OBJECTIVE: To measure the effectiveness of a brief intervention aimed at increasing interest in and use of advanced directives (AD) among primary care patients.
METHODS: Randomized controlled trial. In the intervention arm, patients were given brief oral information and a leaflet on AD by General Practitioners (GPs), in the control group were briefly informed about the study's purpose. Outcome variables were the proportion of patients who expressed interest in AD and those who completed one. Covariates were sex, age, education, race, Charlson comorbidity index (CCI), religion, and possession of financial will.
RESULTS: Overall, 332 patients were recruited; 58 in the intervention and 36 in the control group expressed interest in AD (p = 0.033) and 18 (5.4 %) made an AD (nine in each group). Variables associated with interest were Caucasian race (odds ratio [OR], 1.88), the intervention (OR, 1.86), and CCI extreme scores (OR, 0.36). Variables associated with AD completion were primary education/no schooling (OR, 5.69) and fewer children (OR, 0.57).
CONCLUSIONS: A brief oral and written intervention delivered by GP significantly increased interest in AD and achieved a completion rate of 5.4 %, without differences with the control group.
PRACTICE IMPLICATIONS: AD interventions should focus on individuals already likely to be motivated.
BACKGROUND: A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses. NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of parental bereavement and supported by literature on anticipatory grief interventions for improving the holistic well-being of parent caregivers of seriously ill children.
OBJECTIVE: This study's aim was to provide an accessible platform, NeW-I-which is a strengths- and meaning-focused and therapist-facilitated mobile app and web-based counseling platform-that aims to enhance quality of life, spiritual well-being, hope, and perceived social support and reduce depressive symptoms, caregiver burden, and risk of complicated grief among parents of children with chronic life-threatening illnesses.
METHODS: The NeW-I therapist-facilitated web-based platform comprises a mobile app and a website (both of which have the same content and functionality). NeW-I has been implemented in Singapore as a pilot open-label randomized controlled trial comprising intervention and control groups. Both primary and secondary outcomes will be self-reported by participants through questionnaires. In collaboration with leading pediatric palliative care providers in Singapore, the trial aims to enroll 36 participants in each group (N=72), so that when allowing for 30% attrition at follow-up, the sample size will be adequate to detect a small effect size of 0.2 in the primary outcome measure, with 90% power and two-sided significance level of at least .05. The potential effectiveness of NeW-I and the accessibility and feasibility of implementing and delivering the intervention will be assessed.
RESULTS: Funding support and institutional review board approval for this study have been secured. Data collection started in January 2019 and is ongoing.
CONCLUSIONS: NeW-I aspires to enhance holistic pediatric palliative care services through a structured web-based counseling platform that is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with expressing emotion even during times of loss and separation. The findings of this pilot study will inform the development of a full-scale NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world.
Background: Implantable cardioverter-defibrillators (ICDs) reduce the incidence of sudden cardiac death for high-risk patients with heart failure (HF), but shocks from these devices can also cause pain and anxiety at the end of life. Although professional society recommendations encourage proactive discussions about ICD deactivation, clinicians lack training in conducting these conversations, and they occur infrequently.
Methods: As part of a six-center randomized controlled trial, we evaluated the educational component of a multicomponent intervention shown to increase conversations about ICD deactivation by clinicians who care for a subset of patients with advanced HF. This consisted of a 90-minute training workshop designed to improve the quality and frequency of conversations about ICD management. To characterize its utility as an isolated intervention, we compared HF clinicians' pre- and postworkshop scores (on a 5-point Likert scale) assessing self-reported confidence and skills in specific practices of advance care planning, ICD deactivation discussions, and empathic communication.
Results: Forty intervention-group HF clinicians completed both pre- and postworkshop surveys. Preworkshop scores showed high baseline levels of confidence (4.36, standard deviation [SD = 0.70) and skill (4.08, SD = 0.72), whereas comparisons of pre- and postworkshop scores showed nonsignificant decreases in confidence (-1.16, p = 0.252) and skill (-0.20, p = 0.843) after the training session.
Conclusions: Our findings showed no significant changes in self-assessment ratings immediately after the educational intervention. However, our data did demonstrate that HF clinicians had high baseline self-perceptions of their skills in advance care planning conversations and appear to be well-primed for further professional development to improve communication in the setting of advanced HF.
Introduction: The transplant waiting list exceeds the number of organs available. One means of increasing the organ pool is to broaden potential donors to include those with chronic diseases.
Research Questions: The study tested the effectiveness of using peer mentors to encourage individuals on dialysis to enroll on an organ donor registry.
Design: Dialysis units were pair-matched by size and racial composition and then randomized to one of 2 interventions: meetings with a peer mentor (experimental intervention) or organ donation mailings (control). Peer mentors were trained to discuss organ donation with individuals on dialysis during in-person meetings at dialysis units. The primary outcome was verified registration in the state’s donor registry.
Results: After adjusting for age, gender, race, income, and education and accounting for correlation within the dialysis center, there was a significant intervention effect. Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group.
Discussion: The use of peer mentors to discuss donating organs after death with individuals on dialysis can increase enrollment on a donor registry. Dispelling myths about chronic illness and donation can counter widely held misconceptions and help persons make an informed choice about end-of-life decisions and present an opportunity to increase the number of organs and tissues available for transplant.
Heart failure is the leading cause of morbidity and mortality worldwide. Standard treatment for heart failure includes pharmacotherapy and cardiac device implants. However, supportive approaches in managing dyspnea in heart failure are limited. This study aimed to test the efficacy of 20-minute mindful breathing in reducing dyspnea among patients admitted for acute decompensated heart failure. We conducted a parallel-group, non-blinded, randomized controlled trial of a single session of 20-minute mindful breathing plus standard care versus standard care alone among patients admitted for moderate to severe dyspnea due to acute decompensated heart failure, using the dyspnea score based on the Edmonton Symptom Assessment System (ESAS), at the Cardiology Unit of University Malaya Medical Centre in Malaysia. Thirty participants were randomly assigned to a single session of 20-minute mindful breathing plus standard care (n = 15) or standard care alone (n = 15), with no difference in their demographic and clinical characteristics. There was statistically significant reduction in dyspnea in the intervention group compared to the control group at minute 20 (U = 49.5, n1 = 15, n2 =15, median reduction in ESAS dyspnea score 1 = 2, median reduction in ESAS dyspnea score 2 = 0, mean rank 1 = 11.30, mean rank 2 = 19.70, z = -2.692, r = 0.4, P = 0.007). Our results provided evidence that a single session of 20-minute mindful breathing was efficacious in reducing dyspnea for patients admitted for acute decompensated heart failure.
Background: Little is known about strategies for enrolling patients in home-based palliative care (HBPC) programs, despite the need to conduct effectiveness studies of this emerging industry.
Purpose: We used medical claims data from Accountable Care Organizations in California to identify patients for a randomized controlled trial of HBPC. We report outcomes from this strategy and the implications for future research.
Results: Claims data identified 1,357 patients. Research assistants could not reach 986 patients (72.7%), usually because the phone calls went unanswered (38.5%) and many patients’ phone numbers were missing or incorrect (16.3%). Of 371 patients reached, 163 opted out. Of 208 patients screened, 177 were ineligible for the trial. Just 10 patients were enrolled.
Recommendations: Our findings suggest that medical claims data may not be useful for engaging patients potentially eligible for palliative care research trials. We recommend that alternative identification and recruitment strategies be considered.
Background: o randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).
Materials and methods: Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).
Results: The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12–2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21–1.43). Acute grade =3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.
Conclusion: No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.
Trial tested effect of advance care planning on family/surrogates’ understanding of patients’ end-of-life treatment preferences longitudinally. A multisite, assessor-blinded, intent-to-treat, parallel-group, randomized controlled clinical trial in five hospital-based HIV clinics enrolled 449 participants aged 22 to 77 years during October 2013-March 2017. Patients living with HIV/family dyads were randomized at 2:1 ratio to 2 weekly ~ 60-min sessions either ACP (n = 155 dyads)—(1) ACP facilitated conversation, (2) Advance directive completion; or Control (n = 68 dyads)—(1) Developmental/relationship history, (2) Nutrition/exercise tips. ACP families/surrogates were more likely to accurately report patients’ treatment preferences at Time 1 (T1) and 12 months post-intervention (T2) compared to controls, experiencing high congruence longitudinally (high high transition), [63·6% vs 37·7% (difference = 25·9%, 95% CI: 11·3%, 40·4%, 2 = 11·52, p = 0·01)], even as patients’ preferences changed over time. ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients’ treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3).
BACKGROUND: Early integration of palliative care concurrently to standard cancer care is associated with several benefits for patients and their caregivers. However, communication barriers on part of the caring physicians often impede a timely referral to palliative care. This study describes the protocol of the evaluation of a communication skills training aiming to strengthen the ability of physicians to address palliative care related topics adequately and early during disease trajectory.
METHODS: We will implement a communication skills training and evaluate it within a prospective, multi-centered, two-armed randomized controlled trial (RCT), which will be conducted at four sites in Germany. Eligible subjects are all physicians treating patients with advanced cancer in their daily routine. An intervention group (IG) receiving a group training will be compared to a wait-list control group (CG) receiving the training after completion of data collection. At pre- and post-measurement points, participants will conduct videotaped conversations with standardized simulated patients (SP). Primary outcome will be the external rating of communication skills and consulting competencies addressing palliative care related topics. Secondary outcomes on core concepts of palliative care, basic knowledge, attitudes, confidence and self-efficacy will be assessed by standardized questionnaires and self-developed items. A further external assessment of the quality of physician-patient-interaction will be conducted by the SP. Longitudinal quantitative data will be analyzed using covariate-adjusted linear mixed-models.
DISCUSSION: If the communication skills training proves to be effective, it will provide a feasible intervention to promote an earlier communication of palliative care related topics in the care of advanced cancer patients. This would help to further establish early integration of palliative care as it is recommended by national and international guidelines.
BACKGROUND/OBJECTIVES: To determine the feasibility of conducting a cluster randomized controlled trial providing individualized feedback reports to increase advance care planning (ACP) engagement in the primary care setting.
DESIGN: Pilot cluster randomized controlled trial.
SETTING: Two primary care practices selected for geographic colocation.
PARTICIPANTS: Adults aged 55 years and older.
INTERVENTION: Brief assessment of readiness to engage in (stage of change for) three ACP behaviors (healthcare agent assignment, communication with agent about quality vs quantity of life, and living will completion) generating an individualized feedback report, plus a stage-matched brochure.
MEASURES: Patient recruitment and retention, intervention delivery, baseline characteristics, and stage of change movement.
RESULTS: Recruitment rates differed by practice. Several baseline sociodemographic characteristics differed between the 38 intervention and 41 control participants, including employment status, education, and communication with healthcare agent. Feedback was successfully delivered to all intervention participants, and over 90% of participants completed a 2-month follow-up. More intervention participants demonstrated progression in readiness than did control participants, without testing for statistical significance.
CONCLUSIONS: This pilot demonstrates opportunities and challenges of performing a clustered randomized controlled trial in primary care practices. Differences in the two practice populations highlight the challenges of matching sites. There was a signal for behavior change in the intervention group.
Background: A broad consensus on the optimal structure, intensity, and timing of early specialist palliative care (SPC) intervention is lacking.
Objective: To evaluate the benefit of an early and systematic palliative intervention alongside standard oncology care compared with standard oncology care alone in patients with advanced solid tumors.
Design: PALINT, a single-center RCT, conducted at the Masaryk Memorial Cancer Institute, the largest comprehensive cancer center in the Czech Republic (CR).
Setting/Subjects/Measurements: Patients with newly diagnosed advanced cancer within six weeks from the start of the palliative systemic therapy were randomly assigned to the integration of SPC (intervention; a consultation with a PC physician every six to eight weeks) or to the standard oncology care (control). The primary endpoint was the quality of life (QOL) assessed by EORTC QLQ C30 and Hospital Anxiety and Depression Scale (HADS) at three and six months.
Results: From 2015 to 2017, a total of 126 patients were randomly assigned to intervention (60) or to control (66) arm. At baseline, at three and six months, the global QOL scores (mean, 95% CI) in the intervention and control arm were 58.6 (53.9–63.3), 61.9 (56.4–67.4) and 66.7 (60.2–73.2) versus 54.2 (49.4–58.9), 59.0 (53.7–64.3), and 62.8 (56.7–68.9), respectively. The prevalence of anxiety (HADS-A; value >7) was 36.7%, 27.5%, and 18.9% versus 34.8%, 23.5%, and 16.3% and the prevalence of depression (HADS-D; value >7) was 28.3%, 25.4%, and 29.7% versus 28.8%, 29.4%, and 27.9%, respectively. There was no significant difference between the two arms. The overall survival was similar in both arms (347 vs. 310 days; p = 0.203).
Conclusions: A model of early integration of SPC consisting of a consultation with a PC physician alone every six to eight weeks did not increase the QOL of patients with advanced cancer compared with routine oncology care in a center with widely available supportive services. These negative results underline the importance of the multidisciplinary patient centered approach in the early SPC.
PURPOSE: Patients with advanced cancer often have a poor understanding of cancer incurability, which correlates with more aggressive treatment near the end of life (EOL). We sought to determine whether training oncologists to elicit patient values for goals-of-care (GoC) discussions will increase and improve these discussions. We explored its impact on use of aggressive care at EOL.
METHODS: We enrolled and used block randomization to assign 92% of solid tumor oncologists to 2-hour communication skills training and four coaching sessions. We surveyed 265 patient with newly diagnosed advanced cancer with < 2-year life expectancy at baseline and 6 months. We assessed prevalence and quality of GoC communication, change in communication skills, and use of aggressive care in the last month of life.
RESULTS: Intervention (INT) oncologists' (n = 11) skill to elicit patient values increased (27%-55%), while usual care (UC) oncologists' (n = 11) skill did not (9%-0%; P = .01). Forty-eight percent (n = 74) INT v 51% (n = 56) UC patients reported a GoC discussion (P = .61). There was no difference in the prevalence or quality of GoC communication between groups (global odds ratio, 0.84; 95% CI, 0.57 to 1.23). Within 6 months, there was no difference in deaths (18 INT v 16 UC; P = .51), mean hospitalizations (0.47 INT v 0.42 UC; P = .63), intensive care unit admissions (5% INT v 9% UC; P = .65), or chemotherapy (26% INT v 16% UC; P = .39).
CONCLUSION: Use of a coaching model focused on teaching oncologists to elicit patient values improved that skill but did not increase prevalence or quality of GoC discussions among patients with advanced cancer. There was no impact on high care utilization at EOL.
BACKGROUND: Patients with advanced cancer, receiving at-home palliative care, are subject to numerous symptoms that are changeable and often require attention, a stressful situation that also impacts on the family caregiver. It has been suggested that music therapy may benefit both the patient and the caregiver. We propose a study to analyse the efficacy and cost utility of a music intervention programme, applied as complementary therapy, for cancer patients in palliative care and for their at-home caregivers, compared to usual treatment.
METHOD: A randomised, double-blind, multicentre clinical trial will be performed in cancer patients in at-home palliative care and their family caregivers. The study population will include two samples of 40 patients and two samples of 41 caregivers. Participants will be randomly assigned either to the intervention group or to the control group. The intervention group will receive a seven-day programme including music sessions, while the control group will receive seven sessions of (spoken word) therapeutic education. In this study, the primary outcome measure is the assessment of patients' symptoms, according to the Edmonton Symptom Assessment System, and of the overload experienced by family caregivers, measured by the Caregiver Strain Index. The secondary outcomes considered will be the participants' health-related quality of life, their satisfaction with the intervention, and an economic valuation.
DISCUSSION: This study is expected to enhance our understanding of the efficacy and cost-utility of music therapy for cancer patients in palliative care and for their family caregivers. The results of this project are expected to be applicable and transferrable to usual clinical practice for patients in home palliative care and for their caregivers. The approach described can be incorporated as an additional therapeutic resource within comprehensive palliative care. To our knowledge, no previous high quality studies, based on a double-blind clinical trial, have been undertaken to evaluate the cost-effectiveness of music therapy. The cost-effectiveness of the project will provide information to support decision making, thereby improving the management of health resources and their use within the health system.
Background: Frailty is characterised by increased vulnerability to falls, disability, hospitalisation and care home admission. However, it is relatively reversible in the early stages. Older people living with frailty often have multiple health and social issues which are difficult to address but could benefit from proactive, person-centred care. Personalised care planning aims to improve outcomes through better self-management, care coordination and access to community resources.
Methods: This feasibility cluster randomised controlled trial aims to recruit 400 participants from 11 general practice clusters across Bradford and Leeds in the north of England. Eligible patients will be aged over 65 with an electronic frailty index score of 0.21 (identified via their electronic health record), living in their own homes, without severe cognitive impairment and not in receipt of end of life care. After screening for eligible patients, a restricted 1:1 cluster-level randomisation will be used to allocate practices to the PROSPER intervention, which will be delivered over 12 weeks by a personal independence co-ordinator worker, or usual care. Following initial consent, participants will complete a baseline questionnaire in their own home including measures of health-related quality of life, activities of daily living, depression and health and social care resource use. Follow-up will be at six and 12 months. Feasibility outcomes relate to progression criteria based around recruitment, intervention delivery, retention and follow-up. An embedded process evaluation will contribute to iterative intervention optimisation and logic model development by examining staff training, intervention implementation and contextual factors influencing delivery and uptake of the intervention.
Discussion: Whilst personalised care planning can improve outcomes in long-term conditions, implementation in routine settings is poor. We will evaluate the feasibility of conducting a cluster randomised controlled trial of personalised care planning in a community population based on frailty status. Key objectives will be to test fidelity of trial design, gather data to refine sample size calculation for the planned definitive trial, optimise data collection processes and optimise the intervention including training and delivery.
BACKGROUND: Psychological distress is highly prevalent among patients with metastatic colorectal cancer.
AIMS: To perform an economic evaluation of a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer in comparison with usual care.
DESIGN: Societal costs were collected alongside a cluster randomized controlled trial for 48 weeks. A total of 349 participants were included.
SETTING: Participants were recruited from oncology departments at 16 participating hospitals in the Netherlands.
METHODS: Outcome measures were the Hospital Anxiety and Depression Scale and quality-adjusted life-years. Missing data were imputed using multiple imputation. Uncertainty was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty surrounding the cost-effectiveness estimates. Sensitivity analyses were performed to check robustness of results.
RESULTS: Between treatment arms, no significant differences were found in Hospital Anxiety and Depression Scale score (mean difference: -0.058; 95% confidence interval: -0.13 to 0.011), quality-adjusted life-years (mean difference: 0.042; 95% confidence interval: -0.015 to 0.099), and societal costs (mean difference: -1152; 95% confidence interval: -5058 to 2214). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 0.64 and 0.74 at willingness-to-pay values of €0 and €10,000 per point improvement on the Hospital Anxiety and Depression Scale, respectively. The probability that the intervention was cost-effective compared to usual care for quality-adjusted life-years was 0.64 and 0.79 at willingness-to-pay values of €0 and €20,000 per quality-adjusted life-year, respectively.
CONCLUSION: The intervention is dominant over usual care, primarily due to lower costs in the intervention group. However, there were no statistically significant differences in clinical effects and the uptake of the intervention was quite low. Therefore, widespread implementation cannot be recommended.
Background: Palliative care is a specialized approach to symptom management that focuses on supporting patients' physical and psychological quality of life throughout the disease course. In oncology, palliative care has been increasing in utilization. The evidence base for such care is also growing through the use of randomized controlled trials (RCTs). In this review, we aim to integrate the findings from 4 meta-analyses of palliative oncology care RCTs to examine the impact of palliative care on physical and psychological quality of life and survival.
Method: We considered 4 meta-analyses of palliative oncology care RCTs, which each used slightly different methodologies and analyses. Two of the meta-analyses included both outpatient and inpatient populations, whereas the remaining meta-analyses focused specifically on outpatient palliative oncology care.
Results: All 4 meta-analyses reported a robust quality of life advantage for patients randomized to receive palliative care. Two meta-analyses identified a survival advantage, whereas the other 2 detected no survival differences. In 1 meta-analysis that examined high-quality RCTs of outpatient palliative oncology care, it was found that an increased survival probability for palliative care, compared with standard of care, was confined to 6- to 18-month follow-up.
Conclusions: There is a growing evidence base for palliative oncology care, as highlighted by the 4 meta-analyses considered. Such care successfully improves both physical and psychological quality of life for patients with serious illnesses, especially cancer. Clinicians should educate patients and their caregivers about the findings of these meta-analyses. Finally, governmental policies should focus on increasing palliative care access.
Background: Delirium is a common debilitating complication of advanced cancer.
Objective: To determine if a multicomponent nonpharmacological delirium prevention intervention was feasible for adult patients with advanced cancer, before a phase III (efficacy) trial.
Design: Phase II (feasibility) cluster randomized controlled trial. All sites implemented delirium screening and diagnostic assessment. Strategies within sleep, vision and hearing, hydration, orientation, mobility, and family domains were delivered to enrolled patients at intervention site admission days 1–7. Control sites then implemented the intervention (“waitlist sites”).
Setting: Four Australian palliative care units.
Measurements: The primary outcome was adherence, with an a priori endpoint of at least 60% patients achieving full adherence. Secondary outcomes were interdisciplinary care delivery, delirium measures, and adverse events, analyzed descriptively and inferentially.
Rsults: Sixty-five enrolled patients (25 control, 20 intervention, and 20 waitlist) had 98% delirium screens and 75% diagnostic assessments completed. Nurses (67%), physicians (16%), allied health (8.4%), family (7%), patients (1%), and volunteers (0.5%) delivered the intervention. There was full adherence for 5% patients at intervention sites, partial for 25%. Both full and partial adherence were higher at waitlist sites: 25% and 45%, respectively. One-third of control site patients (32%) became delirious within seven days of admission compared to one-fifth (20%) at both intervention and waitlist sites (p = 0.5). Mean (standard deviation) Delirium Rating Scale-Revised-1998 scores were 16.8 + 12.0 control sites versus 18.4 + 8.2 (p = 0.6) intervention and 18.7 + 7.8 (p = 0.5) waitlist sites. The intervention caused no adverse events.
Conclusion: The intervention requires modification for optimal adherence in a phase III trial.
BACKGROUND: Informal caregivers of palliative patients show higher levels of depression and distress compared with the general population. Fegg's (2013) existential behavioural therapy was shortened to two individual 1-h sessions (short-term existential behavioural therapy).
AIM: Testing the effectiveness of sEBT on psychological symptoms of informal caregivers in comparison with active control.
DESIGN: Randomised controlled trial.
SETTING/PARTICIPANTS: Informal caregivers of palliative in-patients.
METHODS: The primary outcome was depression; secondary outcomes were anxiety, subjective distress and minor mental disorders, positive and negative affect, satisfaction with life, quality of life and direct health care costs. General linear mixed models allow several measurements per participant and change over time. Reasons for declining the intervention were investigated by Rosenstock's Health Belief Model.
RESULTS: Overall inclusion rate was 41.0%. Data of 157 caregivers were available (63.1% females; mean age: 54.6 years, standard deviation (SD): 14.1); 127 participants were included in the main analysis. Participation in sEBT or active control was not significantly associated with post-treatment depression. Outcomes showed prevailingly significant association with time of investigation. Self-efficacy, scepticism of benefit of the intervention, belief of better coping alone and support by family and friends were significant factors in declining participation in the randomised controlled trial.
CONCLUSION: Inclusion rate was tripled compared with a previously evaluated longer EBT group intervention. By shortening the intervention, inclusion rate was traded for effectiveness and the intervention could not impact caregivers' psychological state. Early integration of sEBT and combination of individual and group setting and further study of the optimal length for caregiver interventions are suggested.
Background: Malnutrition worsens health-related quality of life (HRQoL) and the prognosis of patients with advanced cancer. This study aimed to assess the clinical benefits of parenteral nutrition (PN) over oral feeding (OF) for patients with advanced cancer cachexia and without intestinal impairment.
Material and Methods: In this prospective multicentric randomized controlled study, patients with advanced cancer and malnutrition were randomly assigned to optimized nutritional care with or without supplemental PN. Zelen's method was used for randomization to facilitate inclusions. Nutritional and performance status and HRQoL using the European Organization for Research and Treatment of Cancer QLQ-C15-PAL questionnaire were evaluated at baseline and monthly until death. Primary endpoint was HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of =10 points compared with baseline, or death.
Results: Among the 148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent. In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88–1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06–2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80–1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm. In as treated analysis, serious adverse events (mainly infectious) were more frequent in the PN arm than in the OF arm (p = .01).
Conclusion: PN improved neither HRQoL nor survival and induced more serious adverse events than OF among patients with advanced cancer and malnutrition.
Clinical trial identification number. NCT02151214
Implications for Practice: This clinical trial showed that parenteral nutrition improved neither quality of life nor survival and generated more serious adverse events than oral feeding only among patients with advanced cancer cachexia and no intestinal impairment. Parenteral nutrition should not be prescribed for patients with advanced cancer, cachexia, and no intestinal failure when life expectancy is shorter than 3 months. Further studies are needed to assess the useful period with a potential benefit of artificial nutrition for patients with advanced cancer.
Introduction: Although shortcomings in clinician–family communication and decision making for incapacitated, critically ill patients are common, there are few rigorously tested interventions to improve outcomes. In this manuscript, we present our methodology for the Pairing Re-engineered Intensive Care Unit Teams with Nurse-Driven Emotional support and Relationship Building (PARTNER 2) trial, and discuss design challenges and their resolution.
Methods and analysis: This is a pragmatic, stepped-wedge, cluster randomised controlled trial comparing the PARTNER 2 intervention to usual care among 690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania. Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians. The PARTNER intervention is delivered by the interprofessional ICU team and overseen by 4–6 nurses from each ICU. It involves: (1) advanced communication skills training for nurses to deliver support to surrogates throughout the ICU stay; (2) deploying a structured family support pathway; (3) enacting strategies to foster collaboration between ICU and palliative care services and (4) providing intensive implementation support to each ICU to incorporate the family support pathway into clinicians’ workflow. The primary outcome is surrogates’ ratings of the quality of communication during the ICU stay as assessed by telephone at 6-month follow-up. Prespecified secondary outcomes include surrogates’ scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses’ scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.
We also discuss key methodological challenges, including determining the optimal level of randomisation, using existing staff to deploy the intervention and maximising long-term follow-up of participants.
Ethics and dissemination: We obtained ethics approval through the University of Pittsburgh, Human Research Protection Office. The findings will be published in peer-reviewed journals.