Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change in pain perception from baseline, as measured by the visual analog scale (VAS) |
The Visual Analog Scale is a scale ranging from 0 (no pain) to 10 (worst possible pain) and anchored with descriptive faces. |
Baseline, 8 weeks, and 3-months postpartum |
|
| Other |
Change from baseline in quality of life measured by the World Health Organization (WHO) Quality of Life Brief. |
The World Health Organization Quality of Life - Brief instrument contains 26 questions to assess a quality of life profile based on four domains: physical health, psychological health, social relationships, and environment. Each domain ranges in score from 0 to 100 where higher scores denote higher quality of life. |
Baseline, 8 weeks, and 3-months postpartum |
|
| Primary |
Retention in medication treatment for opioid use disorder as assessed by number of weeks buprenorphine or methadone present in urine toxicology screening in clinical record conducted as part of treatment as usual. |
Data collected through review of clinical record review of consented participants. |
baseline to 3-months postpartum |
|
| Primary |
Change in opioid abstinence from baseline as assessed by number of weeks consistently abstinent from opioids as determined by weekly point of care urine toxicology screening conducted as part of treatment as usual. |
Data collected through review of clinical record of consented participants. |
baseline to 3-months postpartum |
|
| Secondary |
Change in opioid and other substance use from baseline, as assessed with the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) V3.0. |
The Alcohol, Smoking and Substance Involvement Screening Test contains 7 questions and asks about past and current substance use and addiction to various substances. Each substance ranges in scores between 0 to 27+ with higher scores indicating greater risk level of addiction and dependence. Opioid addiction severity will be measured by 11 "yes or no" response items aligned with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria with more "yes" responses indicating higher opioid addiction severity. |
Baseline, 8 weeks, and 3-months postpartum |
|
| Secondary |
Change in depression from baseline, as assessed with the Edinburgh Prenatal and Postnatal Depression Scale. |
The Edinburgh Prenatal and Postnatal Depression Scale contains 10 questions with scores ranging from 10 to 40 with higher scores indicating greater depression symptoms. |
Baseline, 8 weeks, and 3-months postpartum |
|
| Secondary |
Change in anxiety from baseline, as assessed with the Generalized Anxiety Disorder Scale (GAD) |
The Generalized Anxiety Disorder Scale contains 7 questions with scores ranging from 0 to 21, with higher scores indicating greater anxiety symptoms. |
Baseline, 8 weeks, and 3-months postpartum |
|
| Secondary |
Change in stress from baseline, as assessed with the Perceived Stress Scale |
The Perceived Stress Scale contains 10 questions with scores ranging from 0 to 40 with higher scores indicating greater stress. |
Baseline, 8 weeks, and 3-months postpartum |
|
| Secondary |
Change in post-traumatic stress from baseline, as assessed with the abbreviated Post-Traumatic Stress Disorder (PTSD) Checklist screening instrument. |
The abbreviated Post-Traumatic Stress Disorder Checklist screening instrument contains 20 questions with scores ranging from 0 to 80 with higher scores indicating greater PTSD symptoms. |
Baseline, 8 weeks, and 3-months postpartum |
|
| Secondary |
Change in mindfulness from baseline, as assessed with the Mindful Attention Awareness Scale (MAAS) |
The Mindful Attention Awareness Scale contains 15 questions with scores ranging between 1 and 6 with higher scores indicating greater mindfulness. |
Baseline, 8 weeks, and 3-months postpartum |
|
