Cargando…

Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial

IMPORTANCE: Palliative care has shown benefits in reducing symptom intensity and quality of life in patients with advanced cancer. However, high-quality evidence to support palliative care policy and service developments for patients with long-term neurological conditions (LTNCs) is lacking. OBJECTI...

Descripción completa

Detalles Bibliográficos
Autores principales: Gao, Wei, Wilson, Rebecca, Hepgul, Nilay, Yi, Deokhee, Evans, Catherine, Bajwah, Sabrina, Crosby, Vincent, Wilcock, Andrew, Lindsay, Fiona, Byrne, Anthony, Young, Carolyn, Groves, Karen, Smith, Clare, Burman, Rachel, Chaudhuri, K. Ray, Silber, Eli, Higginson, Irene J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7455856/
https://www.ncbi.nlm.nih.gov/pubmed/32857151
http://dx.doi.org/10.1001/jamanetworkopen.2020.15061
_version_ 1783575704049287168
author Gao, Wei
Wilson, Rebecca
Hepgul, Nilay
Yi, Deokhee
Evans, Catherine
Bajwah, Sabrina
Crosby, Vincent
Wilcock, Andrew
Lindsay, Fiona
Byrne, Anthony
Young, Carolyn
Groves, Karen
Smith, Clare
Burman, Rachel
Chaudhuri, K. Ray
Silber, Eli
Higginson, Irene J.
author_facet Gao, Wei
Wilson, Rebecca
Hepgul, Nilay
Yi, Deokhee
Evans, Catherine
Bajwah, Sabrina
Crosby, Vincent
Wilcock, Andrew
Lindsay, Fiona
Byrne, Anthony
Young, Carolyn
Groves, Karen
Smith, Clare
Burman, Rachel
Chaudhuri, K. Ray
Silber, Eli
Higginson, Irene J.
author_sort Gao, Wei
collection PubMed
description IMPORTANCE: Palliative care has shown benefits in reducing symptom intensity and quality of life in patients with advanced cancer. However, high-quality evidence to support palliative care policy and service developments for patients with long-term neurological conditions (LTNCs) is lacking. OBJECTIVE: To determine the effectiveness of a short-term integrated palliative care (SIPC) intervention for people with LTNCs. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, phase 3, randomized clinical trial conducted from April 1, 2015, to November 30, 2017, with a last follow-up date of May 31, 2018, in 7 UK hospitals with both neurology and palliative care services. A total of 535 patients with LTNC were assessed for eligibility and 350 were randomized. Inclusion criteria were patients 18 years or older with any advanced stage of multiple sclerosis, motor neuron disease, idiopathic Parkinson disease multiple system atrophy, or progressive supranuclear palsy. Data were analyzed from November 2018 to March 2019. INTERVENTIONS: Patients were randomized 1:1 using minimization method to receive SIPC (intervention, n = 176) or standard care (control, n = 174). MAIN OUTCOMES AND MEASURES: Primary outcome was change in 8 key palliative care symptoms from baseline to 12-weeks, measured by the Integrated Palliative care Outcome Scale for neurological conditions. Secondary outcomes included change in the burden of other symptoms, health-related quality of life, caregiver burden, and costs. Data were collected and analyzed blindly by intention to treat. RESULTS: A total of 350 patients (mean [SD] age 67 [12] years; years since diagnosis, 12 [range, 0-56]; 51% men; 49% requiring considerable assistance) with an advanced stage of LTNC were recruited, along with informal caregivers (n = 229). There were no between-group differences in primary outcome (effect size, −0.16; 95% CI, −0.37 to 0.05), any other patient-reported outcomes, adverse events, or survival. Although there was more symptom reduction in the SIPC group in relation to mean change in primary outcome, the difference between the groups was not statistically significant (−0.78; 95% CI, −1.29 to −0.26 vs −0.28; 95% CI, −0.82 to 0.26; P = .14). There was a decrease in mean health and social care costs from baseline to 12 weeks −$1367 (95% CI, −$2450 to −$282) in the SIPC group and −653 (95% CI, −$1839 to −$532) in the control group, but this difference was not statistically significant (P = .12). SIPC was perceived by patients and caregivers as building resilience, attending to function and deficits, and enabling caregivers. CONCLUSIONS AND RELEVANCE: In this study, SIPC was not statistically significantly different from standard care for the patient-reported outcomes. However, SIPC was associated with lower cost, and in qualitative analysis was well-received by patients and caregivers, and there were no safety concerns. Further research is warranted. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN18337380
format Online
Article
Text
id pubmed-7455856
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher American Medical Association
record_format MEDLINE/PubMed
spelling pubmed-74558562020-09-03 Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial Gao, Wei Wilson, Rebecca Hepgul, Nilay Yi, Deokhee Evans, Catherine Bajwah, Sabrina Crosby, Vincent Wilcock, Andrew Lindsay, Fiona Byrne, Anthony Young, Carolyn Groves, Karen Smith, Clare Burman, Rachel Chaudhuri, K. Ray Silber, Eli Higginson, Irene J. JAMA Netw Open Original Investigation IMPORTANCE: Palliative care has shown benefits in reducing symptom intensity and quality of life in patients with advanced cancer. However, high-quality evidence to support palliative care policy and service developments for patients with long-term neurological conditions (LTNCs) is lacking. OBJECTIVE: To determine the effectiveness of a short-term integrated palliative care (SIPC) intervention for people with LTNCs. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, phase 3, randomized clinical trial conducted from April 1, 2015, to November 30, 2017, with a last follow-up date of May 31, 2018, in 7 UK hospitals with both neurology and palliative care services. A total of 535 patients with LTNC were assessed for eligibility and 350 were randomized. Inclusion criteria were patients 18 years or older with any advanced stage of multiple sclerosis, motor neuron disease, idiopathic Parkinson disease multiple system atrophy, or progressive supranuclear palsy. Data were analyzed from November 2018 to March 2019. INTERVENTIONS: Patients were randomized 1:1 using minimization method to receive SIPC (intervention, n = 176) or standard care (control, n = 174). MAIN OUTCOMES AND MEASURES: Primary outcome was change in 8 key palliative care symptoms from baseline to 12-weeks, measured by the Integrated Palliative care Outcome Scale for neurological conditions. Secondary outcomes included change in the burden of other symptoms, health-related quality of life, caregiver burden, and costs. Data were collected and analyzed blindly by intention to treat. RESULTS: A total of 350 patients (mean [SD] age 67 [12] years; years since diagnosis, 12 [range, 0-56]; 51% men; 49% requiring considerable assistance) with an advanced stage of LTNC were recruited, along with informal caregivers (n = 229). There were no between-group differences in primary outcome (effect size, −0.16; 95% CI, −0.37 to 0.05), any other patient-reported outcomes, adverse events, or survival. Although there was more symptom reduction in the SIPC group in relation to mean change in primary outcome, the difference between the groups was not statistically significant (−0.78; 95% CI, −1.29 to −0.26 vs −0.28; 95% CI, −0.82 to 0.26; P = .14). There was a decrease in mean health and social care costs from baseline to 12 weeks −$1367 (95% CI, −$2450 to −$282) in the SIPC group and −653 (95% CI, −$1839 to −$532) in the control group, but this difference was not statistically significant (P = .12). SIPC was perceived by patients and caregivers as building resilience, attending to function and deficits, and enabling caregivers. CONCLUSIONS AND RELEVANCE: In this study, SIPC was not statistically significantly different from standard care for the patient-reported outcomes. However, SIPC was associated with lower cost, and in qualitative analysis was well-received by patients and caregivers, and there were no safety concerns. Further research is warranted. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN18337380 American Medical Association 2020-08-28 /pmc/articles/PMC7455856/ /pubmed/32857151 http://dx.doi.org/10.1001/jamanetworkopen.2020.15061 Text en Copyright 2020 Gao W et al. JAMA Network Open. http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Gao, Wei
Wilson, Rebecca
Hepgul, Nilay
Yi, Deokhee
Evans, Catherine
Bajwah, Sabrina
Crosby, Vincent
Wilcock, Andrew
Lindsay, Fiona
Byrne, Anthony
Young, Carolyn
Groves, Karen
Smith, Clare
Burman, Rachel
Chaudhuri, K. Ray
Silber, Eli
Higginson, Irene J.
Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial
title Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial
title_full Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial
title_fullStr Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial
title_full_unstemmed Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial
title_short Effect of Short-term Integrated Palliative Care on Patient-Reported Outcomes Among Patients Severely Affected With Long-term Neurological Conditions: A Randomized Clinical Trial
title_sort effect of short-term integrated palliative care on patient-reported outcomes among patients severely affected with long-term neurological conditions: a randomized clinical trial
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7455856/
https://www.ncbi.nlm.nih.gov/pubmed/32857151
http://dx.doi.org/10.1001/jamanetworkopen.2020.15061
work_keys_str_mv AT gaowei effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT wilsonrebecca effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT hepgulnilay effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT yideokhee effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT evanscatherine effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT bajwahsabrina effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT crosbyvincent effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT wilcockandrew effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT lindsayfiona effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT byrneanthony effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT youngcarolyn effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT groveskaren effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT smithclare effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT burmanrachel effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT chaudhurikray effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT silbereli effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial
AT higginsonirenej effectofshorttermintegratedpalliativecareonpatientreportedoutcomesamongpatientsseverelyaffectedwithlongtermneurologicalconditionsarandomizedclinicaltrial