Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

November 28, 2013 updated by: Jordi Gol i Gurina Foundation

Effectiveness of an Intervention to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical Trial

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08007
        • IDIAP Jordi Gol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

up to 24 months
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

baseline, months 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2013

Last Update Submitted That Met QC Criteria

November 28, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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