Dataset Information

A randomised controlled trial of an advance care planning intervention for patients with incurable cancer.

ABSTRACT:

Background

We modified and evaluated an advance care planning (ACP) intervention, which had been shown to improve compliance with patient's end of life (EoL) wishes, in a different patient population.

Methods

Patients with incurable cancer, and a Family Member (FM), were randomised one-to-one to usual care or usual care plus an ACP intervention, between April 2014 and January 2017. Oncologists and participants were non-blinded. ACP was based on the Respecting Patient Choices model, with an offer to provide individualised ranges for typical, best-case and worst-case scenarios for survival time. Seven facilitators (two oncology nurses, two nurses and three allied health professionals) delivered the intervention within 2 weeks of study enrolment. The primary outcome measure, assessed by interviewing the FM 3 months after patient death, was the FM perception that the patient's wishes were discussed, and met.

Results

Six hundred and sixty-five patients from seven Australian metropolitan oncology centres were referred for consideration by their oncologists, 444 (67%) met the study inclusion criteria and were approached by a study researcher. Two hundred and eight patients (47%) and their FM entered the trial as dyads. Fifty-three (46%) dyads in the ACP group and 63 (54%) dyads in the usual-care group had complete primary outcome data (p?=?0.16). Seventy-nine patients and 53 FMs attended an ACP discussion. Mean length of discussion was 57?min. FMs from 23 (43%) dyads allocated to ACP and 21 (33%) dyads allocated usual care reported the patient's EoL wishes were discussed and met (difference 10%, 95% CI: -2 to 8, p?=?0.27). There were no differences in EoL care received, patient satisfaction with care; FM satisfaction with care or with death; or FM well being. Rates of palliative care referral were high in both groups (97% vs 96%).

Conclusions

A formal ACP intervention did not increase the likelihood that EoL care was consistent with patients' preferences.

SUBMITTER: Johnson SB

PROVIDER: S-EPMC6251033 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Publications

A randomised controlled trial of an advance care planning intervention for patients with incurable cancer.

Johnson Stephanie B SB Butow Phyllis N PN Bell Melanie L ML Detering Karen K Clayton Josephine M JM Silvester William W Kiely Belinda E BE Clarke Stephen S Vaccaro Lisa L Stockler Martin R MR Beale Phillip P Fitzgerald Natalie N Tattersall Martin H N MHN

British journal of cancer 20181029 10

<h4>Background</h4>We modified and evaluated an advance care planning (ACP) intervention, which had been shown to improve compliance with patient's end of life (EoL) wishes, in a different patient population.<h4>Methods</h4>Patients with incurable cancer, and a Family Member (FM), were randomised one-to-one to usual care or usual care plus an ACP intervention, between April 2014 and January 2017. Oncologists and participants were non-blinded. ACP was based on the Respecting Patient Choices model ...[more]

PMID: 30369600

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Project description:BackgroundTo 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.MethodsIn 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.DiscussionAugmentation 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 registrationClinicalTrials.gov Identifier: NCT03387436 (Date of registration: 01/02/2018, retrospectively registered.

Project description:ObjectiveTo evaluate the effect of a video decision support tool on the preferences for future medical care in older people if they develop advanced dementia, and the stability of those preferences after six weeks.DesignRandomised controlled trial conducted between 1 September 2007 and 30 May 2008. Setting Four primary care clinics (two geriatric and two adult medicine) affiliated with three academic medical centres in Boston.ParticipantsConvenience sample of 200 older people (>or=65 years) living in the community with previously scheduled appointments at one of the clinics. Mean age was 75 and 58% were women.InterventionVerbal narrative alone (n=106) or with a video decision support tool (n=94).Main outcome measuresPreferred goal of care: life prolonging care (cardiopulmonary resuscitation, mechanical ventilation), limited care (admission to hospital, antibiotics, but not cardiopulmonary resuscitation), or comfort care (treatment only to relieve symptoms). Preferences after six weeks. The principal category for analysis was the difference in proportions of participants in each group who preferred comfort care.ResultsAmong participants receiving the verbal narrative alone, 68 (64%) chose comfort care, 20 (19%) chose limited care, 15 (14%) chose life prolonging care, and three (3%) were uncertain. In the video group, 81 (86%) chose comfort care, eight (9%) chose limited care, four (4%) chose life prolonging care, and one (1%) was uncertain (chi(2)=13.0, df=3, P=0.003). Among all participants the factors associated with a greater likelihood of opting for comfort care were being a college graduate or higher, good or better health status, greater health literacy, white race, and randomisation to the video arm. In multivariable analysis, participants in the video group were more likely to prefer comfort care than those in the verbal group (adjusted odds ratio 3.9, 95% confidence interval 1.8 to 8.6). Participants were re-interviewed after six weeks. Among the 94/106 (89%) participants re-interviewed in the verbal group, 27 (29%) changed their preferences (kappa=0.35). Among the 84/94 (89%) participants re-interviewed in the video group, five (6%) changed their preferences (kappa=0.79) (P<0.001 for difference).ConclusionOlder people who view a video depiction of a patient with advanced dementia after hearing a verbal description of the condition are more likely to opt for comfort as their goal of care compared with those who solely listen to a verbal description. They also have more stable preferences over time.Trial registrationClinicaltrials.gov NCT00704886.

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:Despite positive health outcomes associated with advance care planning (ACP), little research has investigated the impact of ACP in surgical populations. Our goal is to evaluate how an ACP intervention video impacts the patient centredness and ACP of the patient-surgeon conversation during the presurgical consent visit. We hypothesise that patients who view the intervention will engage in a more patient-centred communication with their surgeons compared with patients who view a control video. METHODS AND ANALYSIS:Randomised controlled superiority trial of an ACP video with two study arms (intervention ACP video and control video) and four visits (baseline, presurgical consent, postoperative 1?week and postoperative 1?month). Surgeons, patients, principal investigator and analysts are blinded to the randomisation assignment. SETTING:Single, academic, inner city and tertiary care hospital. Data collection began July 16, 2015 and continues to March 2017. PARTICIPANTS:Patients recruited from nine surgical oncology clinics who are undergoing major cancer surgery. INTERVENTIONS:In the intervention arm, patients view a patient preparedness video developed through extensive engagement with patients, surgeons and other stakeholders. Patients randomised to the control arm viewed an informational video about the hospital surgical programme. MAIN OUTCOMES AND MEASURES:Primary Outcome: Patient centredness and ACP of patient-surgeon conversations during the presurgical consent visit as measured through the Roter Interaction Analysis System. SECONDARY OUTCOMES:patient Hospital Anxiety and Depression Scale score; patient goals of care; patient, companion and surgeon satisfaction; video helpfulness; medical decision maker designation; and the frequency patients watch the video. Intent-to-treat analysis will be used to assess the impact of video assignment on outcomes. Sensitivity analyses will assess whether there are differential effects contingent on patient or surgeon characteristics. ETHICS AND DISSEMINATION:This study has been approved by the Johns Hopkins School of Medicine institutional review board and is registered on clinicaltrials.gov (NCT02489799, First received: July 1, 2015). TRIAL REGISTRATION NUMBER:clinicaltrials.gov, NCT02489799.

Project description:BackgroundThe STADPLAN study is a cluster-randomised controlled trial including 27 home care services in Germany. It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients. Patients received two ACP conversations and an information brochure. Nurses were educated through a two-day programme and topic guides structuring the conversations. Objectives of the process evaluation were to determine: [1] whether the intervention was implemented as planned, [2] which change mechanisms were observed, [3] whether targeted process outcomes were achieved and [4] in which way contextual factors influenced the implementation process.MethodsThe process evaluation is based on a mixed methods approach following the recommendations of the UK-MRC framework for the development and evaluation of complex interventions. Qualitative and quantitative assessments were developed and analysed guided by a logic model comprising intervention, participants, mechanisms of change and context factors. The results of the main trial will be published elsewhere.ResultsEducational programme and topic guides were mostly implemented as planned and resulted in motivation, knowledge, and perceived competencies to facilitate ACP conversations in nurses. Deviances in the performance of ACP conversations indicated patients' varied individual needs, but also obstacles like reluctance of patients and caregivers to participate actively and time constraints of nurse facilitators. Patients and caregivers reported increased awareness of ACP, planning and other activities indicating that targeted process outcomes could be achieved. The relevance of multifaceted contextual factors acting as barriers or facilitators for the engagement in ACP interventions on the individual, organisational and macro level was evident.ConclusionsThe process evaluation elicits obstacles and achievements of the ACP intervention. The logic model organised a plethora of mixed methods data into a holistic picture of multifaceted results. Nurses as ACP facilitators in home care can fulfil a crucial initiating role based on a trusting relationship with their patients. To support older care-dependent people's ACP engagement, access should be simplified. Furthermore, education for nurse facilitators and sufficient resources for service provision are needed. Independent of monetary reimbursement, healthcare providers must respect patients' choice for or against any ACP intervention.Ethics and trial registrationApproved by the Ethics Committees of Martin Luther University Halle-Wittenberg (Ref.-No. 2019-045), Carl von Ossietzky University Oldenburg (Ref.-No. 2019-024), and University of Lübeck (Ref.-No. 19-080).German clinical trials registerDRKS00016886. Registered retrospectively 04/06/2019, first participant included 29/05/2019.

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: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.

Dataset Information

A randomised controlled trial of an advance care planning intervention for patients with incurable cancer.

Background

Methods

Results

Conclusions

Publications

A randomised controlled trial of an advance care planning intervention for patients with incurable cancer.

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