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Trial record 1 of 1 for:    NCT01997671
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Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

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ClinicalTrials.gov Identifier: NCT01997671
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : December 2, 2013
Sponsor:
Collaborators:
Preventive Services and Health Promotion Research Network
Catalan Institute of Health
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief Summary:

OBJECTIVE: To evaluate the impact of an intervention addressed to health professionals to improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular disease and reducing expenditure in this respect.

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Other: Information Support System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of an Intervention to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical Trial
Study Start Date : September 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: 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.
Other: 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).

No Intervention: Control group
Routine clinical practice



Primary Outcome Measures :
  1. percentage of participants with increase of the adequacy of lipid-lowering prescription [ Time Frame: up to 24 months ]

    The primary outcome is the improvement in the appropriateness of prescribing of lipid-lowering therapy in primary prevention as recommended by the guide clinical practice intervention in the Institut Català de la Salut compared with clinical practice group.

    To answer the main objective of the study, two dependent variables were calculated:

    • 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


Secondary Outcome Measures :
  1. percentage of patients with cardiovascular risk register in the clinical records of patients [ Time Frame: up to 24 months ]

    To assess the degree of cardiovascular risk register in the clinical records of patients RECORD variable is calculated:

    Variable RECORD: recording of the cardiovascular risk


  2. Change from baseline in the total cost of the lipid-lowering treatments prescribed during the study period [ Time Frame: baseline, months 24 ]

    to assess the economic impact of the new primary prevention lipid-lowering treatments prescribed during the study period. To be determined by variable COST

    Variable COST: total cost of the inadequate new lipid-lowering treatments




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Ages Eligible for Study:   35 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Population from 35 to 74 years
  • Free of cardiovascular disease
  • Start on lipid-lowering therapy during 2 consecutive years of study

Exclusion Criteria:

  • Previous treatment with lipid-lowering
  • History of cardiovascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997671


Locations
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Spain
IDIAP Jordi Gol
Barcelona, Spain, 08007
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
Catalan Institute of Health
Investigators
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Principal Investigator: Bonaventura Bolíbar Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Study Chair: Sebastià Calero Catalan Institute of Health
Study Chair: Josep Casajuana Catalan Institute of Health
Study Chair: Ermengol Coma Catalan Institute of Health
Study Chair: Francesc Fina Catalan Institute of Health
Study Chair: Mireia Fàbregas Catalan Institute of Health
Study Chair: Eduardo Hermosilla Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Study Chair: Manolo Medina Catalan Institute of Health
Study Chair: Mònica Monteagudo Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Study Chair: Rosa Morros Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Study Chair: Magdalena Rosell Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01997671     History of Changes
Other Study ID Numbers: EC11-342
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013
Keywords provided by Jordi Gol i Gurina Foundation:
Primary Care
Lipid-lowering therapy
Prescription
Adequacy
Primary prevention
Cardiovascular diseases
Electronic Medical records
Clinical Practice Guideline
Additional relevant MeSH terms:
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Cardiovascular Diseases