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Background Advance care planning (ACP), a process of communication about patients’ preferences for future medical care, should be initiated in a timely manner. Ideally situated for this initiation is the general practitioner (GP). The intervention to improve the initiation of ACP for patients with a chronic life-limiting illness in general practice (ACP-GP) includes an ACP workbook for patients, ACP communication training for GPs, planned ACP conversations, and documentation of ACP conversation outcomes in a structured template. We present the study protocol of a Phase-III randomized controlled trial (RCT) of ACP-GP that aims to evaluate its effects on outcomes at the GP, patient, and surrogate decision maker (SDM) levels; and to assess the implementation process of the intervention. Methods This RCT will take place in Flanders, Belgium. Thirty-six GPs, 108 patients with a chronic, life-limiting illness, and their (potential) SDM will be recruited, then cluster-randomized to the ACP-GP intervention or the control condition. The primary outcome for GPs is ACP self-efficacy; primary outcome for patients is level of ACP engagement. Secondary outcomes for GPs are ACP practices, knowledge and attitudes; and documentation of ACP discussion outcomes. Secondary outcomes for patients are quality of life; anxiety; depression; appointment of an SDM; completion of new ACP documents; thinking about ACP; and communication with the GP. The secondary outcome for the SDM is level of engagement with ACP. A process evaluation will assess the recruitment and implementation of the intervention using the RE-AIM framework. Discussion While the general practice setting holds promise for timely initiation of ACP, there is a lack of randomized trial studies evaluating the effectiveness of ACP interventions implemented in this setting. After this Phase-III RCT, we will be able to present valuable evidence of the effects of this ACP-GP intervention, with the potential for offering a well-tested and evaluated program to be implemented in general practice. The results of the process evaluation will provide insight into what contributes to or detracts from implementation success, as well as how the intervention can be adapted to specific contexts or needs. Trial registration Prospectively registered at with ISRCTN (ISRCTN12995230); registered 19/06/2020.

Purpose This study evaluated the effect of early integrated palliative care (PC) in oncology on quality of life (QOL) near the end of life and use of health care resources near the end of life. Method Patients with advanced cancer and a life expectancy of approximately 1 year were randomly assigned to either early and systematic integration of PC into oncological care (intervention) or standard oncological care alone (control). QOL was assessed with the EORTC QLQ-C30 global health status/QOL scale and McGill Quality of Life (MQOL) Single Item Scale and Summary Scale at baseline, 12 weeks and 6 weekly thereafter until death. Use of health care resources was collected from chart review in patient's electronic medical file for patients who died while participating in the study. Results Of the 186 randomised patients, 185 participants had a baseline measurement and were analysed. By November 2017, 128 patients had died while participating in the study. When applying the terminal decline model, patients in the intervention group scored significantly higher on global health status/QOL of the EORTC QLQ C30, at 6 months (difference: 5.9 [0.06; 11.1], p = 0.03), 3 (difference: 6.8 [1.0; 12.6], p = 0.02), and 1 month (difference: 7.6 [0.7; 14.5], p = 0.03) prior to the patient's death compared to the control group. Similar results were found for the Single Item Scale and Summary Score of the MQOL. We did not observe differences in use of health care resources between groups. Discussion Early integrated palliative care in oncology is a valuable approach since it also increases QOL near the end of life and not only soon after initiation of PC.

Context Although early integrated palliative home care (PHC) is believed to be beneficial for patients with chronic obstructive pulmonary disease (COPD), trials testing this hypothesis are rare and show inconclusive results. Objectives To test feasibility, acceptability, and preliminary effectiveness of early integrated PHC for end-stage COPD. Methods Testing a six-month early integrated PHC pilot randomized controlled trial given by palliative home care nurses (PHCNs) for end-stage COPD with five components: 1) preinclusion COPD support training for PHCNs; 2) monthly PHC visits; 3) leaflets on coping mechanisms; 4) a protocol on symptom management and support, a care plan and an action plan; and 5) integration of PHC and usual care through reporting and communication mechanisms. Patient-reported outcomes were assessed six times weekly. Participants and health care professionals involved were interviewed. Results Of 70 eligible patients, 39 (56%) participated (20:19 intervention vs control group) and 64% completed the trial. A patient received on average 3.4 PHC visits, mainly for disease insight, symptom management, and care planning. Nurses distributed all reports but hardly connected with health professionals except general practitioners (GPs); eight of 10 interviewed patients referred to the psychosocial support, breathing exercises, and care decisions as helpful. Some GPs criticized PHC being given too early, but pulmonologists and PHCNs did not. Effectiveness analysis showed no overall intervention effect for the outcomes, but between baseline and week 24, fewer hospitalizations in the control group (P = 0.03) and a trend of higher perceived quality of care in the intervention group (P = 0.06) were found. A clinically relevant difference was observed at week 24 for health-related quality of life in favor of the control group. Conclusion Our intervention on early integrated PHC for end-stage COPD is feasible and accepted but did not yield the anticipated preliminary effectiveness. Before moving to a Phase III trial, enhanced coordination of care, more GP involvement, more intensive training for PHCNs in COPD support, and revision of the trial design, for example, of targeted outcomes in line with individual patient goals and care preferences should be done.

Objectives To describe the nursing and medical interventions performed in the last 48 hours of life and the quality of dying of patients dying in acute geriatric hospital wards. Methods Cross-sectional descriptive study between October 1, 2012 and September 30, 2013. Twenty-three acute geriatric wards in 13 hospitals in Flanders, Belgium. Patients hospitalized for more than 48 hours before dying in the participating wards. Structured after-death questionnaires, filled out by the nurse, the physician, and the family carer most involved in end-of-life care. Main outcome measures were several nursing and medical interventions reported to be performed in the last 48 hours of life and the quality of dying. Results Of 993 patients, we included 338 (mean age 85.7 years; 173 women). Almost 58% had dementia and nearly half were unable to communicate in the last 48 hours of their life. The most frequently continued or started nursing and medical interventions in the last 48 hours of life were measuring temperature (91.6%), repositioning (83.3%), washing (89.5%), oxygen therapy (49.7%), and intravenous fluids and nutrition (30%). Shortness of breath, lack of serenity, lack of peace, and lack of calm were symptoms reported most frequently by nurses and family carers. Conclusion Many nursing and medical interventions are continued or started in the last hours of a patient's life, which may not always be in their best interests. Furthermore, patients dying in acute geriatric wards are often affected by several symptoms.

BACKGROUND: Over 50% of elderly people die in acute hospital settings, where the quality of end-of-life care is often suboptimum. We aimed to assess the effectiveness of the Care Programme for the Last Days of Life (CAREFuL) at improving comfort and quality of care in the dying phase in elderly people. METHODS: We did a cluster randomised controlled trial in acute geriatric wards in ten hospitals in Flemish Region, Belgium, between Oct 1, 2012, and March 31, 2015. Hospitals were randomly assigned to implementation of CAREFuL (CAREFuL group) or to standard care (control group) using a random number generator. Patients and families were masked to interventaion allocation; hospital staff were unmasked. CAREFuL comprised a care guide for the last days of life, training, supportive documentation, and an implementation guide. Primary outcomes were comfort around dying, measured with the End-of-Life in Dementia-Comfort Assessment in Dying (CAD-EOLD), and symptom management, measured with the End-of-Life in Dementia-Symptom Management (SM-EOLD), by nurses and family carers. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01890239. FINDINGS: 451 (11%) of 4241 beds in ten hospitals were included in the analyses. Five hospitals were randomly assigned to standard health care practice and five to the CAREFuL programme; 118 patients in the control group and 164 in the CAREFuL group were eligible for assessment. Assessments were done for 132 (80%) of 164 patients in the CAREFuL group and 109 (92%) of 118 in the control group by nurses, and 48 (29%) in the CAREFuL group and 23 (19%) in the control group by family carers. Implementation of CAREFuL compared with control significantly improved nurse-assessed comfort (CAD-EOLD baseline-adjusted mean difference 4·30, 95% CI 2·07-6·53; p

Background Previous studies in the US and Canada, have shown the positive impact of early palliative care programs for advanced cancer patients on quality of life (QoL) and even survival time. There has been a lack of similar research in Europe. In order to generalize the findings from the US and Canada research on a larger scale, similar studies are needed in different countries with different care settings. The aim of this paper is to describe the research protocol of a randomized controlled trial, situated in Flanders, Belgium, evaluating the effect of systematic early integration of palliative care in standard oncology care. Methods/Design A randomized controlled trial will be conducted as follows: 182 patients with advanced cancer will be recruited from the departments of Medical Oncology, Digestive Oncology and Thoracic Oncology of the Ghent University Hospital. The trial will randomize patients to either systematic early integration of palliative care in standard oncology care or standard oncology care alone. Patients and informal caregivers will be asked to fill out questionnaires on QoL, mood, illness understanding and satisfaction with care at baseline, 12 weeks and every six weeks thereafter. Other outcome measures are end-of-life care decisions and overall survival time. Discussion This trial will be the first randomized controlled trial in the Belgian health care setting to evaluate the effect of systematic early integration of palliative care for advanced cancer patients. The results will enable us to evaluate whether systematic early integration of palliative care has positive effects on QoL, mood and patient illness-understanding and which components of the intervention contribute to these effects. Trial registration Clinicaltrials.gov Identifier: NCT01865396, registered 24th of May, 2013. Electronic supplementary material The online version of this article (doi:10.1186/s12913-015-1207-3) contains supplementary material, which is available to authorized users.