- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01997671
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
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RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08007
- IDIAP Jordi Gol
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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).
|
No Intervention: Control group
Routine clinical practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage of participants with increase of the adequacy of lipid-lowering prescription
Time Frame: up to 24 months
|
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:
|
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
Time Frame: up to 24 months
|
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
Time Frame: baseline, months 24
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bonaventura Bolíbar, Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
- Study Chair: 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC11-342
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Medical College of WisconsinRecruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
Nanjing Medical UniversityRecruiting
-
Centre Hospitalier Universitaire de la RéunionRecruitingCardiovascular DiseaseFrance
-
National Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular DiseaseUnited States
Clinical Trials on Information Support System
-
National Institute of Diabetes and Digestive and...Vermont Program for Quality in Health CareCompleted
-
Fudan UniversityCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Completed
-
University Medical Center GroningenCompletedNeuroendocrine TumorNetherlands
-
Alzheimer's AssociationUnknown
-
Värmland County Council, SwedenCompleted
-
The Jacob and Valeria Langeloth FoundationUnknownAlzheimer DiseaseUnited States
-
Oulu University HospitalUniversity of OuluNot yet recruitingLifestyle | Obesity, Maternal
-
University of California, San DiegoNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease | Alzheimer's Disease | Alzheimer DementiaUnited States
-
University Medical Center GroningenCompletedQuality of Life | Distress | Neuroendocrine TumorNetherlands