhibitors, acid suppressive
therapy and proton pump inhibitors, and anti-platelets. However, their effectiveness in
changing actual practice is unknown. The objectives will be to compare the effectiveness of
educational outreach visits in the implementation of clinical guidelines in primary care in
Portugal against usual implementation strategies and to conduct a cost-effectiveness
analysis of this method.
Methods: The trial will be a parallel, cluster-randomized, unblinded, trial in primary care,
with a 1:1 allocation ratio. This study will assess the effect of educational outreach
visits on physician compliance with prescription guidelines. The general study hypothesis is
whether educational outreach visits are superior to usual implementation of guidelines
regarding the reduction of inappropriate prescribing (compliance with prescription
guidelines). All National Health Service primary care units in the Lisbon (Portugal) region
will be invited to participate. Units will be eligible if they are using an Electronic
Health Record to issue prescriptions and have at least four doctors willing to participate.
Doctors in intervention units will receive three educational outreach visits (one for each
guideline) during a six months period, while the control group doctors will be offered an
unrelated group training session (on using the international classification for primary
care). Intervention visits will be one on one 15 minutes discussions conducted by guideline
authors or trained family physicians at the physician's workplace. There are two primary
outcomes, measured at the physician's level. One is the proportion of COX-2 inhibitors
prescribed within the entire NSAID class, in defined daily doses 18 months after the
intervention. The other is the proportion of omeprazole within the entire proton pump
inhibitors class, in defined daily doses at 18 months post-intervention. Prescription data
will be collected from the regional pharmacy claims database.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | December 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 23 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Physicians of primary care unit with at least four family physicians Exclusion Criteria: - Physicians who are planning to retire within two years - Physicians without an assigned patient list - Physicians with an incomplete patient list |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Portugal | Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School | Lisbon |
Lead Sponsor | Collaborator |
---|---|
Universidade Nova de Lisboa |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of COX-2 inhibitors prescribed within the entire NSAID class | The proportion of prescriptions of COX-2 inhibitors (anatomical therapeutic classification [ATC] M01AH) prescribed within the entire NSAID class (ATC M01A) in defined daily doses 18 months after the intervention. | 18 months | No |
Primary | Proportion of omeprazole prescribed within the entire proton pump inhibitors class | The proportion of prescriptions of omeprazole (ATC A02BC01) within the entire proton pump inhibitors class (ATC A02BC) in defined daily doses 18 months after the intervention. | 18 months | No |
Secondary | Proportion of prescriptions of COX-2 inhibitors within the NSAID class | The proportion of prescriptions of COX-2 inhibitors within the NSAID class at 1 month | 1 month | No |
Secondary | Proportion of omeprazole prescriptions of the proton pump inhibitors class | The proportion of omeprazole prescriptions of the proton pump inhibitors class at 1 month | 1 month | No |
Secondary | Proportion of COX-2 inhibitors prescriptions within the NSAID class | The proportion of COX-2 inhibitors within the NSAID class at 6 months | 6 months | No |
Secondary | Proportion of omeprazole within the proton pump inhibitors class | The proportion of omeprazole within the proton pump inhibitors class at 6 months | 6 months | No |
Secondary | Number of defined daily doses of clopidogrel prescribed 1M | The number of defined daily doses of clopidogrel prescribed per 1000 registered patients at 1 month | 1 month | No |
Secondary | Number of defined daily doses of clopidogrel prescribed 6M | The number of defined daily doses of clopidogrel prescribed per 1000 registered patients at 6 months | 6 months | No |
Secondary | Number of defined daily doses of clopidogrel prescribed 18M | The number of defined daily doses of clopidogrel prescribed per 1000 registered patients at 18 months | 18 months | No |
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