Adverse Events Clinical Trial
Official title:
Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription for Gastropathy Prevention Due to Non-steroidal Anti-inflammatory Drugs (NSAIDs) in Primary Health Care
Background
Despite the low prevalence of serious complications associated with non-steroidal
anti-inflammatory drugs (NSAIDs) use, there is a widespread use of gastroprotective proton
pump inhibitors (PPIs) in order to prevent adverse effects. Inappropriate prescribing of
PPIs includes overprescribing for inappropriate indications and the misuse of first choice
in their class in terms of efficacy, safety and cost. A series of recommendations, based on
the best available scientific evidence, has been established to justify prophylaxis with
PPIs associated to NSAIDs. Therefore, there is the need to encourage the incorporation of
this knowledge to guide decisions of physicians with the objective of improving patient
health and sustainability of the Public Health Service. Although since long ago there is a
great concern regarding rational use of drugs, the available evidence for the most
appropriate strategies to improve prescribing is scarce. Passive dissemination of research
findings are generally ineffective and at best result in small changes in practice.
Multifaceted intervention targeting different barriers to change are more likely to be
effective than single intervention.
Objectives
The objective of this study is to evaluate the effectiveness of two educational multifaceted
strategies aimed at improving PPIs prescription associated to NSAIDs use in primary care. We
will also compare the cost-effectiveness of such strategies.
Hypothesis
It is hypothesized that a quality improvement intervention directed to primary care
physicians will decrease inappropriate PPIs prescriptions associated to NSAIDs prescription.
Methodology
A three-arm prospective quasi-randomized controlled trial will test the effectiveness of two
strategies for improving PPI prescription associated to NSAID in primary care context. Three
of the Canary Islands will be selected and randomized to either a experimental multifaceted
intervention (group education+audit-feedback+CCDSS) group, a experimental multifaceted
intervention (audit-feedback+CCDSS) group, or a control group (usual intervention). From
each of these islands, 6-8 primary care centers will be randomly selected to received the
intervention practices. All family physicians working at each randomly selected primary care
center were mandatorily included. Primary outcome measure is reduction of inappropriate PPI
prescription. The efficacy of the intervention will be examined within a 3, 6 and a 12 month
follow up.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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