Life Stories for Opioid Risk Reduction in the ED
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-001231
Sponsor Protocol Number: 17-001231
About this study
The objective of this study is to compare the effectiveness of (A) a standardized general risk information sheet only, (B) a standardized general risk information sheet plus a probabilistic risk tool, (C) standardized sheet plus narrative enhanced probabilistic risk tool on a variety of patient reported and patient centered outcomes related to pain treatment and the risks and benefits of opioid prescriptions for common, acute pain conditions.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 18 years to 70 years old.
- Experiencing back pain or renal colic.
- Text messaging and/or email capabilities and/or access to a telephone.
- 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 have taken Tramadol in the last 30 days will allowed to be enrolled in the study.
- Patients who are pregnant, in police custody, intoxicated, cognitively impaired, or otherwise unable to fully consent and participate based on provider assessment.
- Patients who are hemodynamically compromised, in respiratory distress, or in severe emotional or physical distress based on provider assessment.
- 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 based on provider assessment.
- Patients who are suicidal or homicidal ideation by chart review and clinician assessment
- Patients with evidence of aberrant behavior based on review of state prescription drug monitoring program (PMP) and/or electronic medical record (EMR)
- Patients who do not have a phone, text messaging OR email address
- Patients under police arrest at ED visit
- Patients who are non-English
- Patients previously enrolled
- Patients who are not able to take an opioid-base medication based on provider assessment. If an allergy to opioids is listed in the EMR, but the provider determines that it is merely intolerance, the patient is still eligible for enrollment.
- Patients who are not able to take NSAIDs based on provider assessment. If an allergy to NSAIDs is listed in the EMR, but the provider determines that it is merely intolerance, the patient is still eligible for enrollment.
- Patient with any current contraindications for NSAIDs or opioid medications including chronic kidney disease (GFR60, if measured) or concurrent use of sedating medications.
- Patients with a diagnosis of back fracture
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available