Opioid DependenceNCT03134092
The Life STORRIED Study
A study testing Probabilistic Risk Communication Tool (PRT) and Narrative Enhanced Risk Tool (NERT) in people with Opioid Dependence and Communication, run by University of Pennsylvania at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, Communication, Risk Behavior
- What is being tested?
- Probabilistic Risk Communication Tool (PRT) and Narrative Enhanced Risk Tool (NERT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,302 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Jun 2017to 19 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama- Birmingham
Birmingham, Alabama, 35249
Northwell Health
Manhasset, New York, 11030
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Dependence, Communication, Risk Behavior, Narrative Medicine
- Being tested
- Probabilistic Risk Communication Tool (PRT), Narrative Enhanced Risk Tool (NERT)
- Medical subject headings
- Opioid-Related Disorders, Communication, Risk-Taking, Narrative Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Probabilistic Risk Communication Tool (PRT); Other: Narrative Enhanced Risk Tool (NERT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 14
Secondary outcomes (14)
Patient Reported Use of Opioid Medication
A second outcome is measuring patient reported opioid medication use by Total morphine equivalents.
Measured: 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.
Measured: Days 1-2
Patient Reported Use of Opioid Medication
Frequency of use
Measured: Day 14, 3 Months
Patient Reported Use of Opioid Medication
Patient reported days to no longer taking opioids
Measured: 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
Measured: 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.
Measured: 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)
Measured: Baseline, Days 1 and 7, Day 14, 3 Months (referred to as "3 M" below)
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.
Measured: 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.
Measured: Days 1 and 7, Day 14, 3 Months
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.
Measured: 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.
Measured: 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.
Measured: At Baseline
Self-Report Additional Provider Visits
Self-Report additional provider visits to measure follow-up visits for pain
Measured: Day 14 and 3 Month
Current Opioid Misuse Measure (COMM)
The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start28 Jun 2017
- Primary completion7 Aug 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Zachary F Meisel, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134092
- Sponsor's protocol ID
- 826673
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2017
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35143273Engel-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.
PubMed 34323984Meisel 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.
PubMed 32969832
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Stories for Opioid Risk Reduction in the ED
- ClinicalTrials.gov ID
- NCT03134092
- Acronym / sponsor ID
- 826673
- Conditions
- Opioid Dependence, Communication, Risk Behavior, Narrative Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,302 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Posted 17 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Probabilistic Risk Communication Tool (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. |
| Narrative Enhanced Risk Tool (NERT) | Active comparator | Other: Probabilistic Risk Communication Tool (PRT), Other: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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), Probabilistic Risk Communication (PRT) |
| 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. | Other | Narrative Enhanced Risk Tool (NERT) |
Primary outcome
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.
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.
14 secondary outcomes
Patient Reported Use of Opioid Medication
Time frame: Days 1-2, days 4-6
Patient Reported Use of Opioid Medication
Time frame: Days 1-2
Patient Reported Use of Opioid Medication
Time frame: Day 14, 3 Months
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.
Reported Use of Non Opioid Pain Medication
Time frame: 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)
Functional Ability/Return to Usual Activities
Time frame: Baseline, Days 1 and 7, Day 14, 3 Months (referred to as "3 M" below)
Patient Reported Shared Decision Making
Time frame: Day 1
Satisfaction With Pain Treatment
Time frame: Days 1 and 7, Day 14, 3 Months
Trust in Provider
Time frame: Day 7
Patient Preference for Treatment Plan
Time frame: At Baseline
Treatment Plan Agreement Between Patient Preference and Provider Decision
Time frame: At Baseline
Self-Report Additional Provider Visits
Time frame: Day 14 and 3 Month
Current Opioid Misuse Measure (COMM)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35143273Meisel 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.
- Derived from this study: PubMed 34323984Engel-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.
- Derived from this study: PubMed 32969832Meisel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary F Meisel, MD principal investigator
University of Pennsylvania
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probabilistic Risk Communication Tool (PRT) and Narrative Enhanced Risk Tool (NERT) in people with Opioid Dependence and Communication, run by University of Pennsylvania at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Awareness and Recall (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03134092, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.