PMID- 35879008 OWN - NLM STAT- MEDLINE DCOM- 20220727 LR - 20220817 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 12 IP - 7 DP - 2022 Jul 25 TI - 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. PG - e059440 LID - 10.1136/bmjopen-2021-059440 [doi] LID - e059440 AB - 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. CI - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Marx, Gabriella AU - Marx G AUID- ORCID: 0000-0001-6807-9518 AD - Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany g.marx@uke.de. FAU - Mallon, Tina AU - Mallon T AUID- ORCID: 0000-0001-5849-6377 AD - Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Pohontsch, Nadine Janis AU - Pohontsch NJ AUID- ORCID: 0000-0002-0966-4087 AD - Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Schade, Franziska AU - Schade F AD - Department of Palliative Medicine, University Medical Center Gottingen, Gottingen, Germany. FAU - Dams, Judith AU - Dams J AUID- ORCID: 0000-0002-6922-434X AD - Department of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Zimansky, Manuel AU - Zimansky M AD - Institute for General Practice and Palliative Care, Hannover Medical School, Hannover, Germany. FAU - Asendorf, Thomas AU - Asendorf T AD - Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany. FAU - Bottcher, Silke AU - Bottcher S AD - Division of General Practice, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany. FAU - Mueller, Christiane A AU - Mueller CA AUID- ORCID: 0000-0002-7871-0884 AD - Department of General Practice, University Medical Center Goettingen, Goettingen, Germany. FAU - Freitag, Michael AU - Freitag M AD - Division of General Practice, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany. FAU - Hummers, Eva AU - Hummers E AUID- ORCID: 0000-0003-2707-6067 AD - Department of General Practice, University Medical Center Goettingen, Goettingen, Germany. FAU - van den Bussche, Hendrik AU - van den Bussche H AD - Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Schafer, Ingmar AU - Schafer I AUID- ORCID: 0000-0002-1038-7478 AD - Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Konig, Hans-Helmut AU - Konig HH AUID- ORCID: 0000-0001-5711-6862 AD - Department of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Stiel, Stephanie AU - Stiel S AD - Institute for General Practice and Palliative Care, Hannover Medical School, Hannover, Germany. FAU - Schneider, Nils AU - Schneider N AD - Institute for General Practice and Palliative Care, Hannover Medical School, Hannover, Germany. FAU - Nauck, Friedemann AU - Nauck F AD - Department of Palliative Medicine, University Medical Center Gottingen, Gottingen, Germany. FAU - Friede, Tim AU - Friede T AUID- ORCID: 0000-0001-5347-7441 AD - Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany. FAU - Scherer, Martin AU - Scherer M AD - Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. LA - eng PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220725 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Chronic Disease MH - *Dementia MH - *Heart Failure/therapy MH - *Home Care Services MH - Humans MH - Multicenter Studies as Topic MH - Palliative Care/methods MH - *Pulmonary Disease, Chronic Obstructive/therapy MH - Quality of Life MH - Randomized Controlled Trials as Topic MH - Referral and Consultation MH - Telephone PMC - PMC9330329 OTO - NOTNLM OT - Chronic airways disease OT - Heart failure OT - INTERNAL MEDICINE OT - PALLIATIVE CARE OT - PRIMARY CARE COIS- Competing interests: None declared. EDAT- 2022/07/26 06:00 MHDA- 2022/07/28 06:00 PMCR- 2022/07/25 CRDT- 2022/07/25 21:12 PHST- 2022/07/25 21:12 [entrez] PHST- 2022/07/26 06:00 [pubmed] PHST- 2022/07/28 06:00 [medline] PHST- 2022/07/25 00:00 [pmc-release] AID - bmjopen-2021-059440 [pii] AID - 10.1136/bmjopen-2021-059440 [doi] PST - epublish SO - BMJ Open. 2022 Jul 25;12(7):e059440. doi: 10.1136/bmjopen-2021-059440.