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Collaborative advance care planning in advanced cancer patients: col-ACP -study - study protocol of a randomised controlled trial.

ABSTRACT: BACKGROUND:To assure patient-centred end-of-life care, palliative interventions need to account for patients' preferences. Advance care planning (ACP) is a structured approach that allows patients, relatives and physicians to discuss end-of-life decisions. Although ACP can improve several patient related outcomes, the implementation of ACP remains difficult. The col-ACP-study (collaborative advance care planning) will investigate a new ACP procedure (col-ACP-intervention (German: Hand-in-Hand Intervention)) in palliative cancer patients and their relatives that addresses individual values and targets barriers of communication before an ACP process. METHODS:In a randomised controlled trial, 270 cancer patients without curative treatment options and their relatives will receive either 1) col-ACP 2) a supportive intervention (active control group) or 3) standard medical care (TAU). col-ACP comprises two steps: a) addressing various barriers of patients and relatives that discourage them from discussing end-of-life issues followed by b) a regular, structured ACP procedure. The col-ACP-intervention consists of 6 sessions. Primary endpoint is the patients' quality of life 16?weeks after randomisation. Secondary endpoints include measurements of distress; depression; communication barriers; caregivers' quality of life; existence of ACP or advance directives; the consistence of end of life care; and others. Patients will be followed up for 13?months. Multivariate analyses will be carried out. Qualitative evaluation of the intervention will be conducted. DISCUSSION:Augmentation of a regular ACP program by a structured psycho-oncological intervention is an innovative approach to target barriers of communication about end-of-life issues. Study findings will help to understand the value of such a combined intervention in palliative care. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03387436 (Date of registration: 01/02/2018, retrospectively registered.

SUBMITTER: Seifart C

PROVIDER: S-EPMC7445911 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Collaborative advance care planning in advanced cancer patients: col-ACP -study - study protocol of a randomised controlled trial.

Seifart Carola C Koch Martin M Leppin Nico N Nagelschmidt Katharina K Knorrenschild Jorge Riera JR Timmesfeld Nina N Rief Winfried W von Blanckenburg Pia P

BMC palliative care 20200824 1

<h4>Background</h4>To assure patient-centred end-of-life care, palliative interventions need to account for patients' preferences. Advance care planning (ACP) is a structured approach that allows patients, relatives and physicians to discuss end-of-life decisions. Although ACP can improve several patient related outcomes, the implementation of ACP remains difficult. The col-ACP-study (collaborative advance care planning) will investigate a new ACP procedure (col-ACP-intervention (German: Hand-in ...[more]

PMID: 32838763

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Project description:BACKGROUND:Research has highlighted the need for improving the implementation of advance care planning (ACP) in nursing homes. We developed a theory-based multicomponent ACP intervention (the ACP+ programme) aimed at supporting nursing home staff with the implementation of ACP into routine nursing home care. We describe here the protocol of a cluster randomised controlled trial (RCT) that aims to evaluate the effects of ACP+ on nursing home staff and volunteer level outcomes and its underlying processes of change. METHODS:We will conduct a cluster RCT in Flanders, Belgium. Fourteen eligible nursing homes will be pair-matched and one from each pair will be randomised to either continue care and education as usual or to receive the ACP+ programme (a multicomponent programme which is delivered stepwise over an eight-month period with the help of an external trainer). Primary outcomes are: nursing home care staff's knowledge of, and self-efficacy regarding ACP. Secondary outcomes are: 1) nursing home care staff's attitudes towards ACP and ACP practices; 2) support staff's and volunteer's ACP practices and 3) support staff's and volunteers' self-efficacy. Measurements will be performed at baseline and eight months post-measurement, using structured self-reported questionnaires. A process evaluation will accompany the outcome evaluation in the intervention group, with measurements throughout and post-intervention to assess implementation, mechanisms of impact and context and will be carried out using a mixed-methods design. DISCUSSION:There is little high-quality evidence regarding the effectiveness and underlying processes of change of ACP in nursing homes. This combined outcome and process evaluation of the ACP+ programme aims to contribute to building the necessary evidence to improve ACP and its uptake for nursing home residents and their family. TRIAL REGISTRATION:The study is registered at ClinicalTrials.gov (no. NCT03521206). Registration date: May 10, 2018. Inclusion of nursing homes started March, 2018. Hence, the trial was retrospectively registered but before end of data collection and analyses.

Project description:INTRODUCTION:It is unclear whether advance care planning (ACP) undertaken with patients living in the community can improve patient care and avoid unwanted interventions and hospital admissions. We have designed a randomised controlled trial (RCT) to examine if ACP undertaken with patients with advanced illnesses attending hospital outpatient clinics can reduce unplanned hospital admissions and improve patient and caregiver well-being. METHODS AND ANALYSIS:Pragmatic RCT involving patients from subspecialty outpatient clinics at five clinical sites in Sydney, Australia. Participants will be ≥18 years screened as potentially having palliative care needs and at risk of dying in 6-12 months. The patients will be randomised to intervention or control group. Intervention group will undertake ACP discussions facilitated by a trained health professional. The control group will receive written information on ACP, representing the current standard of care. The primary outcome is the number of unplanned hospital admissions at the 6-month follow-up. Secondary outcomes include: (i) patient's health-related quality-of-life and quality of chronic disease care; (ii) caregiver's health-related quality-of-life and caregiver burden and (iii) other health outcomes including ambulance usage, emergency department presentations, hospital admissions, resuscitation attempts, intensive care unit admissions, deaths, documentation of patient wishes in patient records and audit of ACP discussions and documents. The staff's self-reported attitudes and knowledge of ACP will also be measured. The data will be collected using self-report questionnaires, hospital records audit, audit of ACP documentation and data linkage analysis. Semistructured interviews and focus group discussions with patients, caregivers and healthcare professionals will explore the acceptability and feasibility of the intervention. ETHICS AND DISSEMINATION:Approved by South-East Sydney Local Health District Human Research Ethics Committee and NSW Population and Health Services Research Ethics Committee. Results will be disseminated via conference presentations, journal publications, seminars and invited talks. TRIAL REGISTRATION NUMBER:ACTRN12617000280303.

Project description:BackgroundAdvance care planning (ACP) supports individuals to define, discuss, and record goals and preferences for future medical treatment and care. Despite being internationally recommended, randomised clinical trials of ACP in patients with advanced cancer are scarce.Methods and findingsTo test the implementation of ACP in patients with advanced cancer, we conducted a cluster-randomised trial in 23 hospitals across Belgium, Denmark, Italy, Netherlands, Slovenia, and United Kingdom in 2015-2018. Patients with advanced lung (stage III/IV) or colorectal (stage IV) cancer, WHO performance status 0-3, and at least 3 months life expectancy were eligible. The ACTION Respecting Choices ACP intervention as offered to patients in the intervention arm included scripted ACP conversations between patients, family members, and certified facilitators; standardised leaflets; and standardised advance directives. Control patients received care as usual. Main outcome measures were quality of life (operationalised as European Organisation for Research and Treatment of Cancer [EORTC] emotional functioning) and symptoms. Secondary outcomes were coping, patient satisfaction, shared decision-making, patient involvement in decision-making, inclusion of advance directives (ADs) in hospital files, and use of hospital care. In all, 1,117 patients were included (442 intervention; 675 control), and 809 (72%) completed the 12-week questionnaire. Patients' age ranged from 18 to 91 years, with a mean of 66; 39% were female. The mean number of ACP conversations per patient was 1.3. Fidelity was 86%. Sixteen percent of patients found ACP conversations distressing. Mean change in patients' quality of life did not differ between intervention and control groups (T-score -1.8 versus -0.8, p = 0.59), nor did changes in symptoms, coping, patient satisfaction, and shared decision-making. Specialist palliative care (37% versus 27%, p = 0.002) and AD inclusion in hospital files (10% versus 3%, p < 0.001) were more likely in the intervention group. A key limitation of the study is that recruitment rates were lower in intervention than in control hospitals.ConclusionsOur results show that quality of life effects were not different between patients who had ACP conversations and those who received usual care. The increased use of specialist palliative care and AD inclusion in hospital files of intervention patients is meaningful and requires further study. Our findings suggest that alternative approaches to support patient-centred end-of-life care in this population are needed.Trial registrationISRCTN registry ISRCTN63110516.

Project description:INTRODUCTION:Patients with multimorbidity plus additional impairments (eg, mobility limitations, disability, cognitive impairments or frailty) are at the highest risk for poor healthcare outcomes. Advanced care planning (ACP) provides patients and their surrogates the opportunity to discuss their goals, values and priorities for healthcare-particularly in the context of end-of-life care. ACP discussions promote more person-centred care; however, it is currently underused. There is a tremendous need for systematic, scalable approaches to individualised ACP that promotes patient and family engagement. Here we describe the study protocol for a randomised effectiveness trial of a nurse navigator and informatics intervention designed to improve the documentation and quality of ACP discussions. METHODS AND ANALYSIS:This is a randomised, pragmatic, effectiveness trial; patients aged 65 years and older who have multimorbidity plus impairments in either physical function (eg, mobility limitations or disability) or cognition, and/or frailty within an affiliated Accountable Care Organization were eligible. The electronic health record was used to develop an automatic prescreening system for eligible patients (n=765) and participants were randomised in a 1:1 ratio to either the nurse navigator-led ACP pathway or usual care. Our primary outcomes are documentation of ACP discussions within the EHR along with the quality of ACP discussions. Secondary outcomes include a broad range of ACP actions (eg, usage of ACP billing codes, choosing a surrogate decision-maker and advance directive documentation). Outcomes will be measured over 12 months of follow-up. ETHICS AND DISSEMINATION:This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards. The results of this study will inform a scalable solution to ACP discussions throughout our healthcare system and statewide. TRIALS REGISTRATION NUMBER:NCT03609658.

Project description:BackgroundAdvance Care Planning (ACP) helps people discuss personal values, goals and priorities regarding future care with family and professionals. It can support care coordination and guide decision-making as health deteriorates. However, uptake remains low internationally. Poor communication and information due to Covid-19 pressures exacerbated public and professional criticism and concerns. Recent recommendations highlight the importance of understanding and addressing public perceptions about ACP combined with person-centred approaches to ACP conversations.ObjectivesTo explore public perceptions of ACP to inform increased public engagement and empowerment.MethodsJoanna Briggs Institute methodology was applied in a rapid scoping review. Three databases (Embase, MEDLINE, APA PsycInfo) were searched for English language reviews and primary or secondary research studies from 2015 to 2021. Following title and abstract review, two researchers screened full-text articles and performed data extraction independently using Covidence. Charted data were analysed for themes and subthemes starting with two recent published reviews. Emerging findings were added and data synthesis reviewed by the research team, including public-patient representatives, to achieve consensus.ResultsOf 336 studies, 20 included reviews and research papers represented diverse public views, situations and contexts. Studies found poor public knowledge of ACP and widespread perceptions of confusing or accessible information. Multiple reports described little personal relevance, perceived risks of emotional distress, fears, mistrust and misconceptions about the purpose and scope of ACP. Studies identified public concerns stemming from reluctance to discuss death and dying despite this being just one aspect of ACP. Research with minority communities and marginalised groups found intensified concerns. Some studies cited people who valued maintaining autonomy by expressing their goals and preferences.ConclusionsStudies reviewed found many members of the public had negative or unclear perceptions of ACP. Improved knowledge and understanding appeared to influence perceptions of ACP but were not considered sufficient to change behaviours. The research provided valuable insights from members of the public that could inform current professional and societal debates about the future of ACP. Findings point to a need for novel approaches to ACP public information and involvement whilst bearing in mind societal norms, diverse cultures and contexts.

Project description:BACKGROUND:While various initiatives have been taken to improve advance care planning in nursing homes, it is difficult to find enough details about interventions to allow comparison, replication and translation into practice. OBJECTIVES:We report on the development and description of the ACP+ program, a multi-component theory-based program that aims to implement advance care planning into routine nursing home care. We aimed to 1) specify how intervention components can be delivered; 2) evaluate the feasibility and acceptability of the program; 3) describe the final program in a standardized manner. DESIGN:To develop and model the intervention, we applied multiple study methods including a literature review, expert discussions and individual and group interviews with nursing home staff and management. We recruited participants through convenience sampling. SETTING AND PARTICIPANTS:Management and staff (n = 17) from five nursing homes in Flanders (Belgium), a multidisciplinary expert group and a palliative care nurse-trainer. METHODS:The work was carried out by means of 1) operationalization of key intervention components-identified as part of a previously developed theory on how advance care planning is expected to lead to its desired outcomes in nursing homes-into specific activities and materials, through expert discussions and review of existing advance care planning programs; 2) evaluation of feasibility and acceptability of the program through interviews with nursing home management and staff and expert revisions; and 3) standardized description of the final program according to the TIDieR checklist. During step 2, we used thematic analysis. RESULTS:The original program with nine key components was expanded to include ten intervention components, 22 activities and 17 materials to support delivery into routine nursing home care. The final ACP+ program includes ongoing training and coaching, management engagement, different roles and responsibilities in organizing advance care planning, conversations, documentation and information transfer, integration of advance care planning into multidisciplinary meetings, auditing, and tailoring to the specific setting. These components are to be implemented stepwise throughout an intervention period. The program involves the entire nursing home workforce. The support of an external trainer decreases as nursing home staff become more autonomous in organizing advance care planning. CONCLUSIONS:The multicomponent ACP+ program involves residents, family, and the different groups of people working in the nursing home. It is deemed feasible and acceptable by nursing home staff and management. The findings presented in this paper, alongside results of the subsequent randomized controlled cluster trial, can facilitate comparison, replicability and translation of the intervention into practice.

Project description:BackgroundBenefits of advance care planning (ACP) have recently been questioned by experts, but ACP is comprised of discrete activities. Little is known about which, if any, ACP activities are associated with patients' greater likelihood of receiving value-concordant end-of-life (EoL) care.ObjectivesTo determine which ACP activities [Do-Not-Resuscitate (DNR) order completion, designation of a healthcare proxy (HCP), and/or EoL discussions with physicians], individually and in combination, are associated with the greatest likelihood of receiving value-concordant care, and how results may vary based on patient-reported EoL care priorities.MethodsData from 2 federally-funded, multisite, prospective cohort studies of EoL cancer care from 2002-2019 were analyzed. Cancer patients (N = 278) with metastatic disease refractory to chemotherapy were interviewed for a baseline assessment and followed prospectively until death. Interviews regarding patient priorities occurred a median of 111 days prior to death; data regarding EoL medical care were collected post-mortem from caregiver interviews and medical record abstraction. Patients who 1) prioritized life-extending care, and then received life-extending care (or avoided hospice care), or 2) prioritized comfort-focused care, and then avoided life-extending care (or received hospice care) in the last week of life, were coded as receiving value-concordant care.ResultsAfter inverse propensity score weighting, the ACP combination associated with the largest proportion of patients receiving value-concordant care was DNR, HCP, and EoL discussions (87% vs. 64% for no ACP activities; OR = 3.91, p = 0.006). In weighted analyses examining each ACP activity individually, DNR orders were associated with decreased likelihood of life-extending care (89% vs. 75%; p = 0.005) and EoL discussions were associated with increased likelihood of hospice care (77% vs. 55%; p = 0.002) among patients prioritizing comfort. ACP activities were not significantly associated with increased likelihood of receiving value-concordant care among patients prioritizing life-extension.Conclusions and relevanceFor patients who prioritize comfort, EoL discussions with physicians and completion of DNR orders may improve odds of receiving value-concordant EoL care. For patients who prioritize life-extension, ACP does not appear to improve odds of receiving value-concordant EoL care.

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Collaborative advance care planning in advanced cancer patients: col-ACP -study - study protocol of a randomised controlled trial.

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Collaborative advance care planning in advanced cancer patients: col-ACP -study - study protocol of a randomised controlled trial.

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