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

Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription for Gastropathy Prevention Due to Non-steroidal Anti-inflammatory Drugs (NSAIDs) in Primary Health Care

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01128127
Enrollment
0
Registered
2010-05-21
Start date
2013-01-31
Completion date
2015-06-30
Last updated
2012-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Events

Keywords

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

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.

Interventions

BEHAVIORALGroup 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.

BEHAVIORALAudit-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.

BEHAVIORALControl

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.

Sponsors

Fundación Canaria de Investigación y Salud
CollaboratorOTHER_GOV
Servicio Canario de Salud
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Rate of inappropriate PPI prescriptionsone yearChange in the proportion of inappropriate PPI prescription associated with NSAID prescription

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026