CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,302 enrolled
Drug / intervention
Probabilistic Risk Communication Tool (PRT) +1 moreother
Likely dose
Not stated in record
Key inclusion· 4
  • Age 18 to 70 years old
  • Presenting with back pain or renal colic
  • Able to communicate via text messaging and internet (email or smartphone)
  • Anticipated ED discharge within 24 hours
Key exclusion· 10
  • Currently taking opioids for chronic pain or cancer treatment
  • Opioid use in past month, except within 48 hours before ED arrival
  • Pregnant, in police custody, intoxicated, cognitively impaired, or unable to consent
  • Hemodynamically unstable, in respiratory distress, or severe physical/emotional distress

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03134092
NCT03134092N/ACompleted

Life Stories for Opioid Risk Reduction in the ED

University of Pennsylvania·interventional·Posted Apr 28, 2017·Updated Jul 14, 2025

In Brief

A clinical study evaluating Probabilistic Risk Communication Tool (PRT) and Narrative Enhanced Risk Tool (NERT) for Opioid Dependence and 3 related conditions. Completed, enrolled 1,302 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 28, 2017
Enrollment StartJun 28, 2017
Primary CompletionAug 7, 2019
Study CompletionNov 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.2 years ago

Interventions

Probabilistic Risk Communication Tool (PRT)other

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.

Narrative Enhanced Risk Tool (NERT)other

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.