An open cluster-randomized, 18 month trial to compare the effectiveness of educational outreach visits with usual guideline dissemination to improve family physician prescribing (TEP (Trial Educational outreach Prescribing))

Study identification

• EU PAS number:
  EUPAS5149
• Study ID:
  6992
• Official title and acronym:
  An open cluster-randomized, 18 month trial to compare the effectiveness of educational outreach visits with usual guideline dissemination to improve family physician prescribing (TEP (Trial Educational outreach Prescribing))
• DARWIN EU® study:
  No
• Study countries:
  Portugal
• Study description:
  Background: 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Faculdade Ciências Médicas - Univ. Nova Lisboa

Study timelines

Date when funding contract was signed

Actual:11/04/2012

Study start date

Planned:29/11/2013

Actual:01/01/2014

Data analysis start date

Planned:30/06/2014

Actual:30/06/2014

Date of final study report

Planned:31/03/2016

Sources of funding

Other

More details on funding

Ministério da Saúde, INSA, I.P.

Regulatory

• Was the study required by a regulatory body?:
  No