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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

Tracking Information
First Submitted Date  ICMJE January 25, 2013
First Posted Date  ICMJE November 28, 2013
Last Update Posted Date December 2, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2013)
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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period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
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
improvement in the appropriateness of prescribing of lipid-lowering therapy in primary prevention as recommended by the guide clinical practice intervention [ Time Frame: September 1, 2011 to August 31, 2013 ]
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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2013)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
  • degree of cardiovascular risk register in the clinical records of patients [ Time Frame: September 1, 2011 to August, 31, 2013 ]
    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
  • economic impact of the new primary prevention lipid-lowering treatments prescribed during the study period [ Time Frame: September 1, 2011 to August 31, 2013 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention
Official Title  ICMJE Effectiveness of an Intervention to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.
    Intervention: Other: Information Support System
  • No Intervention: Control group
    Routine clinical practice
Publications * Fàbregas M, Berges I, Fina F, Hermosilla E, Coma E, Méndez L, Medina M, Calero S, Serrano E, Morros R, Monteagudo M, Bolíbar 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2013)
60000
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01997671
Other Study ID Numbers  ICMJE EC11-342
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jordi Gol i Gurina Foundation
Study Sponsor  ICMJE Jordi Gol i Gurina Foundation
Collaborators  ICMJE
  • Preventive Services and Health Promotion Research Network
  • Catalan Institute of Health
Investigators  ICMJE
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
PRS Account Jordi Gol i Gurina Foundation
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP