Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Adverse Events |
Behavioral: Group education, audit-feedback and computer support Behavioral: Audit-feedback and computer support Behavioral: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| 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 |
- Rate of inappropriate PPI prescriptions [ Time Frame: one year ] [ Designated as safety issue: No ]Change in the proportion of inappropriate PPI prescription associated with NSAID prescription
| Enrollment: | 0 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Multifaceted intervention 1
psycho-educational workshop + audit-feedback + computer-based clinical decision support system (CCDSS) + usual intervention
|
Behavioral: Group education, audit-feedback and computer support
Psycho-educational group workshop: two theory-practice sessions on both evidence-based guidelines on PPI-NSAID prescription and communication and negotiation skills to deal with patients. All participants will fill out an initial questionnaire concerning prescribing patterns and barriers to appropriate prescription. All attendees will be given a reminder printed material designed to give the necessary information in a brief fashion and for maximal visual impact. Audit-Feedback: participants will receive, monthly and by e-mail, an individualized report with data of their own appropriate/inappropriate PPI prescriptions and avoidable costs. CCDSS: interactive computer program designed to assist physicians with decision making when prescribing PPI associated to NSAID. It consists in pop-up alert screens that aim to influence prescription choice according to each patient characteristics and evidence-based clinical guidelines. |
|
Experimental: Multifaceted intervention 2
audit-feedback + computer-based clinical decision support system (CCDSS) + usual intervention
|
Behavioral: Audit-feedback and computer support
Audit-Feedback: participants will receive, monthly and by e-mail, an individualized report with data of their own appropriate/inappropriate PPI prescriptions and avoidable costs CCDSS: interactive computer program designed to assist physicians with decision making when prescribing PPI associated to NSAID. It consists in pop-up alert screens that aim to influence prescription choice according to each patient characteristics and evidence-based clinical guidelines. |
|
Active Comparator: Control
usual intervention
|
Behavioral: Control
Usual intervention includes: Compulsory attendance both to courses (10-12 hours) and to short sessions (around 30 min.) on the rational use of drugs held in groups and during working hours. Each primary care physician attends to 1-2 courses and 3-4 short sessions per year. Every three months, physicians receive a feedback paper with information on his/her own prescribing overall costs comparing to his/her primary care center average cost. Distribution of a printed booklet of recommendations, delivered personally or through mass mailings, on the prescribing of PPI-NSAID. |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Spain | |
| Servicio de Evaluación. Servicio Canario de Salud | |
| Santa Cruz de Tenerife, Spain, 38004 | |
| Principal Investigator: | Pedro G Serrano-Aguilar, MD, PhD | Servicio de Evaluación. Servicio Canario de Salud |
| Study Chair: | Yolanda Ramallo-Fariña, BSc Statist | Fundación Canaria de Investigación y Salud |
| Study Chair: | Maria M Trujillo-Martín, PhD | Fundación Canaria de Investigación y Salud |
| Study Chair: | Melany Worbes-Cerezo, BAEcon | CIBER Epidemiología y Salud Pública (CIBERESP), Spain |
| Study Chair: | Renata Linertova, BA Econ | Fundación Canaria de Investigación y Salud |
| Study Chair: | Francisco J Hernández-Diaz, MD, PhD | Servicio Canario de Salud |
| Study Chair: | Miguel A Hernández-Rodríguez, MD, PhD | Servicio Canario de Salud |
| Study Chair: | Pedro Gonzalez-Leandro, PhD | Universidad de La Laguna |
| Study Chair: | Livia García-Pérez, PhD | Universidad de La Laguna |
More Information
No publications provided
| Responsible Party: | Dr. Pedro Serrano-Aguilar, Servicio de Evaluación. Servicio Canario de Salud |
| ClinicalTrials.gov Identifier: | NCT01128127 History of Changes |
| Other Study ID Numbers: | PI 43 08 |
| Study First Received: | May 20, 2010 |
| Last Updated: | September 13, 2012 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Servicio Canario de Salud:
|
knowledge translation prescription primary care NSAID |
PPI Gastrointestinal damage Inappropriate prescription |
Additional relevant MeSH terms:
|
Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Proton Pump Inhibitors Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013