Trial to Assess the Effectiveness of Educational Outreach in Prescription Guidelines
TEP
An Open Cluster-randomized, 18 Month Trial to Compare the Effectiveness of Educational Outreach Visits With Usual Guideline Dissemination to Improve Family Physician Prescribing
2 other identifiers
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 7, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 7, 2014
November 1, 2014
7 months
November 7, 2013
November 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (7)
Proportion of prescriptions of COX-2 inhibitors within the NSAID class
1 month
Proportion of omeprazole prescriptions of the proton pump inhibitors class
1 month
Proportion of COX-2 inhibitors prescriptions within the NSAID class
6 months
Proportion of omeprazole within the proton pump inhibitors class
6 months
Number of defined daily doses of clopidogrel prescribed 1M
1 month
- +2 more secondary outcomes
Study Arms (2)
Educational Outreach Visits
EXPERIMENTALThe intervention is three educational outreach visits, one per prescription guideline. During each 15 to 20 minutes visit an academic detailer will promote one of the guidelines to a family doctor (up to three physicians may be present in each visit if they wish to, but one to one visits will be preferred and encouraged). The detailer will also distribute a point of care summary highlighting the main messages. The detailers will be mainly Family Physicians and family medicine residents.
Passive Dissemination
ACTIVE COMPARATORUsual 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \- Physicians of primary care unit with at least four family physicians
You may not qualify if:
- Physicians who are planning to retire within two years
- Physicians without an assigned patient list
- Physicians with an incomplete patient list
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School
Lisbon, Lisbon District, 1169-056, Portugal
Related Publications (2)
Pinto D, Heleno B, Rodrigues DS, Papoila AL, Santos I, Caetano PA. Effectiveness of educational outreach visits compared with usual guideline dissemination to improve family physician prescribing-an 18-month open cluster-randomized trial. Implement Sci. 2018 Sep 5;13(1):120. doi: 10.1186/s13012-018-0810-1.
PMID: 30185197DERIVEDPinto D, Heleno B, Rodrigues DS, Papoila AL, Santos I, Caetano PA. An open cluster-randomized, 18-month trial to compare the effectiveness of educational outreach visits with usual guideline dissemination to improve family physician prescribing. Implement Sci. 2014 Jan 15;9:10. doi: 10.1186/1748-5908-9-10.
PMID: 24423370DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro A. Caetano, PhD
Faculdade de Ciências Médicas - Universidade Nova de Lisboa (Nova Medical School)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2013
First Posted
November 14, 2013
Study Start
November 1, 2013
Primary Completion
June 1, 2014
Study Completion
December 1, 2015
Last Updated
November 7, 2014
Record last verified: 2014-11