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临床试验/NCT04119856
NCT04119856已完成不适用

Outgoing Lung Team - a Cross-sectorial and Preventive Intervention in Patients at Risk of Hospitalisation Due to Exacerbation of COPD

University of Aarhus1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2017年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
1
主要终点
Change in admissions and re-admissions.

研究概览

简要总结

This study examines the effects of the work of an outgoing lung team in the Municipality of Aarhus, Denmark to patients with COPD (Chronic obstructive pulmonary disease) at risk of exacerbation of COPD.

The outgoing lung team is a cross-sectorial team of nurses and doctors from Department of Respiratory Diseases and Allergy at Aarhus University Hospital and nurses from the Acute Team in the Municipality of Aarhus.

The work of the outgoing lung team takes place in the patient's home and involves the following:

  • The outgoing lung team teaches the patients, relatives and primary care staff about symptoms, treatments and instructions related to COPD.
  • The patients, relatives and primary care staff can contact the outgoing lung team by telephone day and night.
  • The outgoing lung team initiates appropriate treatment by telephone or a home visit in consultation with a doctor.
  • The patients report symptoms and measurements to the outgoing lung team using telemedicine solutions (AmbuFlex).
  • The outgoing lung team initiates acute consultations at Department of Respiratory Diseases and Allergy based on patient reported outcomes, home visit or telephone call.

Half of the participants are affiliated to the outgoing lung team, while the other half are not, and continue their usual practice by contacting the general practitioners in case of exacerbation of COPD.

The main hypothesis of the project is that outgoing lung team has a positive impact on continuity of care across sectors in the Danish healthcare system for patients with COPD. More specifically the hypotheses are:

  1. Affiliation to the outgoing lung team reduces admissions, readmissions, length of hospital stay and outpatient consultations.
  2. Affiliation to the outgoing lung team reduces anxiety and depression and increases patient involvement, and improves patients' health status and self-efficacy.
  3. Affiliation to the outgoing lung team increases patients' level of health literacy.

详细描述

Background

Worldwide, COPD is a major cause of morbidity and mortality and is currently the fourth leading cause of death and projected to be the third leading cause of death by 2020. In 2010, the estimated number of COPD cases worldwide was 384 million with a prevalence of 11% (95% confidence interval: 8,4%-15,0%).

COPD is characterised by airway obstruction due to inflammation and destruction of lung tissue. The disease causes breathlessness, cough, mucus and frequent respiratory infections and leads to decreased lung function. COPD often affects patients' quality of life negatively as many experience anxiety because of breathlessness. Breathing difficulties reduce patients' level of activity and can lead to social isolation. In Denmark, it is estimated that 320,000 Danes have COPD. In 2018, the number of admissions due to COPD in Denmark was 34,961 with a readmission rate (new hospitalisation within 30 days after the last hospitalisation) of 19% and a 30-day mortality rate of 11%.There were 49,424 outpatient visits due to COPD in Denmark in 2018, and approximately 5,500 annual deaths where COPD is the direct or contributory cause.

It is estimated that the total annual treatment costs for patients with COPD in Denmark amount to approximately DKK 3,345 billion, and most of these costs are related to acute admissions.

Previous research shows that patients with COPD experience not being offered the same quality of treatment as other chronic patients. Furthermore, patients with COPD report that they are not taken seriously by healthcare professionals, which induces insecurity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Citizens of the Municipality of Aarhus
  • •FEV1 <50% predicted and at least one hospitalisation due to COPD and/or two tablet-treated episodes of exacerbation (prednisolone and /or antibiotics) within the last year
  • •Special needs due to anxiety, dyspnea etc. that cause frequent hospitalisations

排除标准

  • •Participation in the pilot project
  • •Inability to speak, read and understand Danish
  • •Severe cognitive disability and thus inability to understand and fill in questionnaires (e.g. dementia)
  • •No wish to participate in the project

研究组 & 干预措施

Intervention group

Other

Affiliation with outgoing lung team

  • Instructions and teaching by the outgoing lung team.
  • Needs-based consultation at Dept. of Respiratory Diseases and Allergy.
  • Contact to the outgoing lung team in case of exacerbation of COPD.

干预措施: Affiliation with the outgoing lung team (Other)

Control group

No Intervention

The usual practice

  • Scheduled consultations at Dept. of Respiratory Diseases and Allergy.
  • Contact to GP/doctor on call in case of exacerbation of COPD.

结局指标

主要结局

Change in admissions and re-admissions.

时间窗: One year. From date of randomization and after one year.

Data from the patients records.

Length of hospitalisation related to COPD.

时间窗: One year. From date of randomization and after one year

Data from the patients records.

次要结局

  • Experiences of affiliation with the outgoing lung team.(One time after, they have been affiliated with the outgoing lung team for at least 7 month.)
  • Change in quality of life(One year. From date of randomization and after one year.)
  • Change in anxiety and depression(One year. From date of randomization and after one year.)
  • Number of outpatient consultations related COPD.(One year. From date of randomization and after one year.)
  • Change in health status(One year. From date of randomization and after one year.)
  • Change in self-efficacy(One year. From date of randomization and after one year.)
  • Measure level of patient involvement(One year. From date of randomization and after one year.)
  • Change in level of health literacy(One year. From date of randomization and after one year.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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