Clinical trial NCT03134092: The Life STORRIED Study
Official title: Life Stories for Opioid Risk Reduction in the ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Dependence
Communication
Risk Behavior
Narrative Medicine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2017-04-28
Enrollment: 1302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

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.

Eligibility 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)

Primary outcomes:
measure: Risk Awareness and Recall
timeFrame: Day 14
measure: Patient Reported Use of Opioid Medication
timeFrame: Day 14
Secondary outcomes:
measure: Patient Reported Use of Opioid Medication
timeFrame: Days 1-2, 4-6
measure: Patient Reported Use of Opioid Medication
timeFrame: Days 1-2, 4-6
measure: Patient Reported Use of Opioid Medication
timeFrame: Day 14, 3 Months
measure: Patient Reported Use of Opioid Medication
timeFrame: Days 1-2, 4-6, day 14, 3 Months
measure: Reported Use of Non Opioid Pain Medication
timeFrame: Days 1-2, 4-6, day 14, 3 Months
measure: Functional Ability/Return to Usual Activities
timeFrame: At Baseline and 3 Months
measure: Functional Ability/Return to Usual Activities
timeFrame: Days 1 and 7, Day 14, 3 Months
measure: Functional Ability/Return to Usual Activities for Back Pain Patients
timeFrame: Days 1 and 7, Day 14, 3 Months
measure: Patient Reported Shared Decision Making
timeFrame: Day 1
measure: Satisfaction With Pain Treatment
timeFrame: Days 1 and 7, Day 14, 3 Months
measure: Trust in Provider
timeFrame: Day 7
measure: Patient Preference for Treatment Plan
timeFrame: At Baseline
measure: Treatment Plan Agreement Between Patient Preference and Provider Decision
timeFrame: At Baseline
measure: Self-Report Additional Provider Visits
timeFrame: Day 14 and 3 Month
measure: Current Opioid Misuse Measure (COMM)
timeFrame: 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama- Birmingham
state: Alabama
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Zachary F Meisel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.