The Life STORRIED Study

• ClinicalTrials.gov Identifier: NCT03134092
• Recruitment Status: Completed
• First Posted: April 28, 2017
• Results First Posted: August 17, 2020
• Last Update Posted: August 17, 2020
• Sponsor: University of Pennsylvania
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid Dependence; Communication; Risk Behavior; Narrative Medicine	Other: Probabilistic Risk Communication Tool (PRT); Other: Narrative Enhanced Risk Tool (NERT)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1302 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Life Stories for Opioid Risk Reduction in the ED
• Actual Study Start Date: June 28, 2017
• Actual Primary Completion Date: August 7, 2019
• Actual Study Completion Date: November 19, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Patient Reported Use of Opioid Medication [ Time Frame: Days 1-2, 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, 4-6 ]
   Patient reported total pills taken
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: Days 1-2, 4-6, day 14, 3 Months ]
   Patient reported days to no longer taking opioids
5. Reported Use of Non Opioid Pain Medication [ Time Frame: Days 1-2, 4-6, 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 ]
   The RAND health- 20 questionnaire will be used to measure functional ability.
7. Functional Ability/Return to Usual Activities [ Time Frame: Days 1 and 7, Day 14, 3 Months ]
   The American Pain Outcome questionnaire will be used to measure functional ability.
8. Functional Ability/Return to Usual Activities for Back Pain Patients [ Time Frame: Days 1 and 7, Day 14, 3 Months ]
   Back Pain Functional scale will be used to measure functional ability for back pain patients.
9. 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.
10. 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.
11. 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.
12. Patient Preference for Treatment Plan [ Time Frame: At Baseline ]
    Patients will be provided options paint treatment for discharge treatment plan.
13. 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.
14. Self-Report Additional Provider Visits [ Time Frame: Day 14 and 3 Month ]
    Self-Report additional provider visits to measure follow-up visits for pain
15. Current Opioid Misuse Measure (COMM) [ Time Frame: 3 months ]
    The Current Opioid Misuse measure (COMM) will be used to measure misuse of opioids.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: If the patient identifies as male or female, we will enter that as such for the study.
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

United States, Alabama

University of Alabama- Birmingham

Birmingham, Alabama, United States, 35249

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55902

United States, New York

Northwell Health

Manhasset, New York, United States, 11030

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Zachary F Meisel, MD; University of Pennsylvania

  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:

Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03134092
• Other Study ID Numbers: 826673
• First Posted: April 28, 2017
• Results First Posted: August 17, 2020
• Last Update Posted: August 17, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders