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Completed

NCT Number: NCT01997671

Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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

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Key information

Age range

35 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDIAP Jordi Gol

Barcelona, 08007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Information Support System

Other

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Catalan Institute of Health
  • Preventive Services and Health Promotion Research Network

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2013
Registry last updated
Dec 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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