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OpenTrials
Completed

NCT Number: NCT03134092

The Life STORRIED Study

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama- Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. Patient Reported Use of Opioid Medication

    Time frame: Days 1-2

    Patient reported total pills taken in the first 48 hours after baseline enrollment.

  3. Patient Reported Use of Opioid Medication

    Time frame: Day 14, 3 Months

    Frequency of use

  4. 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

  5. Reported Use of Non Opioid Pain Medication

    Time frame: Days 1, day 14, 3 Months

    Patient reported use and dose of NSAIDs and acetaminophen

  6. 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.

  7. 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)

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Self-Report Additional Provider Visits

    Time frame: Day 14 and 3 Month

    Self-Report additional provider visits to measure follow-up visits for pain

  14. Current Opioid Misuse Measure (COMM)

    Time frame: 3 months

    The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Life Stories for Opioid Risk Reduction in the ED

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2017
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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