Status: Ongoing First registered on: 24/11/2013
Last updated on: 02/07/2014
1. Study identification
EU PAS Register NumberEUPAS5149
Official titleAn open cluster-randomized, 18 month trial to compare the effectiveness of educational outreach visits with usual guideline dissemination to improve family physician prescribing
Study title acronymTEP (Trial Educational outreach Prescribing)
Study typeOther: Clinical Trial with no Human Medicine (Behavior Intervention)
Brief description of the studyBackground: The Portuguese National Health Directorate has issued guidelines on prescription of anti-inflammatory drugs, acid suppressive therapy, and antiplatelets. However, their effectiveness in changing actual practice is unknown. Methods: The study will compare the effectiveness of educational outreach visits regarding the improvement of clinical guidelines compliance with usual dissemination strategies. A cost-benefit analysis will also be conducted. We will carry out a parallel, open, superiority, randomized trial directed to primary care physicians. Physicians will be recruited and allocated at a cluster-level (primary care unit) by minimization. Data will be analyzed at the physician level. Primary care units will be eligible if they use electronic prescribing and have at least four physicians willing to participate. Physicians in intervention units will be offered individual educational outreach visits (one for each guideline) at their workplace during a six months period. Physicians in the control group will be offered a single unrelated group training session. Primary outcomes will be the proportion of cyclooxygenase-2 inhibitors prescribed in the anti-inflammatory class, and the proportion of omeprazole in the proton pump inhibitors class at 18 months post-intervention. Prescription data will be collected from the regional pharmacy claims database. We estimated a sample size of 110 physicians in each group, corresponding to 19 clusters with a mean size of 6 physicians. Outcome collection and data analysis will be blinded to allocation, but due to the nature of the intervention physicians and detailers cannot be blinded. Discussion: This trial will attempt to address unresolved issues in the literature, namely, long term persistence of effect, the importance of sequential visits in an outreach program, and cost issues. If successful, this trial may be the cornerstone for deploying large scale educational outreach programs in Portugal.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCEDOC/FCM-UNL
Department/Research groupCEDOC - Chronic Diseases Research Center of the Faculdade de Ciências Médicas da Universidade Nova de Lisboa
Organisation/affiliationFaculdade Ciências Médicas Univ. Nova Lisboa
Website/Homepagehttp://cedoc.unl.pt/
Details of (Primary) lead investigator
Title Professor
Last name Caetano
First name Pedro
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Portugal
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed11/04/2012
Start date of data collection29/11/201301/01/2014
Start date of data analysis30/06/201430/06/2014
Date of interim report, if expected
Date of final study report31/03/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyMinistério da Saúde, INSA, I.P.100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Caetano
First name Pedro
Address line 1Grupo de Informação Académica Independente
Address line 2CEDOC da Faculdade de Ciências Médicas - UNL 
Address line 3Ed. CEDOC I, Rua do Instituto Bacteriológico, n.º 5, 5-A e 5-B, 2º piso, sala 2.20 
CityLisbon 
Postcode1150-190 
CountryPortugal
Phone number (incl. country code)00351218803101 
Alternative phone number 
Fax number (incl. country code) 
Email address giai@fcm.unl.pt
Public Enquiries
Title Mrs 
Last name Gomes 
First name Ines 
Address line 1Grupo de Informação Académica Independente 
Address line 2CEDOC da Faculdade de Ciências Médicas - UNL 
Address line 3Ed. CEDOC I, Rua do Instituto Bacteriológico, n.º 5, 5-A, 5-B, 2º piso, sala 2.11 
CityLisbon 
Postcode1150-190 
CountryPortugal 
Phone number (incl. country code)351218803101 
Alternative phone number 
Fax number (incl. country code) 
Email address giai@fcm.unl.pt 
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