Clinical trial NCT01997671: Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention
Official title: Effectiveness of an Intervention to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Primary Care
Lipid-lowering therapy
Prescription
Adequacy
Primary prevention
Cardiovascular diseases
Electronic Medical records
Clinical Practice Guideline
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
name: Catalan Institute of Health
First posted: 2013-11-28
Enrollment: 60000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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


Eligibility criteria: 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

Primary outcomes:
measure: percentage of participants with increase of the adequacy of lipid-lowering prescription
timeFrame: up to 24 months
Secondary outcomes:
measure: percentage of patients with cardiovascular risk register in the clinical records of patients
timeFrame: up to 24 months
measure: Change from baseline in the total cost of the lipid-lowering treatments prescribed during the study period
timeFrame: baseline, months 24
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
Study officials:
affiliation: Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
name: Bonaventura Bolíbar
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Sebastià Calero
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Josep Casajuana
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Ermengol Coma
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Francesc Fina
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Mireia Fàbregas
role: STUDY_CHAIR
affiliation: Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
name: Eduardo Hermosilla
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Manolo Medina
role: STUDY_CHAIR
affiliation: Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
name: Mònica Monteagudo
role: STUDY_CHAIR
affiliation: Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
name: Rosa Morros
role: STUDY_CHAIR
affiliation: Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
name: Magdalena Rosell
role: STUDY_CHAIR
References:
citation: Fabregas M, Berges I, Fina F, Hermosilla E, Coma E, Mendez L, Medina M, Calero S, Serrano E, Morros R, Monteagudo M, Bolibar B. Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial. BMC Fam Pract. 2014 Jul 15;15:135. doi: 10.1186/1471-2296-15-135.