- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129658
Heart Failure in Southern Sweden (HISS)
Heart Failure in Southern Sweden - Improving the Quality of Diagnosis and Treatment Through a Educational Intervention in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background Congestive heart failure is one of the most common chronic diseases worldwide, with a prevalence of 2% of the population. With approximately 30000 affected patients, congestive heart failure is also one the most common reasons for hospital admissions in people over 65 years in southern Sweden. Heart failure means lower quality of life, a larger need for hospital care due to shortness of breath and leg swelling, risk for life threatening arrhythmia and high mortality. Several evidence-based treatment modalities have demonstrated good effect on life quality and mortality. In Sweden, there are large geographical differences in compliance to treatment guidelines. According to statistics from the National Board for Health and Welfare, in the Southern part of Sweden, Skåne, only 55% of the patients with congestive heart failure are treated with the combination of angiotensin converting enzyme inhibitors or angiotensin receptor blockers along with beta blockers. The national guidelines are recommending a target level of 65%.
The aim of this study is to assess to which extent an outreach educational program involving a cardiologist in primary care can raise the number of patients with congestive heart failure receiving evidence-based treatment, to study the cost-effectiveness of the intervention and to create a biobank for future studies in the field.
Methods The study design is prospective observational, with two patient cohorts followed over time. One cohort of patients will participate in an educational/AUDIT intervention including a cardiologist and the primary care physicians responsible for the patients. The control group will be the rest of the population in Southern Sweden, receiving usual care.
Settings Patients with a heart failure diagnosis registered in the electronic medical record (EMR) in different primary health care centers (PHCCs) will be invited to participate in the intervention group. Blood tests and electrocardiography will be performed. Blood samples for a biobank will be saved following well- regulated procedures.
Data collection Data will be collected from the EMRs in a Case Report Form (CRF). Primary outcome variable is the change in the proportion of patients receiving treatment with the combination of angiotensin converting enzyme inhibitors or angiotensin receptor blockers along with beta blockers, six months after the educational intervention.
Secondary outcome variables are the change between the groups in health care consumption and mortality as well as evidence-based treatment one year from the base line.
Data analysis The power estimation indicates that 850 patients will be required to the intervention group. Data will be analyzed with descriptive statistics and group comparison analysis for the primary outcome variable (McNemar's test and/or conditional logistic regression). Secondary outcome variables will be analyzed with group comparison for independent groups (Mann-Whitney or Student's T-test). In order to adjust for different confounders, we will use regression models. Generalized estimations equations will be used since patients are clustered within the PHCCs and can therefore not be labeled as independent.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Malmö, Sweden
- Vårdcentralen Granen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients with ICD diagnose I50, I11.0, I42 and I43 in the electronic medical journal and who have left informed consent to participate in the study
Exclusion Criteria:
- patients with ICD diagnose I42.1, I42.2
- patients where the heart failure diagnose is set on wrong grounds according to the information in the electronic medical journal, as normal NT-proBNP or/and normal ecocardiogram.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intervention
The patients are registered at PHCCs who agreed to participate into the study, the patients have provided an informed consent.
The PHCCs (seventeen according to the power calculation) will receive an educational outreach visit by a cardiologist, discussing evidence-based treatment.
The physician will decide afterwords if the treatment will be adjusted.
Blood samples and electrocardiography will be collected before the intervention, data from the EMR will be collected before and after the intervention.
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Two-four hours of discussion between a cardiologist and the primary care physicians at the PHCC encompassing evidence-based treatment guidelines and counseling upon specific patient cases and their diagnose and treatment for congestive heart failure.
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Control
The control group will be the rest of the patients with heart failure in Southern Sweden.
Data from the regional data base on medication and heath care consumption will be collected at base line and 6 and 12 months after.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication change
Time Frame: 6 months after inclusion
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Change in proportion of patients treated with the combination angiotensin conversion enzyme-inhibitors(ACEi) or angiotensin receptor blockers (ARB) and betablockers
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6 months after inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in health care consumption
Time Frame: One year after the intervention
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Difference between the groups in change in number of visits in hospitals or primary care
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One year after the intervention
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Change in mortality rate
Time Frame: One year after the intervention
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Difference between the groups in change in number of visits in hospitals or primary care
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One year after the intervention
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Change in medication
Time Frame: Six months after the intervention
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Difference between the groups in change of medication with mineral receptor antagonists (MRA), cardiac resynchronisation therapy (CRT), other implantable devices for treatment of heart failure (ICD) and intravenous iron for patients with iron deficiency
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Six months after the intervention
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Change in diagnostics
Time Frame: Six months after the intervention
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Difference between groups in change for proportion of patients getting the diagnosis with ecocardiogram and NYHA classification
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Six months after the intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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