Adverse EventsNCT01128127
Strategies for Improving Proton Pump Inhibitors (PPIs) Prescription Associated to Non-steroidal Anti-inflammatory Drugs (NSAIDs)
A study testing Group education, audit-feedback and computer support and Audit-feedback and computer support in people with Adverse Events, run by Servicio Canario de Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Events
- What is being tested?
- Group education, audit-feedback and computer support and Audit-feedback and computer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary care physicians
Who cannot join
- Participating as a subject in any other clinical research study
- Have received any other intervention on the subject within the last 6 months
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Evaluación. Servicio Canario de Salud
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38004
About this study
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
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.
Read more
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
- Being tested
- Group education, audit-feedback and computer support, Audit-feedback and computer support, Control
- Keywords
- knowledge translation, prescription, primary care, NSAID, PPI, Gastrointestinal damage, Inappropriate prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group education, audit-feedback and computer supportBehavioural
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.
Audit-feedback and computer supportBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted intervention 1 | Experimental | psycho-educational workshop + audit-feedback + computer-based clinical decision support system (CCDSS) + usual intervention Receives: Behavioral: Group education, audit-feedback and computer support |
| Multifaceted intervention 2 | Experimental | audit-feedback + computer-based clinical decision support system (CCDSS) + usual intervention Receives: Behavioral: Audit-feedback and computer support |
| Control | Active comparator | usual intervention Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of inappropriate PPI prescriptions
Change in the proportion of inappropriate PPI prescription associated with NSAID prescription
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJan 2013
- Primary completionNov 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servicio Canario de Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Canaria de Investigación y Salud
- Investigators
- Pedro G Serrano-Aguilar, MD, PhD, Principal investigator, Servicio de Evaluación. Servicio Canario de SaludYolanda Ramallo-Fariña, BSc Statist, Study chair, Fundación Canaria de Investigación y SaludMaria M Trujillo-Martín, PhD, Study chair, Fundación Canaria de Investigación y SaludMelany Worbes-Cerezo, BAEcon, Study chair, CIBER Epidemiología y Salud Pública (CIBERESP), SpainRenata Linertova, BA Econ, Study chair, Fundación Canaria de Investigación y SaludFrancisco J Hernández-Diaz, MD, PhD, Study chair, Servicio Canario de SaludMiguel A Hernández-Rodríguez, MD, PhD, Study chair, Servicio Canario de SaludPedro Gonzalez-Leandro, PhD, Study chair, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128127
- Sponsor's protocol ID
- PI 43 08
- Status last verified
- Sep 2012
- First submitted
- 20 May 2010
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01128127
- Acronym / sponsor ID
- PI 43 08
- Conditions
- Adverse Events
- Keywords
- knowledge translation, prescription, primary care, NSAID, PPI, Gastrointestinal damage, Inappropriate prescription
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Servicio Canario de SaludUniversity, hospital or other
- Collaborators
- Fundación Canaria de Investigación y Salud
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multifaceted intervention 1 | Experimental | Behavioral: Group education, audit-feedback and computer supportpsycho-educational workshop + audit-feedback + computer-based clinical decision support system (CCDSS) + usual intervention |
| Multifaceted intervention 2 | Experimental | Behavioral: Audit-feedback and computer supportaudit-feedback + computer-based clinical decision support system (CCDSS) + usual intervention |
| Control | Active comparator | Behavioral: Controlusual intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care physicians
Key exclusion criteria (2 listed)
- Participating as a subject in any other clinical research study
- Have received any other intervention on the subject within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group education, audit-feedback and computer supportPsycho-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. | Behavioural | Multifaceted intervention 1 |
| Audit-feedback and computer supportAudit-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. | Behavioural | Multifaceted intervention 2 |
| ControlUsual 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. | Behavioural | Control |
Primary outcome
Rate of inappropriate PPI prescriptions
Time frame: one year
Change in the proportion of inappropriate PPI prescription associated with NSAID prescription
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro G Serrano-Aguilar, MD, PhD principal investigator
Servicio de Evaluación. Servicio Canario de Salud
Yolanda Ramallo-Fariña, BSc Statist study chair
Fundación Canaria de Investigación y Salud
Maria M Trujillo-Martín, PhD study chair
Fundación Canaria de Investigación y Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group education, audit-feedback and computer support and Audit-feedback and computer support in people with Adverse Events, run by Servicio Canario de Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of inappropriate PPI prescriptions (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2012.