Overcoming recruitment challenges in a randomized clinical trial of early palliative care.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 140-140
Author(s):  
Susanne Zwahlen ◽  
Monica Fliedner ◽  
Steffen Eychmüller

140 Background: Reasons why clinical trials of early palliative care (ePC) interventions have prolonged patient recruitment time frames have been researched mainly qualitatively. Our objective was to identify major recruitment barriers encountered in our ePC trial, as well as to implement actions to overcome them. The impact of these changes on recruitment was measured. Methods: Data from all patients screened at the main study site (Inselspital, University Hospital Bern) between October 2013 and April 2016 were prospectively analyzed for: date of contact, reporting department, eligibility status, as well as consent status. Data until march 2014 was used to identify the main recruitment barriers. Starting in march 2014 changes to the recruitment process were implemented and all data from then onwards was used to estimate the impact of these adaptations. Results: The three main barriers identified were: Logistic, motivational, or related to eligibility criteria. Logistic barriers were overcome by changing from voluntary referral by the treating physician to systematically screening outpatient clinics of medical oncology, radio-oncology, gyneco-oncology and the internal medicine ward. Motivational barriers were addressed through education and dedicated study staff. Eligibility criteria were widened to include pancreatic and urothelial cancer. The actions implemented increased the accrual rate from one patient during a five month period to 2,8 patients per month. The widening of the eligibility criteria contributed to this result by recruiting 0,5 patients per month. The implementation of a systematic screening procedure increased the number of eligible patients invited to participate from one per month to 4,8 per month. An increase in the study consent rate from 20 % to 58 % can be translated into an increased acceptance of early palliative care. Conclusions: Education and dedicated study staff in order to increase the acceptance of ePC as well as a tool to identify eligible patients in a time-efficient manner improved patient recruitment in our ePC trial. We suggest that these factors can be relevant for the successful integration of ePC in standard oncology care.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 153-153
Author(s):  
Alina Basnet ◽  
Wajihuddin Syed ◽  
Shreya Sinha ◽  
Rashad Khan ◽  
Pallavi Kopparthy ◽  
...  

153 Background: Five year overall survival rate for localized and metastatic pancreatic adenocarcinoma (PAC) is discouraging at 31.5% and 2.7%, respectively. Evidence supports that early palliative care (PC) involvement leads to better quality of life and prolongs OS. Referral to PC is often delayed as it is perceived as an alternative rather than adjunctive care. We conducted a retrospective study to identify different variables that affect PC consultation among patients (pts) with PAC admitted to the hospital and to study the impact of health care utilizations on OS. Methods: A retrospective medical record review of pts with PAC diagnosed/treated at SUNY Upstate University hospital was conducted (2011-2015). Variables like age, sex, race, stage at diagnosis, insurance status, performance status (PS), frequency of hospital admissions, nights spent, procedure visits, blood products used, and time variable to PC referral from diagnosis were collected. OS was calculated using Kaplan Meier analysis. Results: We identified 325 pts with diagnosis of PAC. 86.72% pts had one or more hospital admissions during course of their illness and of these, 15.85% saw PC during initial inpatient admission. 36.23% saw PC later in the course of their illness and 13.96% pts were offered palliative care in first outpatient visit. Median time interval to see palliative care was 75 days (d) from diagnosis, with 25% pts seeing PC 304d from diagnosis. Variables that had significant impact on early palliative care encounter (0-30d) were age > 70, stage IV at diagnosis, PS of 4, medicare insurance, offered PC in first visit (p< 0.001). OS was not statistically significant between groups who had ≥ 1 vs 0 blood products given, < 3 vs ≥ 3 hospital admissions, ≤ 13 vs > 13 nights spent, ≥ 1 vs 0 procedures done, ≤ 3 vs > 3 consults service seen. Median OS for pts with time interval to see PC 0-30d vs > 120d was 33d and 510d respectively with adjusted hazard ratio of 6.252 (95% CI 3.462-11.29). Conclusions: We demonstrated that PC is underutilized with only minority of pts benefiting from it during their cancer treatment. OS was poor in group evaluated by palliative care early than late which could be due to patients with advanced disease and poor PS being referred early.


Author(s):  
Heather Carmichael ◽  
Hareklia Brackett ◽  
Maurice C Scott ◽  
Margaret M Dines ◽  
Sarah E Mather ◽  
...  

Abstract Despite significant morbidity and mortality for major burns, palliative care consultation (PCC) is underutilized in this population. The purpose of this study is to examine the impact of a protocol using recommended “triggers” for PCC at a single academic burn center. This is a retrospective review of patient deaths over a four-year period. Use of life-sustaining treatments, comfort care (de-escalation of one or more life-sustaining treatments) and do not attempt resuscitation (DNAR) orders were determined. Use of PCC was compared during periods before and after a protocol establishing recommended triggers for early (&lt;72 hrs of admission) PCC was instituted in 2019. A total of 33 patient deaths were reviewed. Most patients were male (n=28, 85%) and median age was 62 years [IQR 42-72]. Median revised Baux score was 112 [IQR 81-133]. Many patients had life-sustaining interventions such as intubation, dialysis, or cardiopulmonary resuscitation, often prior to admission. Amongst patients who survived &gt;24 hrs, 67% (n=14/21) had PCC. Frequency of PCC increased after protocol development, with 100% vs. 36% of these patients having PCC before death (p=0.004). However, even during the later period, less than half of patients had early PCC despite meeting criteria at admission. In conclusion, initiation of life-sustaining measures in severely injured burn patients occurs prior to or early during hospitalization. Thus, value-based early goals of care discussions are valuable to prevent interventions that do not align with patient values and assist with de-escalation of life-sustaining treatment. In this small sample, we found that while there was increasing use of PCC overall after developing a protocol of recommended triggers for consultation, many patients who met criteria at admission did not receive early PCC. Further research is needed to elucidate reasons why providers may be resistant to PCC.


2020 ◽  
Vol 10 (4) ◽  
pp. 395-403
Author(s):  
Silvia Tanzi ◽  
Francesco Venturelli ◽  
Stefano Luminari ◽  
Franco Domenico Merlo ◽  
Luca Braglia ◽  
...  

BackgroundEarly palliative care together with standard haematological care for advanced patients is needed worldwide. Little is known about its effect. The aim of the review is to synthesise the evidence on the impact of early palliative care on haematologic cancer patients’ quality of life and resource use.Patients and methodsA systematic review was conducted. The search terms were early palliative care or simultaneous or integrated or concurrent care and haematological or oncohaematological patients. The following databases were searched: PubMed, Embase, Cochrane, CINHAL and Scopus. Additional studies were identified through cross-checking the reference articles. Studies were in the English language, with no restriction for years. Two researchers independently reviewed the titles and abstracts, and one author assessed full articles for eligibility.ResultsA total of 296 studies titles were reviewed. Eight articles were included in the synthesis of the results, two controlled studies provided data on the comparative efficacy of PC interventions, and six one-arm studies were included. Since data pooling and meta-analysis were not possible, only a narrative synthesis of the study results was performed. The quality of the two included comparative studies was low overall. The quality of the six non-comparative studies was high overall, without the possibility of linking the observed results to the implemented interventions.ConclusionsStudies on early palliative care and patients with haematological cancer are scarce and have not been prospectively designed. More research on the specific population target, type and timing of palliative care intervention and standardisation of collected outcomes is required.PROSPERO registration numberCRD42020141322.


2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 138-138
Author(s):  
Breffni Hannon ◽  
Nadia Swami ◽  
Monika K. Krzyzanowska ◽  
Natasha B. Leighl ◽  
Amit M. Oza ◽  
...  

138 Background: Early palliative care referral is encouraged for patients with advanced cancer. However, little is known about patients’ perceptions of the impact and relevance of early referral. We conducted a qualitative study in which patients with advanced cancer were interviewed following completion of a randomized controlled trial comparing early palliative care with standard oncology care. Our aim was to delineate what, in the opinion of patients, were the respective roles of the oncology and palliative care teams in an outpatient setting. Methods: We conducted qualitative interviews with patients following completion of a cluster randomised controlled trial of early versus routine palliative care referral. Participants were recruited from 24 medical oncology clinics at a comprehensive cancer center. Selective sampling was employed to ensure equivalent numbers of participants from intervention vs. control arms, male vs. female, age ≥60 vs. <60 years, with high vs. low self-reported quality of life, and with high vs. low satisfaction with care. Forty-eight patients (26 intervention and 22 control) with advanced lung, breast, gynecological, gastrointestinal and genitourinary cancers completed interviews lasting 25 to 90 minutes. Control patients were asked about the role of oncology; intervention patients were asked about both teams. Interviews were recorded, transcribed and analysed using NVivo. A grounded theory approach was used to explore emerging themes. Results: Several themes emerged in relation to the contrast between oncology (OC) and palliative care (PC) including (1) the focus of the consultation, with OC tending to focus on cancer or treatment options while PC was regarded as being more holistic, including physical, psychological and family domains; (2) the model of care delivery, with OC described as being clinician-led and time-limited, in contrast with PC where time was more flexible and the patient set the agenda; and (3) the complementary nature of early palliative care alongside standard oncology care in terms of overall well-being. Conclusions: From a patient perspective, palliative care and medical oncology have distinct and complementary roles, supporting the relevance of early referral.


2020 ◽  
Author(s):  
Ximena Garcia-Quintero ◽  
Luis Gabriel Parra-Lara ◽  
Angelica Claros-Hulbert ◽  
Maria Isabel Cuervo-Suarez ◽  
Wendy Gomez-Garcia ◽  
...  

Abstract Background: The disparities in access to pediatric palliative care and pain management in Latin America remains an unaddressed global health issue. Efforts to improve the development of Palliative Care (PC) provision have traditionally targeted services for adults, leaving the pediatric population unaddressed. Examples of such services are scarce and should be portrayed in scientific literature to inform decision-makers and service providers on models of care available to tackle the burden of Pediatric Palliative Care (PPC) in Low-and middle-income countries (LMIC). The purpose of this study is to describe the implementation of a pediatric palliative care program, “Taking Care of You ” (TCY) , in a tertiary care, university hospital in Cali, Colombia. Methods: A program’s database was built with children between 0 to 18 years old and their families, from year 2017 to 2019. Descriptive analysis was carried out to evaluate the impact of the program and service delivery. A theory-based method was directed to describe the PPC program, according to the implementation of self-designed taxonomy, mapping theoretical levels and domains. Clinical outcomes in patients were included in the analysis. Results: Since 2017 the program has provided PPC services to 1.965 children. Most of them had an oncologic diagnosis and were referred from hospitalization services (53%). The number of ambulatory patients increased by 80% every trimester between 2017-2018. A 50% increase was reported in hospitalization, emergency, and intensive care units during the same time period. Conclusions: The program addressed a gap in the provision of PPC to children in Cali. It shows effective strategies used to implement a PPC program and how the referral times, coordination of care, communication with other hospital services were improved while providing compassionate/holistic care to children with life-limiting and threatening diseases and in end-of-life. The implementation of this program has required the onset of specific strategies and arrangements to promote awareness and education proving it a hard task, yet not impossible.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20639-e20639
Author(s):  
Breffni Hannon ◽  
Nadia Swami ◽  
Monika Krzyzanowska ◽  
Natasha B. Leighl ◽  
Amit M. Oza ◽  
...  

e20639 Background: Early palliative care referral is encouraged for patients with advanced cancer. However, little is known about patients’ perceptions of the impact and relevance of early referral. We conducted a qualitative study in which patients with advanced cancer were interviewed following completion of a randomized controlled trial comparing early palliative care with standard oncology care. Our aim was to delineate what, in the opinion of patients, were the respective roles of the oncology and palliative care teams in an outpatient setting. Methods: We conducted qualitative interviews with patients following completion of a cluster randomised controlled trial of early versus routine palliative care referral. Participants were recruited from 24 medical oncology clinics at a comprehensive cancer center. Selective sampling was employed to ensure equivalent numbers of participants from intervention vs. control arms, male vs. female, age ≥60 vs. <60 years, with high vs. low self-reported quality of life, and with high vs. low satisfaction with care. Forty-eight patients (26 intervention and 22 control) with advanced lung, breast, gynecological, gastrointestinal and genitourinary cancers completed interviews lasting 25 to 90 minutes. Control patients were asked about the role of oncology; intervention patients were asked about both teams. Interviews were recorded, transcribed and analysed using NVivo. A grounded theory approach was used to explore emerging themes. Results: Several themes emerged in relation to the contrast between oncology (OC) and palliative care (PC) including (1) the focus of the consultation, with OC tending to focus on cancer or treatment options while PC was regarded as being more holistic, including physical, psychological and family domains; (2) the model of care delivery, with OC described as being clinician-led and time-limited, in contrast with PC where time was more flexible and the patient set the agenda; and (3) the complementary nature of early palliative care alongside standard oncology care in terms of overall well-being. Conclusions: From a patient perspective, palliative care and medical oncology have distinct and complementary roles, supporting the relevance of early referral.


2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 137-137
Author(s):  
Jessica A. Lynch ◽  
Susan DeSanto-Madeya ◽  
Jessica A. Zerillo ◽  
Matt Gregas ◽  
David F. McDermott ◽  
...  

137 Background: Early palliative care (PC) improves quality of life (QOL) and enhances end-of-life (EOL) care, but the optimal timing and most effective model for integrating PC into oncologic care is uncertain. To understand the impact of an integrated model with PC providers embedded with oncologists vs. usual care (UC) with referral at the discretion of the same oncologists, we examined the timing and delivery of PC and Quality Oncology Practice Initiative (QPOI) EOL metrics among patients with RCC and M in a single clinic. We hypothesized that integrated PC would result in more referrals, earlier contact with PC and better QOPI EOL metrics compared with UC. Methods: In a retrospective cohort study of patients with RCC and M in the Beth Israel Deaconess Biologics Clinic who expired between 10/1/12 and 12/31/14, we compared patients seen 2 days/week, when referral to PC was discretionary, with a third day when PC providers shared the clinic for real-time consultations. Patients were identified as meeting PC eligibility if they had recurrent, metastatic disease and were on active treatment or had a symptom severity of 7+ on Edmonton Symptom Assessment Scale (ESAS). Two oncologists saw all patients, regardless of day. Results: Seventy-six patients expired, 19 in the Integrated PC model and 57 with UC. Patients were similar with respect to diagnosis and demographics except for smoking. The integrated model substantially improved timing and location of PC. In the integrated PC model, 85% were seen by PC compared with 45% in UC (P = 0.002). All patients in the integrated model began PC as an outpatient compared with 36% in UC (P < 0.001). The mean number of days from first PC contact to death was 28 (SD = 54) for UC and 118 (SD = 120) with integrated PC (P < 0.001). The location of death did not differ significantly between models, occurring outside the hospital with hospice among 71% of patients in the integrated model and 53% in UC (P = 0.25). Results were similar in relative risk models adjusted for smoking. Conclusions: A practice model that integrated PC with oncologic care was associated with more PC referrals, earlier contact, and a nonsignificant trend toward fewer deaths in hospital and ICU.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17503-e17503
Author(s):  
Vittoria G. Espeli ◽  
Claudia Gamondi ◽  
Tanja Fusi-Schmidhauser

e17503 Background: early palliative care (PC) for patients with advanced cancer improves quality of life, promotes home deaths and can improve survival. Limited data are available regarding PC in advanced head and neck cancer (HNC) patients. To investigate the effect of introducing specialized PC in patients with relapsed and/or metastatic head and neck cancer. Methods: between October 2010 and December 2018, the medical charts of all patients treated in the Oncology Institute of Southern Switzerland with relapsed and/or metastatic HNC were reviewed. Site, status of disease (metastatic at diagnosis, locally or metastatic relapsed), type and lines of treatment, treatment response and referral to specialist palliative care (yes or no) were documented. Comparisons were made between patients referred and non-referred to PC. Results: sixty-two patients with relapsed/metastatic HNC were identified, 32 (51.6%) of which were referred to specialized PC. Patients were mainly men (47, 75.8%), with a median age of 66 years (range 43 – 86). Forty-two patients (67.7%) had a metastatic disease and the most common site of tumor was the oropharynx (35.5%), followed by oral cavity (32.3%), larynx (16.1%), hypopharynx (12.9%), and unknown primary (3.2%). Forty-eight patients (77.4%) were treated with systemic treatment (75% in the PC group and 80% in the non-PC group, p = 0.638). The median overall survival was 8.1 months for all patients, 8 months for the PC group and 8.7 months for the non-PC group, without significant difference (p = 0.440). Of the deceased patients, 70% of the PC group and 73.3% of the non-PC group received chemotherapy in the last three months of life. A greater percentage of patients in the PC group died at home, but without significant difference (39.2% vs. 19%, p = 0.134). Conclusions: only half of the patient had access to specialized PC. Whereas it did not seem to affect overall survival nor influence chemotherapy prescription, it seemed to favor home deaths. Further studies investigating the impact of early PC in recurrent and/or metastatic HNC are needed to improve access to PC and maximize benefits.


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS777-TPS777
Author(s):  
Stephanie Lelond ◽  
Harvey Chochinov ◽  
Paul Joseph Daeninck ◽  
Benjamin Adam Goldenberg ◽  
Lisa Lix ◽  
...  

TPS777 Background: Pancreatic cancer is lethal. Chemotherapy can improve survival by months; however, many patients experience an overwhelming burden of cancer-associated symptoms and poor quality of life (QOL). Early palliative care (EPC) alongside standard oncologic care results in improved QOL and survival in patients with lung cancer. Although international guidelines recommend EPC for patients with advanced pancreatic cancer (PANC), the benefit is not known. Objectives: The primary objective is to test for change in QOL between baseline (BL) and 16 weeks (wk). Secondary objectives are to test for change between BL and 16 wk in (a) symptom control; and (b) depression and anxiety. Methods: This prospective case-crossover study of patients with PANC provides EPC plus standard oncologic care. Primary oncology clinics refer patients to an EPC team led by a palliative care physician and a clinical nurse specialist. BL questionnaires are completed prior to initial EPC assessment, then every 4 wk until wk 16. EPC visits are every 2 wk for the first month, every 4 wk until wk 16, and then as needed. QOL, symptom control, anxiety and depression are measured using the FACT-Hep tool, ESAS-r, HADS and PHQ-9, respectively. A generalized linear model will test for statistically significant change in scores between BL and 16 wk; chemotherapy (yes/no) is included as a confounding covariate; model fit will be assessed. A sample size of 20 patients provides 80% power after controlling for covariate effects. 40 patients will be enrolled to account for missing data. To date, 28 patients have enrolled and 17 have completed the intervention. Significance: The benefit of EPC for patients with PANC is not known, however, EPC is increasingly recognized internationally by patients and stakeholders as a critical intervention which may improve both QOL and satisfaction with care. The Canadian Partnership Against Cancer’s report on the patient experience states “the best possible patient experience means all people with cancer have equitable access to high-quality person-centered palliative care”. This study offers access to EPC and provides an environment in which the benefit of an integrated approach is evaluated.


2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi201-vi201 ◽  
Author(s):  
Margaret Johnson ◽  
Luis Ramirez ◽  
James Herndon ◽  
Woody Massey ◽  
Eric Lipp ◽  
...  

Abstract OBJECTIVE There is no validated model for delivering palliative care (PC) in the glioblastoma (GBM) population. The primary objectives were to assess the feasibility and determine the acceptability of a time-based model of integrated specialty PC to patients and providers. Secondary objectives were to estimate the impact on healthcare utilization and quality of life (QoL) compared to historical controls. METHODS We consented and referred patients to PC at their initial Neuro-Oncology consultation between 4/2018 and 5/2019. We conducted QoL assessments (NCCN Distress Tool; Functional Assessment of Cancer Therapy-Brain (FACT-BR); Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); Epworth Sleepiness Scale (ESS)) at (1) baseline (2) immediately after chemoradiation, and (3) 6 months following chemoradiation. Ongoing PC follow-up was at the discretion of the PC provider. We administered the Edmonton Symptom Assessment System (ESAS) before and after PC visits. We measured patient and referring provider satisfaction using FAMCARE-16 and a PC departmental survey, respectively. RESULTS We did not meet our goal enrollment of 50 patients. 32 were offered participation, 12 consented and 8 attended at least one PC visit. The mean number of PC visits was 1.6. Mean age was 62 (42–79). 75% had a KPS ≥80. Of those that did not complete the study, 2 died and 5 either withdrew consent or declined further visits. At baseline, 91.7 % had a NCCN distress score ≥4. Patients were overall satisfied with the intervention. CONCLUSION Introduction of specialty PC at the time of GBM diagnosis is challenging. Participants reported their experience as overall positive. Results from referring providers are pending. Due to low-enrollment we did not pursue further statistical comparisons regarding healthcare utilization compared to historical controls.


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