Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997671
• Other study ID #: EC11-342
• Status: Completed
• Phase: N/A
• First received: January 25, 2013
• Last updated: November 28, 2013
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60000
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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).

Locations

Country	Name	City	State
Spain	IDIAP Jordi Gol	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Catalan Institute of Health, Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of participants with increase of the adequacy of lipid-lowering prescription	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	Yes
Secondary	percentage of patients with cardiovascular risk register in the clinical records of patients	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	Yes
Secondary	Change from baseline in the total cost of the lipid-lowering treatments prescribed during the study period	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	Yes