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

Abstract

IntroductionProgressive 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 analysisMulticentre 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 disseminationThe 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 numberDRKS00017795; German Clinical Trials Register.

Development of a patient assessment to meet the needs of patients suffering from advanced non-oncological diseases – the KOPAL study

“…The KOPAL conversation guide aims to cover relevant care aspects and to reveal individual gaps and needs in healthcare provision. The KOPAL conversation guide has been developed as part of the KOPAL-study [14] and will be presented in this paper. The process of development was guided by the following question: Which key topics and detailed foci should be addressed to fully identify possible palliative care needs of patients suffering from progressed non-oncological chronic diseases?…”

“…The design of the study has been described elsewhere. [14] In brief, the study is conducted in three steps: 1) Development of the KOPAL conversation guide, 2) intervention (home visit by SPHC nurse followed by a brief SPHC team consultation and an interprofessional telephone case conference between GP, SPHC nurse and SPHC doctor to discuss the patient's health and care situation and needs) and quantitative investigation at baseline and four follow-up points within 48 weeks, 3a) health economic analyses and 3b) qualitative evaluation of the KOPAL-intervention. In this paper, we describe step 1, development of the KOPAL conversation guide.…”

Consideration points in the decision making in chronic respiratory diseases

“…Although there is an existing body of research that has delved into multidisciplinary case discussions and practical approaches pertaining to COPD 8 , 9 , 10 ) , a noticeable gap in the literature lies in the scarcity of studies that explicitly concentrate on the practices of multidisciplinary case discussions concerning decision-making support for daily activities, medical care, and prospective treatments for patients afflicted by chronic respiratory diseases, including COPD. Furthermore, the specific details and content of these discussions remain inadequately elucidated.…”