Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention

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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Information Support System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Information Support System<br>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<br>* 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).<br>|
| No Intervention: Control group<br>Routine clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Care, Lipid-lowering therapy, Prescription, Adequacy, Primary prevention, Cardiovascular diseases, Electronic Medical records, Clinical Practice Guideline