Heart Failure in Southern Sweden (HISS)
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|ClinicalTrials.gov Identifier: NCT04129658|
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment|
|Heart Failure，Congestive Drug Use Patient Care||Behavioral: Educational outreach visit|
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 :||Observational [Patient Registry]|
|Estimated Enrollment :||850 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Heart Failure in Southern Sweden - Improving the Quality of Diagnosis and Treatment Through a Educational Intervention in Primary Care|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2026|
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.
Behavioral: Educational outreach visit
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.
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.
- Medication change [ Time Frame: 6 months after inclusion ]Change in proportion of patients treated with the combination angiotensin conversion enzyme-inhibitors(ACEi) or angiotensin receptor blockers (ARB) and betablockers
- Change in health care consumption [ Time Frame: One year after the intervention ]Difference between the groups in change in number of visits in hospitals or primary care
- Change in mortality rate [ Time Frame: One year after the intervention ]Difference between the groups in change in number of visits in hospitals or primary care
- Change in medication [ Time Frame: Six months after the intervention ]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
- Change in diagnostics [ Time Frame: Six months after the intervention ]Difference between groups in change for proportion of patients getting the diagnosis with ecocardiogram and NYHA classification