Clinical trial NCT01128127: Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adverse Events
Keywords: knowledge translation
prescription
primary care
NSAID
PPI
Gastrointestinal damage
Inappropriate prescription
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
Collaborators: name: Fundación Canaria de Investigación y Salud
First posted: 2010-05-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Primary care physicians

Exclusion Criteria:

* Participating as a subject in any other clinical research study
* Have received any other intervention on the subject within the last 6 months

Primary outcomes:
measure: Rate of inappropriate PPI prescriptions
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz de Tenerife
country: Spain
facility: Servicio de Evaluación. Servicio Canario de Salud
Study officials:
affiliation: Servicio de Evaluación. Servicio Canario de Salud
name: Pedro G Serrano-Aguilar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación Canaria de Investigación y Salud
name: Yolanda Ramallo-Fariña, BSc Statist
role: STUDY_CHAIR
affiliation: Fundación Canaria de Investigación y Salud
name: Maria M Trujillo-Martín, PhD
role: STUDY_CHAIR
affiliation: CIBER Epidemiología y Salud Pública (CIBERESP), Spain
name: Melany Worbes-Cerezo, BAEcon
role: STUDY_CHAIR
affiliation: Fundación Canaria de Investigación y Salud
name: Renata Linertova, BA Econ
role: STUDY_CHAIR
affiliation: Servicio Canario de Salud
name: Francisco J Hernández-Diaz, MD, PhD
role: STUDY_CHAIR
affiliation: Servicio Canario de Salud
name: Miguel A Hernández-Rodríguez, MD, PhD
role: STUDY_CHAIR
affiliation: University of La Laguna
name: Pedro Gonzalez-Leandro, PhD
role: STUDY_CHAIR
affiliation: University of La Laguna
name: Livia García-Pérez, PhD
role: STUDY_CHAIR
References: