Effect of inpatient palliative care on supportive care measures in patients undergoing hematopoietic cell transplantation (HCT).

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 70-70
Author(s):  
Areej El-Jawahri ◽  
Harry VanDusen ◽  
Alyssa L. Fenech ◽  
Alison Kavanaugh ◽  
Vicki A. Jackson ◽  
...  

70 Background: Inpatient palliative care integrated with transplant care has been shown to improve patient-reported quality of life (QOL), symptom burden, and psychological distress during hospitalization for HCT. However, the impact of palliative care on supportive care practices during HSCT remains unknown. Methods: This secondary analysis is based on a single-site randomized clinical trial of 160 patients with hematologic malignancies undergoing HSCT between 8/2014 and 1/2016. Participants received either inpatient palliative care integrated with transplant care (n = 81) or transplant care alone (n = 79). We used the electronic health record to obtain data on supportive care measures during HSCT including the use of patient-controlled analgesia (PCA), intravenous pain medications, atypical antipsychotics (used to treat nausea/anxiety), psychostimulants, antidepressants, hypnotics, and the use of standing orders (as opposed to as needed ‘PRN’) for supportive care medications. We compared the proportion of subjects in each group receiving these supportive care measures using Fisher’s exact test. Results: Patients randomized to the palliative care intervention were more likely to use PCA (32.1% vs. 15.19%, P = 0.015), and atypical antipsychotics (35.8% vs. 17.7%, P = 0.012) compared to those receiving transplant care alone. Intervention participants were also more likely to have standing orders for their supportive care medications (74.1% vs. 56.9%, P = 0.030) compared to those receiving transplant care alone. Study groups did not differ in the of intravenous pain medications, psychostimulants, antidepressants, or hypnotics. Conclusions: Patients receiving inpatient integrated palliative and transplant care were more likely to utilize PCA and atypical antipsychotics during HCT compared to those receiving transplant care alone. Future work should examine whether these differences in supportive care practices mediate the effect of the palliative care intervention on patient-reported outcomes. Clinical trial information: NCT02207322.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10005-10005
Author(s):  
Areej El-Jawahri ◽  
Lara Traeger ◽  
Harry VanDusen ◽  
Joseph A. Greer ◽  
Vicki A. Jackson ◽  
...  

10005 Background: Patients’ experience during HCT hospitalization leads to significant psychological distress post-HCT. Inpatient palliative care integrated with transplant care improves patient-reported QOL and symptom burden during hospitalization for HCT. We assessed the impact of the inpatient palliative care intervention on patients’ QOL, mood, and post-traumatic stress disorder (PTSD) at 6 months post-HCT. Methods: We randomized 160 patients with hematologic malignancies admitted for autologous or allogeneic HCT to an inpatient palliative care intervention (n=81) integrated with transplant care compared to transplant care alone (n=79). At baseline and 6 months post-HCT, we assessed QOL, mood, and PTSD symptoms using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), the Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9), and the PTSD checklist, respectively. To assess symptom burden during HCT hospitalization, we used the Edmonton Symptom Assessment Scale. We utilized linear regression models controlling for baseline values to analyze the intervention effects on outcomes at 6 months. We conducted causal mediation analyses to examine whether symptom burden during HCT mediated the effect of the intervention on o utcomes at 6 months. Results: Between 8/14 and 1/16, we enrolled 160/186 (86%) of potentially eligible patients. At 6 months post-HCT, the intervention led to improvements in depression and PTSD symptoms, but not QOL or anxiety [Table]. Improvement in symptom burden during HCT hospitalization partially mediated the effect of the intervention on patient-reported outcomes at six months post-HCT. Conclusions: Inpatient palliative care integrated with transplant care leads to improvements in depression and PTSD symptoms at 6 months post-HCT. Addressing symptom burden during HCT hospitalization partially accounts for the effect of the intervention on these long-term outcomes. Clinical trial information: NCT02207322. [Table: see text]


2021 ◽  
Author(s):  
Damien Giacchero ◽  
Guillaume Buiret ◽  
Cecile Grosjean ◽  
CHARLES TAIEB ◽  
Mahasti Saghatchian ◽  
...  

Abstract The absence of a specific tool to evaluate the impact of Supportive care in general and socioesthetics in particular as a rendered medical service is undoubtedly at the origin of the lack of published research based on scientific standards.In this context, we developed one supportive-care patient-reported outcome [PRO] using the multistep methods following COSMIN recommendations. Its construction followed all recommended steps: elaboration of the questionnaire, measurement properties of the questionnaire, internal and external validation, test-retest validation and translation, cross-cultural adaptation and cognitive debriefing. In total, our questionnaire includes11 items. It is scored by adding each VAS, making it range from 0 to 110, with a higher benefit when the score is higher. The Cronbach’s α coefficient is 0.88 for the entire questionnaire. The questionnaire thus constructed is a reflection of the patient's feelings, and it is quite natural that the name The “patient centricity questionnaire” (PCQ) was retained and validated by the Scientific Committee. The PCQ correlated negatively and moderately with the PSS, positively and moderately with the mental dimension of the and poorly with the WB12, the physical dimension of the SF-12 and the satisfaction EVA. Constructed according to the recommendations, the PCQ meets the prerequisite for this type of questionnaire. Its short format (11 questions) and simplicity of use allow it to be used by a large number of people and provides an pragmatic answer by making available to research teams a simple, reliable, easy-to-use and validated tool. It makes possible randomized studies to prove the impact on quality of life of the Supportive care in general and socioesthetics" in particular.


Author(s):  
Samantha Cruz Rivera ◽  
Derek G. Kyte ◽  
Olalekan Lee Aiyegbusi ◽  
Anita L. Slade ◽  
Christel McMullan ◽  
...  

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.


2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 103-103 ◽  
Author(s):  
Areej El-Jawahri ◽  
Thomas William LeBlanc ◽  
Harry VanDusen ◽  
Lara Traeger ◽  
Joseph A. Greer ◽  
...  

103 Background: During HCT, patients experience physical and psychological symptoms that negatively impact their quality of life (QOL). We assessed the impact of an inpatient palliative care intervention on patient QOL, symptom burden, and mood during HCT hospitalization and at 3 months post-HCT. Methods: We randomized 160 patients with hematologic malignancies admitted for autologous or allogeneic HCT to an inpatient palliative care intervention (n=81) integrated with transplant care compared to transplant care alone (n=79). We used the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) to assess QOL, the Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9) to assess mood, and Edmonton Symptom Assessment Scale (ESAS) to measure symptoms at baseline, week-2, and 3 months post-HCT. We measured post-traumatic stress (PTSD) symptoms using the PTSD checklist at baseline and 3 months post-HCT. We used linear regression models controlling for baseline values to assess the intervention effects on outcomes at week-2 and 3 months post-HCT. Results: Between 8/2014 and 1/2016, we enrolled 160/186 (86%) of potentially eligible patients. At week-2, the intervention led to improvements in QOL, depression, anxiety, and symptom burden. At 3 months post-HCT, the intervention led to improvements in QOL, depression, and PTSD [Table 1]. PHQ-9 scores at week-2 and HADS-anxiety scores at 3 months did not differ significantly. Conclusions: Palliative care improved QOL, depression, anxiety, and symptom burden in patients hospitalized for HCT with notable sustained effects 3 months post-HCT. Involvement of palliative care for patients with hematologic malignancies can improve their outcomes and substantially reduce the morbidity of HCT. Clinical trial information: NCT02207322. [Table: see text]


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12001-12001
Author(s):  
Thomas J. Smith ◽  
Vincent Chung ◽  
Mark T. Hughes ◽  
Marianna Koczywas ◽  
Nilofer Saba Azad ◽  
...  

12001 Background: The purpose of this study was to test a Palliative Care Intervention for patients with solid tumors enrolled in phase I therapeutic trials. Methods: This randomized trial compared patients accrued to phase I Clinical Trials in groups of Usual Care compared to a Palliative Care Intervention (PCI) in two comprehensive cancer centers. The PCI included assessment of quality of life (QOL) and symptoms, an interdisciplinary meeting to discuss the care plan, including goals of care, and two nurse-delivered teaching sessions. Subjects (n=479) were followed for 24 weeks, with 12 weeks as the primary outcome point. Results: Outcomes revealed that relative to Usual Care, PCI subjects showed less Psychological Distress (1.9 in Intervention and 1.2 in Control pts, p=0.03) and a trend toward improved QOL (3.7 versus 1.6, p=0.07), with differences between sites. We observed high rates of symptom-management admissions (41.3%) and low rates of Advance Directive completion (39%), and use of supportive care services including hospice (30.7%, for only1.2 months duration), despite a median survival for all patients in both groups of 10.1 months from initiating a phase 1 study until death. Patient satisfaction with oncology care was already high at baseline, and we did not see clinically significant changes in those scores by week 12. Conclusions: Palliative care interventions can improve QOL outcomes and distress for patients participating in phase 1 trials. Greater integration of PC is needed to provide quality care to these patients and to support transitions from treatment to supportive care, especially at the end of life. Clinical trial information: NCT01828775 .


2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 73-73
Author(s):  
Jessica Ruth Bauman ◽  
Jessie Panick ◽  
Thomas James Galloway ◽  
John A. Ridge ◽  
Melissa McShane ◽  
...  

73 Background: Patients receiving curative chemoradiation treatment (CRT) for head and neck cancer (HNC) undergo one of the most intensive treatments in oncology, resulting in immense physical and psychological symptoms. Integrated palliative care can improve symptoms and coping in patients with advanced cancer, but has not been evaluated in patients with curable solid tumors. Thus, we are conducting the first pilot study of a collaborative palliative and oncology care intervention among patients receiving CRT to assess feasibility and acceptability. Methods: Eligible participants include newly diagnosed HNC patients starting curative-intent CRT. The intervention entails weekly in-person palliative care (PC) visits integrated with standard oncology care during CRT, followed by 4 weekly phone calls after CRT ends. The PC visits are conducted primarily by a PC RN, with a supervising MD or NP available. Visits focus on coping and managing prominent symptoms during CRT. PC clinicians also receive a weekly patient-reported symptom assessment. Acceptability of the intervention is assessed at 1 month post CRT. The primary outcome is feasibility, defined as a >50% enrollment rate with >70% of participants attending at least half of the PC visits. Planned accrual is 20 patients. Results: We have enrolled 88% (14/16) of eligible patients to date. 11/14 (79%) have p16+ disease. All 14 have completed CRT and are evaluable for feasibility. Participants attended 98% (94/96) of all possible PC visits and completed 99% (95/96) of weekly symptom assessments. PC clinicians spent an average of 35.5 minutes (SD 15.1) per visit with participants. Among the 10 participants who completed the intervention and are evaluable for acceptability, 100% found the intervention “very helpful” and would “definitely recommend” it to others undergoing CRT. Conclusions: An integrated PC intervention to improve symptoms and coping during CRT for HNC is both feasible and acceptable with a high enrollment rate, excellent intervention compliance, and high patient satisfaction. Future studies will evaluate the effects of the integrated intervention on patient-reported outcomes and health care utilization. Clinical trial information: NCT03760471.


2021 ◽  
Author(s):  
Angély Loubert ◽  
Antoine Regnault ◽  
Véronique Sébille ◽  
Jean-Benoit Hardouin

Abstract BackgroundIn the analysis of clinical trial endpoints, calibration of patient-reported outcomes (PRO) instruments ensures that resulting “scores” represent the same quantity of the measured concept between applications. Rasch measurement theory (RMT) is a psychometric approach that guarantees algebraic separation of person and item parameter estimates, allowing formal calibration of PRO instruments. In the RMT framework, calibration is performed using the item parameter estimates obtained from a previous “calibration” study. But if calibration is based on poorly estimated item parameters (e.g., because the sample size of the calibration sample was low), this may hamper the ability to detect a treatment effect, and direct estimation of item parameters from the trial data (non-calibration) may then be preferred. The objective of this simulation study was to assess the impact of calibration on the comparison of PRO results between treatment groups, using different analysis methods.MethodsPRO results were simulated following a polytomous Rasch model, for a calibration and a trial sample. Scenarios included varying sample sizes, with instrument of varying number of items and modalities, and varying item parameters distributions. Different treatment effect sizes and distributions of the two patient samples were also explored. Comparison of treatment groups was performed using different methods based on a random effect Rasch model. Calibrated and non-calibrated approaches were compared based on type-I error, power, bias, and variance of the estimates for the difference between groups.Results There was no impact of the calibration approach on type-I error, power, bias, and dispersion of the estimates. Among other findings, mistargeting between the PRO instrument and patients from the trial sample (regarding the level of measured concept) resulted in a lower power and higher position bias than appropriate targeting. ConclusionsCalibration of PROs in clinical trials does not compromise the ability to accurately assess a treatment effect and is essential to properly interpret PRO results. Given its important added value, calibration should thus always be performed when a PRO instrument is used as an endpoint in a clinical trial, in the RMT framework.


2020 ◽  
pp. bmjspcare-2020-002220
Author(s):  
Lisa Barbera ◽  
Rinku Sutradhar ◽  
Craig C Earle ◽  
Doris Howell ◽  
Nicole Mittman ◽  
...  

BackgroundIn 2007, Cancer Care Ontario began standardised symptom assessment as part of routine care using the Edmonton Symptom Assessment System (ESAS).AimThe purpose of this study was to evaluate the impact of ESAS on receipt of palliative care when compared with a matched group of unexposed patients.DesignA retrospective-matched cohort study examined the impact of ESAS screening on initiation of palliative care services provided by physicians or homecare nurses. The study included adult patients diagnosed with cancer between 2007 and 2015. Exposure was defined as completing ≥1 ESAS during the study period. Using 4 hard and 14 propensity score-matched variables, patients with cancer exposed to ESAS were matched 1:1 to those who were not. Matched patients were followed from first ESAS until initiation of palliative care, death or end of study.ResultsThe final cohort consisted of 204 688 matched patients with no prior palliative care consult. The pairs were well matched. The cumulative incidence of receiving palliative care within the first 5 years was higher among those exposed to ESAS compared with those who were not (27.9% (95% CI: 27.5% to 28.2%) versus 27.9% (95% CI: 27.5% to 28.2%)), when death is considered as a competing event. In the adjusted cause-specific Cox proportional hazards model, ESAS assessment was associated with a 6% increase in palliative care services (HR: 1.06, 95% CI: 1.04 to 1.08).ConclusionWe have demonstrated that patients exposed to ESAS were more likely to receive palliative care services compared with patients who were not exposed. This observation provides real-world data of the impact of routine assessment with a patient-reported outcome.


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