The Life STORRIED Study

NCT03134092 | Completed Results DMC

• 1 other identifier: 826673
• Study Type: interventional
• Target: 1,302
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Opioid Dependence; Communication; Risk Behavior; Narrative Medicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Patient Reported Use of Opioid Medication

  Days 1-2, days 4-6

• Patient Reported Use of Opioid Medication

  Days 1-2

• Patient Reported Use of Opioid Medication

  Day 14, 3 Months

• Patient Reported Use of Opioid Medication

  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

  Days 1, day 14, 3 Months

Study Arms (3)

Generalized Risk Communication (GRC)

NO INTERVENTION

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.

Probabilistic Risk Communication (PRT)

ACTIVE COMPARATOR

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)

Narrative Enhanced Risk Tool (NERT)

ACTIVE COMPARATOR

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); Other: Narrative Enhanced Risk Tool (NERT)

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); Probabilistic Risk Communication (PRT)

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.

Narrative Enhanced Risk Tool (NERT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: If the patient identifies as male or female, we will enter that as such for the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

University of Alabama- Birmingham

Birmingham, Alabama, 35249, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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.

  PMID: 35143273 DERIVED

• 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.

  PMID: 34323984 DERIVED

• 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.

  PMID: 32969832 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Communication; Risk-Taking; Narrative Medicine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Narration

Results Point of Contact

• Title: Dr. Zachary Meisel
• Organization: University of Pennsylvania Perelman School of Medicine

zfm@pennmedicine.upenn.edu

215-746-5618

Study Officials

• Zachary F Meisel, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 28, 2017
• Study Start: June 28, 2017
• Primary Completion: August 7, 2019
• Study Completion: November 19, 2019
• Last Updated: July 14, 2025
• Results First Posted: August 17, 2020

Record last verified: 2025-07

Locations

US (4)