Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

NCT01997671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60000

Last updated 2013-12-02

No results posted yet for this study

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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

Conditions

Interventions

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).

Sponsors & Collaborators

  • Preventive Services and Health Promotion Research Network

    collaborator OTHER
  • Catalan Institute of Health

    collaborator OTHER_GOV
  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • Bonaventura Bolíbar · Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

  • Sebastià Calero · Catalan Institute of Health

  • Josep Casajuana · Catalan Institute of Health

  • Ermengol Coma · Catalan Institute of Health

  • Francesc Fina · Catalan Institute of Health

  • Mireia Fàbregas · Catalan Institute of Health

  • Eduardo Hermosilla · Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

  • Manolo Medina · Catalan Institute of Health

  • Mònica Monteagudo · Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

  • Rosa Morros · Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

  • Magdalena Rosell · Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01997671 on ClinicalTrials.gov