Dataset Information

The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home.

ABSTRACT:

Background

The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate whether an accelerated transition process from oncological treatment to continuing SPC at home for patients with incurable cancer results in more patients reaching their preferred place of care and death. The SPC in this trial is enriched with a manualized psychological intervention.

Methods/design

DOMUS is a controlled randomized clinical trial with a balanced parallel-group randomization (1:1). The planned sample size is 340 in- and outpatients treated at the Department of Oncology at Copenhagen University Hospital. Patients are randomly assigned either to: a) standard care plus SPC enriched with a standardized psychological intervention for patients and caregivers at home or b) standard care alone. Inclusion criteria are incurable cancer with no or limited antineoplastic treatment options.

Discussion

Programs that facilitate transition from hospital treatment to SPC at home for patients with incurable cancer can be a powerful tool to improve patients' quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient's preferred place of care and attempt to clarify challenges.

Trial registration

Clinicaltrials.gov Identifier: NCT01885637.

SUBMITTER: Nordly M

PROVIDER: S-EPMC4169691 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home.

Nordly Mie M Benthien Kirstine Skov KS Von Der Maase Hans H Johansen Christoffer C Kruse Marie M Timm Helle H Vadstrup Eva Soelberg ES Kurita Geana Paula GP von Heymann-Horan Annika Berglind AB Sjøgren Per P

BMC palliative care 20140909

<h4>Background</h4>The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate whether an accelerated transition process from oncological treatment to continuing SPC at home for patients with incurable cancer results in more patients reaching their preferred place of care ...[more]

PMID: 25242890

Similar Datasets

Project description:BackgroundWhile hospitals remain the most common place of death in many western countries, specialised palliative care (SPC) at home is an alternative to improve the quality of life for patients with incurable cancer. We evaluated the cost-effectiveness of a systematic fast-track transition process from oncological treatment to SPC enriched with a psychological intervention at home for patients with incurable cancer and their caregivers.MethodsA full economic evaluation with a time horizon of six months was performed from a societal perspective within a randomised controlled trial, the DOMUS trial ( Clinicaltrials.gov : NCT01885637). The primary outcome of the health economic analysis was a incremental cost-effectiveness ratio (ICER), which is obtained by comparing costs required per gain in Quality-Adjusted Life Years (QALY). The costs included primary and secondary healthcare costs, cost of intervention and informal care from caregivers. Public transfers were analysed in seperate analysis. QALYs were measured using EORTC QLQ-C30 for patients and SF-36 for caregivers. Bootstrap simulations were performed to obtain the ICER estimate.ResultsIn total, 321 patients (162 in intervention group, 159 in control group) and 235 caregivers (126 in intervention group, 109 in control group) completed the study. The intervention resulted in significantly higher QALYs for patients when compared to usual care (p-value = 0.026), while being more expensive as well. In the 6 months observation period, the average incremental cost of intervention compared to usual care was €2015 per patient (p value < 0.000). The mean incremental gain was 0.01678 QALY (p-value = 0.026). Thereby, the ICER was €118,292/QALY when adjusting for baseline costs and quality of life. For the caregivers, we found no significant differences in QALYs between the intervention and control group (p-value = 0.630). At a willingness to pay of €80,000 per QALY, the probability that the intervention is cost-effective lies at 15% in the base case scenario.ConclusionThis model of fast-track SPC enriched with a psychological intervention yields better QALYs than usual care with a large increase in costs.Trial registrationThe trial was prospectively registered 25.6.2013. Clinicaltrials.gov Identifier: NCT01885637 .

Project description:IntroductionOver the last decades, patient-reported outcome (PRO) measures have been developed to better understand the patient's perspective and enable patient-centred care. In palliative care, the Integrated Palliative care Outcome Scale (IPOS) is recommended as a PRO tool. Its implementation in specialised palliative home care (SPHC) would benefit from an electronic version validated for the setting.Following the Medical Research Council (MRC) guidance, the study Palli-MONITOR is developing (phase 1) and testing the feasibility (phase 2) of implementing the electronic version of IPOS (eIPOS) in the SPHC setting to inform a cluster-randomised phase 3 trial.Methods and analysisPalli-MONITOR is a multicentre, sequential mixed-methods, two-phase development and feasibility study. The study consists of four substudies. In phase 1 (MRC development phase), qualitative patient interviews and focus groups with SPHC professionals are used to identify barriers and facilitators of eIPOS (substudy I). Substudy II tests the equivalence of eIPOS and IPOS in a crossover randomised controlled trial. Phase 2 (MRC feasibility/piloting phase) includes a quasi-experimental study with two control groups (substudy III), and qualitative interviews as well as focus groups to explore the feasibility and acceptability of the developed intervention (substudy IV).Qualitative data will be analysed with thematic analysis following the framework approach. Quantitative analysis uses a two-way intraclass correlation coefficients model for the equivalence testing. Quantitative analysis of the quasi-experimental study will focus on the primary outcomes, recruitment rates and completeness of eIPOS. Secondary outcomes will include intraindividual change in palliative symptoms and concerns, quality of life and symptom burden.Ethics and disseminationApproval of the ethics committee of the Ludwig Maximilian University Munich was received for all study parts. Results and experiences will be presented at congresses and in written form. Additionally, participating SPHC teams will receive summarised results.Trial registration numberNCT03879668.

Project description:BackgroundSpecialist palliative home care (SPHC) aims to maintain and improve patients' quality of life in the community setting. Symptom burden may differ between oncological and non-oncological patients. However, little is known about diagnosis-related differences of SPHC patients. This study aims to describe the prevalence of physical symptom burden and psychosocial problems of adult patients in SPHC, and to evaluate diagnosis-related symptom clusters.MethodsSecondary analysis of data from a prospective, cross-sectional, multi-centre study on complexity of patients, registered at the German Register for Clinical Studies (DRKS trial registration number: DRKS00020517, 12/10/2020). Descriptive statistics on physical symptom burden and psychosocial problems at the beginning of care episodes. Exploratory and confirmatory factor analyses to identify symptom and problem clusters.ResultsSeven hundred seventy-eight episodes from nine SPHC teams were included, average age was 75 years, mean duration of episode 18.6 days (SD 19.4). 212/778 (27.2%) had a non-oncological diagnosis. Main burden in non-oncological episodes was due to poor mobility (194/211; 91.9%) with significant diagnosis-related differences (χ² = 8.145, df = 1, p = .004; oncological: 472/562; 84.0%), and due to weakness (522/565; 92.4%) in oncological episodes. Two symptom clusters (psychosocial and physical) for non-oncological and three clusters (psychosocial, physical and communicational/practical) for oncological groups were identified. More patients in the non-oncological group compared to the oncological group showed at least one symptom cluster (83/212; 39.2% vs. 172/566; 30.4%).ConclusionPatients with non-oncological diseases had shorter episode durations and were more affected by symptom clusters, whereas patients with oncological diseases showed an additional communicational/practical cluster. Our findings indicate the high relevance of care planning as an important part of SPHC to facilitate anticipatory symptom control in both groups.

Project description:BACKGROUND:The work of specialized palliative care (SPC) teams is often challenged by substantial amounts of time spent driving to and from patients' homes and long distances between the patients and the hospitals. OBJECTIVE:Video consultations may be a solution for real-time SPC at home. The aim of this study was to explore the use of video consultations, experienced by patients and their relatives, as part of SPC at home. METHODS:This explorative and qualitative study included palliative care patients in different stages and relatives to use video consultations as a part of their SPC between October 2016 and March 2017. Data collection took place in the patients' homes and consisted of participant observations followed by semistructured interviews. Inclusion criteria consisted of patients with the need for SPC, aged more than 18 years, who agreed to participate, and relatives wanting to participate in the video consultations. Data were analyzed with Giorgi's descriptive phenomenological methodology. RESULTS:A number of patients (n=11) and relatives (n=3) were included and, in total, 86 video consultations were conducted. Patients participating varied in time from 1 month to 6 months, and the number of video consultations per patient varied from 3 to 18. The use of video consultations led to a situation where patients, despite life-threatening illnesses and technical difficulties, took an active role. In addition, relatives were able to join on equal terms, which increased active involvement. The patients had different opinions on when to initiate the use of video consultations in SPC; it was experienced as optional at the initiating stage as well as the final stage of illness. If the video consultations included multiple participants from the SPC team, the use of video consultations could be difficult to complete without interruptions. CONCLUSIONS:Video consultations in SPC for home-based patients are feasible and facilitate a strengthened involvement and communication between patients, relatives, and SPC team members.

Project description: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.

Project description:BackgroundResearch studies demonstrate that palliative care can improve patient outcomes such as quality of life, symptom burden and patient satisfaction with care (Gomes B, et al. Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database Syst Rev. 2013(6):CD00776) (World Health Organization. Palliative Care. Published 2020.). While 76% of patients who need palliative care live in limited-resource countries, access to high quality palliative services in these countries is minimal (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care (2nd ed). 2020.). In 2014 the Worldwide Hospice Palliative Care Alliance, with strong endorsement by the WHO, released the Palliative Care Toolkit to provide a training and implementation toolkit for empowering community members to deliver palliative care in resource poor settings (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care at the End of Life. Geneva, Switzerland 2014.). They encouraged researchers and public health practitioners to conduct rigorous evaluation of the toolkit in diverse settings and contexts. To address this need, we will conduct a pilot randomized controlled trial (RCT) to examine implementation and explore potential effect of an intervention based upon the Palliative Care Toolkit, as adapted and used by community health workers (CHWs) working with a cancer center in Kolkata, India to deliver home-based palliative care for rural patients.MethodsUtilizing a randomized controlled trial design, intervention patients (n = 45) receive home-based palliative services (Pal-Care) delivered by community health workers (CHWs), with comparison against a control group of patients (n = 45) who receive usual cancer-center-based palliative services. Primary outcome measures include evaluation of CHW training outcomes, roles and responsibilities of the CHWS and how they assist patients, trial recruitment, stakeholder perceptions of the intervention, and fidelity to study protocol. Secondary outcomes measure patient self-report of health-related quality of life, symptom burden, palliative needs and patient care experience, outcomes The RE-AIM framework guides our evaluation plan to measure the reach, effectiveness, adoption, implementation and maintenance of the Pal-Care intervention (Gaglio B, et al. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013;103(6):e38?46.). Data will be analyzed in SAS. All measures will be evaluated overall and by patient age, gender and cancer type and by CHW caseload.DiscussionPal-Care is a RCT funded by the NCI to explore utilization of CHWs to deliver a home-based palliative care intervention built upon the WHO Palliative Care toolkit (PCT), as compared to a usual care control group. The long-term goal of this research is to develop an effective and sustainable model for delivering home-based palliative care for cancer patients in underserved areas.Trial registration (trn)ClinicalTrials.gov ID# NCT04972630.

Project description:BackgroundIntegration of symptom and palliative care for people with advanced cancer is established in many tumour types, but its role in people with hepatocellular carcinoma (HCC) has not been clearly defined. This study aims to evaluate the clinical and cost effectiveness of an intervention involving a suite of strategies designed to assess and treat palliative care symptoms and needs in adult outpatients with HCC attending four New South Wales (NSW) metropolitan tertiary hospitals.MethodsThis trial will use a pragmatic cluster-based randomised-controlled design, with ambulatory HCC services as the clusters. HCC patients will be recruited if they have Barcelona Clinical Liver Cancer (BCLC) stage A disease with active tumour or a current or prior diagnosis of BCLC stage B or C disease regardless of tumour activity. Patients with BCLC stage D disease will be excluded as palliative care is the standard of care (SOC) in this group. Cluster sites will be randomised to the study intervention or control where patients are managed according to SOC. All participants will complete the liver-specific Edmonton Symptom Assessment Scale (ESAS) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at regular ambulatory clinic appointments. At intervention sites, patients scoring ≥ 5 on any liver-specific ESAS symptom will be referred to palliative care physicians for consultation. The primary clinical outcome will be improvement in all symptoms scored ≥ 5 on the liver-specific ESAS by 50% within 3 months and the primary implementation outcome will recording the liver-specific ESAS in ≥ 80% of all participants attending clinic appointments. Caregivers of patients enrolled in the trial will be invited to perform Carer Support Needs Assessment Tool at each appointment.DiscussionThis trial will inform if earlier palliative care involvement significantly reduces the symptom burden associated with HCC. If found to be effective, earlier implementation of palliative care consultation should be included in HCC treatment guidelines.Trial registrationACTRN12623000010695. Registered on September 1, 2023.

Dataset Information

The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home.

Background

Methods/design

Discussion

Trial registration

Publications

The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets