The Life STORRIED Study

Life Stories for Opioid Risk Reduction in the ED

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 Overview

• Status: Completed
• Conditions: Risk Behavior; Communication; Opioid Dependence; Narrative Medicine
• Intervention / Treatment: Other: Probabilistic Risk Communication Tool (PRT); Other: Narrative Enhanced Risk Tool (NERT)

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.

• Study Type: Interventional
• Enrollment (Actual): 1302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama- Birmingham
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 years to 70 years old
• Experiencing back pain or renal colic
• Text messaging and internet access including email capabilities or access to a smartphone
• Anticipated discharge within 24 hours

Exclusion Criteria:

• Patients who take opioids for chronic pain or cancer treatments
• Patients who have taken opioids in the past month with the exception of patients who have taken opioids in the previous 48 hours before arriving at the ED for their presenting condition based on provider assessment
• Patients who are pregnant, in police custody, intoxicated, cognitively impaired, or otherwise unable to fully consent and participate
• Patients who are hemodynamically compromised, in respiratory distress, or in severe emotional or physical distress.
• Patients older than 70 or younger than 18
• Patients who will be admitted to hospital or deemed to have a critical illness based on provider assessment
• Patients who are cognitively impaired
• Patients who are suicidal or homicidal ideation by chart review and clinician assessment.
• Patients with evidence of aberrant behavior based on clinical assessment
• Patients who do not have a phone, text messaging OR email address
• Patients under police arrest at ED visit
• Patients who are non-English or Spanish speaking
• Patients previously enrolled
• Patient with any current contraindications for NSAIDs or opioid medications including allergies, chronic kidney disease (GFR60, if measured)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Generalized Risk Communication (GRC); Generalized Risk Communication (GRC): Participants in this arm will receive standard discharge instructions similar to instructions they would receive during usual care. This arm represents a standardized way of communicating post-discharge risk-benefit information about treatment options for patients with back pain and renal colic. The GRC, includes a standardized discharge information sheet about the clinical condition of interest and a written overview of population based evidence describing comparative benefits and side effects of alternative classes of medication acute pain.
Active Comparator: Probabilistic Risk Communication (PRT); Probabilistic Risk Communication (PRT): 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.	Other: Probabilistic Risk Communication Tool (PRT); 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.
Active Comparator: Narrative Enhanced Risk Tool (NERT); Narrative Enhanced Risk Tool (NERT): 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 related to prolonged opioid use. Narrative videos are developed from actual patient stories - put into a in a structured format of ~ 2-minute length and recorded.	Other: Probabilistic Risk Communication Tool (PRT); 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.; Other: Narrative Enhanced Risk Tool (NERT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Awareness and Recall	The primary outcome of this study is for patients to gain an understanding of individual risk using the Opioid Risk Tool (ORT). The ORT is a brief screening tool allowing patients to confidentially enter their own history to determine the probability opioid dependency and addiction. High concordance between measured risk and patient recall might indicate sustained effectiveness (or stickiness) of the risk communication tool. Discordance might indicate a failure of risk communication and knowledge of individualized risk. This outcome is dichotomous, categorized as "Yes" the person correctly recalled their risk category or "No", either they did not correctly recall their risk category or they did not remember their risk category at all. The count of participants is the amount categorized as "Yes", they correctly recalled their risk category.	Day 14
Patient Reported Use of Opioid Medication	Taking opioid medication at Day 14. This outcome is dichotomous. "Yes" if they were taking opioids at Day 14, or "No" if they were not taking opioids at Day 14.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Use of Opioid Medication	Frequency of use	Day 14, 3 Months
Patient Reported Shared Decision Making	The CollaboRATE93 scale- a brief, patient reported measure of shared decision making after a clinical encounter will be used. The scale will be adapted to reflect the context of an acute pain clinical encounter in the emergency department. There are three questions scored 0-9 with higher values meaning more collaboration. The average score of the three questions was calculated.	Day 1
Satisfaction With Pain Treatment	Participants are asked "How satisfied were you with the results of your pain treatment while in the hospital?" with 0 = extremely dissatisfied and 10 = extremely satisfied.	Days 1 and 7, Day 14, 3 Months
Self-Report Additional Provider Visits	Self-Report additional provider visits to measure follow-up visits for pain	Day 14 and 3 Month
Current Opioid Misuse Measure (COMM)	The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.	3 months
Patient Reported Use of Opioid Medication	A second outcome is measuring patient reported opioid medication use by Total morphine equivalents.	Days 1-2, days 4-6
Patient Reported Use of Opioid Medication	Patient reported total pills taken in the first 48 hours after baseline enrollment.	Days 1-2
Patient Reported Use of Opioid Medication	Patient reported days to no longer taking opioids	Time from emergency department visit to ceasing opioid use. We assessed at days 1-2, 4-6, 14, and month 3, data up to 3 months reported.
Reported Use of Non Opioid Pain Medication	Patient reported use and dose of NSAIDs and acetaminophen	Days 1, day 14, 3 Months
Functional Ability/Return to Usual Activities	The RAND health- 20 questionnaire will be used to measure functional ability. We report the domain of "Role Function". Scores for this domain are reported on a scale of 0% to 100%, with 0% representing the worst possible score in that domain and 100% the best possible score.	At Baseline and 3 Months (referred to as "3 M" below)
Functional Ability/Return to Usual Activities	The American Pain Outcome questionnaire will be used to measure functional ability. We report the change in the score for "In the last 24 hours how much has pain interfered/prevented you from... Doing activities such as walking, sitting, or standing" between Baseline and 3 months. (scale: 0 = 0% of the time, 10 = 100% of the time)	Baseline, Days 1 and 7, Day 14, 3 Months (referred to as "3 M" below)
Trust in Provider	The Trust in Physician scale, will be used to measure the patient's their trust in their provider. Allows Patient to report their perception of their provider. Patients are more likely to be adherent to medical care when they trust their physicians. We report the "Trust in lead clinician" item. Score 0-100, where higher indicates more trust.	Day 7
Patient Preference for Treatment Plan	Patients will be provided options for pain treatment for discharge treatment plan. We are reporting out on patients who indicated they preferred any type of opioid.	At Baseline
Treatment Plan Agreement Between Patient Preference and Provider Decision	Patient preference will be linked to electronic medical record data. Discordance between risk informed patient preferences and provider selection may indicate failure to achieve an optimized patient centered outcome. We report overall alignment.	At Baseline

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Zachary F Meisel, MD, University of Pennsylvania

Publications and helpful links

General Publications

• Meisel ZF, Shofer F, Dolan A, Goldberg EB, Rhodes KV, Hess EP, Bellamkonda VR, Perrone J, Cannuscio CC, Becker L, Rodgers MA, Zyla MM, Bell JJ, McCollum S, Engel-Rebitzer E, Tiako MJN, Ridgeway G, Schapira MM. A Multicentered Randomized Controlled Trial Comparing the Effectiveness of Pain Treatment Communication Tools in Emergency Department Patients With Back or Kidney Stone Pain. Am J Public Health. 2022 Feb;112(S1):S45-S55. doi: 10.2105/AJPH.2021.306511.
• Engel-Rebitzer E, Dolan AR, Aronowitz SV, Shofer FS, Nguemeni Tiako MJ, Schapira MM, Perrone J, Hess EP, Rhodes KV, Bellamkonda VR, Cannuscio CC, Goldberg E, Bell J, Rodgers MA, Zyla M, Becker LB, McCollum S, Meisel ZF. Patient Preference and Risk Assessment in Opioid Prescribing Disparities: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2118801. doi: 10.1001/jamanetworkopen.2021.18801.
• Meisel ZF, Goldberg EB, Dolan AR, Bansal E, Rhodes KV, Hess EP, Cannuscio CC, Schapira MM, Perrone J, Rodgers MA, Zyla MM, Bell JJ, McCollum S, Shofer FS. Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial. JMIR Res Protoc. 2020 Sep 24;9(9):e19496. doi: 10.2196/19496.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Actual): August 7, 2019
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 826673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No