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The Life STORRIED Study

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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:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Pennsylvania

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.

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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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134092


Locations
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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
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Principal Investigator: Zachary F Meisel, MD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03134092    
Other Study ID Numbers: 826673
First Posted: April 28, 2017    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders