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Abstract
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.
- PALLIATIVE CARE
- PRIMARY CARE
- Heart failure
- INTERNAL MEDICINE
- Chronic airways disease
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Strengths and limitations of this study
The mixed-methods design including multiperspective evaluation allows insights into acceptance, practicability, beneficial aspects and barriers of the KOPAL intervention (a concept for strenghtening interprofessional collaboration for patients with palliative care needs).
In-depth interviews with health providers and interpretative analysis will reveal possible unconscious obstacles that might hinder early integration of specialist palliative home care in general.
Analysis of observed telephone case conferences will show details of roles and competencies of interprofessional interaction.
As KOPAL is a cluster randomised study, the risk of selection bias cannot be ruled out but will be minimised by the standardised patient-screening.
Introduction
Congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia are among the most common chronic, non-malignant diseases (CNMD) and causes of death in Europe and worldwide.1–4 Due to demographic change, these diseases will be of growing relevance. The course of CNMD is progressive, characterised by ‘long-term limitations with intermittent serious episodes’5 and, with increasing age, by higher hospitalisation rate when crises occur. These phases of crisis and well-being make the course of the diseases difficult to predict.5 6 In 2015, the overall hospitalisation rate in Germany for CHF was 20.6%, 11.7% for COPD, and 24%–44% of patients with advanced dementia were hospitalised at least once during the end stage of the disease.7 Hospitalisation may not only be traumatic for patients but also a major cost factor within health expenditure in Germany.7–10 While most patients wish to be cared for at home, about 46% die in hospitals.11–13 Studies showed that inpatient as well as outpatient palliative care programmes helped to reduce the hospitalisation rate by up to 50% and may reduce hospitalisation cost as well as overall healthcare costs.14–20 At the same time, research points to an increased unmet demand of specialised palliative care among patients with final-stage CNMD,21 yet 80%–90% of medical end-of-life care for CNMD patients is provided by general practitioners (GPs).22 During the course of the illness, patients are increasingly afflicted with physical and mental impairments, experience a loss of autonomy, change in their social role and reduced quality of life wherefore palliative care focuses on four dimensions of life following WHO definition of palliative care: physical, mental, social and spiritual.23
Due to the complex medical conditions and prognostic uncertainty of the course of CNMD, early interprofessional care planning among GPs who provide general palliative care and specialist palliative home care (SPHC) teams seems mandatory. Forming an early collaboration with SPHC teams would allow to form a treatment plan based on the patients’ individual disease and burden management, including multiple care providers (eg, palliative care (PC) nurses, physiotherapists, music therapists, pastors) and volunteers. The complex medical conditions of patients with CNMD demand interprofessional collaboration, since evidence points to the necessity of such collaboration.24 25 An Australian pilot study by Mitchell et al showed first evidence for the beneficial use of case conferences for CNMD patients with primary care and specialist public sector-based professionals.26 Mitchell et al reported a reduction in emergency department visits, number of hospital admissions and length of stay. Further national and international studies refer to the wish for intensified collaboration among GPs and SPHC providers.22 27–30 Mahtani-Chugani et al, however, found barriers to palliative care provision by patients as well as providers (lack of clarity about illness prognosis, the hegemony of the curative approach, avoiding words such as palliative care and cheating death which is still considered a taboo) that may hinder early collaboration and need to be overcome.31
In Germany, GPs and SPHC providers need to consolidate their collaboration and broaden their interconnectedness. Coordination of medical services from different care suppliers is restricted due to the heterogeneous structural conditions in SPHC across the federal states in Germany. Therefore, the KOPAL study (a concept for strenghtening interprofessional collaboration for patients with palliative care needs) aims to develop and implement a structured palliative care nurse home visit followed by an interprofessional telephone case conference. KOPAL further aims at enhancing the collaboration between GPs and SPHC teams and enabling an early interprofessional care planning for patients with CHF, COPD and dementia in an advanced stage and thereby improving healthcare for this special group of patients. We hypothesise a reduction in hospitalisation within 48 weeks (primary outcome) as well as a decrease in symptom burden, use of medication and increase in quality of life of these patients and collaboration among the medical providers (secondary outcomes).
Methods and analysis
Study design and study setting
The KOPAL study is a multicentre, two-arm, cluster randomised controlled trial with usual care in the control arm (funding period: 1 June 2019 to 30 November 2022). The study is carried out in the cooperation of Departments of Primary Care, Palliative Care, Health Economics and Statistics of four Universities in Hamburg, Hannover, Goettingen and Oldenburg located in two federal states of northern Germany. The latter ensures to cover different medical service structures of the SPHC teams.
The study will be conducted in three steps: (1) Development of the ‘KOPAL conversation guide’, (2) intervention and quantitative investigation, (3) Evaluation: 3(a) health economic analyses and 3(b) qualitative evaluation of the KOPAL intervention.
Step 1: Development of the ‘KOPAL conversation guide’
The ‘KOPAL conversation guide’ for the SPHC nurses’ conversation with the patients will be developed based on the British ‘PEPSI COLA aide memoire’ (used with permission from the National GSF Centre in End of Life Care).32 The PEPSI COLA aide memoire is a holistic common assessment of supportive and palliative care needs for adults with cancer. It aims to detect needs in the following areas of life during the interview: physical, emotional, personal, social support, information/communication, control/autonomy, out of hours/emergency, living with your illness and after care. For KOPAL, the PEPSI COLA framework will be adapted to the German healthcare system with a focus on patients with CHF, COPD and dementia in an advanced stage. The prefinal ‘KOPAL conversation guide’ will be discussed and revised in three workshops with patients of the target group and/or their relatives, with healthcare providers (eg, palliative care providers, GPs), and with scientific experts and representatives, that is, the advisory board (see figure 1).
Illustration of the investigation of the KOPAL intervention (a concept for strenghtening interprofessional collaboration for patients with palliative care needs). SPHC, specialist palliative home care.
Step 2: Quantitative investigation of the KOPAL intervention
The second step will investigate the effectiveness of the KOPAL intervention at five time points (baseline, after 6, 12, 24 and 48 weeks). Data collection will take place in the broader region of Hamburg and Lower Saxony.
Recruitment and eligibility
In Germany, SPHC teams provide care in a defined local region. All SPHC teams of Hamburg and Lower Saxony will be assigned to a study centre and invited to participate in written form, successively. SPHC teams are eligible for participation if the participating nurses and doctors have a specialised qualification in palliative care. Once a SPHC team will have agreed to take part, all GPs within the respective regions will be invited to participate. Inclusion criteria for GPs are specialisation in primary care or internal medicine, focus on primary care medicine and a computer-based documentation software, which allows to filter for patients according to their diagnosis and last visit in the last quarter. GPs who work as a palliative care specialist in a SPHC team will be excluded. Since recruitment of GPs in palliative care research can be challenging,33 we decided to invite all GPs of the respective regions. Invitation includes a short description of the main aspects of the study and a short questionnaire on eligibility criteria. Furthermore, invited GPs will be contacted by phone to ask for willingness to participate and to ensure eligibility.
After written consent is given by the practice, GPs will be provided with a study folder and assisted by study staff (via telephone or on site) in case of any difficulties regarding the screening process. Patients will be screened by the GP according to inclusion criteria: confirmed diagnosis of CHF with New York Heart Association (NYHA) classification 3–4, COPD with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage classification 3–4, group D or dementia with stage 4 or above in the Global Deterioration Scale (GDS). Additionally, participants must have had at least one consultation with the GP during the last 3 months and the ability to give oral/written consent. If possible, participants with dementia will be informed and will sign the consent form. If unable to consent, a legal representative will sign on behalf of the participant. Exclusion criteria for participants are no hospital admission during the last 12 months in patients with CHF, current cancer diagnosis, current SPHC support, no signed consent form.
Eligible patients will be invited in written form by their GP. Patients or their legal representatives willing to participate can contact the research team of the responsible study centre by sending in the included contact form. After having received the contact form, the research team will contact the patient or the legal representative and will arrange a personal meeting at the patient’s home. At this meeting, detailed study information will be given in written and oral form. Participation is voluntary. Patients/legal representatives give their informed consent in written form (translated consent form, see online supplemental file 1).
Supplemental material
Randomisation and blinding
Block-randomisation will take place on practice level immediately after inclusion. Allocation concealment is carried out on confirmation of participation. Randomisation will be performed by the local research teams using a web-based programme provided by the Clinical Trial Unit Goettingen. Since the intervention includes a face-to-face conversation, blinding is not possible for participating patients, providers and researchers, who are involved in data collection. Allocation concealment is ensured when practices confirm their participation.
Intervention
The KOPAL intervention is a low-threshold and easy-to-use medical concept to strengthen the interprofessional collaboration among GPs and SPHC teams. It consists of (a) one home visit of approximately 60 min by a SPHC nurse to assess the participant’s current life and health situation using the ‘KOPAL conversation guide’, (b) a brief consultation between SPHC nurse and SPHC physician regarding the patient’s situation and (c) the interprofessional telephone case conference of approximately 30 min between the GP, SPHC nurse and SPHC physician to discuss the patient’s current health and care situation as well as possible PC needs and next steps of treatment and care. A scientific researcher will be present to protocol the telephone case conference. To evaluate the results from the SPHC’s home visit and telephone case conference, the SPHC nurse will forward the completed ‘KOPAL conversation guide’ form to the research team. A maximum of 14 days is scheduled between the SPHC home visit and the telephone case conference. Baseline will be assessed 1 day before the SPHC home visit.
Participants of the control group will receive care as usual. Possible prescription of SPHC during the course of the study does not lead to exclusion but will be documented.
SPHC training
To improve intervention protocol adherence, SPHC nurses will be provided with a full online training course on background information of the KOPAL study, the use of the ‘KOPAL conversation guide’ and data security before starting the intervention. Additionally, SPHC teams will be provided with a detailed description of their role within the KOPAL study and an intervention checklist.
Primary and secondary outcome measures
Primary outcome is the number of hospital admissions 48 weeks after baseline, as documented by participant. In case of missing or invalid data, hospital admissions according to discharge report will be collected from the GP.
As for secondary outcomes, symptom burden will be measured with the Integrated Patient Outcome Scale (IPOS).34 The Brief Pain Inventory (BPI)35 will particularly be used to measure pain and impairment due to pain. To observe pain in non-communicative participants with dementia, the Pain Assessment in Advanced Dementia Scale (PAINAD, German version Beurteilung von Schmerzen bei Demenz, BESD)36 will be used. Health-related quality of life will be assessed using EQ-5D-5L.37 The Questionnaire for Health-Related Resource Use in an Elderly Population (FIMA)38 will be used to measure healthcare utilisation, including current medication, involved healthcare providers and health costs. Participants will be asked about their thoughts on preferred place of death.
Additional measures
Diagnosis of hospital admission and discharge as well as the number of days in intensive or palliative care unit, the reason for admission (scheduled or emergency) and collaboration among the medical providers serve as additional secondary outcomes (see table 1).
KOPAL measurements
Participants will receive the ‘KOPAL patient diary’, including visualisation aides for scales used during the interviews (t0–t4), which allows participants to record hospital admissions as well as consultations with doctors and therapists. This diary will help participants in remembering events since the last interview and helps to improve adherence to follow-up interviews.
To describe the sample and to gain knowledge about selected aspects of patients, participants will further be asked about the use of SPHC services, living will and healthcare proxy, sociodemographic questions. In case of drop-out or death of the participants, GPs will provide date, place and cause of death. Demographic data on GP specialisation, number of years of experience and changes in their medical service due to the COVID-19 pandemic will be assessed.
Numbers of completed interviews, home visits, case conferences and GP participant interviews will be recorded. In case of drop-out, information on hospital admissions and diagnosis during the last follow-up and time of drop-out will be gathered from the participant’s GP.
Data collection
Data will be collected at baseline and four follow-up time points (after 6, 12, 24 and 48 weeks) by members of the research team, who undergo a prior training. For participants in the control group, the follow-up date refers to baseline, while for participants in the intervention group, it refers to the date of the telephone case conference. All parameters (except sociodemographic data) will be collected at each time point. Baseline will be assessed as face-to-face interview to establish a relationship with persons of this vulnerable group. Data at follow-up will be collected by telephone. GPs data will be assessed via telephone at baseline and at follow-up 48 weeks after baseline or at the time of drop-out/death of the participant. The electronic data capture system and database (secuTrial) will be used in this study and was configured by the department for biostatistics and data management of the University Medical Center Goettingen. For instruments and timing, see table 1.
Sample size and power
Participants with the abovementioned diseases and severity levels are usually admitted to hospital several times a year; we expect an average of about two admissions per participant per year. A 30% reduction is relevant and realistic.15 16 Under these assumptions, a case number of 93 participants per group gives a statistical power of 90% for a test comparing two Poisson rates to the usual bilateral significance level of 5%. The distribution of hospital admissions per participant shows some extra-Poisson variation, that is, the variance is greater than the mean.19 We correct the overdispersion, defined as variance/mean, by multiplying the number of cases by the corresponding factor of 2.39 We also correct for 20% dropout of participants. This results in a total case number of 465 participants. The cluster randomisation and the expected cluster size of 11 participants per practice, which are based on the assumptions of population-related values for palliative care needs for the selected chronic diseases,40 feasibility of the intervention at GP level and assumed intracluster correlation (ICC) of 0.032,41 result in a design effect of 1.32.42 This results in a rounded total case number of 616 participants (56 practices with 11 participants each, 28 practices per group). Practices, which drop out, will be replaced. The aim is to recruit 7 GP practices with 11 participants each in all four study centres per condition (intervention and control). Since literature on annual hospitalisation rates varies and the assumptions on extra-Poisson variation, ICC and dropout are subjected to a certain degree of uncertainty, we will conduct a sample size review after recruitment of the first 300 participants, and adjust case number planning accordingly.43
However, start of recruitment coincided with the spread of the COVID-19 pandemic. Since the progression of the pandemic was difficult to predict, the KOPAL study group, in consultation with the funder, decided to close recruitment at the scheduled time and to recalculate the study power. Therefore, the sample size was reduced to 191 participants, resulting in 51 practices with approximately four participants each. With the same ICC as in the original planning, the design effect was, therefore, reduced to 1.096 (down from 1.32 in the original sample size calculation). Then, using the same methodology as in the original sample size calculation, a total sample size of 191 participants would be sufficient to prove a significant difference between intervention and control group with 80% power (down from 90%), assuming a likewise clinically relevant reduction in hospitalisations of 40% (up from 30%). Significance level, dropout rate and assumptions on overdispersion were kept as planned originally. A further review of the sample size was no longer performed as raising the sample size would not have been possible.
Statistical analysis
The primary analysis will follow the intention-to-treat (ITT) principle. The effect of the KOPAL intervention on the number of hospital admissions will be analysed using a generalised linear model with logarithmic link function as well as fixed effects for the intervention and important prognostic factors at practice and participant level (eg, size of the practicunderlying disease of the participant) and random effects for the practices. The data of all recruited participants will be included in the analysis regardless of the time of drop out or death; the logarithmic follow-up times will be included in the model as offset. The intervention effect will be reported as an incidence ratio with a 95% CI and p value testing the null hypothesis of the incidence ratio being equal to 1. If mortality within the 48-week period is considerable (greater than 20%), a joined frailty model will be applied to the recurrent hospitalisations and time-to-death will be modelled as a competing event. Further secondary effects will be examined by linear regression analyses in a multilevel model. Binary outcomes will be modelled by logistic regression with mixed effects. Furthermore, GP factors and specific symptom complexes of the participant can be considered as possible confounders. Participant subgroups will be formed based on diagnoses, symptom burden, socioeconomics, etc and included in the analyses on an exploratory basis. Missing data will be dealt with using multiple imputation methods. The statistical evaluations are further detailed in a statistical analysis plan.
Step 3: Evaluation
Step 3A: Health economic analysis
Health economic analysis will include the evaluation of healthcare utilisation, costs and cost-effectiveness from a healthcare payer’s and societal perspective. Healthcare utilisation will be assessed using the FIMA questionnaire, which was adapted to the diseases focused in KOPAL and the palliative care setting. Subsequently, healthcare utilisation will be monetarily valued by standardised unit costs in Germany.44 Besides descriptive analysis, cost determinants will be evaluated using regression models, which will account for the skewness of costs distributions. For cost-effectiveness analysis, the incremental cost-effectiveness ratio (ICER) will be calculated. The effectiveness will be measured by quality-adjusted life years based on the EQ-5D-5L index.45 Finally, uncertainty in the ICER will be evaluated by cost-effectiveness acceptability curves based on the net-benefit regression approach.46
Step 3B: Qualitative evaluation of the KOPAL intervention
With regard to the implementation of the KOPAL intervention qualitative evaluation will assess acceptance and feasibility considering different perspectives: health providers, patients/proxys and relatives/associates.
Health providers: after follow-up 4, all 28 GPs of the intervention group and all involved members of the SPHC teams will be interviewed individually by trained members of the research team. Narrative interview techniques will be used in order to allow individual accentuation of relevancies.47 The focus will be on: acceptance, practicability, beneficial aspects and barriers of the KOPAL intervention as well as interprofessional communication and consequences on participants’ care previous to the KOPAL intervention according to each perspective. Interviews will be audio recorded, transcribed verbatim and analysed with a grounded theory approach48 using abductive reasoning49 in order to transfer the practical experiences into a databased theory on interprofessional collaboration in the area of primary and palliative care. We decided to apply an in-depth approach to go beyond a manifest level of reflected attitudes and opinions regarding palliative care provision for non-oncological patients and cooperation with SPHC providers, since the aim of the study is to reveal possible unconscious barriers or reservations, which will not be able to be explicated by participants.
Additionally, all telephone case conferences will be observed by a researcher using an observation protocol (non-participating observation43). Matters of interest are course of actions, constellation of interactions, proportion of speech, main focus, omissions and conclusions. According to Grounded Theory, observation protocols will enrich the analysis of interviews with GPs and SPHC teams.
Participants/proxies and relatives/associates: semistructured interviews43 50 will be conducted with 16–22 participants (or proxies respectively) of the intervention group. Two focus groups including 5–8 participants each43 with relatives (or associates respectively) of KOPAL participants on their perception and experiences of the (effects of the) KOPAL intervention, for example, relevant changes in daily life and care. Audio recordings of the interviews and focus groups will be transcribed verbatim and analysed with a qualitative content analysis approach.51 In contrast to analysis of provider interviews, we aim at analysing individual meanings and experiences with intervention reported on a manifest level wherefore we decided the chosen approach to be appropriate.
Findings from the qualitative evaluation will give insights into strengths and limitations of interprofessional collaboration among GPs, SPHC nurses and SPHC physicians at the intersection of primary and specialised palliative home care. Considering the needs of participants and their relatives will provide the basis for identifying structural or professional collaboration barriers.
Monitoring
All aspects of study design and data collection have been discussed in advance with the advisory board of the KOPAL study. The advisory board, which is independent from the investigator and the sponsor, will supervise the study process at least once a year. The department for biostatistics and data management of the University Medical Center Goettingen will continuously monitor all steps of data collection, quality assurance and data analysis and will conduct a blinded interim analysis to proof the statistical power. They will oversee the intrastudy data sharing process. The main risks of the study are possible negative events for the patients due to talking about their life situation. In case of negative events occurring during data collection, the monitoring and safety board will be informed. If the board decides that these events are to be seen in connection with study participation or trial conditions, the trial will be stopped. All participating patients receive usual care. In case of early withdrawal, the GP will be informed about the end of further patient-related data collection and usual care will continue.
Patient and public involvement statement
Participants affected by COPD and CHF, patient representatives for participants with dementia and professional caregivers (nurses and physicians) will be involved in the development of the ‘KOPAL conversation guide’. Their experiences and opinions will be discussed in three workshops and considered in the final version of the guide. Professional caregivers and patient representatives are members of the advisory board. The general public will not be actively involved.
Ethics and dissemination
KOPAL has been approved by the local ethics committee of the Medical Association Hamburg, Germany (number PV7090) as well as the ethics committees of the University Medical Centre Goettingen, Germany (number 34/1/20Ü), the Hannover Medical School (number 8815 BO K 2019) and the University of Oldenburg (number 2019–145). The trial is registered on the German clinical trial register (registration number DRKS00017795; 17 November 2021, V.05). Important protocol modifications will be submitted to the ethical boards as well as they will be communicated to the funder, the trial registry and to participating GPs, SPHC teams and patients.
Study participants will be informed about the study details by members of the respective research team. All participants (including those affected with dementia) will give written informed consent. Additionally, for participants with dementia, a legal representative will have to give informed consent on participant’s behalf. Participants and legal representatives have the right to withdraw from the study at any point during the study without giving reasons, or any negative effect on patient care. In this case, the GP will be informed about withdrawal and no further data will be collected. All study and patient-related information will be stored securely at the study sites.
The KOPAL study will develop and test an intervention of a low threshold contributing to strengthen interprofessional collaboration in palliative care and cross-sectoral care. The intervention will be tested in two German federal states. In case of effectiveness, the concept of the KOPAL study could serve as a blueprint for other regions and meet the challenges of geographical equity in end-of-life care.
To ensure that the results of this study are accessible to the public, the results will be published in peer-reviewed international and national journals and disseminated through national and international conferences. The main findings will be published in the German Clinical Trials Register.
Discussion
Notwithstanding given differences among countries, a general need of improvement in palliative primary healthcare is observed in European countries.52 Palliative care is underprovided in general but in particular for patients with other conditions than cancer.53–55 In Germany, palliative care is structurally separated into two coverage areas, primary (general) and specialised palliative care. While the need for SPHC for non-oncological patients is accepted, it is still mostly provided to patients suffering from cancer for historical reasons. The integration of a concept to strengthen the early collaboration of primary and outpatient specialised palliative care providers in general and the interprofessional collaboration in particular could be a relevant step to consider more strongly the palliative care needs of patients with non-cancer in primary care. The multicentre KOPAL RCT aims to develop and test an intervention, including a home visit by an SPHC nurse using the ‘KOPAL conversation guide’ followed by an interprofessional telephone case conference.
Unfortunately, the scheduled start of recruitment and data collection coincided with the increase in the COVID-19 pandemic in Germany, which had a retarding effect on the study progress. The SPHC teams were faced with a strong increase in SPHC prescriptions. Movable hospitalisations were stopped to keep hospital beds for patients with COVID-19, which were often forwarded to SPHC to compensate for homecare needs. During the following months, also GPs reported increase in workload caused by insufficient information, lack of personal protective equipment, the need to restructure practice procedures and insufficient individual and structural pandemic preparedness. The fact of the fast worldwide spread and the absence of medication and vaccine led to high additional workload and financial worries.56 Although this shows the relevance of SPHC providers as well as GPs and thus the relevance of research in this field, recruitment process was challenging and the sample size needed to be reduced in consultation with the funder.
To gain information about possible confounding factors of the pandemic on the effectiveness of the KOPAL intervention, additional health-related questions regarding the COVID-19 pandemic will be collected at baseline with GPs and patients.
Ethics statements
Patient consent for publication
Acknowledgments
Scientific experts and representatives (physicians, nurses, researcher and patient representatives) serve as advisory board and counsel the KOPAL study group once a year. Principles and materials for The Gold Standards Framework © K Thomas, the National GSF Centre 2003 - 2019. Used with permission from the National GSF Centre in End of Life Care. http://www.goldstandardsframework.org.uk/
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Twitter @tim_friede, @degampraesident
Contributors GM, TM, NJP, FS, JD, MZ, TA, SB, CAM, MF, EH, HvdB, IS, H-HK, SSt, NS, FN, TF, MS contributed substantially to the conception of the study. MS (principal investigator), GM (coprincipal investigator), MF, EH, HvdB, IS, H-HK, SSt, NS, FN and TF are the applicants of the trial. GM coordinates the trial. TF and TA are the trial statisticians and contributed to the statistical analysis aspect of the protocol. GM, NJP, MZ and FS contributed substantially to the qualitative method of the protocol. GM and TM coordinated ethics approval and wrote the first draft of the manuscript. All authors revised the draft critically and gave approval of the final version of the protocol.
Funding The KOPAL study was supported by the Federal Joint Committee (G-BA), grant number 01VSF18024. Funding period: 06/2019 – 05/2022. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. (https://innovationsfonds.g-ba.de/).
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.