Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Fundación Canaria de Investigación y Salud
Information provided by:
Servicio Canario de Salud
ClinicalTrials.gov Identifier:
NCT01128127
First received: May 20, 2010
Last updated: September 13, 2012
Last verified: September 2012
  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

Further study details as provided by Servicio Canario de Salud:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128127

Locations
Spain
Servicio de Evaluación. Servicio Canario de Salud
Santa Cruz de Tenerife, Spain, 38004
Sponsors and Collaborators
Servicio Canario de Salud
Fundación Canaria de Investigación y Salud
Investigators
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 July 23, 2014