Dry mouth in patients with a life-limiting condition or frailty: a study protocol for two intervention studies and a nested qualitative sub-study (the Dry mOuth Project, DROP).

BACKGROUND: Despite its prevalent and impactful nature, dry mouth remains an underexposed and undertreated symptom in patients with a life-limiting condition or frailty. The main contributing factors are a lack of awareness and knowledge amongst both healthcare professionals and patients, and a scarcity of effective, evidence-based interventions. In the DRy mOuth Project (DROP), we address these factors by investigating both a non-pharmacological and a pharmacological intervention: a nurse-led patient education program and locally applied pilocarpine. METHODS: This intervention-based research project consists of two parallel studies. The non-pharmacological study is a cluster non-randomized controlled trial in 228 palliative nursing home and hospital patients, investigating the effect of structured use of guidelines and of patient education on dry mouth symptoms. This intervention, a nurse-led patient education program (the Mouth Education Program, MEP), will be compared to care as usual, the control. The pharmacological study is a double-blind placebo-controlled randomized trial that examines the effect of locally applied pilocarpine drops in 120 patients with dry mouth symptoms. Both studies use the same mixed-methods study design, in which the primary outcome is the clinical response to the intervention at 4 weeks, as measured by a dry mouth severity score (numeric rating scale from 0 to 10). Other outcomes, as measured by questionnaires over a 12-week follow-up period, include durability of the effect, impact on quality of life and, adherence and acceptability of the intervention. In addition, the feasibility and cost-effectiveness are evaluated by means of questionnaires and focus groups with healthcare professionals, and interviews with patients. DISCUSSION: This study investigates the effectiveness and feasibility of two interventions for dry mouth symptoms in patients with life-limiting conditions or frailty. Due to the large-scale and mixed-method nature of the study, this study will also improve our understanding of dry mouth and its relating factors and of the patients' and healthcare professionals' experiences with symptoms, care and guidelines of dry mouth, including any perceived barriers and facilitators. TRIAL REGISTRATION: NCT05964959 & NCT05506137.

Assessment of patient symptom burden and information needs helps tailoring palliative care consultations: An observational study.

OBJECTIVE: The objective of this study is to study (1) the relationship between patient-reported symptom burden and information needs in hospital-based palliative care and (2) differences in patient-reported needs during the disease trajectory. METHODS: Observational study: patient-reported symptom burden and information needs were collected via a conversation guide comprising assessment scales for 12 symptoms (0-10), the question which symptom has priority to be solved and a question prompt list on 75 palliative care-related items (35 topics, 40 questions). Non-parametric tests assessed associations. RESULTS: Conversation guides were used by 266 patients. Median age was 65 years (IQ-range, 57-72), 49% were male and 96% had cancer. Patients reported highest burden for Fatigue (median = 7) and Loss of appetite (median = 6) and prioritised Pain (26%), Fatigue (9%) and Shortness of breath (9%). Patients wanted information about 1-38 (median = 14) items, mostly Fatigue (68%), Possibilities to manage future symptoms (68%) and Possible future symptoms (67%). Patients also wanted information about symptoms for which they reported low burden. Patients in the symptom-directed phase needed more information about hospice care. CONCLUSION: Symptom burden and information needs are related. Patients often also want information about non-prioritised symptoms and other palliative care domains. Tailored information-provision includes inviting patients to also discuss topics they did not consider themselves.

A simple risk score list can be used to predict the occurrence of delirium in patients admitted to inpatient hospice care: A medical record study.

OBJECTIVE: This study aimed to examine whether the 10-item Risk Score List (RSL) accurately predicts delirium in patients admitted to inpatient hospice care and whether this instrument can be simplified. Determining the risk for developing delirium can help to treat these patients in a timely manner. METHODS: This was a retrospective medical record study in patients who died in 2019 or 2020 in three hospices. Predictive values were examined using Cox regression analysis, crosstabs, and C-statistic. RESULTS: In total, 240 patients were included. Median age at admission was 78 (IQR 70-84) years. Primary diagnosis most often was cancer (n = 186, 78%); 173 (72%) patients had an increased risk of delirium according to RSL, of whom 120 (69%) developed delirium. Overall, 147 (61%) patients developed delirium. The RSL significantly predicted future delirium (HR 3.25, CI 1.87-5.65, p < 0.01) and had a sensitivity of 85%, a specificity of 43%, positive predictive value of 62%, negative predictive value of 73%, and a C-statistic of 0.64. Simplifying the RSL to four items still significantly predicted future delirium, with similar predictive values. CONCLUSION: Delirium occurs in more than half of patients admitted to hospice care. The RSL can be simplified to four items, without compromising on predictive accuracy.

Palliative care needs of advanced cancer patients in the emergency department at the end of life: an observational cohort study.

PURPOSE: Patients with advanced cancer commonly visit the emergency department (ED) during the last 3 months of life. Identification of these patients and their palliative care needs help initiating appropriate care according to patients' wishes. Our objective was to provide insight into ED visits of advanced cancer patients at the end of life. METHODS: Adult palliative patients with solid tumours who died < 3 months after their ED visit were included (2011-2014). Patients, ED visits, and follow-up were described. Factors associated with approaching death were assessed using Cox proportional hazards models. RESULTS: Four hundred twenty patients were included, 54.5% was male, median age 63 years. A total of 54.6% was on systemic anti-cancer treatments and 10.5% received home care ≥ 1 per day. ED visits were initiated by patients and family in 34.0% and 51.9% occurred during out-of-office hours. Dyspnoea (21.0%) or pain (18.6%) were most reported symptoms. Before the ED visit, limitations on life-sustaining treatments were discussed in 33.8%, during or after the ED visit in 70.7%. Median stay at the ED was 3:29 h (range 00:12-18:01 h), and 319 (76.0%) were hospitalized. Median survival was 18 days (IQ range 7-41). One hundred four (24.8%) died within 7 days after the ED visit, of which 71.2% in-hospital. Factors associated with approaching death were lung cancer, neurologic deterioration, dyspnoea, hypercalcemia, and jaundice. CONCLUSION: ED visits of advanced cancer patients often lead to hospitalization and in-hospital deaths. Timely recognition of patients with limited life expectancies and urgent palliative care needs, and awareness among ED staff of the potential of ED-initiated palliative care may improve the end-of-life trajectory of these patients.

The COMPASS study: A descriptive study on the characteristics of palliative care team consultation for cancer patients in hospitals.

OBJECTIVE: To describe the characteristics of palliative care team (PCT) consultation for patients with cancer who are admitted in hospital and to investigate when and why PCTs are consulted. METHODS: In this descriptive study in ten Dutch hospitals, the COMPASS study, we compared characteristics of patients with cancer for whom a PCT was or was not consulted (substudy 1). We also collected information about the process of PCT consultations and the disciplines involved (substudy 2). RESULTS: In substudy 1, we included 476 patients. A life expectancy <3 months, unplanned hospitalisation and lack of options for anti-cancer treatment increased the likelihood of PCT consultation. In substudy 2, 64% of 550 consultations concerned patients with a life expectancy of <3 months. The most frequently mentioned problems that were identified by the PCTS were complex pain problems (56%), issues around the organisation of care (31%), fatigue (27%) and dyspnoea (27%). There was much variance between hospitals in the disciplines that were involved in consultations. CONCLUSION: Palliative care teams in Dutch hospitals are most often consulted for patients with a life expectancy of <3 months who have an unplanned hospital admission because of physical symptoms or problems. We found much variance between hospitals in the composition and activities of PCTs.

The effect and process evaluations of the national quality improvement programme for palliative care: the study protocol.

BACKGROUND: The nationwide integration of palliative care best practices into general care settings is challenging but important in improving the quality of palliative care. This is why the Dutch National Quality Improvement Programme for Palliative Care has recently been launched. This four-year programme consists of about 70 implementation trajectories of best practices. A large evaluation study has been set up to evaluate this national programme and separate implementation trajectories. METHODS/DESIGN: This paper presents the protocol of the evaluation study consisting of a quantitative effect evaluation and a qualitative process evaluation. The effect evaluation has a pre-test post-test design, with measurements before implementation (month 0) and after implementation (month 9) of a best practice. Patients are eligible if they have a life expectancy of less than six months and/or if they are undergoing palliative treatment and provided they are physically and mentally capable of responding to questionnaires. Bereaved relatives are eligible if they have been involved in the care of a deceased patient who died after a sickbed between six weeks and six months ago. Three types of measurement instruments are used: (1) numerical rating scales for six symptoms (pain, fatigue, breathlessness, obstipation, sadness and anxiety), (2) the Consumer Quality Index Palliative Care - patient version and (3) the version for bereaved relatives.The process evaluation consists of analysing implementation plans and reports of the implementation, and individual and group interviews with healthcare professionals. This will be done nine to eleven months after the start of the implementation of a best practice. DISCUSSION: This mixed-method evaluation study gives more insight into the effects of the total programme and the separate implementation trajectories. However, evaluation of large quality improvement programmes is complicated due to changing, non-controlled environments. Therefore, it is important that an effect evaluation is combined with a process evaluation. TRIAL REGISTRATION: NTR-4085.

Association between Inappropriate End-of-Life Cancer Care and Specialist Palliative Care: A Retrospective Observational Study in Two Acute Care Hospitals.

A substantial number of patients with life-threatening illnesses like cancer receive inappropriate end-of-life care. Improving their quality of end-of-life care is a priority for patients and their families and for public health. To investigate the association between provision, timing, and initial setting of hospital-based specialist palliative care and potentially inappropriate end-of-life care for patients with cancer in two acute care hospitals in the Netherlands, we conducted a retrospective observational study using hospital administrative databases. All adults diagnosed with or treated for cancer in the year preceding their death in 2018 or 2019 were included. The main exposure was hospital-based specialist palliative care initiated >30 days before death. The outcome measures in the last 30 days of life were six quality indicators for inappropriate end-of-life care (≥2 ED-visits, ≥2 hospital admissions, >14 days hospitalization, ICU-admission, chemotherapy, hospital death). We identified 2603 deceased patients, of whom 14% (n = 359) received specialist palliative care >30 days before death (exposure group). Overall, 27% (n = 690) received potentially inappropriate end-of-life care: 19% in the exposure group, versus 28% in the non-exposure group (p < 0.001). The exposure group was 45% less likely to receive potentially inappropriate end-of-life care (AOR 0.55; 95% CI 0.41 to 0.73). Early (>90 days) and late (≤90 and >30 days) initiation of specialist palliative care, as well as outpatient and inpatient initiation, were all associated with less potentially inappropriate end-of-life care (AOR 0.49; 0.62; 0.32; 0.64, respectively). Thus, timely access to hospital-based specialist palliative care is associated with less potentially inappropriate end-of-life care for patients with cancer. The outpatient initiation of specialist palliative care seems to enhance this result.

Randomized controlled study of pain education in patients receiving radiotherapy for painful bone metastases.

BACKGROUND: Although short-course radiotherapy is an effective treatment for patients with painful bone metastases, pain is not always sufficiently controlled. We therefore investigated the additional effect of a nurse-led pain education program on pain control and quality of life (QoL). PATIENTS AND METHODS: In this multicenter study, patients with solid tumor bone metastases and a worst pain intensity of ≥5 on a 0-10 numeric rating scale (NRS) were randomized between care as usual (control-group) and care as usual plus the Pain Education Program (PEP-group). PEP consisted of a structured interview and personalized education with follow-up phone calls. Patients completed the Brief Pain Inventory, EORTC QLQ-C15-PAL and BM22 at week 0, 1, 4, 8 and 12. The primary outcome was pain control, defined as the number of patients whose worst pain intensity was <5 on a 0-10 NRS after 12 weeks. Secondary outcomes were time to reach control of pain (NRS < 5), mean worst pain and average pain, and QoL at weeks 1, 4, 8 and 12. RESULTS: Of 308 included patients, 182 (92 PEP-group) completed 12 weeks follow-up. At 12 weeks, more patients in the PEP-group (71%) compared to the control-group (52%) reported pain control (P =.008). In the PEP-group, pain control was reached earlier than in the control-group (median 29 days versus 56 days; P =.003). Mean worst and average pain decreased in both groups but decreased more in the PEP-group. QoL did not differ between the groups. CONCLUSION: The addition of PEP to care as usual for patients treated with radiotherapy for painful bone metastases resulted in less pain and faster pain control.

Non-specialist palliative care - question prompt list preparation: patient, family and clinician experiences.

OBJECTIVES: Question prompt lists (QPLs) support patients and family to ask questions they consider important during conversations with clinicians. We aimed to evaluate how a QPL developed for specialist palliative care is used during consultations and is perceived by patients and family, and how non-specialist clinicians would use the QPL. We further developed the QPL using these perspectives. METHODS: The QPL is part of a conversation guide on palliative care. Patients and family were asked to select topics and questions before consultation with a palliative care consultant. This qualitative study (2016-2018) included 18 interviews with patients and family who had used the QPL, 17 interviews with non-specialist clinicians and 32 audiotaped consultations with palliative care consultants. The data were analysed thematically and iteratively to adjust the QPL accordingly. RESULTS: All participants considered the QPL elaborate, but recommended keeping all content. Patients and family found that it helps to structure thoughts, ask questions and regain a sense of control. They also felt the QPL could support them in gathering information. Although it could evoke strong emotions, their real challenge was being in the palliative phase. Clinicians considered the QPL especially helpful as an overview of possible discussion topics. During audiotaped consultations, topics other than those selected were also addressed. CONCLUSION: By using the QPL, patients and family felt empowered to express their information needs. Its use may not be as unsettling as clinicians assume. Nevertheless, clinicians who hand out the QPL should introduce the QPL properly to optimise its use.

The self-perceived palliative care barriers and educational needs of clinicians working in hospital primary care teams and referral patterns: lessons learned from a single-center survey and cohort study.

BACKGROUND: Within the generalist-plus-specialist palliative care model, palliative care is mainly provided by nurses and physicians of hospital primary care teams. Palliative care consultation teams (PCCTs) support these clinicians in adequately caring for patients with advanced illnesses. Our team started in 2012. The aim of this study was to assess the self-perceived barriers, educational needs and awareness of available palliative care support options among our hospital primary care teams. In addition, palliative care referral patterns were evaluated. METHODS: Single-center mixed methods study. Outcomes of two surveys of primary care team clinicians (2012 and 2016) on barriers to palliative care, educational needs and awareness of palliative care support options were compared (chi-square, Mann-Whitney U tests, qualitative analysis). Palliative care referral characteristics were evaluated (2012-2017), including referral timing (survival since referral) (descriptive statistics, Kaplan-Meier methodology). Predictions of survival at referral were analyzed (weighted Kappa). RESULTS: In 2012 and 2016, the most frequently reported barrier was the late initiation of the palliative care approach. Clinicians reported a need for education on physical symptom management and basic palliative care principles. Awareness of support options increased from 2012 to 2016, including improved familiarity with the PCCT (56% vs. 85%, P<0.001) and positive appraisal of the team (8% vs. 40% gave an 'excellent' rating, P<0.001). The use of national symptom management guidelines also improved (23% vs. 53%, P<0.001). Of 1,404 referrals, 86% were for cancer patients. Referrals increased by 28% (mean) per year. Medical oncology clinicians referred most frequently (27%) and increasingly early in the disease trajectory (survival ≥3 months after referral) (P=0.016). Median survival after referral was 0.9 (range, 0-83.3) months. Referring physicians overestimated survival in 44% of patients (kappa 0.36, 95% CI: 0.30-0.42). CONCLUSIONS: Primary care team clinicians persistently reported needing support with basic palliative care skills. PCCTs should continuously focus on educating primary care teams and promoting the use of guidelines. Because physicians tend to overestimate survival and usually referred patients late for specialist palliative care, consultation teams should support primary care teams to identify, treat and refer patients with palliative care needs in a timely manner.

Surprise Question and Performance Status Indicate Urgency of Palliative Care Needs in Patients with Advanced Cancer at the Emergency Department: An Observational Cohort Study.

Background: The surprise question (SQ), "Would I be surprised if this patient died within one year?", is a simple instrument to identify patients with palliative care needs. The SQ-performance has not been evaluated in patients with advanced cancer visiting the emergency department (ED). Objective: To evaluate SQ's test characteristics and predictive value in patients with advanced cancer visiting the ED. Design: Observational cohort study. Setting: Patients >18 years with advanced cancer in the palliative phase visiting the ED of an academic medical center. Methods: Attending physicians answered the SQ (not surprised [NS] or surprised [S]) and estimated Eastern Cooperative Oncology Group (ECOG)-performance status. Disease, visit, and follow-up characteristics were retrospectively collected from charts. SQ's sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), and Harrell's c-index were calculated. Prognostic values of SQ and other variables were assessed by using Cox proportional hazards models. Results: Two-hundred-and-forty-five patients were included (203 NS [83%] and 42 S [17%]), median age 62 years, 48% male. Follow-up on overall survival was updated until February 2019. At ED entry, NS-patients had worse ECOG-performance and more symptoms. At study closure, 233 patients had died (95%). Median survival was three months for NS-patients (interquartile [IQ]-range: 1-8); nine months for S-patients (IQ-range: 3-28) (p < 0.0001). SQ-performance for one-year mortality: sensitivity 89%, specificity 40%, PPV 85%, NPV 50%, c-index 0.56, and hazard ratio 2.1 for approaching death. ECOG 3-4 predicted death in NS-patients; addition to the SQ improved c-index (0.65); sensitivity (40%), specificity (92%), PPV (95%), and NPV (29%). Conclusions: At the ED, the SQ plus ECOG 3-4 helps identifying patients with advanced cancer and a limited life expectancy. Its use supports initiating appropriate care related to urgency of palliative care needs.

End-of-Life Trajectories of Patients With Hematological Malignancies and Patients With Advanced Solid Tumors Visiting the Emergency Department: The Need for a Proactive Integrated Care Approach.

PURPOSE: Patients with hematological malignancies (HM) have more unpredictable disease trajectories compared to patients with advanced solid tumors (STs) and miss opportunities for a palliative care approach. They often undergo intensive disease-directed treatments until the end of life with frequent emergency department (ED) visits and in-hospital deaths. Insight into end-of-life trajectories and quality of end-of-life care can support arranging appropriate care according to patients' wishes. METHOD: Mortality follow-back study to compare of end-of-life trajectories of HM and ST patients who died <3 months after their ED visit. Five indicators based on Earle et al. for quality of end-of-life care were assessed: intensive anticancer treatment <3 months, ED visits <6 months, in-hospital death, death in the intensive care unit (ICU), and in-hospice death. RESULTS: We included 78 HM patients and 420 ST patients, with a median age of 63 years; 35% had Eastern Cooperative Oncology Group performance status 3-4. At the ED, common symptoms were dyspnea (22%), pain (18%), and fever (11%). After ED visit, 91% of HM patients versus 76% of ST patients were hospitalized (P = .001). Median survival was 17 days (95% confidence interval [CI]: 15-19): 15 days in HM patients (95% CI: 10-20) versus 18 days in ST patients (95% CI: 15-21), P = .028. Compared to ST patients, HM patients more often died in hospital (68% vs 30%, P < .0001) and in the ICU or ED (30% vs 3%, P < .0001). CONCLUSION: Because end-of-life care is more aggressive in HM patients compared to ST patients, a proactive integrated care approach with early start of palliative care alongside curative care is warranted. Timely discussions with patients and family about advance care planning and end-of-life choices can avoid inappropriate care at the end of life.

Validation of the Dutch version of the Edmonton Symptom Assessment System.

BACKGROUND: The Utrecht Symptom Diary (USD) is a Dutch and adapted version of the Edmonton Symptom Assessment System, a patient-reported outcome measurement (PROM) tool to asses and monitor symptoms in cancer patients. This study analyses the validity and responsiveness of the USD and the cutoff points to determine the clinical significance of a symptom score. METHODS: Observational longitudinal cohort study including adult in- and outpatients treated in an academic hospital in the Netherlands who completed at least one USD as part of routine care (2012-2019). The distress thermometer and problem checklist (DT&PC) was used as a reference PROM. Content, construct and criterion validity, responsiveness, and cutoff points are shown with prevalences, area under receiver operating characteristic (ROC) curve, Chi-squared test, Wilcoxon signed-rank test, and positive and negative predictive values, respectively. RESULTS: A total of 3913 patients completed 22 400 USDs. Content validity was confirmed for all added USD items with prevalences of ≥22%. All USD items also present on the DT&PC demonstrated a good criterion validity (ROC >0.8). Construct validity was confirmed for the USD as a whole and for the items dry mouth, dysphagia and well-being (P < .0001). USD scores differed significantly for patients when improving or deteriorating on the DT&PC which confirmed responsiveness. Optimal cutoff points (3 or 4) differed per symptom. CONCLUSION: The USD is a valid 12-item PROM for the most prevalent symptoms in cancer patients, which has content, criterion, and construct validity, and detects clinically important changes over time, in both curative and palliative phase.

Nursing intervention for fatigue during the treatment for cancer.

Cancer-related fatigue (CRF) is a common symptom in patients treated for cancer. For patients receiving chemotherapy, the prevalence is 75% to 90%; in those receiving radiation, 65%. The management of CRF is difficult because its nature is not yet fully explained and it has a variety of causes. The purpose of the review is to identify interventions that can be used by nurses successfully to reduce fatigue during cancer treatment. A search of the medical (PubMed) and nursing (CINAHL) literature (1995 to February 2005) produced 18 studies. In two-thirds of the studies, the populations were breast cancer patients. Half of the studies had a sample size of less then 30 patients. The studies included dealt with sleep promotion (1), instruction and education (5), exercise (10), and distraction and relaxation (2). Significant effects were found in studies promoting exercise. For interventions on sleep promotion and on education and counseling, a positive result was found, but this was not significant. For distraction and relaxation, only an effect until a few hours after the intervention was found. Given the multidimensional nature of CRF, a combination of interventions is most likely to be effective. Thus far, such an approach by nurses during cancer treatment has not been tested.