Table 2 Aims, Outcomes and Measures
Outcome | Instrument | Time of administration |
|---|---|---|
Aim 1: Determine efficacy of STOP as compared to EUC for reducing risky opioid use | ||
 Risky Opioid Use | Healthy Living Survey | Baseline, monthly |
Timeline Follow-Back [76] | 3Â m, 6Â m | |
Urine Toxicology Screen | Baseline, 6Â m, 12Â m | |
Aim 2: Examine the impact of STOP on important patient-level outcomes | ||
 Substance Use | ||
  Binge alcohol use, benzodiazepine use, stimulant use, other drug use | Healthy Living Survey | Baseline, monthly |
Urine Toxicology Screen | Baseline, 6Â m, 12Â m | |
  Tobacco | E-cigarette and vaping | Baseline, 6 m, 12 m |
  Marijuana use | Healthy Living Survey | Baseline, monthly |
Marijuana Use assessment [77] | Baseline, 12Â m | |
  Prescription opioid misuse behaviors among individuals with prescribed opioids | Current Opioid Misuse Measure (COMM) [32] | Baseline, 6 m, 12 m |
  Incidence of Moderate-Severe OUD | CIDI [34] | Baseline, 6 m, 12 m |
  Overdose risk behavior | Non-fatal overdose questionnaire [47] | Baseline, 6 m, 12 m |
Other outcomes | ||
 Alcohol and drug use disorder | Baseline, 6 m, 12 m | |
 Pain symptoms and functioning | BPI – short form [79] | Baseline, 3 m, 6 m, 9 m, 12 m |
 Depression and Suicide | Baseline, 6 m, 12 m | |
 Anxiety | PROMIS anxiety short form [41] | Baseline, 6 m, 12 m |
 Sleep Quality | PROMIS sleep 4a [83] | Baseline, 6 m, 12 m |
 Health Related Quality of Life | SF-12 measure [84] | Baseline, 6 m, 12 m |
 Health Care Utilization | Patient reported ED visits and hospitalizations | Baseline, 6 m, 12 m |
Aim 3: Characterize the impact of STOP on primary care provider behaviors | ||
 Rates of opioid prescribing, including high dose | Chart Abstraction | 12 m |
 Rates of Benzodiazepine prescribing | Chart Abstraction | 12 m |
 Receipt of naloxone kita | Chart Abstraction | 12 m |
Nurse Care Manager checklist | Cumulative 12Â months | |
 Monitoring for patients prescribed opioids | Chart Abstraction | 12 m |
Other outcomes | ||
 Organizational context in readiness to change | ORCA Context Items [85] | Baseline |
 Experience with assessment and treatment of pain, COT management | Modified TOPCARE survey [26] | Baseline, 12 m |
 Substance use and misuse in patients: knowledge and attitudes | Modified ASIP survey [86] | Baseline, 12 m |
 Experience with management of risky opioid use, OUD, overdose prevention, X-waiver | Modified TOPCARE survey [26] | Baseline, 12 m |
 Feedback on intervention (intervention PCPs only) | 12 m | |