Background: Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers. Families are rarely prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options especially during the end stage. West Virginia (WV) has the highest rate of HF deaths in the U.S. where 14% of the population over 65 years have HF. Thus, there is a need to investigate a new family EOLPC intervention (FamPALcare), where nurses coach family-managed advanced HF care at home.
Methods: This study uses a randomized controlled trial (RCT) design stratified by gender to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care group outcomes (N = 72). Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF. Aim 2 is to assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials. Intervention group will receive routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. The intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions based on patients’ preferences. Data are collected at baseline, 3, and 6 months. Recruitment is from sites affiliated with a large regional hospital in WV and community centers across the state.
Discussion: The outcomes of this clinical trial will result in new knowledge on coaching techniques for EOLPC and approaches to palliative and end-of-life rural home care. The HF population in WV will benefit from a reduction in suffering from the most common advanced HF symptoms, selecting their preferred EOLPC care options, determining their advance directives, and increasing skills and resources for advanced HF home care. The study will provide a long-term collaboration with rural community leaders, and collection of data on the implementation and research procedures for a subsequent large multi-site clinical trial of the FamPALcare intervention. Multidisciplinary students have opportunity to engage in the research process.
BJECTIVES: Older people approaching end of life are commonly prescribed multiple medications, many of which may be inappropriate or futile. Our objective was to examine the effect of applying the STOPPFrail, a recently developed deprescribing tool, to the medication regimens of older patients with advanced frailty.
DESIGN: Randomized controlled trial.
SETTING: Two acute hospitals in Ireland.
PARTICIPANTS: Adults 75 years or older (n = 130) with advanced frailty and polypharmacy (five or more drugs), transferring to long-term nursing home care.
INTERVENTION: A STOPPFrail-guided deprescribing plan was presented to attending physicians who judged whether or not to implement recommended medication changes.
MEASUREMENTS: The primary outcome was the change in the number of regular medications at 3 months. Secondary outcomes included unscheduled hospital presentations, falls, quality of life, monthly medication costs, and mortality.
RESULTS: Intervention (n = 65) and control group (n = 65) participants were prescribed a mean (plus or minus standard deviation [SD]) of 11.5 (±3.0) and 10.9 (±3.5) medications, respectively, at baseline. The mean (SD) change in the number of medications at 3 months was -2.6 (±2.73) in the intervention group and -.36 (±2.60) in the control group (mean difference = 2.25 ± .54; 95% confidence interval [CI] = 1.18-3.32; P < .001). The mean change in monthly medication cost was –$74.97 (±$148.32) in the intervention group and –$13.22 (±$110.40) in the control group (mean difference $61.74 ± $26.60; 95% CI = 8.95-114.53; P = .02). No significant differences were found between groups for any of the other secondary outcomes.
CONCLUSION: STOPPFrail-guided deprescribing significantly reduced polypharmacy and medication costs in frail older people. No significant differences between groups were observed with regard to falls, hospital presentations, quality of life, and mortality, although the trial was likely underpowered to detect differences in these outcomes.
Chronic obstructive pulmonary disease (COPD) is common chronic respiratory disorder, predominantly caused by exposure to cigarette smoke or biomass fuels, and it usually affects older adults. Dyspnea in COPD that is unresponsive to traditional management is a challenging disease complication for both the patient and the health care professional. Off-label use of opioids has been advocated as a pharmacotherapy strategy for refractory dyspnea. However, negative respiratory outcomes are a potential concern with opioids drugs, especially among individuals with COPD. In this review, randomized controlled trials evaluating opioid efficacy among individuals with COPD are reviewed and critically analyzed, and data from observational drug safety studies is also presented. In summary, the evidence in support of using opioids for refractory dyspnea in COPD is minimal and weak, and there is mounting data demonstrating that opioids are associated with increased respiratory-related morbidity and mortality in this population. Therefore, current evidence does not support the broad application of opioids for refractory dyspnea among individuals with COPD. However, there may be subsets of individuals that experience modest improvement in dyspnea with opioids, and better understanding predictors and mechanisms of such opioid responsiveness should be a focus of future research endeavours.
Context: Advance care planning (ACP) in a healthy general population could improve the quality of care when a health problem arises.
Objectives: The purpose of this study was to evaluate the efficacy of video decision-support aid in increasing the intention to document ACP in the general, healthy population.
Methods: In this randomized controlled trial, we enrolled 250 members of the general population (aged =20 years and determined to be healthy), stratified by age and sex. The intervention was a video that provided information about ACP and end-of-life care options such as CPR and palliative care. An attention-control arm was given a booklet about advance directives. Primary outcome was a change in intention to document ACP. Secondary outcomes included the intention to refuse CPR at terminal status, CPR and palliative care knowledge score, and the Hospital Anxiety and Depression Scale (HADS).
Results: 250 participants were randomly assigned, half to the video-assisted intervention group and half to the attention-control group. Within 1 week post-intervention, the intention to document ACP was significantly higher in the video-assisted intervention arm (68.0% vs 39.2%; p < 0.001) and changes in the intention to document ACP were significantly greater in the video group than in the brochure group (p = 0.008; = 14.4%). Palliative care knowledge score was also significantly increased in the video group (p = 0.036).
Conclusion: A well-constructed, video decision support intervention can increase the intention to document ACP in the general population that presumably had little opportunity to discuss ACP with physicians.
Objectives: A randomized control trial (RCT) to estimate the effect of an interventional video on improving palliative care knowledge, acceptability and attendance to outpatient services in gynecologic oncology patients.
Methods: Women receiving treatment for gynecologic malignancy recruited at an academic tertiary care center were randomized to: palliative care educational video or non-directive cancer center video. The primary outcome was referral to palliative care. Function and knowledge were assessed using the Functional Assessment of Cancer Therapy and the Palliative Care Knowledge Scale. Data analyses were performed using t-tests, Wilcoxon rank sum or Fisher's exact tests with significance level of a = 0.05.
Results: 111 women were enrolled. Demographic characteristics were equally distributed between groups with respect to age, race, cancer, and stage. There was no statistical difference in knowledge scores or in referral to palliative care between the patients that watched the educational versus control video (29% vs. 27%; p = .79). Secondary analysis showed a statistically significant increase in utilization of palliative care services compared to historic institutional data (8.8% to 31.5%; p =.001). Further, those referred had significantly worse baseline functional scores.
Conclusions: Use of a palliative care educational video did not increase knowledge or acceptability of palliative services within this RCT. However, the rate of patients referred to palliative care tripled compared to historic rates. Further studies should investigate whether discussion regarding palliative care services alone may increase desire for referral, and if use of Fact-G scores may identify patients in greatest need of services.
BACKGROUND: Although patients often prefer less rather than more treatment at the end of life, in the absence of contrary instructions, the medical profession's de facto position is to treat aggressively. It is unknown whether a computer-based decision aid can affect treatment choices.
METHODS: Secondary analysis of a single-center, single-blind randomized controlled trial of an advance care planning (ACP) intervention among 200 patients with stage IV cancer. Participants were randomized to intervention (Making Your Wishes Known, a values-neutral, educational, computer-based decision aid) or control (standard living will + brochure). After reading a hypothetical clinical vignette, participants were asked whether they would want 11 medical/surgical treatments in that situation (dialysis, cardiopulmonary resuscitation [CPR], ventilator, feeding tube, etc). The median number of treatments wanted by participants was compared between groups, and logistic regression was used to compare between-group likelihood of not wanting each specific treatment.
RESULTS: The median number of treatments wanted was 1 in the intervention group versus 5 in the control (P < .001). For 6 of 11 treatments, the intervention group was significantly less likely than control to want aggressive treatment. Most notably, compared to control, intervention participants were less likely to want CPR (odds ratio [OR] = 0.31), short-term mechanical ventilation (OR = 0.34), short-term dialysis (OR = 0.38), surgery (OR = 0.37), and transfusion (OR = 0.21).
CONCLUSIONS: Individuals using an educational ACP decision aid were less likely to want aggressive medical treatment than those completing standard living wills. These findings have implications not only for how to respect patient's wishes but also potentially for reducing costs at the end of life.
Background: Compulsory admission to psychiatric hospital is rising despite serious ethical concerns. Among measures to reduce compulsory admissions, Psychiatric Advance Directives (PAD) are the most promising, with intensive PAD (i.e. facilitated and shared) being the most effective. The aim of the study is to experiment Psychiatric Advance Directives in France.
Methods: A multicentre randomized controlled trial and qualitative approach conducted from January 2019 to January 2021 with intent-to-treat analysis.
Setting: Seven hospitals in three French cities: Lyon, Marseille, and Paris. Research assistants meet each participant at baseline, 6 months and 12 months after inclusion for face-to-face interviews.
Participants: 400 persons with a DSM-5 diagnosis of bipolar I disorder (BP1), schizophrenia (SCZ), or schizoaffective disorders (SCZaff), compulsorily admitted to hospital within the last 12 months, with capacity to consent (MacCAT-CR), over 18 years old, and able to understand French.
Interventions: The experimental group (PAD) (expected n = 200) is invited to fill in a document describing their crisis plan and their wishes in case of loss of mental capacity. Participants meet a facilitator, who is a peer support worker specially trained to help them. They are invited to nominate a healthcare agent, and to share the document with them, as well as with their psychiatrist. The Usual Care (UC) group (expected n = 200) receives routine care.
Main outcomes and measures: The primary outcome is the rate of compulsory admissions to hospital during the 12-month follow-up. Secondary outcomes include quality of life (S-QoL18), satisfaction (CSQ8), therapeutic alliance (4-PAS), mental health symptoms (MCSI), awareness of disorders (SUMD), severity of disease (ICG), empowerment (ES), recovery (RAS), and overall costs.
Discussion: Implication of peer support workers in PAD, potential barriers of supported-decision making, methodological issues of evaluating complex interventions, evidence-based policy making, and the importance of qualitative evaluation in the context of constraint are discussed.
Trial registration: ClinicalTrials.gov identifier: NCT03630822. Registered 14th August 2018.
Background: In medical oncology settings, early specialist palliative care interventions have demonstrated improvements in patient quality of life and survival compared with usual oncologic care. However, the effect of early specialist palliative care interventions in surgical oncology settings is not well studied.
Methods: The Surgery for Cancer with Option for Palliative Care Expert (SCOPE) Trial is a single-center, prospective, single-blind, randomized controlled trial of a specialist palliative care intervention for cancer patients undergoing non-palliative surgery. It will enroll 236 patients scheduled for major abdominal operations for malignancy, who will be randomized 1:1 at enrollment to receive usual care (control arm) or specialist palliative care consultation (intervention arm). Intervention arm patients will receive consultations from a palliative care specialist (physician or nurse practitioner) preoperatively and postoperatively. The primary outcome is physical and functional wellbeing at 90 days postoperatively. Secondary outcomes are quality of life at 90 days postoperatively, posttraumatic stress disorder symptoms at 180 days postoperatively, days alive at home without an emergency room visit in the first 90 postoperative days, and overall survival at 1 year postoperatively. Participants will be followed for 3 years after surgery for exploratory analyses of their ongoing quality of life, healthcare utilization, and mortality.
Discussion: SCOPE is an ongoing randomized controlled trial evaluating specialist palliative care interventions for cancer patients undergoing non-palliative oncologic surgery. Findings from the study will inform ways to identify and improve care of surgical patients who will likely benefit from specialist palliative care services.
Trial registration: ClinicalTrials.gov Identifier: NCT03436290
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.
Informal caregivers are at risk of being overwhelmed by various sources of suffering while caring for their significant others. It is, therefore, important for caregivers to take care of themselves. In the self-care context, mindfulness has the potential to reduce caregiver suffering. We studied the effect of a single session of 20-minute mindful breathing on the perceived level of suffering, together with the changes in bispectral index score (BIS) among palliative care informal caregivers. This was a randomized controlled study conducted at the University of Malaya Medical Centre, Malaysia. Forty adult palliative care informal caregivers were recruited and randomly assigned to either 20-minute mindful breathing or 20-minute supportive listening. The changes in perceived suffering and BIS were measured preintervention and postintervention. The reduction in suffering score in the intervention group was significantly more than the control group at minute 20 (U = 124.0, n1 = n2 = 20, mean rank1 = 24.30, mean rank2 = 16.70, z = -2.095, P = .036). The reduction in BIS in the intervention group was also significantly greater than the control group at minute 20 (U = 19.5, n1 = n2 = 20, mean rank1 = 29.52, mean rank2 = 11.48, z = -4.900, P < .0001). Twenty minutes of mindful breathing was more efficacious than 20 minutes of supportive listening in the reduction in suffering among palliative care informal caregivers.
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.
Background: Dignity is a vitally important aspect of the lives of advanced cancer patients. We conducted a systematic review and meta-analysis of the effectiveness of dignity therapy in this patient population.
Methods: We searched for randomized controlled trials comparing dignity therapy versus standard care for patients with advanced cancer in five comprehensive databases (March 2019), two clinical trial registries and one gray literature database (August 2019). The quality of the studies was assessed using the risk of bias tool recommended by the Cochrane Handbook Version 5.1.0. We used GRADE approach to assess the certainty of evidence. Meta-analysis was performed with RevMan version 5.3. Outcomes of interest included anxiety, depression, dignity-related distress and quality of life (QoL).
Results: Ten trials evaluating 904 patients (control, 449; experimental, 455) were identified. Six trials included patients with different types of advanced cancer, and four trials included patients with a single advanced cancer (lung cancer [20%], breast cancer [10%], and hepatocellular carcinoma [10%]). Compared with the standard care, dignity therapy decreased the score of anxiety, depression, and dignity-related distress of the advanced cancer patients (SMD = -1.07, 95% CI: [-1.57, -0.58], p < .05; SMD = -1.31, 95% CI: [-1.92, -0.70], p < .05; MD = -7.30, 95% CI: [- 12.04, - 2.56], p < .05). In addition, no significant differences were found in the patient's QoL (p > .05).
Conclusion: Very low certainty evidence demonstrated that dignity therapy might be a promising treatment, especially in reducing anxiety and depression in advanced cancer patients.
Background: Treatment of delirium often includes haloperidol. Second-generation antipsychotics like olanzapine have emerged as an alternative with possibly fewer side effects. The aim of this multicenter, phase III, randomized clinical trial was to compare the efficacy and tolerability of olanzapine with haloperidol for the treatment of delirium in hospitalized patients with advanced cancer.
Materials and Methods: Eligible adult patients (=18 years) with advanced cancer and delirium (Delirium Rating Scale-Revised-98 [DRS-R-98] total score =17.75) were randomized 1:1 to receive either haloperidol or olanzapine (age-adjusted, titratable doses). Primary endpoint was delirium response rate (DRR), defined as number of patients with DRS-R-98 severity score <15.25 and =4.5 points reduction. Secondary endpoints included time to response (TTR), tolerability, and delirium-related distress.
Results: Between January 2011 and June 2016, 98 patients were included in the intention-to-treat analysis. DRR was 45% (95% confidence interval [CI], 31–59) for olanzapine and 57% (95% CI, 43–71) for haloperidol ( DRR -12%; odds ratio [OR], 0.61; 95% CI, 0.2–1.4; p = .23). Mean TTR was 4.5 days (95% CI, 3.2–5.9 days) for olanzapine and 2.8 days (95% CI, 1.9–3.7 days; p = .18) for haloperidol. Grade =3 treatmen-related adverse events occurred in 5 patients (10.2%) and 10 patients (20.4%) in the olanzapine and haloperidol arm, respectively. Distress rates were similar in both groups. The study was terminated early because of futility.
Conclusion: Delirium treatment with olanzapine in hospitalized patients with advanced cancer did not result in improvement of DRR or TTR compared with haloperidol. Clinical trial identification number. NCT01539733. Dutch Trial Register. NTR2559.
Implications for Practice: Guidelines recommend that pharmacological interventions for delirium treatment in adults with cancer should be limited to patients who have distressing delirium symptoms. It was suggested that atypical antipsychotics, such as olanzapine, outperform haloperidol in efficacy and safety. However, collective data comparing the efficacy and safety of typical versus atypical antipsychotics in patients with cancer are limited. If targeted and judicious use of antipsychotics is considered for the treatment of delirium in patients with advanced cancer, this study demonstrated that there was no statistically significant difference in response to haloperidol or olanzapine. Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.
BACKGROUND: Diagnosis and treatment of incurable cancer as a life-changing experience evokes difficult existential questions.
AIM: A structured reflection could improve patients' quality of life and spiritual well-being. We developed an interview model on life events and ultimate life goals and performed a randomized controlled trial to evaluate the effect thereof on quality of life and spiritual well-being.
DESIGN: The intervention group had two consultations with a spiritual counselor. The control group received care as usual. EORTC QLQ-C15-PAL and the FACIT-sp were administered at baseline and 2 and 4 months after baseline. Linear mixed model analysis was performed to test between-group differences over time.
PARTICIPANTS: Adult patients with incurable cancer and a life expectancy >=6 months were randomized in a 1:1 ratio to the intervention or control group.
RESULTS: A total of 153 patients from six different hospitals were included: 77 in the intervention group and 76 in the control group. Quality of life and spiritual well-being did not significantly change over time between groups. The experience of Meaning/Peace was found to significantly influence quality of life (beta = 0.52, adj. R(exp2) = 0.26) and satisfaction with life (beta = 0.61, adj. R(exp2) = 0.37).
CONCLUSION: Although our newly developed interview model was well perceived by patients, we were not able to demonstrate a significant difference in quality of life and spiritual well-being between groups. Future interventions by spiritual counselors aimed at improving quality of life, and spiritual well-being should focus on the provision of sources of meaning and peace.
OBJECTIVES: Advance care planning (ACP) is seldom initiated with people with dementia (PWD) and mainly focuses on medical end-of-life decisions. We studied the effects of an educational intervention for general practitioners (GPs) aimed at initiating and optimizing ACP, with a focus on discussing medical and nonmedical preferences of future care.
DESIGN: A single-blinded cluster randomized controlled trial.
SETTING AND PARTICIPANTS: In 2016, 38 Dutch GPs (all from different practices) completed the study. They recruited 140 PWD, aged = }65 years at any stage and with any type of dementia, from their practice.
METHODS: Intervention group GPs were trained in ACP, including shared decision-making and role-playing exercises. Control group GPs provided usual care. The primary outcome was ACP initiation: the proportion of PWD that had at least 1 ACP conversation documented in their medical file. Key secondary outcomes were the number of medical (ie, resuscitation, hospital admission) and nonmedical (ie, activities, social contacts) preferences discussed. At the 6-month follow-up, subjects' medical records were analyzed using random effect logistics and linear models with correction for GP clustering.
RESULTS: 38 GP clusters (19 intervention; 19 control) included 140 PWD (intervention 73; control 67). Four PWD (2.9%) dropped out on the primary and key secondary outcomes. After 6 months, intervention group GPs initiated ACP with 35 PWD (49.3%), and control group GPs initiated ACP with 9 PWD (13.9%) [odds ratio (OR) 1.99; P = .002]. Intervention group GPs discussed 0.8 more medical [95% confidence interval (CI) 0.3, 1.3; P = .003] and 1.5 more nonmedical (95% CI 0.8, 2.3; P < .001) preferences per person with dementia than control group GPs.
CONCLUSIONS AND IMPLICATIONS: Our educational intervention increased ACP initiation, and the number of nonmedical and medical preferences discussed. This intervention has the potential to better align future care of PWD with their preferences but because of the short follow-up, the GPs' long-term adoption remains unknown.
CONTEXT: Unrelieved cancer pain at the end of life interferes with achieving patient-centered goals.
OBJECTIVE: To compare effects of usual hospice care and PAINRelieveIt® on pain outcomes in patients and their lay caregivers.
METHODS: In a 5-step, stepped wedge randomized, controlled study, 234 patients (49% male, 18% Hispanic, 51% racial minorities) and 231 lay caregivers (26% male, 20% Hispanic, 54% racial minorities) completed pre/post pain measures. They received usual hospice care with intervention components that included a summary of the patient's pain data, decision support for hospice nurses, and multimedia education tailored to the patient's and lay caregiver's misconceptions about pain.
RESULTS: The intervention effect on analgesic adherence (primary outcome) was not significant. Posttest worst pain intensity was significantly higher for the experimental group, but the difference (0.70; CI=[0.12, 1.27]) was not clinically meaningful. There was nearly universal availability of prescriptions for strong opioids and adjuvant analgesics for neuropathic pain in both groups. Lay caregivers' pain misconceptions (0-5 scale) were significantly lower in the experimental group compared to the usual care group (mean difference controlling for baseline is 0.38; CI=[0.08, 0.67]; p=.01).
CONCLUSION: This RCT was a negative trial for the primary study outcomes, but positive for a secondary outcome. The trial is important for clearly demonstrating the feasibility of implementing the innovative set of interventions.
Background: Recognising dying is a key clinical skill for doctors, yet there is little training.
Aim: To assess the effectiveness of an online training resource designed to enhance medical students’ ability to recognise dying.
Design: online multicentre double-blind randomised controlled trial (NCT03360812). The training resource for the intervention group was developed from a group of expert palliative care doctors’ weightings of various signs/symptoms to recognise dying. The control group received no training.
Setting/participants: Participants were senior UK medical students. They reviewed 92 patient summaries and provided a probability of death within 72 hours (0% certain survival – 100% certain death) pre, post, and 2 weeks after the training. Primary outcome: (1) Mean Absolute Difference (MAD) score between participants’ and the experts’ scores, immediately post intervention. Secondary outcomes: (2) weight attributed to each factor, (3) learning effect and (4) level of expertise (Cochran–Weiss–Shanteau (CWS)).
Results: Out of 168 participants, 135 completed the trial (80%); 66 received the intervention (49%). After using the training resource, the intervention group had better agreement with the experts in their survival estimates (dMAD = -3.43, 95% CI -0.11 to -0.34, p = <0.001) and weighting of clinical factors. There was no learning effect of the MAD scores at the 2-week time point (dMAD = 1.50, 95% CI -0.87 to 3.86, p = 0.21). At the 2-week time point, the intervention group was statistically more expert in their decision-making versus controls (intervention CWS = 146.04 (SD 140.21), control CWS = 110.75 (SD 104.05); p = 0.01).
Conclusion: The online training resource proved effective in altering the decision-making of medical students to agree more with expert decision-making.
INTRODUCTION: Almost all patients with end-of-life cancer experience cancer-related fatigue; however, there are only a few known effective coping methods.
OBJECTIVES: We will conduct a prospective, multi-center, single-blinded randomized controlled study to evaluate the efficacy of acupuncture for cancer-related fatigue in patients with end-of-life cancer.
METHODS: We will enroll 120 patients with cancer hospitalized in a palliative care unit or receiving consultation from a palliative care team in four hospitals. We will add acupuncture treatment; specifically, contact needle therapy (CNT), consisting of an intervention per week period to the usual care. The primary outcome measure will be the Cancer Fatigue Scale (CFS) score while the secondary outcome measures will be the Numerical Rating Scale (NRS) score for fatigue, pain, and salivary amylase levels.
CONCLUSION: We will evaluate the possibility of using acupuncture therapy, that is, CNT, in relieving fatigue sensation in patients with advanced cancer.
TRIAL REGISTRATION: UMIN000028304, registered on July 21st, 2017; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032401.
INTRODUCTION: Minimising bias in randomised controlled trials (RCTs) includes intention-to-treat (ITT) analyses. Hospice/palliative care RCTs are constrained by high attrition unpredictable when consenting, including withdrawals between randomisation and first exposure to the intervention. Such withdrawals may systematically bias findings away from the new intervention being evaluated if they are considered non-responders. This study aimed to quantify this impact within ITT principles.
METHODS: A theoretical model was developed to assess the impact of withdrawals between randomisation and first exposure on i) study power and ii) effect sizes. Ten reported hospice/palliative care studies had power recalculated accounting for such withdrawal.
RESULTS: In the theoretical model, when 5% of withdrawals occurred between randomisation and first exposure to the intervention, change in power was demonstrated in binary outcomes (2.0-2.2%), continuous outcomes (0.8-2.0%) and time-to-event outcomes (1.6-2.0%), and odds ratios were changed by 0.06-0.17. Greater power loss was observed with larger effect sizes. Withdrawal rates were 0.9%-10% in the ten reported RCTs, corresponding to power losses of 0.1%-2.2%. For studies with binary outcomes, withdrawal rates were 0.3-1.2%, changing odds ratios by 0.01-0.22.
DISCUSSION: If blinding is maintained and all interventions are available simultaneously, our model suggests that excluding data from withdrawals between randomisation and first exposure to the intervention minimises one bias. This is the safety population as defined by the International Committee on Harmonisation. When planning for future trials, minimising the time between randomisation and first exposure to the intervention will minimise the problem. Power should be calculated on people who receive the intervention.
Importance: High-quality evidence on how to improve palliative care in nursing homes is lacking.
Objective: To investigate the effect of the Palliative Care for Older People (PACE) Steps to Success Program on resident and staff outcomes.
Design, Setting, and Participants: A cluster-randomized clinical trial (2015-2017) in 78 nursing homes in 7 countries comparing PACE Steps to Success Program (intervention) with usual care (control). Randomization was stratified by country and median number of beds in each country in a 1:1 ratio.
Interventions: The PACE Steps to Success Program is a multicomponent intervention to integrate basic nonspecialist palliative care in nursing homes. Using a train-the-trainer approach, an external trainer supports staff in nursing homes to introduce a palliative care approach over the course of 1 year following a 6-steps program. The steps are (1) advance care planning with residents and family, (2) assessment, care planning, and review of needs and problems, (3) coordination of care via monthly multidisciplinary review meetings, (4) delivery of high-quality care focusing on pain and depression, (5) care in the last days of life, and (6) care after death.
Main Outcomes and Measures: The primary resident outcome was comfort in the last week of life measured after death by staff using the End-of-Life in Dementia Scale Comfort Assessment While Dying (EOLD-CAD; range, 14-42). The primary staff outcome was knowledge of palliative care reported by staff using the Palliative Care Survey (PCS; range, 0-1).
Results: Concerning deceased residents, we collected 551 of 610 questionnaires from staff at baseline and 984 of 1178 postintervention in 37 intervention and 36 control homes. Mean (SD) age at time of death ranged between 85.22 (9.13) and 85.91 (8.57) years, and between 60.6% (160/264) and 70.6% (190/269) of residents were women across the different groups. Residents’ comfort in the last week of life did not differ between intervention and control groups (baseline-adjusted mean difference, -0.55; 95% CI, -1.71 to 0.61; P = .35). Concerning staff, we collected 2680 of 3638 questionnaires at baseline and 2437 of 3510 postintervention in 37 intervention and 38 control homes. Mean (SD) age of staff ranged between 42.3 (12.1) and 44.1 (11.7) years, and between 87.2% (1092/1253) and 89% (1224/1375) of staff were women across the different groups. Staff in the intervention group had statistically significantly better knowledge of palliative care than staff in the control group, but the clinical difference was minimal (baseline-adjusted mean difference, 0.04; 95% CI, 0.02-0.05; P < .001). Data analyses began on April 20, 2018.
Conclusions and Relevance: Residents' comfort in the last week of life did not improve after introducing the PACE Steps to Success Program. Improvements in staff knowledge of palliative care were clinically not important.
Trial Registration: ISRCTN Identifier: ISRCTN14741671.