Cardiovascular DiseasesNCT01997671
Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention
A study testing Information Support System in people with Cardiovascular Diseases, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Information Support System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,000 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Population from 35 to 74 years
- Free of cardiovascular disease
- Start on lipid-lowering therapy during 2 consecutive years of study
Who cannot join
- Previous treatment with lipid-lowering
- History of cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Information Support System
- Keywords
- Primary Care, Lipid-lowering therapy, Prescription, Adequacy, Primary prevention, Cardiovascular diseases, Electronic Medical records, Clinical Practice Guideline
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information Support SystemOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Information Support System |
| Control group | No intervention | Routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 months
Secondary outcomes (2)
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
Measured: 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
Measured: baseline, months 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network, Catalan Institute of Health
- Responsible party
- Sponsor
- Investigators
- Bonaventura Bolíbar, Principal investigator, Jordi Gol i Gurina Foundation - IDIAP Jordi GolSebastià Calero, Study chair, Catalan Institute of HealthJosep Casajuana, Study chair, Catalan Institute of HealthErmengol Coma, Study chair, Catalan Institute of HealthFrancesc Fina, Study chair, Catalan Institute of HealthMireia Fàbregas, Study chair, Catalan Institute of HealthEduardo Hermosilla, Study chair, Jordi Gol i Gurina Foundation - IDIAP Jordi GolManolo Medina, Study chair, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997671
- Sponsor's protocol ID
- EC11-342
- Status last verified
- Nov 2013
- First submitted
- 25 Jan 2013
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25027229
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01997671
- Acronym / sponsor ID
- EC11-342
- Conditions
- Cardiovascular Diseases
- Keywords
- Primary Care, Lipid-lowering therapy, Prescription, Adequacy, Primary prevention, Cardiovascular diseases, Electronic Medical records, Clinical Practice Guideline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60,000 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network, Catalan Institute of Health
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information Support System | Experimental | Other: Information Support SystemPractitioners 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. |
| Control group | No intervention | –Routine clinical practice |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Population from 35 to 74 years
- Free of cardiovascular disease
- Start on lipid-lowering therapy during 2 consecutive years of study
Key exclusion criteria (2 listed)
- Previous treatment with lipid-lowering
- History of cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information Support SystemPractitioners 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). | Other | Information Support System |
Primary outcome
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: * 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
percentage of patients with cardiovascular risk register in the clinical records of patients
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
- Derived from this study: PubMed 25027229Fabregas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonaventura Bolíbar principal investigator
Jordi Gol i Gurina Foundation - IDIAP Jordi Gol
Sebastià Calero study chair
Catalan Institute of Health
Josep Casajuana study chair
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information Support System in people with Cardiovascular Diseases, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of participants with increase of the adequacy of lipid-lowering prescription (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2013.