N/A
Completed N=1,302
The Life STORRIED Study
opioid dependence · Communication · Risk Behavior · Narrative Medicine
Source: ClinicalTrials.gov NCT03134092 ↗
Enrolled (actual)
1,302
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Risk Awareness and Recall — 118; 129 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk Awareness and Recall |
118; 129 | — |
| PRIMARY Patient Reported Use of Opioid Medication |
6; 5; 4 | — |
| SECONDARY Patient Reported Use of Opioid Medication |
6; 5; 4 | — |
| SECONDARY Patient Reported Use of Opioid Medication |
6; 5; 4 | — |
| SECONDARY Patient Reported Use of Opioid Medication |
6; 5; 4 | — |
| SECONDARY Patient Reported Use of Opioid Medication |
6; 5; 4 | — |
| SECONDARY Reported Use of Non Opioid Pain Medication |
47; 55; 64; 193; 170; 167 | — |
| SECONDARY Functional Ability/Return to Usual Activities |
4.46; 4.82; 4.67 | — |
| SECONDARY Functional Ability/Return to Usual Activities |
4.46; 4.82; 4.67 | — |
| SECONDARY Patient Reported Shared Decision Making |
6.826797; 7.070968; 7.220430 | — |
| SECONDARY Satisfaction With Pain Treatment |
6.57; 6.58; 7.25; 6.50; 6.49; 6.92 | — |
| SECONDARY Trust in Provider |
76.23; 73.62; 75.20 | — |
| SECONDARY Patient Preference for Treatment Plan |
143; 123; 112 | — |
| SECONDARY Treatment Plan Agreement Between Patient Preference and Provider Decision |
286; 300; 303 | — |
| SECONDARY Self-Report Additional Provider Visits |
125; 127; 121; 113; 128; 124 | — |
| SECONDARY Current Opioid Misuse Measure (COMM) |
17; 9; 9 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03134092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.