Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trial

Introduction Progressive chronic, non-malignant diseases (CNMD) like congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia are of growing relevance in primary care. Most of these patients suffer from severe symptoms, reduced quality of life and increased numbers o...

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Main Authors: Judith Dams, Hans-Helmut König, Tim Friede, Nils Schneider, Stephanie Stiel, Martin Scherer, Silke Böttcher, Gabriella Marx, Ingmar Schäfer, Nadine Janis Pohontsch, Hendrik van den Bussche, Friedemann Nauck, Michael Freitag, Eva Hummers, Tina Mallon, Franziska Schade, Manuel Zimansky, Thomas Asendorf, Christiane A Mueller
Format: Article
Language:English
Published: BMJ Publishing Group 2022-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/7/e059440.full
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author Judith Dams
Hans-Helmut König
Tim Friede
Nils Schneider
Stephanie Stiel
Martin Scherer
Silke Böttcher
Gabriella Marx
Ingmar Schäfer
Nadine Janis Pohontsch
Hendrik van den Bussche
Friedemann Nauck
Michael Freitag
Eva Hummers
Tina Mallon
Franziska Schade
Manuel Zimansky
Thomas Asendorf
Christiane A Mueller
author_facet Judith Dams
Hans-Helmut König
Tim Friede
Nils Schneider
Stephanie Stiel
Martin Scherer
Silke Böttcher
Gabriella Marx
Ingmar Schäfer
Nadine Janis Pohontsch
Hendrik van den Bussche
Friedemann Nauck
Michael Freitag
Eva Hummers
Tina Mallon
Franziska Schade
Manuel Zimansky
Thomas Asendorf
Christiane A Mueller
author_sort Judith Dams
collection DOAJ
description Introduction Progressive chronic, non-malignant diseases (CNMD) like congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia are of growing relevance in primary care. Most of these patients suffer from severe symptoms, reduced quality of life and increased numbers of hospitalisations. Outpatient palliative care can help to reduce hospitalisation rate by up to 50%. Due to the complex medical conditions and prognostic uncertainty of the course of CNMD, early interprofessional care planning among general practitioners who provide general palliative care and specialist palliative home care (SPHC) teams seems mandatory. The KOPAL study (a concept for strenghtening interprofessional collaboration for patients with palliative care needs) will test the effectiveness of a SPHC nurse–patient consultation followed by an interprofessional telephone case conference.Methods and analysis Multicentre two-arm cluster randomised controlled trial KOPAL with usual care as control arm. The study is located in Northern Germany and aims to recruit 616 patients in 56 GP practices (because of pandemic reasons reduced to 191 participants). Randomisation will take place on GP practice level immediately after inclusion (intervention group/control group). Allocation concealment is carried out on confirmation of participation. Patients diagnosed with CHF (New York Heart Association (NYHA) classification 3–4), COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage classification 3–4, group D) or dementia GDS stage 4 or above). Primary outcome is a reduced hospital admission within 48 weeks after baseline, secondary outcomes include symptom burden, quality of life and health costs. The primary analysis will follow the intention-to-treat principle. Intervention will be evaluated after the observation period using qualitative methods.Ethics and dissemination The responsible ethics committees of the cooperating centres approved the study. All steps of data collection, quality assurance and data analysis will continuously be monitored. The concept of KOPAL could serve as a blueprint for other regions and meet the challenges of geographical equity in end-of-life care.Trial registration number DRKS00017795; German Clinical Trials Register.
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spelling doaj-art-114b5247f4e54321b02d378840d365b52025-01-31T15:50:09ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-059440Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trialJudith Dams0Hans-Helmut König1Tim Friede2Nils Schneider3Stephanie Stiel4Martin Scherer5Silke Böttcher6Gabriella Marx7Ingmar Schäfer8Nadine Janis Pohontsch9Hendrik van den Bussche10Friedemann Nauck11Michael Freitag12Eva Hummers13Tina Mallon14Franziska Schade15Manuel Zimansky16Thomas Asendorf17Christiane A Mueller18Department of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment for Health Economics and Health Services Research, Universitatsklinikum Hamburg-Eppendorf, Hamburg, GermanyDepartment of Medical Statistics, University Medical Center Goettingen, Goettingen, GermanyInstitute for General Practice and Palliative Care, Hannover Medical School, Hannover, GermanyInstitute for General Practice, Hannover Medical School, Hanover, GermanyDepartment of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDivision of General Practice, Carl von Ossietzky University of Oldenburg, Oldenburg, GermanyDepartment of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany1 Department of Palliative Medicine, University Medical Center Göttingen, Göttingen, GermanyDivision of General Practice, Carl von Ossietzky University of Oldenburg, Oldenburg, GermanyDepartment of General Practice, University Medical Center Goettingen, Goettingen, GermanyDepartment of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyInstitute for General Practice and Palliative Care, Hannover Medical School, Hannover, GermanyInstitute for General Practice and Palliative Care, Hannover Medical School, Hannover, GermanyDepartment of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany3 Department of General Practice, University Medical Center Göttingen, Göttingen, GermanyIntroduction Progressive chronic, non-malignant diseases (CNMD) like congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia are of growing relevance in primary care. Most of these patients suffer from severe symptoms, reduced quality of life and increased numbers of hospitalisations. Outpatient palliative care can help to reduce hospitalisation rate by up to 50%. Due to the complex medical conditions and prognostic uncertainty of the course of CNMD, early interprofessional care planning among general practitioners who provide general palliative care and specialist palliative home care (SPHC) teams seems mandatory. The KOPAL study (a concept for strenghtening interprofessional collaboration for patients with palliative care needs) will test the effectiveness of a SPHC nurse–patient consultation followed by an interprofessional telephone case conference.Methods and analysis Multicentre two-arm cluster randomised controlled trial KOPAL with usual care as control arm. The study is located in Northern Germany and aims to recruit 616 patients in 56 GP practices (because of pandemic reasons reduced to 191 participants). Randomisation will take place on GP practice level immediately after inclusion (intervention group/control group). Allocation concealment is carried out on confirmation of participation. Patients diagnosed with CHF (New York Heart Association (NYHA) classification 3–4), COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage classification 3–4, group D) or dementia GDS stage 4 or above). Primary outcome is a reduced hospital admission within 48 weeks after baseline, secondary outcomes include symptom burden, quality of life and health costs. The primary analysis will follow the intention-to-treat principle. Intervention will be evaluated after the observation period using qualitative methods.Ethics and dissemination The responsible ethics committees of the cooperating centres approved the study. All steps of data collection, quality assurance and data analysis will continuously be monitored. The concept of KOPAL could serve as a blueprint for other regions and meet the challenges of geographical equity in end-of-life care.Trial registration number DRKS00017795; German Clinical Trials Register.https://bmjopen.bmj.com/content/12/7/e059440.full
spellingShingle Judith Dams
Hans-Helmut König
Tim Friede
Nils Schneider
Stephanie Stiel
Martin Scherer
Silke Böttcher
Gabriella Marx
Ingmar Schäfer
Nadine Janis Pohontsch
Hendrik van den Bussche
Friedemann Nauck
Michael Freitag
Eva Hummers
Tina Mallon
Franziska Schade
Manuel Zimansky
Thomas Asendorf
Christiane A Mueller
Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trial
BMJ Open
title Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trial
title_full Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trial
title_fullStr Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trial
title_full_unstemmed Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trial
title_short Effectiveness of a specialist palliative home care nurse–patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non-oncological palliative care needs: protocol for the multicentre KOPAL cluster-randomised controlled trial
title_sort effectiveness of a specialist palliative home care nurse patient consultation followed by an interprofessional telephone case conference compared with usual care among patients with non oncological palliative care needs protocol for the multicentre kopal cluster randomised controlled trial
url https://bmjopen.bmj.com/content/12/7/e059440.full
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