Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Other: Information Support System

Study type: Interventional

Funder types: Other

Identifiers

NCT01997671

EC11-342

Details and patient eligibility

About

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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

Enrollment: 60,000 patients

Sex: All

Ages: 35 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60,000 participants in 2 patient groups

Information Support System

Experimental group

Description:

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.

Treatment:

Other: Information Support System

Control group

No Intervention group

Description:

Routine clinical practice