Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial

Background Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative–enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. Objective Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. Methods This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative–enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. Results A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. Conclusions This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. Trial Registration ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092 International Registered Report Identifier (IRRID) DERR1-10.2196/19496

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Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial (Preprint)

10.2196/preprints.19496 ◽

2020 ◽

Author(s):

Zachary F Meisel ◽

Erica B Goldberg ◽

Abby R Dolan ◽

Esha Bansal ◽

Karin V Rhodes ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Risk Communication ◽

Acute Care ◽

Acute Pain ◽

Kidney Stone ◽

Controlled Trial ◽

Risk Information ◽

Opioid Use ◽

Information Sheet ◽

Randomized Controlled

BACKGROUND Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative–enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. OBJECTIVE Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. METHODS This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative–enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. RESULTS A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. CONCLUSIONS This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. CLINICALTRIAL ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19496

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Using Stories to Communicate Individual Risk for Opioid Prescriptions: Study Protocol for the Life STORRIED Multicenter Randomized Clinical Trial

10.21203/rs.1.19/v1 ◽

2018 ◽

Author(s):

Zachary F Meisel ◽

Esha Bansal ◽

Marilyn M Schapira ◽

Jeanmarie Perrone ◽

Carolyn C Cannuscio ◽

...

Keyword(s):

United States ◽

Clinical Trial ◽

Risk Communication ◽

Randomized Clinical Trial ◽

Acute Care ◽

Acute Pain ◽

The United States ◽

Risk Information ◽

Information Sheet ◽

Health Crisis

Abstract Background: Prescription opioid abuse in the United States is a devastating public health crisis, of which many chronic opioid users were originally prescribed the medication for acute pain. Narrative enhanced risk communication may improve patient outcomes such as knowledge of opioid risk and opioid use behaviors in the setting of acute pain. Methods & Design: Patients presenting to the acute care facilities of four geographically and ethnically diverse United States hospital centers with renal colic or musculoskeletal back pain will be eligible for this multicenter randomized clinical trial. A control group of patients receiving a standardized, general risk information sheet will be compared to two intervention groups, one receiving the risk information sheet plus a probabilistic opioid risk tool and another receiving the risk information sheet plus a narrative enhanced probabilistic opioid risk tool. We will study the effect of probabilistic and narrative enhanced opioid risk communication on: 1) knowledge as measured by risk awareness and treatment preferences for fewer opioids; 2) reduced use of opioids as measured by quantity of opioids taken, functional improvement, and repeat use of unscheduled visits for pain; 3) patient-provider alignment as measured by concordance between patient preference and finalized prescription plan and the presence of shared decision making. To assess these outcomes, we will administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the ninety days after discharge. Discussion: This study seeks to assess the potential clinical role of narrative enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, stakeholder involvement, and dissemination considerations.

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A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial

Trials ◽

10.1186/s13063-021-05421-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jennifer A. Rabbitts ◽

Chuan Zhou ◽

Rocio de la Vega ◽

Homer Aalfs ◽

Caitlin B. Murray ◽

...

Keyword(s):

Chronic Pain ◽

Randomized Controlled Trial ◽

Spinal Fusion ◽

Acute Pain ◽

Controlled Trial ◽

Opioid Use ◽

Cognitive Behavioral Intervention ◽

Postsurgical Pain ◽

Randomized Controlled ◽

Chronic Postsurgical Pain

Abstract Background Spinal fusion surgery is associated with severe acute postsurgical pain and high rates of chronic postsurgical pain in adolescents. Psychological distress, sleep disturbance, and low pain self-efficacy predict higher acute pain and likelihood of developing chronic postsurgical pain. Interventions targeting baseline psychosocial risk factors have potential to interrupt a negative trajectory of continued pain and poor health-related quality of life (HRQL) over time but have not yet been developed and evaluated. This randomized controlled trial will test effectiveness of a digital peri-operative cognitive-behavioral intervention (SurgeryPalTM) vs. education-control delivered to adolescents and their parents to improve acute and chronic pain and health outcomes in adolescents undergoing spine surgery. Methods Adolescents 12–18 years of age undergoing spinal fusion for idiopathic conditions, and their parent, will be recruited from pediatric centers across the USA, for a target complete sample of 400 dyads. Adolescents will be randomized into 4 study arms using a factorial design to SurgeryPalTM or education control during 2 phases of treatment: (1) pre-operative phase (one-month before surgery) and (2) post-operative phase (1 month after surgery). Acute pain severity and interference (primary acute outcomes) and opioid use will be assessed daily for 14 days following hospital discharge. Chronic pain severity and interference (primary acute outcomes), as well as HRQL, parent and adolescent distress, sleep quality, and opioid use/misuse (secondary outcomes), will be assessed at 3 months and 6 months post-surgery. Discussion Demonstration of effectiveness and understanding optimal timing of perioperative intervention will enable implementation of this scalable psychosocial intervention into perioperative care. Ultimately, the goal is to improve pain outcomes and reduce reliance on opioids in adolescents after spine surgery. Trial registration NCT04637802 ClinicalTrials.gov. Registered on November 20, 2020

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