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Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01997671
Enrollment
60000
Registered
2013-11-28
Start date
2011-09-30
Completion date
2013-09-30
Last updated
2013-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

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

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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

Interventions

OTHERInformation 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

Preventive Services and Health Promotion Research Network
CollaboratorOTHER
Catalan Institute of Health
CollaboratorOTHER_GOV
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 74 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
percentage of participants with increase of the adequacy of lipid-lowering prescriptionup to 24 monthsThe 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

Secondary

MeasureTime frameDescription
percentage of patients with cardiovascular risk register in the clinical records of patientsup to 24 monthsTo assess the degree of cardiovascular risk register in the clinical records of patients RECORD variable is calculated: Variable RECORD: recording of the cardiovascular risk
Change from baseline in the total cost of the lipid-lowering treatments prescribed during the study periodbaseline, months 24to 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026