The Life STORRIED Study
Condition: Opioid Dependence; Communication; Risk Behavior; Narrative Medicine
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      To compare the effectiveness of 3 strategies to inform patients of their risks associated
      with misuse of opioid prescriptions after treatment in the ED from renal colic or
      musculoskeletal back pain. Randomization will be to 3 arms for the Randomized Practical
      Control Trial across 3 sites (A) standardized general risk information sheet only (B)
      standardized general risk information sheet plus a visual probabilistic risk tool (C)
      standardized sheet plus narrative enhanced probabilistic risk tool.
    

Detailed description: 
      Amid a devastating public health crisis, in which 19,000 overdose deaths per year in the
      United States are due to prescription opioids, the investigators ask the following questions:
      Can risk-informed communication (with or without a narrative-enhanced tool) improve
      patient-centered outcomes in the domains of knowledge, opioid use, functional outcomes, and
      patient provider therapeutic alignment? This question has implications for over 17 million
      patients who present to acute care settings with acute pain from common conditions. Can these
      goals be accomplished in a real-world setting, for a diverse patient population? The
      investigators approach to this project includes a practical randomized controlled trial,
      conducted in nine acute care settings, at three geographically distinct hospital centers,
      with broad inclusion criteria and a diverse population. Aims: This project aims to compare
      the effectiveness of 1) a standardized general risk information sheet only; 2 a standardized
      general risk information sheet plus a probabilistic risk tool; and 3) a standardized sheet
      plus narrative-enhanced probabilistic risk tool on the following outcomes: * Knowledge as
      measured by risk awareness and treatment preferences for fewer opioids, particularly among
      those at higher risk for addiction * Reduced use of opioids as measured by quantity of
      opioids taken, functional improvement, and repeat use of unscheduled visits for pain at 14
      days * Patient provider alignment as measured by concordance between patient preference and
      finalized prescription plan, and the presence of shared decision making. These aims will be
      achieved in a multicenter randomized practical clinical trial of 1,300 patients who are
      planned for discharge from acute care settings after being treated for acute back or acute
      kidney stone pain. The investigators hypothesize that, compared with patients receiving a
      generalized risk information sheet or a probabilistic risk communication tool alone, patients
      with acute renal colic and musculoskeletal back pain randomized to receive narrative-enhanced
      risk communication, will do the following: (H1) demonstrate greater knowledge, as determined
      by awareness of risk for opioid dependency; (H2a) select a treatment plan with fewer opioids;
      (H2b) take fewer opioids for fewer days, while achieving the same degree of pain relief and
      improved functional status; (H3a) enjoy greater levels of concordance between the
      patient-preferred and provider-selected treatment plans; and (H3b) engage in greater shared
      decision making with their providers. How these aims are important to patients: The research
      question is important to patients because 1) patients are frequently exposed to the potential
      for either under- or over-treatment of pain; 2) patients have different risk factors for
      dependency, which may impact the appropriateness of certain medications for pain relief; and
      3) opioid dependence and misuse which often begin with prescriptions for acute pain are
      costly and common, and affect families, communities, and society as a whole.
    

Intervention name(s): Probabilistic Risk Communication Tool (PRT); Narrative Enhanced Risk Tool (NERT)
Intervention type(s): Other; Other
Intervention description(s): The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.; Participants assigned to this arm will receive the PRT described above but will also be instructed to watch one or more narrative videos. This video intervention will include a brief narrative video of an individuals' cautionary tale around prolonged opioid uses. Narrative videos are developed from actual patients sharing their stories - put into a in a structured format of ~ 2-minute length and recorded.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention