Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention
NCT ID: NCT01997671
Last Updated: 2013-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60000 participants
INTERVENTIONAL
2011-09-30
2013-09-30
Brief Summary
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DESIGN: a cluster randomized clinical trial, not blind; Data were obtained from medical records and other primary care databases.
SETTING: 279 primary health care teams in Catalonia (Spain), centers managed by Catalan Health Institute (ICS)
SUBJECTS: Population from 35 to 74 years, free of cardiovascular disease, who have been started on lipid-lowering therapy during 2 consecutive years of study.
INTERVENTION: Practitioners in the intervention group may have access, whenever they want and through the computerized medical record program, to personalized information on their assigned patients who have started treatment of cardiovascular primary prevention with lipid-lowering. This information is updated monthly for 12 consecutive months.Information will be presented in two different and complementary ways to each practitioner: asynchronous information (the patient is not present when the practitioner receives the information) and synchronous information (the patient is present when the practitioner receives the information).
VARIABLES:
1. Primary Outcomes are:
* Variable RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.
* Variable EVITA: New lipid-lowering treatments started during the intervention period and considered as inadequate.
2. Secondary Outcomes are:
* Variable COST: total cost of the inadequate new lipid-lowering treatments.
* Variable RECORD: recording of the cardiovascular risk.
2.Other variables:
* Principal: intervention/control group assignment of health professional.
* Patient variables: demographic and clinical.
* Professional variables: quality of care indicators.
STATISTICAL ANALYSIS: Descriptive analysis, agreggated at health professional level, will be performed and subsequently multilevel analysis techniques will be used to estimate the effect of intervention according to hierarchic data structure and, in particular, patient variables effect.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Information Support System
Practitioners in the intervention group may have access, whenever they want and through the computerized medical record program, to personalized information on their assigned patients who have started treatment of cardiovascular primary prevention with lipid-lowering.
Information Support System
Practitioners in the intervention group may have access, whenever they want and through the computerized medical record program, to personalized information on their assigned patients who have started treatment of cardiovascular primary prevention with lipid-lowering. This information is updated monthly for 12 consecutive months.Information will be presented in two different and complementary ways to each practitioner: asynchronous information (the patient is not present when the practitioner receives the information) and synchronous information (the patient is present when the practitioner receives the information).
Control group
Routine clinical practice
No interventions assigned to this group
Interventions
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Information Support System
Practitioners in the intervention group may have access, whenever they want and through the computerized medical record program, to personalized information on their assigned patients who have started treatment of cardiovascular primary prevention with lipid-lowering. This information is updated monthly for 12 consecutive months.Information will be presented in two different and complementary ways to each practitioner: asynchronous information (the patient is not present when the practitioner receives the information) and synchronous information (the patient is present when the practitioner receives the information).
Eligibility Criteria
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Inclusion Criteria
* Free of cardiovascular disease
* Start on lipid-lowering therapy during 2 consecutive years of study
Exclusion Criteria
* History of cardiovascular disease
35 Years
74 Years
ALL
No
Sponsors
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Preventive Services and Health Promotion Research Network
OTHER
Catalan Institute of Health
OTHER_GOV
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Principal Investigators
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Bonaventura Bolíbar
Role: PRINCIPAL_INVESTIGATOR
Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Sebastià Calero
Role: STUDY_CHAIR
Catalan Institute of Health
Josep Casajuana
Role: STUDY_CHAIR
Catalan Institute of Health
Ermengol Coma
Role: STUDY_CHAIR
Catalan Institute of Health
Francesc Fina
Role: STUDY_CHAIR
Catalan Institute of Health
Mireia Fàbregas
Role: STUDY_CHAIR
Catalan Institute of Health
Eduardo Hermosilla
Role: STUDY_CHAIR
Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Manolo Medina
Role: STUDY_CHAIR
Catalan Institute of Health
Mònica Monteagudo
Role: STUDY_CHAIR
Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Rosa Morros
Role: STUDY_CHAIR
Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Magdalena Rosell
Role: STUDY_CHAIR
Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Locations
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IDIAP Jordi Gol
Barcelona, Barcelona, Spain
Countries
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References
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Fabregas M, Berges I, Fina F, Hermosilla E, Coma E, Mendez L, Medina M, Calero S, Serrano E, Morros R, Monteagudo M, Bolibar B. Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial. BMC Fam Pract. 2014 Jul 15;15:135. doi: 10.1186/1471-2296-15-135.
Other Identifiers
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EC11-342
Identifier Type: -
Identifier Source: org_study_id