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Trial to Assess the Effectiveness of Educational Outreach in Prescription Guidelines (TEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01984034
Recruitment Status : Unknown
Verified November 2014 by Universidade Nova de Lisboa.
Recruitment status was:  Active, not recruiting
First Posted : November 14, 2013
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Universidade Nova de Lisboa

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.


Condition or disease Intervention/treatment Phase
Inflammation Gastroesophageal Reflux Gastrointestinal Diseases Cardiovascular Diseases Behavioral: Educational Outreach Visits Other: Passive Dissemination Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official 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
Study Start Date : November 2013
Actual Primary Completion Date : June 2014
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Educational Outreach Visits
The 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.
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 Name: Academic Detailing

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Proportion of COX-2 inhibitors prescribed within the entire NSAID class [ Time Frame: 18 months ]
    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.

  2. Proportion of omeprazole prescribed within the entire proton pump inhibitors class [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. Proportion of prescriptions of COX-2 inhibitors within the NSAID class [ Time Frame: 1 month ]
    The proportion of prescriptions of COX-2 inhibitors within the NSAID class at 1 month

  2. Proportion of omeprazole prescriptions of the proton pump inhibitors class [ Time Frame: 1 month ]
    The proportion of omeprazole prescriptions of the proton pump inhibitors class at 1 month

  3. Proportion of COX-2 inhibitors prescriptions within the NSAID class [ Time Frame: 6 months ]
    The proportion of COX-2 inhibitors within the NSAID class at 6 months

  4. Proportion of omeprazole within the proton pump inhibitors class [ Time Frame: 6 months ]
    The proportion of omeprazole within the proton pump inhibitors class at 6 months

  5. Number of defined daily doses of clopidogrel prescribed 1M [ Time Frame: 1 month ]
    The number of defined daily doses of clopidogrel prescribed per 1000 registered patients at 1 month

  6. Number of defined daily doses of clopidogrel prescribed 6M [ Time Frame: 6 months ]
    The number of defined daily doses of clopidogrel prescribed per 1000 registered patients at 6 months

  7. Number of defined daily doses of clopidogrel prescribed 18M [ Time Frame: 18 months ]
    The number of defined daily doses of clopidogrel prescribed per 1000 registered patients at 18 months



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984034


Locations
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Portugal
Faculdade Ciências Médicas Universidade Nova de Lisboa - Nova Medical School
Lisbon, Portugal, 1169-056
Sponsors and Collaborators
Universidade Nova de Lisboa
Investigators
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Principal Investigator: Pedro A. Caetano, PhD Faculdade de Ciências Médicas - Universidade Nova de Lisboa (Nova Medical School)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidade Nova de Lisboa
ClinicalTrials.gov Identifier: NCT01984034    
Other Study ID Numbers: FCMGIAI1
2011EXT577 ( Other Grant/Funding Number: MS-INSA (Portuguese Ministry of Health) )
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014
Keywords provided by Universidade Nova de Lisboa:
Educational outreach
Academic detailing
Guideline adherence
Family Practice
Drug utilization
Program evaluation
Cost effectiveness
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Gastrointestinal Diseases
Inflammation
Cardiovascular Diseases
Digestive System Diseases
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases