Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

NCT01997671 | Completed DMC

• 1 other identifier: EC11-342
• Study Type: interventional
• Target: 60,000
• Locations: 1 country
• Sites: 1

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:

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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

Cardiovascular Diseases

Keywords

Primary Care; Lipid-lowering therapy; Prescription; Adequacy; Primary prevention; Cardiovascular diseases; Electronic Medical records; Clinical Practice Guideline

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• percentage of patients with cardiovascular risk register in the clinical records of patients

  up to 24 months

• Change from baseline in the total cost of the lipid-lowering treatments prescribed during the study period

  baseline, months 24

Study Arms (2)

Information Support System

EXPERIMENTAL

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.

Other: Information Support System

Control group

NO INTERVENTION

Routine clinical practice

Interventions

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).

Information Support System

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Population from 35 to 74 years
• Free of cardiovascular disease
• Start on lipid-lowering therapy during 2 consecutive years of study

You may not qualify if:

• Previous treatment with lipid-lowering
• History of cardiovascular disease

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Preventive Services and Health Promotion Research Network: collaborator
• Catalan Institute of Health: collaborator

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Barcelona, 08007, Spain

Location

Related Publications (1)

• 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.

  PMID: 25027229 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Bonaventura Bolíbar

  Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

  PRINCIPAL INVESTIGATOR

• Sebastià Calero

  Catalan Institute of Health

  STUDY CHAIR

• Josep Casajuana

  Catalan Institute of Health

  STUDY CHAIR

• Ermengol Coma

  Catalan Institute of Health

  STUDY CHAIR

• Francesc Fina

  Catalan Institute of Health

  STUDY CHAIR

• Mireia Fàbregas

  Catalan Institute of Health

  STUDY CHAIR

• Eduardo Hermosilla

  Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

  STUDY CHAIR

• Manolo Medina

  Catalan Institute of Health

  STUDY CHAIR

• Mònica Monteagudo

  Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

  STUDY CHAIR

• Rosa Morros

  Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

  STUDY CHAIR

• Magdalena Rosell

  Jordi Gol i Gurina Foundation - IDIAP Jordi Gol

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: November 28, 2013
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 2, 2013

Record last verified: 2013-11

Locations

ES (1)