The Life STORRIED Study



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:11/30/2018
Start Date:June 28, 2017
End Date:September 30, 2019
Contact:Erica B Goldberg, MSW
Email:erica.goldberg@uphs.upenn.edu
Phone:215-573-2944

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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.

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 1,100 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.

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)
We found this trial at
4
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Erik P Hess, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Manhasset, New York 11030
Principal Investigator: Karin V Rhodes, MD
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Manhasset, NY
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-573-2944
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Rochester, Minnesota 55905
Principal Investigator: Venkatesh R Bellamkonda, MD
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Rochester, MN
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