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

NCT01128127 | Withdrawn

• 1 other identifier: PI 43 08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Events

Keywords

knowledge translation; prescription; primary care; NSAID; PPI; Gastrointestinal damage; Inappropriate prescription

Outcome Measures

Primary Outcomes (1)

• Rate of inappropriate PPI prescriptions

  Change in the proportion of inappropriate PPI prescription associated with NSAID prescription

  one year

Study Arms (3)

Multifaceted intervention 1

EXPERIMENTAL

psycho-educational workshop + audit-feedback + computer-based clinical decision support system (CCDSS) + usual intervention

Behavioral: Group education, audit-feedback and computer support

Multifaceted intervention 2

EXPERIMENTAL

audit-feedback + computer-based clinical decision support system (CCDSS) + usual intervention

Behavioral: Audit-feedback and computer support

Control

ACTIVE COMPARATOR

usual intervention

Behavioral: Control

Interventions

Group education, audit-feedback and computer support BEHAVIORAL

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.

Multifaceted intervention 1

Audit-feedback and computer support BEHAVIORAL

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.

Multifaceted intervention 2

Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care physicians

You may not qualify if:

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

Sponsors & Collaborators

• Servicio Canario de Salud: lead
• Fundación Canaria de Investigación y Salud: collaborator

Study Sites (1)

Servicio de Evaluación. Servicio Canario de Salud

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38004, Spain

Location

Study Officials

• Pedro G Serrano-Aguilar, MD, PhD

  Servicio de Evaluación. Servicio Canario de Salud

  PRINCIPAL INVESTIGATOR

• 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

  University of La Laguna

  STUDY CHAIR

• Livia García-Pérez, PhD

  University of La Laguna

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: January 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: June 1, 2015
• Last Updated: September 14, 2012

Record last verified: 2012-09

Locations

ES (1)