The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial

Abstract Background Orthopedic trauma patients face complex pain management needs and are frequently prescribed opioids, leaving them at-risk for prolonged opioid use. To date, post-trauma pain management research has placed little emphasis on individualized risk assessments for misuse and systemati...

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Autores principales:	Nicholas A. Giordano, Jesse Seilern und Aspang, J‘Lynn Baker, Cammie Wolf Rice, Bailey Barrell, Lauren Kirk, Erika Ortega, Michelle Wallace, Alaina Steck, Mara L. Schenker
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Orthopedic trauma Life Care Specialist Opioid utilization Pain management Opioid use disorder Substance misuse Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/7b0494d9a0994ed98d6758a6e37f8a06
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spelling	oai:doaj.org-article:7b0494d9a0994ed98d6758a6e37f8a062021-11-28T12:28:22ZThe effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial10.1186/s13063-021-05841-11745-6215https://doaj.org/article/7b0494d9a0994ed98d6758a6e37f8a062021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05841-1https://doaj.org/toc/1745-6215Abstract Background Orthopedic trauma patients face complex pain management needs and are frequently prescribed opioids, leaving them at-risk for prolonged opioid use. To date, post-trauma pain management research has placed little emphasis on individualized risk assessments for misuse and systematically implementing non-pharmacologic pain management strategies. Therefore, a community-academic partnership was formed to design a novel position in the healthcare field (Life Care Specialist (LCS)), who will educate patients on the risks of opioids, tapering usage, safe disposal practices, and harm reduction strategies. In addition, the LCS teaches patients behavior-based strategies for pain management, utilizing well-described techniques for coping and resilience. This study aims to determine the effects of LCS intervention on opioid utilization, pain control, and patient satisfaction in the aftermath of orthopedic trauma. Methods In total, 200 orthopedic trauma patients will be randomized to receive an intervention (LCS) or a standard-of-care control at an urban level 1 trauma center. All patients will be assessed with comprehensive social determinants of health and substance use surveys immediately after surgery (baseline). Follow-up assessments will be performed at 2, 6, and 12 weeks postoperatively, and will include pain medication utilization (morphine milligram equivalents), pain scores, and other substance use. In addition, overall patient wellness will be evaluated with objective actigraphy measures and patient-reported outcomes. Finally, a survey of patient understanding of risks of opioid use and misuse will be collected, to assess the influence of LCS opioid education. Discussion There is limited data on the role of individualized, multimodal, non-pharmacologic, behavioral-based pain management intervention in opioid-related risk-mitigation in high-risk populations, including the orthopedic trauma patients. The findings from this randomized controlled trial will provide scientific and clinical evidence on the efficacy and feasibility of the LCS intervention. Moreover, the final aim will provide early evidence into which patients benefit most from LCS intervention. Trial registration ClinicalTrials.gov NCT04154384 . Registered on 11/6/2019 (last updated on 6/10/2021).Nicholas A. GiordanoJesse Seilern und AspangJ‘Lynn BakerCammie Wolf RiceBailey BarrellLauren KirkErika OrtegaMichelle WallaceAlaina SteckMara L. SchenkerBMCarticleOrthopedic traumaLife Care SpecialistOpioid utilizationPain managementOpioid use disorderSubstance misuseMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-17 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Orthopedic trauma Life Care Specialist Opioid utilization Pain management Opioid use disorder Substance misuse Medicine (General) R5-920
spellingShingle	Orthopedic trauma Life Care Specialist Opioid utilization Pain management Opioid use disorder Substance misuse Medicine (General) R5-920 Nicholas A. Giordano Jesse Seilern und Aspang J‘Lynn Baker Cammie Wolf Rice Bailey Barrell Lauren Kirk Erika Ortega Michelle Wallace Alaina Steck Mara L. Schenker The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial
description	Abstract Background Orthopedic trauma patients face complex pain management needs and are frequently prescribed opioids, leaving them at-risk for prolonged opioid use. To date, post-trauma pain management research has placed little emphasis on individualized risk assessments for misuse and systematically implementing non-pharmacologic pain management strategies. Therefore, a community-academic partnership was formed to design a novel position in the healthcare field (Life Care Specialist (LCS)), who will educate patients on the risks of opioids, tapering usage, safe disposal practices, and harm reduction strategies. In addition, the LCS teaches patients behavior-based strategies for pain management, utilizing well-described techniques for coping and resilience. This study aims to determine the effects of LCS intervention on opioid utilization, pain control, and patient satisfaction in the aftermath of orthopedic trauma. Methods In total, 200 orthopedic trauma patients will be randomized to receive an intervention (LCS) or a standard-of-care control at an urban level 1 trauma center. All patients will be assessed with comprehensive social determinants of health and substance use surveys immediately after surgery (baseline). Follow-up assessments will be performed at 2, 6, and 12 weeks postoperatively, and will include pain medication utilization (morphine milligram equivalents), pain scores, and other substance use. In addition, overall patient wellness will be evaluated with objective actigraphy measures and patient-reported outcomes. Finally, a survey of patient understanding of risks of opioid use and misuse will be collected, to assess the influence of LCS opioid education. Discussion There is limited data on the role of individualized, multimodal, non-pharmacologic, behavioral-based pain management intervention in opioid-related risk-mitigation in high-risk populations, including the orthopedic trauma patients. The findings from this randomized controlled trial will provide scientific and clinical evidence on the efficacy and feasibility of the LCS intervention. Moreover, the final aim will provide early evidence into which patients benefit most from LCS intervention. Trial registration ClinicalTrials.gov NCT04154384 . Registered on 11/6/2019 (last updated on 6/10/2021).
format	article
author	Nicholas A. Giordano Jesse Seilern und Aspang J‘Lynn Baker Cammie Wolf Rice Bailey Barrell Lauren Kirk Erika Ortega Michelle Wallace Alaina Steck Mara L. Schenker
author_facet	Nicholas A. Giordano Jesse Seilern und Aspang J‘Lynn Baker Cammie Wolf Rice Bailey Barrell Lauren Kirk Erika Ortega Michelle Wallace Alaina Steck Mara L. Schenker
author_sort	Nicholas A. Giordano
title	The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial
title_short	The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial
title_full	The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial
title_fullStr	The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial
title_full_unstemmed	The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial
title_sort	effect of a life care specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/7b0494d9a0994ed98d6758a6e37f8a06
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The effect of a Life Care Specialist on pain management and opioid-related outcomes among patients with orthopedic trauma: study protocol for a randomized controlled trial

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