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临床试验/NCT04129658
NCT04129658已完成不适用

Heart Failure in Southern Sweden - Improving the Quality of Diagnosis and Treatment Through a Educational Intervention in Primary Care

Region Skane1 个研究点 分布在 1 个国家目标入组 563 人开始时间: 2021年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
563
试验地点
1
主要终点
Medication change

研究概览

简要总结

The aim of the study is to optimize diagnosis and treatment for patients with heart failure in Swedish primary care. Patient with the diagnose heart failure registered in the electronic medical record (EMR) at seventeen primary health care centers (PHCCs) will be invited to to participate in the study. Blood testing and electrocardiography will be performed. Data on diagnosis and medical treatment will be collected from the EMR. An educational visit with a cardiologist will be performed at the PHCC, in order to discuss evidence-based diagnoses and treatment of heart failure. Data on drug therapy and health care consumption will be collected after six and twelve months.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Medication change

时间窗: 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

次要结局

  • Change in diagnostics(Six months after the intervention)
  • Change in medication(Six months after the intervention)
  • Change in health care consumption(One year after the intervention)
  • Change in mortality rate(One year after the intervention)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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