Trial · NCT03932799
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subacute Phase - More Than 7 Days of Opioids | 6-12 weeks after injury | More than 7 unique days of opioids within the time period |
| Primary | Chronic Phase - Composite (Meeting ≥1 of the 3 Chronic Phase Metrics) | 3-6, 6-9, and 9-12 months after injury | At least 1 instance of either chronic opioid prescribing, concurrent opioid and sedative prescribing, or high dose opioid prescribing attributed to a worker within the time period |
| Primary | Chronic Phase - Chronic Opioids (≥60 Days' Supply) | 3-6, 6-9, and 9-12 months after injury | 60 or more unique days of opioids within the time period |
| Primary | Chronic Phase - Concurrent (Concurrent Sedatives/Hypnotics and Opioids on ≥1 Day) | 3-6, 6-9, and 9-12 months | At least 1 overlapping day of both a sedative and an opioid within the time period |
| Primary | Chronic Phase - High Dose (Average of ≥50 Morphine Equivalent Daily Dose [MEDD] Among All Days With Opioids) | 3-6, 6-9, and 9-12 months after injury | Mean MEDD of 50 or more during the days a worker received opioids (based on days' supply) within the time period |
| Secondary | ≥30% Decrease in Pain Intensity/Interference (PEG-3) | 12 months after injury | Clinically important improvement in pain intensity/interference defined as obtaining a ≥30% reduction in pain intensity and interference from baseline. This was assessed with the PEG-3, which is comprised of 3 items assessing pain intensity and pain interference with enjoyment of life/general activity on a 0 to 10 numerical rating scale (0 = no pain/does not interfere, 10 = pain as bad as you can imagine/completely interferes). 1 = ≥30% reduction in mean PEG-3 summary score from baseline; 0 = otherwise. |
| Secondary | Anxious Symptoms (PHQ-4) | 12 months after injury | 2-item PHQ-4 subscale assessed how often participant was bothered by anxious symptoms on 4-point scale (0 = not at all, 3 = nearly every day). 1 = summed subscale score ≥3; 0 = otherwise. |
| Secondary | Depressive Symptoms (PHQ-4) | 12 months after injury | 2-item PHQ-4 subscale assessing how often participant was bothered by depressive symptoms on 4-point scale (0 = not at all, 3 = nearly every day). 1 = summed subscale score ≥3; 0 = otherwise. |
| Secondary | Global Improvement (GIC) | 12 months after injury | Global Impression of Change on 7-point Likert scale. Participants asked to rate how they compared now to immediately after their injury (1 = very much improved, 7 = very much worse) 1 = "much improved" or "very much improved"; 0 = otherwise. |
| Secondary | Disability - Activity Limitation | 12 months after injury | Modified activity limitation items from the National Health Interview Survey (NHIS) 2011 Adult Functioning Supplement. Participants were asked to rate on a 3-point scale (limited a lot, limited a little, not limited at all) whether their health was limited in four domains: participating in leisure or social activities, getting out with friends or family, doing household chores such as cooking and cleaning, and using transportation to get to places you want to go. 1 = "limited a lot" ; 0 = otherwise. |
| Secondary | Not Working for Pay | 12 months after injury | Participants asked whether they worked for pay in the past week. 1 = did not work for pay in the week prior to assessment; 0 = otherwise. |
| Secondary | On Time Loss (Not Working) | 12 months after injury | 1 = on time loss (workers' compensation warrant data); 0 = otherwise. |
| Secondary | Earning Less Than Before Injury | 12 months after injury | Participants asked to rate on a 5-point Likert scale the extent to which earnings differed from earnings at time of injury (1 = a lot more than before the injury, 5 = a lot less than before the injury). 1 = "somewhat less than before", "a lot less than before the injury", or not working; 0 = otherwise. |
| Secondary | Opioid Overdose/Adverse Effects | 12 months after injury | Qualifying International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes: first 3 digits = "T40" and 5th digit = ("0","1","2","3","4","6") and 7th digit not = "6" (excludes underdosing). 1 = presence of qualifying ICD-10-CM diagnosis code; 0 = otherwise. |
| Secondary | Quality of Life (EuroQol EQ-5D) | 12 months after injury | 5-item scale in which participants were asked to rate the extent to which they experienced problems with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale (1 = no problems, 5 = extreme problems). Individual item responses were used to create score profiles (range 11111 to 55555), which were then converted to an index value using a US-based value set. -0.573 (worst health state) to 1 (best health state) |
| Secondary | Satisfaction With Overall Treatment | 12 months after injury | Single-item 5-point Likert scale rating of how satisfied participants were with all injury-related treatment (-2 = very dissatisfied, 2 = very satisfied). |
| Secondary | Satisfaction With Pain-related Treatment | 12 months after injury | Single-item 5-point Likert scale rating of how satisfied participants were with treatment received for injury-related pain (-2 = very dissatisfied, 2 = very satisfied). |
| Other | Problematic Opioid Use (TAPS) | 12 months after injury | 3-item TAPS tool Part 2 assessing any problematic opioid use in the past 3 months. Participants asked if they used a prescription opioid not as prescribed, if they failed in cutting down on opioid use, and if anyone has expressed concern about their opioid use (0 = no, 1 = yes). The items were summed to create a summary score in which scores ≥1 represented problematic or high-risk opioid use. 1 = summed subscale score ≥1; 0 = otherwise. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03932799/registered