Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD
Condition: COPD; COPD Exacerbation
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      As patients with COPD constitute a large group in both the primary and secondary care, we
      intend to improve the collaboration between the two sectors based on patients´ preferences.
      The patients emphasized the importance of having the possibility to contact a specialised
      respiratory nurse 24-7. Patients reported that they preferred education to take place close
      to home, as transportation to hospital or the community support centre for older people were
      both mentally and physically straining.

      Research showed that home visits by a respiratory nurse from the hospital reduce admissions
      and readmissions. Furthermore, research showed that home visits by the nurses in primary care
      also decrease admissions and readmissions. Some of the interventions were treatment at home
      and some comprised education regarding management of acute exacerbations and observations of
      symptoms, inhalation, smoking cessation, nutrition etc.

      The interventions consisted of collaboration between primary care nurses and the general
      practitioners (GPs), and in other interventions primary care nurses were supervised by the
      specialist respiratory nurses at the hospital often by phone or at joint visits in the
      patients' home.

      Home visits after discharge paid by a respiratory nurse and interdisciplinary cooperation
      showed that patients with COPD felt safe and comforted and were motivated to make changes to
      achieve better health.

      However, other studies showed that education improved patients' knowledge but it did not
      prevent readmissions.

      So far, no studies have been performed investigating cross-sectorial collaboration with a
      lung team and preventive intervention in patients at risk of hospitalisation due to
      exacerbation of COPD.

      Department of Respiratory Diseases and Allergy at Aarhus University Hospital, Denmark and the
      Acute Team in the Municipality of Aarhus, Denmark started a pilot project from September 2015
      until October 2016. The project concerned establishment of an outgoing lung team comprised by
      a team of nurses from both the primary and secondary sector. The aim was to increase
      knowledge and competences among patients, relatives and staff in relation to care and
      treatment, to reduce the rate of hospitalisation and readmission and to evaluate the impact
      of the outgoing lung team on participants' health status. The pilot project had several
      limitations 1) It was only possible to evaluate the effect of the outgoing lung team during
      six months. We were thus unable to evaluate variety over the year which may have impacted on
      the number of hospitalisations, readmissions and episodes of exacerbation. 2) The pilot
      project had no control group. We thus wanted to qualify the project by using a randomised
      controlled trial design.

      We also wanted to examine the impact of the outgoing lung team on the level of patient
      involvement, anxiety, depression and health literacy. Health literacy is linked to literacy
      and entails people's knowledge, motivation and competences to access, understand, appraise
      and apply health information in order to make judgements and take decisions in everyday life
      concerning health care, disease prevention and health promotion to maintain or improve
      quality of life during the life course. Studies show that patients with COPD have lower
      levels of health literacy compared with people with no chronic diseases. Increasing the level
      of health literacy in this population would thus be relevant.

      Furthermore, we wished to examine the effect of the outgoing lung team on patients' health
      status, their experiences of being affiliated to the outgoing lung team as well as their
      self-efficacy.

      Objective

      The aim is to examine the effects of the work of an outgoing lung team in the Municipality of
      Aarhus to patients with COPD at risk of exacerbation of COPD.

      Hypothesis

      The main hypothesis is that outgoing lung team has a positive impact on continuity of care
      across sectors in the Danish healthcare system for patients with COPD. To examine this we
      have three subhypotheses.

        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.

      Materials and method

      Setting and location

      The outgoing lung team is a cross-sectorial team of nurses and doctors from Department of
      Respiratory Diseases and Allergy at Aarhus University Hospital in Denmark and nurses from the
      Acute Team in the Municipality of Aarhus in Denmark. The outgoing lung team intends to
      preserve, detect, diagnose and treat patients with an exacerbation of COPD. The outgoing lung
      team is physically located at the office of the Acute Team; in this office knowledge sharing
      and upgrading of skills take place.

      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 patients report symptoms and measurements to the outgoing lung team using
           telemedicine solutions, also known as patient reported outcomes.

        -  The outgoing lung team initiates appropriate treatment by telephone or a home visit. The
           outgoing lung team always consults a doctor from the Department of Respiratory Diseases
           and Allergy before initiating treatment.

        -  The outgoing lung team initiates acute consultations at Department of Respiratory
           Diseases and Allergy based on patient reported outcomes, home visit or telephone call.

      Doctors at Department of Respiratory Diseases and Allergy are responsible for the medical
      treatment as long as the patient participates in the project. The GPs in the Municipality of
      Aarhus have agreed to this. The GPs can refer patients to the project and some of them
      participate in a project advisory board.

      Study design

      The project is designed as a mixed-method study based on a randomised controlled trial with
      an intervention group connected to the outgoing lung team and a control group attending the
      standard pathway programme at Department of Respiratory Diseases and Allergy at Aarhus
      University Hospital, Denmark.

      Sample size

      Based on a retrospective sample of admissions related to COPD in the period from February to
      August 2014-2016, an expected decrease in length of hospital stay can be calculated as the
      outgoing lung team was introduced in 2016. Mean number of admission days in the retrospective
      sample followed a normal distribution after logarithmic transformation, as assessed by
      histograms. Number of admission days (geometric mean) was 5.69 (95% CI: 2.78-11.6) in
      2014-2015, and 4.50 (2.62-7.76) in 2016. Based on these numbers, the power calculation
      resulted in inclusion of 64 patients in the intervention and control group, respectively to
      be able to demonstrate a significant difference with a power of 80% and at a significance
      level of 5%.

      In the pilot project the withdrawal was 23%. With an estimated withdrawal at 23% we will need
      83 patients in each group.

      Missing data

      After one year, we contact all participants and arrange a plan for answering the
      questionnaires. The missing data, will be registered in Stata and mentioned in the study.

      Analysis

      Data will be statistically analysed both descriptive and analytically. Correlations and
      significant factors as lung function, gender, age etc. will be examined and significant
      differences between the two groups (intervention group and control group) in the studies
      which may have an impact on results.

      To identify predictors of the impact on the dependent variable we will use bivariate x 2 test
      and calculation of odds ratios, multiple logistic regression and logarithmic data. The
      statistical analysis will be performed in Stata 16.

      Qualitative data from the interviews in will be transcribed and analysed based on meaning
      condensation analysis.

      Ethics

      Ethical approval will be obtained from Central Denmark Region Committees on Health Research
      Ethics and approval of data archives and storage will be obtained from the Danish Data
      Protection Agency in Central Denmark Region in RedCap. All collected personal data will be
      anonymised, processed, analysed and stored in accordance with the Danish Data Protection
      Agency. All participants will receive oral and written information. Patients who agree to
      participate will provide written informed consent.
    

Intervention name(s): Affiliation with the outgoing lung team
Intervention type(s): Other
Intervention description(s): 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 patients report symptoms and measurements to the outgoing lung team using telemedicine as patient reported outcomes.
The outgoing lung team initiates appropriate treatment by telephone or a home visit. The outgoing lung team always consults a doctor from the Department of Respiratory Diseases and Allergy before initiating treatment.
The outgoing lung team initiates acute consultations at Department of Respiratory Diseases and Allergy based on patient reported outcomes, home visit or telephone call.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cross-sectorial; Hospitalization; Self-efficacy; Patient Involvement; Health Literacy; Anxiety