Background: People with advanced cancer face difficulties with their everyday activities at home that may reduce their health-related quality of life. To address these difficulties, we developed the ‘Cancer Home-Life Intervention’.
Aim: To evaluate the efficacy of the ‘Cancer Home Life-Intervention’ compared with usual care with regard to patients’ performance of, and participation in, everyday activities, and their health-related quality of life.
Design and intervention: A randomised controlled trial (ClinicalTrials.gov NCT02356627). The ‘Cancer Home-Life Intervention’ is a brief, tailored, occupational therapy–based and adaptive programme for people with advanced cancer targeting the performance of their prioritised everyday activities.
Setting/participants: Home-living adults diagnosed with advanced cancer experiencing functional limitations were recruited from two Danish hospitals. They were assessed at baseline, and at 6 and 12 weeks of follow-up. The primary outcome was activities of daily living motor ability. Secondary outcomes were activities of daily living process ability, difficulty performing prioritised everyday activities, participation restrictions and health-related quality of life.
Results: A total of 242 participants were randomised either to the intervention group (n = 121) or the control group (n = 121). No effect was found on the primary outcome (between-group mean change: -0.04 logits (95% confidence interval: -0.23 to 0.15); p = 0.69). Nor was any effect on the secondary outcomes observed.
Conclusion: In most cases, the ‘Cancer Home-Life Intervention’ was delivered through only one home visit and one follow-up telephone contact, which not was effective in maintaining or improving participants’ everyday activities and health-related quality of life. Future research should pay even more attention to intervention development and feasibility testing.
Background: Previous literature suggests that ketamine may be an effective drug in the palliative care population as this drug has been shown to treat multiple conditions that are common in these patients.
Objective: This review examines the efficacy of ketamine for the treatment of depression and physical pain in palliative care patients.
Methods: Eleven studies were included on the topic of ketamine as an antidepressant in the palliative care population. Additionally, 5 RCT studies were included on the topic of physical pain in this population.
Results: All 11 studies, including one RCT, found antidepressant effects of ketamine in this patient population. Ketamine's effect on treating physical pain was mixed with the largest and most recent RCTs suggesting no significant analgesic effect.
Discussion: This review suggests that starting qualified patients on intravenous (IV) ketamine and switching to oral or intranasal administration may be the most effective and convenient for treating depression, especially for patients who wish to receive treatment at home. Significant analgesia was found in patients who received epidural or intrathecal ketamine as well as in one study using intravenous administration. More research is necessary to determine which palliative care patients may benefit from ketamine treatment.
PURPOSE: We designed a novel, manualized intervention called Emotion And Symptom-focused Engagement (EASE) for acute leukemia (AL) and report here on a phase II randomized controlled trial (RCT) to assess its feasibility and preliminary efficacy.
METHODS: Patients were recruited within 1 month of hospital admission and randomized to EASE plus usual care (UC) or UC alone. EASE includes (1) EASE-psy, a tailored psychotherapy delivered over 8 weeks, and (2) EASE-phys, weekly physical symptom screening over 8 weeks to trigger early palliative care. The primary outcome was traumatic stress symptoms; secondary outcomes included physical symptom burden and quality of life. Assessments were conducted at baseline and at 4, 8, and 12 weeks. Between-group differences were evaluated using multilevel modeling.
RESULTS: Forty-two patients were randomized to EASE (n = 22) or UC (n = 20), with 76% retention at 12 weeks. Predefined feasibility outcomes were met: 86% (19/22) of EASE participants completed = 50% of EASE-psy sessions (goal = 64%); 100% received Edmonton Symptom Assessment System (ESAS, modified for AL) screenings, 64% (14/22) of whom completed = 50% of planned screenings (goal =50%); and 100% with scores = 4/10 on any physical ESAS-AL item had = 1 meeting with the EASE-phys team (goal 100%). Significant treatment-group differences favoring EASE were observed in traumatic stress symptoms at 4 and 12 weeks, and pain intensity and interference at 12 weeks (all p < .05).
CONCLUSIONS: EASE is feasible in patients newly diagnosed with AL and shows promise of effectiveness. These results warrant a larger RCT to provide evidence for its more routine use as a standard of care.
BACKGROUND: The number of old patients suffering from colorectal cancer rises. In clinical trials, old patients are underrepresented, and chemotherapy is significantly less often performed in elderly patients. We analyzed the impact of elder age for palliative chemotherapy in patients suffering from metastatic colorectal cancer, according to therapeutic drugs used, intensity of treatment performed, and therapeutic results.
MATERIALS AND METHODS: We analyzed consecutive patients with metastatic colorectal cancer treated in palliative intention in our department. Assessed data included age (> 75 years), sex, comorbidity, site of primary tumor, k-ras-status, site and amount of metastasis, number and kind of chemotherapeutic agents used, number of consecutive therapy lines performed, dose intensity, toxicity, time between start and end of palliative chemotherapy, and overall survival. Prognostic variables were tested in uni- and multivariate analysis.
RESULTS: Ninety-seven patients (69 < 75, 18 > 75 years) were included. Age groups were well balanced according to site of primary tumor, k-ras-mutational status, localization, and number of metastatic sites. Cardial and renal comorbidity was more frequent in elderly patients. The median number of chemotherapeutic drugs used and lines of therapy performed did not differ between age groups, except of oxaliplatin, which was significantly less often used in old patients. Median survival did not differ between age groups (23.4 vs. 23.5 months). In multivariate analysis, only left-sided primary tumor and more than 3 lines of therapy performed were prognostic positive variables.
CONCLUSION: Old patients can profit from palliative chemotherapy to the same extent as younger ones.
BACKGROUND: Dyspnea is commonly found in most conditions among patients with progressive noncancer disease.
OBJECTIVE: To clarify the effectiveness and safety of opioid administration for the treatment of dyspnea immediately before death in patients with noncancer disease.
METHODS: A retrospective case-series study involving 13 consecutive terminally ill patients who were near death and diagnosed with noncancer disease, and had refractory dyspnea and received opioid therapy, was performed. The authors investigated the route of administration, period, dosage of opioids, intensity of dyspnea-scored according to the Japanese version of the Support Team Assessment Schedule-and clinical course from a review of medical records.
RESULTS: The mean age of the patients was 86.5 ± 7.6years (range: 72-98years). The primary causes of dyspnea that led to opioid administration were heart failure (n = 10) and respiratory failure (n = 3). Oxycodone was used in one patient who experienced a complication of chronic renal failure; morphine was used in the other 12 patients. The route of opioid administration was continuous infusions in 11 patients, suppository in one, and oral administration in one. The final dose of oral morphine equivalents was 20.1 ± 8.1 mg/d (range: 5-36 mg [median: 18 mg]). All patients improved in symptom score after opioid administration. The score was significantly decreased from 3.2 ± 0.7 at the beginning of opioid administration to 1.2 ± 0.6 at final estimation ( P < .001). No severe adverse events occurred.
CONCLUSIONS:: Low-dose opioid administration in patients with terminally ill noncancer improved dyspnea and occurred no severe adverse events.
Aim: The aim of the study is to assess which factors are associated with self-efficacy for making these decisions in surrogates of end-stage kidney disease patients.
Materials and Methods: Cross-sectional study conducted in the hemodialysis clinic of a private hospital in Mexico City. A total of 124 surrogates of patients in hemodialysis were included in the study. Self-efficacy for decision-making was assessed with the Family Decision-Making Self-Efficacy Scale. As factors related to decision-making self-efficacy, sociodemographic data, health information, and professional help received for dealing with end-of-life issues were assessed in both patients and surrogates. Functional status and advanced directives of the patient as well as prior experience in decision-making of the surrogates were also included. Logistic regression models were used to establish the associations.
Results: The mean age of participants was 49.4 years (standard deviation: 14). Factors associated to decision-making self-efficacy were awareness of the surrogate about the terminal disease of the patient (P < 0.001), prior conversation between the surrogate and the patient about end-of-life preferences (P = 0.037), time between the patient was told dialysis was required and accepting it inferior to 1 month (P = 0.016), and visual impairment of the patient (0.040).
Conclusions: This study provides information of which factors are associated with self-effectiveness in surrogates of terminally ill renal patients so that strategies based on these considerations might be implemented in the future.
Importance Earlier clinician-patient conversations about patients’ values, goals, and preferences in serious illness (ie, serious illness conversations) are associated with better outcomes but occur inconsistently in cancer care.
Objective To evaluate the efficacy of a communication quality-improvement intervention in improving the occurrence, timing, quality, and accessibility of documented serious illness conversations between oncology clinicians and patients with advanced cancer.
Design, Setting, Participants This cluster randomized clinical trial in outpatient oncology was conducted at the Dana-Farber Cancer Institute and included physicians, advanced-practice clinicians, and patients with cancer who were at high risk of death.
Main Outcomes and Measures The primary outcomes (goal-concordant care and peacefulness at the end of life) are published elsewhere. Secondary outcomes are reported herein, including (1) documentation of at least 1 serious illness conversation before death, (2) timing of the initial conversation before death, (3) quality of conversations, and (4) their accessibility in the electronic medical record (EMR).
Results We enrolled 91 clinicians (48 intervention, 43 control) and 278 patients (134 intervention, 144 control). Of enrolled patients, 58% died during the study (n=161); mean age was 62.3 years (95% CI, 58.9-65.6 years); 55% were women (n=88). These patients were cared for by 76 of the 91 enrolled clinicians (37 intervention, 39 control); years in practice, 11.5 (95% CI, 9.2-13.8); 57% female (n=43). Medical record review after patients’ death demonstrated that a significantly higher proportion of intervention patients had a documented discussion compared with controls (96% vs 79%, P = .005) and intervention conversations occurred a median of 2.4 months earlier (median, 143 days vs 71 days, P < .001). Conversation documentation for intervention patients was significantly more comprehensive and patient centered, with a greater focus on values or goals (89% vs 44%, P < .001), prognosis or illness understanding (91% vs 48%, P < .001), and life-sustaining treatment preferences (63% vs 32%, P = .004). Documentation about end-of-life care planning did not differ between arms (80% intervention vs 68% control, P = .08). Significantly more intervention patients had documentation that was accessible in the EMR (61% vs 11%, P < .001).
Conclusions and Relevance This communication quality-improvement intervention resulted in more, earlier, better, and more accessible serious illness conversations documented in the EMR. To our knowledge, this is the first such study to demonstrate improvement in all 4 of these outcomes.
BACKGROUND: Respiratory distress protocols (RDPs) are protocolized prescriptions comprised of 3 medications (a benzodiazepine, an opioid, and an anticholinergic) administered simultaneously as an emergency treatment for respiratory distress in palliative care patients in the province of Quebec, Canada. However, data on appropriate use that justifies the combination of all 3 components is scarce and based on individual pharmacodynamic properties along with expert consensus.
OBJECTIVES: Our study aimed to evaluate the conformity and the effectiveness of RDPs prescribed and administered to hospitalized adult patients.
METHODS: This was a prospective and descriptive study conducted in a single center. Prescription and administration conformity were assessed based on predefined appropriateness criteria.
RESULTS: A total of 467 adult patients were prescribed a RDP, 175 administrations were documented, and 78 patients received at least 1 RDP. Prescription conformity was assessed on 1473 separate occasions over the trial period. Overall prescription conformity was found to be 37% (95% confidence interval [CI]: 33.6-40.4), and administration conformity was 37.7% (95% CI: 26.2-50.7). Low administration conformity was primarily explained by incorrect indications for RDP use. Seemingly important determinants of higher conformity were prescriber's speciality in palliative care, use of preprinted orders, pharmacist involvement, and hospitalization in the palliative care unit.
CONCLUSION: This study highlights important gaps in the use of RDPs in our institution. Health-care provider training appears necessary in order to ensure adequate conformity and allow for further evaluation of RDP effectiveness.
Introduction: Emergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement.
Methods and analysis: This is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate <15 mL/min/m2, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life.
Ethics and dissemination Institutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal.
BACKGROUND: Despite the significant impact of chronic symptoms on quality of life with cystic fibrosis (CF), the role of palliative care in management of this disease is not well defined. The coping, goal assessment, and relief from evolving CF symptoms (CF-CARES) model is a primary palliative care intervention designed to provide chronic symptom management at all stages of the disease. The goal of this pilot study was to estimate the effectiveness of the CF-CARES intervention on improving chronic symptoms and quality of life for people living with CF.
METHODS: A structured assessment was used to guide referral to supportive services intended to address burdensome symptoms. Follow-up assessments were performed approximately 3 and 6 months later. Longitudinal regression analyses of changes in symptoms and quality of life were performed for all participants regardless of utilization of supportive services. Subgroup analyses were performed for subjects participating in mental health and alternative health services.
RESULTS: Forty-one subjects completed assessment and referral processes. The mean number of CF-associated symptoms decreased over time, as did respiratory symptom-related distress and depressive symptoms. Subjects utilizing alternative health services reported less psychological distress at follow-up. Among subjects with severe disease, mental health, and quality of life improved, especially for those using mental health services.
CONCLUSIONS: The CF-CARES model resulted in significant mental health and quality-of-life benefits, suggesting the value of integrating symptom management interventions into routine CF care. Moreover, mental health services can play a key role in CF-specific primary palliative care, especially for those with advanced disease.
BACKGROUND: Suicide bereavement is a risk factor for adverse outcomes related to grief, social functioning, mental health and suicidal behaviour. Consequently, suicide bereavement support (i.e., postvention) has been identified as an important suicide prevention strategy. However, little is known about its effectiveness. To redress this gap, this review aimed to assess the evidence of effectiveness of interventions for people bereaved by suicide, and appraise the quality of the research in this field.
METHODS: We conducted a systematic review according to PRISMA guidelines. Searches of peer-reviewed literature in Medline, PsycINFO, Embase and EBM Reviews identified 12 papers reporting on 11 relevant studies conducted between 1984 and 2018.
RESULTS: Across studies, there was a wide variety of intervention modalities, study populations, control groups, and grief, psychosocial and suicide-related outcome measures. Overall, the quality of studies was weak. While there was some evidence of the effectiveness of interventions for uncomplicated grief, evidence of the effectiveness of complicated grief interventions was lacking. Based on this scant evidence, interventions which seem to show promise include supportive, therapeutic and educational approaches, involve the social environment of the bereaved, and comprise a series of sessions led by trained facilitators.
CONCLUSIONS: There is a clear need for additional methodologically sound studies in this area. Specifically, selection procedures, sample sizes, randomization, and the use of appropriate measures are crucial. As people bereaved by suicide are at-risk of adverse grief, mental ill-health and suicidal behaviour, further research across the life-span is essential to prevent grief and mental health ramifications.
Background: An important part of palliative care is discussing preferences at end of life, however such conversations may not often occur. Care staff with greater self-efficacy towards end-of-life communication are probably more likely to have such discussions, however, there is a lack of research on self-efficacy towards end-of-life discussions among long-term care staff in Europe and related factors.
Objectives: Firstly, to describe and compare the self-efficacy level of long-term care staff regarding end-of-life communication across six countries; secondly, to analyse characteristics of staff and facilities which are associated to self-efficacy towards end-of-life communication.
Design: Cross-sectional survey.
Settings: Long-term care facilities in Belgium, England, Finland, Italy, the Netherlands and Poland (n=290).
Participants: Nurses and care assistants (n=1680) completed a self-efficacy scale and were included in the analyses.
Methods: Care staff rated their self-efficacy (confidence in their own ability) on a scale of 0 (cannot do at all) to 7 -(certain can do) of the 8-item communication subscale of the Self-efficacy in End-of-Life Care survey. Staff characteristics included age, gender, professional role, education level, training in palliative care and years working in direct care. Facility characteristics included facility type and availability of palliative care guidelines, palliative care team and palliative care advice. Analyses were conducted using Generalized Estimating Equations, to account for clustering of data at facility level.
Results: The proportion of staff with a mean self-efficacy score >5 was highest in the Netherlands (76.4%), ranged between 55.9% and 60.0% in Belgium, Poland, England and Finland and was lowest in Italy (29.6%). Higher levels of self-efficacy (>5) were associated with: staff over 50 years of age (OR 1.86 95% CI[1.30-2.65]); nurses (compared to care assistants) (1.75 [1.20-2.54]); completion of higher secondary or tertiary education (respectively 2.22 [1.53-3.21] and 3.11 [2.05-4.71]; formal palliative care training (1.71 [1.32-2.21]); working in direct care for over 10 years (1.53 [1.14-2.05]); working in a facility with care provided by onsite nurses and care assistants and offsite physicians (1.86 [1.30-2.65]); and working in a facility where guidelines for palliative care were available (1.39 [1.03-1.88]).
Conclusion: Self-efficacy towards end-of-life communication was most often low in Italy and most often high in the Netherlands. In all countries, low self-efficacy was found relatively often for discussion of prognosis. Palliative care education and guidelines for palliative care could improve the self-efficacy of care staff.
The average expected lifespan in Canadian long-term care (LTC) homes is now less than two years post-admission, making LTC a palliative care setting. As little is known about the readiness of LTC staff in Canada to embrace a palliative care mandate, the main objective of this study was to assess qualities relevant to palliative care, including personal emotional wellbeing, palliative care self-efficacy and person-centred practices (e.g. knowing the person, comfort care). A convenience sample of 228 professional and non-professional staff (e.g. nurses and nursing assistants) across four Canadian LTC homes participated in a survey. Burnout, secondary traumatic stress and poor job satisfaction were well below accepted thresholds, e.g. burnout: mean = 20.49 (standard deviation (SD) = 5.39) for professionals; mean = 22.09 (SD = 4.98) for non-professionals; cut score = 42. Furthermore, only 0â€“1 per cent of each group showed a score above cut-off for any of these variables. Reported self-efficacy was moderate, e.g. efficacy in delivery: mean = 18.63 (SD = 6.29) for professionals; mean = 15.33 (SD = 7.52) for non-professionals; maximum = 32. The same was true of self-reported person-centred care, e.g. knowing the person; mean = 22.05 (SD = 6.55) for professionals; mean = 22.91 (SD = 6.16) for non-professionals; maximum = 35. t-Tests showed that non-professional staff reported relatively higher levels of burnout, while professional staff reported greater job satisfaction and self-efficacy (p < 0.05). There was no difference in secondary traumatic stress or person-centred care (p > 0.05). Overall, these results suggest that the emotional wellbeing of the Canadian LTC workforce is unlikely to impede effective palliative care. However, palliative care self-efficacy and person-centred care can be further cultivated in this context.
BACKGROUND: In Germany, some units of specialized palliative care (SPC) offer a 6- to 12-month rotation for resident physicians (RPs) and fellows from different specialties.
OBJECTIVE: This pilot study aimed to evaluate feasibility of assessing palliative care knowledge (PCK) and palliative care self-efficacy (PCSE) using a paper-based questionnaire.
METHODS: Palliative care knowledge and PCSE were assessed by introducing a score, followed by a descriptive analysis (determination of frequency, mean, median, and range) using nonparametric tests ( 2 test, Mannâ€“Whitney U test).
RESULTS:: We assessed 17 RPs following SPC rotation and 16 board-certified specialists (BCSs) who had no experience in SPC from 3 German comprehensive cancer centers. Resident physicians were predominantly enrolled in residency programs of hematology and oncology (n = 6), anesthesiology (n = 6), and psychosomatic medicine (n = 3). Resident physicians rotated between year 1 and 8 of residency. Fifteen RPs (88%) had elected this rotation and 72% preferred 12-month duration. The total PCK score of PCK was 27 (RPs) and 24 (BCSs; P = .002). Mean PCSE scores were 46 (RPs) and 39 (BCSs; P = .016). Of 71% of RPs, only 27% of BCSs knew how support of hospice service was initiated ( P = .004). Participants rated the items as comprehensible (n = 24; 73%), relevant (n = 25; 76%) and the questionnaire as adequately long (n = 23; 70%).
CONCLUSION: An improved PCK and PCSE were observed in physicians who rotated through an SPC unit; this resulted in an increased tangibility of local palliative care and hospice services. The questionnaire was comprehensible, relevant in terms of content, and adequate in length for a prospective multicenter survey.
Objective: Radiotherapy is the standard local treatment for patients with painful bone metastases, but effectiveness has primarily been evaluated in trial populations. The aim of this study was to study pain response to palliative radiotherapy in a prospective cohort of unselected patients with bone metastases.
Methods: Patients with painful bone metastases referred to the UMC Utrecht for radiotherapy and enrolled in the PRESENT cohort were included in this study. For all patients, pain response to radiotherapy was assessed, and responders were defined as patients with a complete or partial pain response. Patients with stable pain scores, pain increase, or undetermined response were regarded non-responders. Pain scores obtained at baseline and after 2, 4, 6, 8, and 12 weeks following radiotherapy were obtained. Pain response rates of the total treated population, as well as response rates of the assessable patients, were calculated. To measure the percentage of the remaining time spent with pain relief, the net pain relief (NPR) was calculated by dividing the period of pain relief by the period of survival.
Results: Of the 432 patients enrolled in this study, 262 patients (61%) experienced a complete or partial response. In the 390 assessable patients, this percentage was 67%. Median time to response was 4 weeks (range 1-15 weeks), and the NPR was 64%.
Conclusion: Compared to randomized trial populations, palliative radiotherapy in our unselected patients with bone metastases showed similar pain response rates (61%), with a reasonable duration of this effect.
BACKGROUND: Health-care providers report a lack of training in end-of-life care and limited opportunities exist to learn about the dying process in home settings where most prefer to die.
AIM:: To evaluate the effectiveness of a Community Action, Research, and Education (CARE) program designed to promote empathy and self-efficacy communicating with and caring for terminally ill patients.
METHODS: This mixed-methods study collected preâ€“post data from 18 undergraduates (7 men= 11 women) in a 8-week immersive program where they served as primary caregivers in residential homes for the dying providing 200 hours of bedside care to hospice patients during their final days. Quantitative measures assessed empathy using the Jefferson Scale of Empathy-Health Professions (JSE-HPS) version and self-efficacy using a 20-question palliative care skill assessment. Qualitative analyses were conducted on reflective journals to further assess knowledge, skill, and value development.
RESULTS: Paired t tests revealed significant increases in empathy ( P < .05) and self-efficacy ( P < .001) to provide end-of-life care. Thematic analysis of reflective journals further demonstrated specific instances of empathy and self-efficacy.
CONCLUSIONS: Community-run residential homes for the dying offer a unique opportunity for skills training in end-of-life care. The opportunity to serve as a caregiver for the dying improved students' confidence and ability to provide empathic patient- and family-centered end-of-life care to hospice patients in their final days.
BACKGROUND: Evidence about the effectiveness of music therapy for improving the quality of life of palliative care patients is positive but weak in terms of risk of bias.
METHODS: This study aimed to determine the feasibility of a randomised controlled trial to evaluate the effectiveness of music therapy for improving the quality of life of hospice inpatients, as measured by the McGill Quality of Life questionnaire. Objectives included recruitment of 52 participants over 12 months and provision of data to support the calculation of the required sample size for a definitive randomised trial, taking into account the retention rates of recruited participants; and evaluation of the viability of the intervention and the acceptability of the assessment tool. The design was a single-centre, researcher-blinded randomised pilot and feasibility study involving two parallel groups. Participants were recruited from one inpatient hospice unit in Northern Ireland. Eligibility criteria were an Eastern Cooperative Oncology Group performance status of two or lower and an Abbreviated Mental Test score of seven or more. Consenting patients were randomly allocated to the intervention or control group using a 1:1 allocation ratio. The intervention group received up to six individual music therapy sessions over 3 weeks in addition to usual care. The control group received usual care only.
RESULTS: Fifty one participants were recruited over 12 months. Twenty five were allocated to the intervention group and 26 to the control group. Seventy one percent of participants were lost to follow up by week 3, the proposed primary endpoint. The primary endpoint was moved from week 3, when 71% were lost to follow up to week 1, when 33% were lost. The McGill Quality of Life questionnaire was generally acceptable to participants. In order to detect a small to moderate effect size of 0.3, a fully powered study would require the recruitment of 698 participants.
CONCLUSIONS: A Phase III randomised controlled trial to evaluate the effectiveness of music therapy in improving the quality of life of hospice inpatients is feasible.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT02791048 . Registered 6 June 2016.
Importance: Advance care planning improves the receipt of medical care aligned with patients' values; however, it remains suboptimal among diverse patient populations. To mitigate literacy, cultural, and language barriers to advance care planning, easy-to-read advance directives and a patient-directed, online advance care planning program called PREPARE For Your Care (PREPARE) were created in English and Spanish.
Objective: To compare the efficacy of PREPARE plus an easy-to-read advance directive with an advance directive alone to increase advance care planning documentation and patient-reported engagement.
Design, Setting, and Participants: A comparative efficacy randomized clinical trial was conducted from February 1, 2014, to November 30, 2017, at 4 safety-net, primary-care clinics in San Francisco among 986 English-speaking or Spanish-speaking primary care patients 55 years or older with 2 or more chronic or serious illnesses.
Interventions: Participants were randomized to PREPARE plus an easy-to-read advance directive (PREPARE arm) or the advance directive alone. There were no clinician-level or system-level interventions. Staff were blinded for all follow-up measurements.
Main Outcomes and Measures: The primary outcome was documentation of new advance care planning (ie, legal forms and/or documented discussions) at 15 months. Patient-reported outcomes included advance care planning engagement at baseline, 1 week, 3 months, 6 months, and 12 months using validated surveys. Intention-to-treat analyses were performed using mixed-effects logistic and linear regression, controlling for time, health literacy, and baseline advance care planning, clustering by physician, and stratifying by language.
Results: Among the 986 participants (603 women and 383 men), the mean (SD) age was 63.3 (6.4) years, 387 of 975 (39.7%) had limited health literacy, and 445 (45.1%) were Spanish speaking. No participant characteristic differed between the 2 groups, and retention was 85.9% (832 of 969) among survivors. Compared with the advance directive alone, PREPARE resulted in a higher rate of advance care planning documentation (unadjusted, 43.0% [207 of 481] vs 33.1% [167 of 505]; P < .001; adjusted, 43.0% vs 32.0%; P < .001) and higher self-reported increased advance care planning engagement scores (98.1% vs 89.5%; P < .001). Results remained significant among English speakers and Spanish speakers.
Conclusions and Relevance: The patient-facing PREPARE program and an easy-to-read advance directive, without clinician-level or system-level interventions, increased documentation of advance care planning and patient-reported engagement, with statistically higher gains for PREPARE vs advance directive alone. These tools may mitigate literacy and language barriers to advance care planning, allow patients to begin planning on their own, and could substantially improve the process for diverse English-speaking and Spanish-speaking populations.
Trial Registration: ClinicalTrials.gov identifiers: NCT01990235 and NCT02072941.
BACKGROUND: Treating chronic, uncontrolled, cancer pain with subcutaneous ketamine in patients unresponsive to opioids and co-analgesics remains controversial, especially in light of recent evidence demonstrating ketamine does not have net clinical benefit in this setting.
AIM: To evaluate the cost-effectiveness of subcutaneous ketamine versus placebo in this patient population.
DESIGN AND SETTING: A within-trial cost-effectiveness analysis of the Australian Palliative Care Clinical Studies Collaborative's randomised, double-blind, placebo-controlled trial of ketamine was conducted from a healthcare provider perspective. Mean costs and outcomes were estimated from participant-level data over 5 days including positive response, health-related quality of life (HrQOL) measured with the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal), ketamine costs, medication usage and in-patient stays.
RESULTS: There was no statistically significant difference in responder rates, but higher toxicity and worse HrQOL for ketamine participants (mean change -3.10 (standard error (SE) 1.76), ketamine n = 93; 4.53 (SE 1.38), placebo n = 92). Estimated total mean costs were AU$706 higher per ketamine participant (AU$6608) compared with placebo (AU$5902), attributable to the cost of higher in-patient costs as well as costs of ketamine administration. The results were robust to sensitivity analyses accounting for different medication use costing methods and removal of cost outliers.
CONCLUSION: The findings suggest subcutaneous ketamine in conjunction with opioids and standard adjuvant therapy is neither an effective nor cost-effective treatment for refractory pain in advanced cancer patients.
BACKGROUND: Studies have shown positive clinical outcomes of specialist palliative care for end-stage heart failure patients, but cost-effectiveness evaluation is lacking.
AIM: To examine the cost-effectiveness of a transitional home-based palliative care program for patients with end-stage heart failure patients as compared to the customary palliative care service.
DESIGN: A cost-effectiveness analysis was conducted alongside a randomized controlled trial (Trial number: NCT02086305). The costs included pre-program training, intervention, and hospital use. Quality of life was measured using SF-6D.
SETTING/PARTICIPANTS: The study took place in three hospitals in Hong Kong. The inclusion criteria were meeting clinical indicators for end-stage heart failure patients including clinician-judged last year of life, discharged to home within the service area, and palliative care referral accepted. A total of 84 subjects (study = 43, control = 41) were recruited.
RESULTS: When the study group was compared to the control group, the net incremental quality-adjusted life years gain was 0.0012 (28 days)/0.0077 (84 days) and the net incremental costs per case was -HK$7935 (28 days)/-HK$26,084 (84 days). The probability of being cost-effective was 85% (28 days)/100% (84 days) based on the cost-effectiveness thresholds recommended both by National Institute for Health and Clinical Excellence (£20,000/quality-adjusted life years) and World Health Organization (Hong Kong gross domestic product/capita in 2015, HK$328117).
CONCLUSION: Results suggest that a transitional home-based palliative care program is more cost-effective than customary palliative care service. Limitations of the study include small sample size, study confined to one city, clinic consultation costs, and societal costs including patient costs and unpaid care-giving costs were not included.