Trial to Assess the Effectiveness of Educational Outreach in Prescription Guidelines

Summary

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.

Conditions

• Inflammation
• Gastroesophageal Reflux
• Gastrointestinal Diseases
• Cardiovascular Diseases

Interventions

BEHAVIORAL

Educational Outreach Visits

The 3 members of the steering committee completed training regarding delivery of visits with the National Resource Center for Academic Detailing (Boston, MA). The other detailers were trained locally by this committee, with pre-training study assignments, and 12 hours of face-to-face training which included the principles of academic detailing, role-play, video-recording and feedback, discussion of the scientific content of each guideline, and knowledge assessment. To ensure consistency, the contents of each visit have been prepared in advanced by the committee and were used in the training sessions. Whenever possible, a single detailer will perform all three visits to the same doctor.

OTHER

Passive Dissemination

Usual guideline implementation consists of passive dissemination by their publication on the National Health Directorate's website. Doctors in units randomized to the control group will be offered an unrelated training session (coding with the International Classification of Primary Care, second edition) as a token of good will for participating in the trial.

Sponsors & Collaborators

• Universidade Nova de Lisboa

  lead OTHER

Principal Investigators

• Pedro A. Caetano, PhD · Faculdade de Ciências Médicas - Universidade Nova de Lisboa (Nova Medical School)

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

23 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2014-06-30

Completion

2015-12-31

Countries

• Portugal

Study Locations