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

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ClinicalTrials.gov Identifier: NCT04119856
Recruitment Status : Active, not recruiting
First Posted : October 8, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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:

  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.

Condition or disease Intervention/treatment Phase
COPD COPD Exacerbation Other: Affiliation with the outgoing lung team Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Outgoing Lung Team - a Cross-sectorial and Preventive Intervention in Patients at Risk of Hospitalisation Due to Exacerbation of COPD
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Intervention group

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

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.

No Intervention: Control group

The usual practice

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



Primary Outcome Measures :
  1. Change in admissions and re-admissions. [ Time Frame: One year. From date of randomization and after one year. ]
    Data from the patients records.


Secondary Outcome Measures :
  1. Length of hospitalisation related to COPD. [ Time Frame: One year. From date of randomization and after one year. ]
    Data from the patients records.

  2. Number of outpatient consultations related COPD. [ Time Frame: One year. From date of randomization and after one year. ]
    Data from the patients records.

  3. Measure level of patient involvement [ Time Frame: One year. From date of randomization and after one year. ]
    Self reported level of patient involvement. The questionnaire PACIC (Patient Assessment of Chronic Illness Care) comprised of 20-items. Each item is scored "Never", "Usually not", "Sometimes" "Usually" or "Always"

  4. Change in health status [ Time Frame: One year. From date of randomization and after one year. ]
    Self reported health status. The questionnaire CAT (COPD Assessment Test) comprised of 8 items. Each item is scored 0-5 (O = never, and 5 = always)

  5. Change in quality of life [ Time Frame: One year. From date of randomization and after one year. ]
    Self reported data based on the questionaire EQ-5D-3L (Euro-quality of life group- 5 dimensions- 3 level). Each item is scores 1-3 (1= No problems, 3= Many problems)

  6. Change in anxiety and depression [ Time Frame: One year. From date of randomization and after one year. ]
    Self reported data based on the questionaire HADS (Hospital Anxiety and Depression Scale). It consists of 14 items. Each items is scored 1-4 (1 = Most of the time/ definitely to 4= very rare/ definitely not)

  7. Change in level of health literacy [ Time Frame: One year. From date of randomization and after one year. ]
    Self reported data based on the questionaire HLQ (Health Literacy Questionnaire). It comprises of 9 domains. In this study we use 3 domains and it consists of 15 items. 1 domain comprised of 5 items, and each item is scored from "totally not agree" to " not agree", "agree" and "totally agree". The two other domains comprises in total of 10 domains, where each item is scored from "Always difficult", "Often difficult", "Sometimes difficult", "Often easy" and "Always easy".

  8. Change in self-efficacy [ Time Frame: One year. From date of randomization and after one year. ]
    Self reported data based on the questionaire CSES (COPD Self-Efficacy Scale). It comprises of 34 items, and each item is scores from "very sure", "pretty Sure", "partly sure", "not very sure" and definitely not sure"

  9. Experiences of affiliation with the outgoing lung team. [ Time Frame: One time after, they have been affiliated with the outgoing lung team for at least 7 month. ]
    Interviews with patients who have been affiliated with the outgoing lung team.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Citizens of the Municipality of Aarhus
  2. 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
  3. Special needs due to anxiety, dyspnea etc. that cause frequent hospitalisations

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119856


Locations
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Denmark
Department of Respiratory Diseases and Allergy
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Birgit R Iversen, Ph.d.-stud. Department of Respiratory Diseases and Allergy, Aarhus University Hospital

Publications:
Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for Diagnosis, Management, and Prevention of COPD - 2019. 2019; Available at: https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-v1.7-FINAL-14Nov2018-WMS.pdf. Accessed 15.04, 2019.
Sundhedsstyrelsen. Anbefalinger for tværsektorielle forløb for mennesker med KOL. 2017; Available at: https://www.sst.dk/da/udgivelser/2017/~/media/8365DCEC9BB240A0BD6387A81CBDBB49.ashx. Accessed 04.07, 2017.
Dansk Register for Kronisk Obstruktiv Lungesygdom. Appendiks til National årsrapport 2018. 2019; Available at: https://www.sundhed.dk/content/cms/90/4690_appendix_drkol-aarsrapport-2018_05052019_offentlig.pdf. Accessed 12.08, 2019.
Dansk Register for Kronisk Obstruktiv Lungesygdom. National årsrapport 2018. 2019; Available at: https://www.sundhed.dk/content/cms/90/4690_drkol-aarsrapport-2018_offentlig.pdf. Accessed 12.08, 2019.
Witzel S, Nielsen PB, Jensen M. Patienternes perspektiv på kronisk sygdom - Oplevelser på tværs af sundhedsvæsenet i Region Midtjylland. CFK - Folkesundhed og Kvalitetsudvikling. 2012; Available at: http://www.defactum.dk/publikationer/ShowPublication?id=421&pageId=309986. Accessed 05.07, 2016.
Martin HM, Borst L. Sammenhæng i tværsektorielle KOL - forløb. En undersøgelse af patient er og pårørendes oplevelser. KORA - Det Nationale Institut for Kommuners og Regioners Analyse og Forskning. 2013; Available at: https://www.vive.dk/media/pure/9106/2043881. Accessed 05.07, 2019.
Rasmussen L, Ølsgaard G. Forslag til kvalitetsforbedringer fra patienter og fagpersoner i indsatsen for kronisk syge - en opfølgning på rapporten "Patientens perspektiv på kronisk sygdom". CFK - Folkesundhed og Kvalitetsudvikling. 2014; Available at: http://www.defactum.dk/publikationer/ShowPublication?id=435&pageId=309986. Accessed 05.07, 2016.
World Health Organization Europe. Health Literacy - The solid facts. 2013; Available at: http://www.euro.who.int/__data/assets/pdf_file/0008/190655/e96854.pdf?ua=1. Accessed 01.03, 2017.
Friis K, Jensen ML, Lasgaard M, Maindal HT. Sundhedskompetence blandt personer med kronisk sygdom. Region Midtjylland CFK - Folkesundhed og Kvalitetsudvikling. 2015; Available at: https://www.rm.dk/siteassets/om-os/aktuelt/nyheder/sundhedskompetence_kronisk_sygdom_2015_temaanalyse.pdf. Accessed 13.07, 2016.
Kvale S, Brinkmann S. Interview : det kvalitative forskningsinterview som håndværk. 3rd ed. København: Hans Reitzel; 2015.

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04119856     History of Changes
Other Study ID Numbers: Outgoing Lung Team
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Cross-sectorial
Hospitalization
Self-efficacy
Patient Involvement
Health Literacy
Anxiety
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases