Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in the number of days of Opioid use |
Self-reported number of days of risky (illicit or nonmedical) opioid use in the past 180 days, assessed at 6 months after the baseline visit using single items from the Addiction Severity Index. Participants are asked to specify the number of days of illicit opioid use and of nonmedical opioid use in the past 30 days (range is 0-30 days). Illicit opioid use includes use of heroin or synthetic opioids. Nonmedical opioid use includes using prescribed opioids more frequently or at higher doses than instructed on the prescription (e.g., taking 2 tablets when the prescription indicates a dose of 1 tablet), or taking pharmaceutical opioids that were not prescribed to them. Prescribed opioids may be prescribed by the participating PCP or by another medical provider. The measure is calculated as the sum of all days of use reported on the assessments of past 30-day drug use for the first 6 months . |
6 months after baseline |
|
Secondary |
Change in Substance use disorder |
Opioid use disorder is assessed at baseline and at 12 months using the modified World Mental Health Composite International Diagnostic Interview (CIDI). Drug and alcohol use disorder measures are collected using the Psychiatric Diagnostic Screening Questionnaire (PDSQ) at baseline and at 6 and 12 months. The PDSQ is a brief self-administered instrument to assess DSM-4 Axis I disorders, including alcohol use disorder (AUD) and drug use disorder (DUD). It is the only brief questionnaire assessing DSM-4 substance use disorder that has been validated for self-administration. The PDSQ was validated in more than 3,000 in both medical and mental health outpatient settings.There are 6 items assessing AUD and 6 items for DUD, all using a yes/no response format and a 2-week timeframe. The PDSQ is used for baseline and follow-up assessments of AUD, DUD, and depression. Because the PDSQ does not specify drug class the CIDI, rather than the PDSQ, is used to measure DSM-5 OUD. |
Screening/Baseline, 6 months and 12 months |
|
Secondary |
Change in Overdose risk behaviors and events |
Measured using the Overdose Risk Behavior Questionnaire to assess Overdose risk behavior and behavioral intention to reduce risk.Overdose risk behavior is assessed using a 9-item self-administered questionnaire that was developed by a group of opioid researchers based on knowledge of overdose behavioral risk factors, and used in 3 prior studies to capture overdose risk behavior. These questions measure the frequency, in the past 3 months, at which individuals used alone; used in a new place/environment; used other substances (alcohol, benzodiazepines, stimulants) within 2 hours of opioids; used more than one opioid; used more than the usual amount; and used inhaled or injected opioids. The total risk score is an aggregation of responses to the individual questions. The overdose risk behavior questionnaire is self-administered. |
at baseline and at 6 and 12 months |
|
Secondary |
Change in Pain symptoms and pain-related functioning |
Pain symptoms (severity, impact on functioning) are measured at baseline and at 3, 6, 9, and 12 months using the Brief Pain Inventory Short Form (BPI) short form items on pain and functioning. The BPI short form is widely used to measure clinical pain for clinical and research purposes. The 15-item self-administered questionnaire measures the "sensory" dimension of pain (intensity, or severity) and the "reactive" dimension of pain (interference with daily function) experienced in the past 24 hours. The form asks a series of questions to measure the intensity of pain, and the rate at which pain interferes with daily activities, using a 0 to 10 scale. The BPI short form has been validated as a tool to assess the severity of pain and the impact pain has on an individual's quality of life. |
Baseline, at 3, 6, 9 and 12 months |
|
Secondary |
Change in Mental health |
Anxiety symptoms are measured at baseline and 6 and 12 months. Depression symptoms are measured at baseline and at 6 and 12 months (PHQ-8 ). Assessment of depression symptoms is accomplished with the Patient Health Questionnaire (PHQ-8) depression screening tool. The ninth item of the PHQ-9 is about suicidal ideation, which is queried separately in our study as part of the Patient Safety Screener (PSS). The PHQ-8 has been validated as a measure of depression, independent of the PHQ- 9. |
Baseline, at 6 and at 12 months |
|
Secondary |
Change in Mental health |
Anxiety symptoms are measured at baseline and 6 and 12 months. Assessment of suicidal ideation is accomplished with the Patient Safety Screener (PSS). The ninth item of the Patient Health Questionnaire (PHQ-9) is about suicidal ideation, which is queried separately in our study as part of the PSS. The PSS is a validated screening instrument that was used in the ED-SAFE study. It consists of one item about suicidal ideation in the past two weeks, followed by one item about lifetime suicide attempts, in a yes/no format. Individuals reporting a suicide attempt are asked when this last occurred. The PSS is administered by research staff for safety reasons, to allow for rapid assessment and response for patients with suicidality. |
Baseline, at 6 and at 12 months |
|
Secondary |
Health-related quality of life |
Health-Related Quality of Life (SF-12) is measured at baseline and at 6 and 12 months.The SF-12 is part of the CTN DSC recommended assessment battery that measures overall functional health and well-being. The questionnaire begins by asking to rate one's overall health on a scale of 1 to 5, followed by two items on daily living activities. Additional questions address physical and emotional health as well as pain interference during the past 4 weeks. The SF-12 is a validated tool for measuring health-related quality of life. |
Baseline, at 6 and 12 months |
|
Secondary |
Acute health care utilization |
ED and hospital utilization is measured using participant self-report of acute care events, collected at baseline and at 6 and 12 months. Acute care admissions are a meaningful outcome for health systems and policymakers and will be measured using the CTN DSC questionnaire. Patient participants will report the number of ED visits and number of hospitalizations in the past 6 months. For any reported hospitalization, days in the hospital will be asked. |
Baseline, at 6 and 12 months |
|