Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD

NCT04119856 | Completed

• 1 other identifier: Outgoing Lung Team
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Conditions

COPD; COPD Exacerbation

Keywords

Cross-sectorial; Hospitalization; Self-efficacy; Patient Involvement; Health Literacy; Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in admissions and re-admissions.

  Data from the patients records.

  One year. From date of randomization and after one year.

• Length of hospitalisation related to COPD.

  Data from the patients records.

  One year. From date of randomization and after one year

Secondary Outcomes (8)

• Number of outpatient consultations related COPD.

  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 health status

  One year. From date of randomization and after one year.

• 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.

Study Arms (2)

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.

Other: Affiliation with the outgoing lung team

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.

Interventions

Affiliation with the outgoing lung team OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Respiratory Diseases and Allergy

Aarhus N, 8200, Denmark

Location

Related Publications (26)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Patient Participation; Anxiety Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Mental Disorders

Study Officials

• Birgit R Iversen, Ph.d.-stud.

  Department of Respiratory Diseases and Allergy, Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 8, 2019
• Study Start: September 25, 2017
• Primary Completion: March 31, 2020
• Study Completion: November 30, 2020
• Last Updated: January 22, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)