The Life STORRIED Study

July 11, 2025 updated by: University of Pennsylvania

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1302

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Risk Awareness and Recall
Time Frame: Day 14
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
Time Frame: Day 14
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Reported Use of Opioid Medication
Time Frame: Day 14, 3 Months
Frequency of use
Day 14, 3 Months
Patient Reported Shared Decision Making
Time Frame: Day 1
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
Time Frame: Days 1 and 7, Day 14, 3 Months
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
Time Frame: Day 14 and 3 Month
Self-Report additional provider visits to measure follow-up visits for pain
Day 14 and 3 Month
Current Opioid Misuse Measure (COMM)
Time Frame: 3 months
The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.
3 months
Patient Reported Use of Opioid Medication
Time Frame: Days 1-2, days 4-6
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
Time Frame: Days 1-2
Patient reported total pills taken in the first 48 hours after baseline enrollment.
Days 1-2
Patient Reported Use of Opioid Medication
Time Frame: 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.
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
Time Frame: Days 1, day 14, 3 Months
Patient reported use and dose of NSAIDs and acetaminophen
Days 1, day 14, 3 Months
Functional Ability/Return to Usual Activities
Time Frame: At Baseline and 3 Months (referred to as "3 M" below)

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
Time Frame: Baseline, Days 1 and 7, Day 14, 3 Months (referred to as "3 M" below)
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
Time Frame: Day 7
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
Time Frame: At Baseline
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
Time Frame: At Baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zachary F Meisel, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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