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 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.govNCT04154384. Registered on 11/6/2019 (last updated on 6/10/2021).

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The Effect of a Life Care Specialist on Pain Management and Opioid-Related Outcomes Among Patients with Orthopaedic Trauma: Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-659890/v1 ◽

2021 ◽

Author(s):

Nicholas A. Giordano ◽

Jesse Seilern und Aspang ◽

J'Lynn Baker ◽

Cammie Wolf Rice ◽

Bailey Barrell ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Substance Use ◽

Pain Management ◽

Controlled Trial ◽

Trauma Patients ◽

Orthopaedic Trauma ◽

Life Care ◽

Opioid Use ◽

Randomized Controlled ◽

Care Specialist

Abstract Background:Orthopaedic 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 orthopaedic trauma.Methods: In total, 200 orthopaedic 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 orthopaedic 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). https://clinicaltrials.gov/ct2/show/NCT04154384?term=life+care+specialist&draw=2&rank=1

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The Effect of Virtual Reality on Anxiety and Pain in Patients Undergoing Gynecological Surgery (VRAP-G); a Randomized Controlled Trial

Austin Journal of Anesthesia and Analgesia ◽

10.26420/austinjanesthesiaandanalgesia.2021.1095 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Kreijveld BJ ◽

◽

Bekkers IPW ◽

Mulder E ◽

Wassen MMLH ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Pain Management ◽

Postoperative Pain ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Gynecological Surgery ◽

Opioid Use ◽

Randomized Controlled

Background: Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. There is increasing evidence that Virtual Reality (VR) is effective in the reduction of acute pain. Alternative methods to reduce postoperative pain and multimodal analgesia are necessary for acute postoperative pain management and to reduce opioid use and their adverse effects. The aim of this study is to explore the effect of VR on pain in the postoperative period after elective gynecological surgery. Methods and Design: The study concerns a non-blinded, single center, randomized controlled trial. Eligible women fulfilling the inclusion criteria and receive elective gynecological surgery in the Zuyderland Medical Center will be randomized for participation. The study population will be randomly divided into the intervention group (VR-group) or the standard care- group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the pre- and postoperative period additional to the usual standard care. The participants randomized to the standard caregroup will receive only the usual standard care pre-and postoperative. The primary outcome is postoperative pain measured on a Numeric Rating Scale (NRS). A total of 30 patients have to be included in each group. This means that a total of 60 women will have to be included in this study. Secondary outcomes are; evaluating pre-and postoperative anxiety, pain catastrophizing, analgesic use, length of hospital stay between both groups and to explore tolerability, feasibility and satisfaction of VR use. Discussion: This study will provide insight as to whether in women who receive gynecological surgery, VR is an effective method to reduce postoperative pain and subsequently opioid use.

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