Opioid-use Disorder
Conditions
Brief summary
The Subthreshold Opioid Use Disorder Prevention (STOP) trial will test the efficacy of a primary care intervention to reduce opioid use and overdose risk, and prevent progression to OUD, in adults with unhealthy use of illicit or prescribed opioids. STOP is a collaborative care model. A cluster-randomized trial, conducted in 5 primary care sites, with 100 PCPs and 300adult primary care patients, will test the efficacy of STOP versus enhanced usual care (EUC). The STOP intervention, if proven efficacious, will provide a solution to preventing OUD among patients who are most at risk, thus addressing a key aspect of the current opioid crisis.
Detailed description
This cluster randomized trial, conducted in primary care clinics and randomized at the level of the PCP, will compare the STOP intervention to enhanced usual care (EUC) for 12 months. Patients who are eligible and enroll will receive the intervention according to the assignment of their PCP. In the EUC arm, PCPs conduct primary care as usual, without support of the nurse care manager. Patient participants receive an educational pamphlet about overdose prevention and watch a brief video on healthy living that is not specific to substance use. In the STOP arm, PCPs and their enrolled patient participants receive the STOP intervention, consisting of a NCM, brief advice about health risks of opioid misuse, and telephone health coaching. Patient participants in either arm who are found by clinical providers to have developed a moderate-severe OUD at any time during the study can be offered medication for OUD and linked to treatment by clinical staff in the EUC arm, and the NCM in the STOP arm, to formal assessment and MOUD treatment.
Interventions
BEHAVIORALPCP brief advice
Brief advice will be delivered by the patient participant's PCP as part of the medical visit or via phone call. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the research staff. The summary advises the PCP that their patient participant screened positive for risky opioid use, lists the patient participant's screening results (TAPS Tool +/- COMM) and gives a suggested counseling script. The counseling script will include specific advice on opioid-related risks, will inform patient participants of resources to help them reduce their risk, and will include a recommendation to reduce their risk behavior.
BEHAVIORALVideo doctor
During the baseline visit with the research staff, patient participants will view a video on tablet or desktop computer that reinforces the PCP's counseling. The video is a recording of a provider delivering brief advice about opioid use that includes the same elements covered in the summary report outlined above.
BEHAVIORALTelephone health coaching
All patient participants in the STOP arm will receive telephonic health coaching sessions at approximately 2- and 4-weeks post-baseline. Patient participants who may benefit from additional coaching (for example, those who do not improve or who experience clinical worsening of unhealthy opioid use) may receive additional coaching sessions (approximately 4 sessions) from the telephone health coach. Coaching is delivered from a centralized call center, by staff that receive standardized training and supervision. To the extent possible, calls will be scheduled at the patient participant's convenience (e.g., evenings, weekends).
BEHAVIORALNurse Care Manager (NCM) intervention
NCMs will provide health education and counseling on risk reduction, overdose prevention and self-management skills. Patient participants will be asked to participate in a baseline visit with the NCM, which will occur on the same day as the baseline research visit if possible. The NCM continues working with patients in the STOP condition throughout their 12 months of study participation. Following the initial visit with the NCM, the frequency of visits depends on patient participant needs.
Sponsors
National Institute on Drug Abuse (NIDA)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PCP Inclusion Criteria * Licensed medical professional (MD, DO, PA, NP). * Currently providing care to approximately 4 or more adult patients (18 years or older) who are receiving chronic opioid treatment and/or have risky opioid use. * Total patient volume is approximately 40 or more adult patients (18 years or older) per week on a typical week * Willing to be randomized to either of the two study conditions Patient Participant Inclusion Criteria * PCP is enrolled in the study. * Age 18 years or older at time of prescreening. * Proficient in spoken and written English, as determined by patient self-report and research staff evaluation. * Risky opioid use in the past 90 days from date of prescreening, as determined by a TAPS score \>1 for heroin and/or prescription opioids and/or a positive response (\>Never) to any of the three COMM items indicating taking more opioid medication than prescribed * Access to phone that can receive text messages, and access to internet (via smartphone, tablet, or computer), per patient self-report. * Able to provide informed consent. PCP
Exclusion criteria
* Planning to resign from the clinic in the next 24 months, per PCP self-report. * Planning to change their schedule in the next 24 months such that they would no longer meet the inclusion criteria for patient volume, per PCP self-report. Patient Participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of Risky Opioid Use in Past 180 Days | Up to Month 6 | 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. 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 (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of Benzodiazepine Use in Past 180 Days | Up to Month 6 | Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180). |
| Days of Stimulant Use in Past 180 Days | Up to Month 6 | Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180). |
| Days of Marijuana Use in Past 180 Days | Up to Month 6 | Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180). |
| Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days. | Up to Month 6 | Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180). |
| Days of Binge Alcohol Use in Past 180 Days | Up to Month 6 | Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180). Binge alcohol use defined as 5+ drinks/day for men under age 65 and 4+ drinks/day for women and men age 65 and over. |
| Number of Participants With Opioid Use Disorder | Month 6 | Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI). |
| Number of Participants With Drug (Other Than Opioid) Use Disorder | Month 6 | Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ). |
| Number of Participants With Alcohol Use Disorder | Month 6 | Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ). |
| Change in Overdose Risk Behavior Questionnaire Score | Baseline, Month 6 | 13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors. |
| Days of Risky Opioid Use in Past 180 Days | Month 7 up to Month 12 | Self-reported number of days of risky (illicit or nonmedical) opioid use in the past 180 days, assessed at 12 months after the baseline visit using single items from the Addiction Severity Index. 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 months 7-12. |
| Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity | Month 6 | Items 3-6 from the BPI short form will be completed to assess pain severity. Items 3-6 are rated on a Likert scale from 0 (no pain) to 10 (pain as bad as you can imagine). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain severity. |
| Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference | Month 6 | Items 9A-9G from the BPI short form will be completed to assess pain interference. Items 9A-9G are rated on a Likert scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain interference. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score | Month 6 | The PROMIS Anxiety Short Form comprises 8 questions assessing anxiety. Each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses and ranges from 8 to 40. The raw score is converted to a standardized t-score ranging from 0-100 with a mean of 50 and a standard deviation of 10. Higher t-scores indicate greater levels of anxiety. |
| PROMIS Anxiety Short Form Score | Month 12 | The PROMIS Anxiety Short Form comprises 8 questions assessing anxiety. Each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses and ranges from 8 to 40. The raw score is converted to a standardized t-score ranging from 0-100 with a mean of 50 and a standard deviation of 10. Higher t-scores indicate greater levels of anxiety. |
| Patient Health Questionnaire-8 (PHQ-8) Score | Month 6 | The Patient Health Questionnaire-8 (PHQ-8) is a self-reported questionnaire that measures depressive symptoms. The PHQ-8 score is calculated by adding up the scores from each of the eight items on the questionnaire. The score ranges from 0 to 24, with higher scores indicating more severe depression. |
| Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS) | Month 6 | Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Physical Component Summary (PCS) subscale comprises physical health-related questions in the SF-12. The PCS raw score is the sum of responses. The PCS raw score is converted into a total score ranging from 0-100; higher scores indicate better physical health. |
| Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS) | Month 6 | Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Mental Component Summary (MCS) subscale comprises mental health-related questions in the SF-12. The MCS raw score is the sum of responses. The MCS raw score is converted into a total score ranging from 0-100; higher scores indicate better mental health. |
| Number of Acute Care Events | Up to Month 6 | Measured as the total number of self-reported emergency department (ED) visits in the past six months. |
| Number of Acute Care Events (Self-Report) | Up to Month 6 | Measured as the total number of self-reported hospital utilizations in the past six months. |
| Episodes of Non-Fatal Overdose | Month 6 | Number of non-fatal drug or alcohol overdoses per participant. |
Countries
United States
Participant flow
Pre-assignment details
Randomization occurred at the level of the PCP. Patients who were eligible and enrolled received the intervention according to the assignment of their PCP.
Participants by arm
| Arm | Count |
|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention - Patients At baseline, patient participants in the STOP arm will receive the intervention components of brief advice from their PCP and a video doctor , printed educational materials, interaction with the NCM, and telephone health coaching. Brief advice will be delivered by the patient participant's PCP as part of the medical visit or via phone call. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the research staff. During the baseline visit, patient participants also meet with the research staff to view a video on tablet or desktop computer that reinforces the PCP's counseling. | 88 |
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention - PCPs PCPs of participants in the STOP arm. | 58 |
| Enhanced Usual Care (EUC) - Patients PCPs will conduct primary care as usual, without the support of the NCM. At the baseline visit, patient participants receive an educational pamphlet and view a short video on overdose and cancer screening. The pamphlet includes information about preventing opioid-related overdose, including how to obtain a naloxone kit. The video content will feature the health benefits of exercise. It will be viewed on a tablet or desktop computer and will be approximately 2 minutes long. All EUC patient participants receive the same video, which is not tailored to the responses given on their questionnaires. There is no study intervention after the baseline visit. | 114 |
| Enhanced Usual Care (EUC) - PCPs PCPs of participants in the EUC arm. | 60 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 2 | 0 |
| Overall Study | No longer interested in participating | 0 | 1 | 0 | 0 |
| Overall Study | PCP plans to leave practice | 0 | 8 | 0 | 5 |
| Overall Study | Practical problems (e.g., no childcare or transportation) | 3 | 0 | 0 | 0 |
| Overall Study | Reduced panel | 0 | 0 | 0 | 1 |
| Overall Study | Unable to contact participant | 4 | 0 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Enhanced Usual Care (EUC) - PCPs | Total | Subthreshold Opioid Use Disorder Prevention(STOP) Intervention - Patients | Subthreshold Opioid Use Disorder Prevention(STOP) Intervention - PCPs | Enhanced Usual Care (EUC) - Patients |
|---|---|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 12.23 | 55.7 years STANDARD_DEVIATION 12.68 | 54.1 years STANDARD_DEVIATION 13.31 | 41.4 years STANDARD_DEVIATION 7.6 | 56.9 years STANDARD_DEVIATION 12.09 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 22 Participants | 1 Participants | 8 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 45 Participants | 21 Participants | 1 Participants | 22 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 12 Participants | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants | 9 Participants | 3 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 55 Participants | 301 Participants | 86 Participants | 51 Participants | 109 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 9 Participants | 3 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown or refused to answer | 4 Participants | 9 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Refused to Answer | 3 Participants | 7 Participants | 0 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 41 Participants | 222 Participants | 60 Participants | 38 Participants | 83 Participants |
| Region of Enrollment United States | 60 participants | 316 participants | 88 participants | 58 participants | 114 participants |
| Sex/Gender, Customized Female | 34 Participants | 200 Participants | 65 Participants | 38 Participants | 63 Participants |
| Sex/Gender, Customized Male | 26 Participants | 116 Participants | 23 Participants | 16 Participants | 51 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 0 Participants | 4 Participants | 0 Participants | 4 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 2 / 114 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Days of Risky Opioid Use in Past 180 Days
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. 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 (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Time frame: Up to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Risky Opioid Use in Past 180 Days | 12.2 days | Standard Deviation 27.73 |
| Enhanced Usual Care (EUC) | Days of Risky Opioid Use in Past 180 Days | 15.5 days | Standard Deviation 32.64 |
Secondary
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference
Items 9A-9G from the BPI short form will be completed to assess pain interference. Items 9A-9G are rated on a Likert scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain interference.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference | 4.14 score on a scale | Standard Deviation 2.79 |
| Enhanced Usual Care (EUC) | Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference | 3.87 score on a scale | Standard Deviation 2.8 |
Secondary
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference
Items 9A-9G from the BPI short form will be completed to assess pain interference. Items 9A-9G are rated on a Likert scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain interference.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference | 4.38 score on a scale | Standard Deviation 2.91 |
| Enhanced Usual Care (EUC) | Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference | 4.32 score on a scale | Standard Deviation 2.87 |
Secondary
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity
Items 3-6 from the BPI short form will be completed to assess pain severity. Items 3-6 are rated on a Likert scale from 0 (no pain) to 10 (pain as bad as you can imagine). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain severity.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity | 4.46 score on a scale | Standard Deviation 2.29 |
| Enhanced Usual Care (EUC) | Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity | 3.98 score on a scale | Standard Deviation 2.58 |
Secondary
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity
Items 3-6 from the BPI short form will be completed to assess pain severity. Items 3-6 are rated on a Likert scale from 0 (no pain) to 10 (pain as bad as you can imagine). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain severity.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity | 4.46 score on a scale | Standard Deviation 2.2 |
| Enhanced Usual Care (EUC) | Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity | 4.34 score on a scale | Standard Deviation 2.56 |
Secondary
Change in Overdose Risk Behavior Questionnaire Score
13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Change in Overdose Risk Behavior Questionnaire Score | -1.61 score on a scale | Standard Deviation 3.37 |
| Enhanced Usual Care (EUC) | Change in Overdose Risk Behavior Questionnaire Score | -1.15 score on a scale | Standard Deviation 3.07 |
Secondary
Change in Overdose Risk Behavior Questionnaire Score
13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Change in Overdose Risk Behavior Questionnaire Score | -1.43 score on a scale | Standard Deviation 2.75 |
| Enhanced Usual Care (EUC) | Change in Overdose Risk Behavior Questionnaire Score | -1.25 score on a scale | Standard Deviation 3.03 |
Secondary
Days of Benzodiazepine Use in Past 180 Days
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Time frame: Up to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Benzodiazepine Use in Past 180 Days | 2.4 days | Standard Deviation 11.05 |
| Enhanced Usual Care (EUC) | Days of Benzodiazepine Use in Past 180 Days | 4 days | Standard Deviation 18.66 |
Secondary
Days of Benzodiazepine Use in Past 180 Days
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12.
Time frame: Month 7 up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Benzodiazepine Use in Past 180 Days | 2.9 days | Standard Deviation 10.8 |
| Enhanced Usual Care (EUC) | Days of Benzodiazepine Use in Past 180 Days | 3 days | Standard Deviation 16.36 |
Secondary
Days of Binge Alcohol Use in Past 180 Days
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12 (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180). Binge alcohol use defined as 5+ drinks/day for men under age 65 and 4+ drinks/day for women and men age 65 and over.
Time frame: Month 7 up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Binge Alcohol Use in Past 180 Days | 7.0 days | Standard Deviation 21.76 |
| Enhanced Usual Care (EUC) | Days of Binge Alcohol Use in Past 180 Days | 11.2 days | Standard Deviation 28.47 |
Secondary
Days of Binge Alcohol Use in Past 180 Days
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180). Binge alcohol use defined as 5+ drinks/day for men under age 65 and 4+ drinks/day for women and men age 65 and over.
Time frame: Up to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Binge Alcohol Use in Past 180 Days | 7.3 days | Standard Deviation 18.06 |
| Enhanced Usual Care (EUC) | Days of Binge Alcohol Use in Past 180 Days | 9.9 days | Standard Deviation 23.01 |
Secondary
Days of Marijuana Use in Past 180 Days
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12(i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Time frame: Month 7 up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Marijuana Use in Past 180 Days | 33.2 days | Standard Deviation 61.19 |
| Enhanced Usual Care (EUC) | Days of Marijuana Use in Past 180 Days | 34.0 days | Standard Deviation 58.38 |
Secondary
Days of Marijuana Use in Past 180 Days
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Time frame: Up to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Marijuana Use in Past 180 Days | 34.3 days | Standard Deviation 61.47 |
| Enhanced Usual Care (EUC) | Days of Marijuana Use in Past 180 Days | 31.0 days | Standard Deviation 55.19 |
Secondary
Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12 (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Time frame: Month 7 up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days. | 0.0 days | Standard Deviation 0.11 |
| Enhanced Usual Care (EUC) | Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days. | 0.0 days | Standard Deviation 0.35 |
Secondary
Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Time frame: Up to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days. | 0.0 days | Standard Deviation 0.25 |
| Enhanced Usual Care (EUC) | Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days. | 0.1 days | Standard Deviation 0.69 |
Secondary
Days of Risky Opioid Use in Past 180 Days
Self-reported number of days of risky (illicit or nonmedical) opioid use in the past 180 days, assessed at 12 months after the baseline visit using single items from the Addiction Severity Index. 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 months 7-12.
Time frame: Month 7 up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Risky Opioid Use in Past 180 Days | 10.7 days | Standard Deviation 30.14 |
| Enhanced Usual Care (EUC) | Days of Risky Opioid Use in Past 180 Days | 10.1 days | Standard Deviation 27.75 |
Secondary
Days of Stimulant Use in Past 180 Days
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12 (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Time frame: Month 7 up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Stimulant Use in Past 180 Days | 2.0 days | Standard Deviation 15.41 |
| Enhanced Usual Care (EUC) | Days of Stimulant Use in Past 180 Days | 0.9 days | Standard Deviation 4.3 |
Secondary
Days of Stimulant Use in Past 180 Days
Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Time frame: Up to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Days of Stimulant Use in Past 180 Days | 1.2 days | Standard Deviation 8.1 |
| Enhanced Usual Care (EUC) | Days of Stimulant Use in Past 180 Days | 0.6 days | Standard Deviation 3.54 |
Secondary
Episodes of Non-Fatal Overdose
Number of non-fatal drug or alcohol overdoses per participant.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Episodes of Non-Fatal Overdose | 0.7 episodes | Standard Deviation 5.85 |
| Enhanced Usual Care (EUC) | Episodes of Non-Fatal Overdose | 0.7 episodes | Standard Deviation 4.53 |
Secondary
Episodes of Non-Fatal Overdose
Number of non-fatal drug or alcohol overdoses per participant.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Episodes of Non-Fatal Overdose | 0.3 episodes | Standard Deviation 1.66 |
| Enhanced Usual Care (EUC) | Episodes of Non-Fatal Overdose | 0.3 episodes | Standard Deviation 1.11 |
Secondary
Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)
Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Mental Component Summary (MCS) subscale comprises mental health-related questions in the SF-12. The MCS raw score is the sum of responses. The MCS raw score is converted into a total score ranging from 0-100; higher scores indicate better mental health.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS) | 46.56 score on a scale | Standard Deviation 12.32 |
| Enhanced Usual Care (EUC) | Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS) | 47.01 score on a scale | Standard Deviation 11.26 |
Secondary
Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)
Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Mental Component Summary (MCS) subscale comprises mental health-related questions in the SF-12. The MCS raw score is the sum of responses. The MCS raw score is converted into a total score ranging from 0-100; higher scores indicate better mental health.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS) | 46.11 score on a scale | Standard Deviation 11.59 |
| Enhanced Usual Care (EUC) | Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS) | 46.05 score on a scale | Standard Deviation 9.32 |
Secondary
Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)
Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Physical Component Summary (PCS) subscale comprises physical health-related questions in the SF-12. The PCS raw score is the sum of responses. The PCS raw score is converted into a total score ranging from 0-100; higher scores indicate better physical health.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS) | 39.43 score on a scale | Standard Deviation 10.63 |
| Enhanced Usual Care (EUC) | Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS) | 40.45 score on a scale | Standard Deviation 11.48 |
Secondary
Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)
Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Physical Component Summary (PCS) subscale comprises physical health-related questions in the SF-12. The PCS raw score is the sum of responses. The PCS raw score is converted into a total score ranging from 0-100; higher scores indicate better physical health.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS) | 39.51 score on a scale | Standard Deviation 10.99 |
| Enhanced Usual Care (EUC) | Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS) | 41.84 score on a scale | Standard Deviation 11.84 |
Secondary
Number of Acute Care Events
Measured as the total number of self-reported emergency department (ED) visits in the past six months.
Time frame: Month 7 up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Acute Care Events | 0.45 Events | Standard Deviation 0.76 |
| Enhanced Usual Care (EUC) | Number of Acute Care Events | 0.30 Events | Standard Deviation 0.73 |
Secondary
Number of Acute Care Events
Measured as the total number of self-reported emergency department (ED) visits in the past six months.
Time frame: Up to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Acute Care Events | 0.37 Events | Standard Deviation 0.76 |
| Enhanced Usual Care (EUC) | Number of Acute Care Events | 0.36 Events | Standard Deviation 0.81 |
Secondary
Number of Acute Care Events (Self-Report)
Measured as the total number of self-reported hospital utilizations in the past six months.
Time frame: Month 7 up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Acute Care Events (Self-Report) | 0.28 Events | Standard Deviation 0.96 |
| Enhanced Usual Care (EUC) | Number of Acute Care Events (Self-Report) | 0.20 Events | Standard Deviation 0.92 |
Secondary
Number of Acute Care Events (Self-Report)
Measured as the total number of self-reported hospital utilizations in the past six months.
Time frame: Up to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Acute Care Events (Self-Report) | 0.26 Events | Standard Deviation 0.91 |
| Enhanced Usual Care (EUC) | Number of Acute Care Events (Self-Report) | 0.12 Events | Standard Deviation 0.38 |
Secondary
Number of Participants With Alcohol Use Disorder
Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Time frame: Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Participants With Alcohol Use Disorder | 10 Participants |
| Enhanced Usual Care (EUC) | Number of Participants With Alcohol Use Disorder | 26 Participants |
Secondary
Number of Participants With Alcohol Use Disorder
Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Time frame: Month 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Participants With Alcohol Use Disorder | 9 Participants |
| Enhanced Usual Care (EUC) | Number of Participants With Alcohol Use Disorder | 20 Participants |
Secondary
Number of Participants With Drug (Other Than Opioid) Use Disorder
Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Time frame: Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Participants With Drug (Other Than Opioid) Use Disorder | 6 Participants |
| Enhanced Usual Care (EUC) | Number of Participants With Drug (Other Than Opioid) Use Disorder | 25 Participants |
Secondary
Number of Participants With Drug (Other Than Opioid) Use Disorder
Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Time frame: Month 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Participants With Drug (Other Than Opioid) Use Disorder | 8 Participants |
| Enhanced Usual Care (EUC) | Number of Participants With Drug (Other Than Opioid) Use Disorder | 22 Participants |
Secondary
Number of Participants With Opioid Use Disorder
Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI).
Time frame: Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Participants With Opioid Use Disorder | 1 Participants |
| Enhanced Usual Care (EUC) | Number of Participants With Opioid Use Disorder | 13 Participants |
Secondary
Number of Participants With Opioid Use Disorder
Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI).
Time frame: Month 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Number of Participants With Opioid Use Disorder | 3 Participants |
| Enhanced Usual Care (EUC) | Number of Participants With Opioid Use Disorder | 6 Participants |
Secondary
Patient Health Questionnaire-8 (PHQ-8) Score
The Patient Health Questionnaire-8 (PHQ-8) is a self-reported questionnaire that measures depressive symptoms. The PHQ-8 score is calculated by adding up the scores from each of the eight items on the questionnaire. The score ranges from 0 to 24, with higher scores indicating more severe depression.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Patient Health Questionnaire-8 (PHQ-8) Score | 5.77 score on a scale | Standard Deviation 5.16 |
| Enhanced Usual Care (EUC) | Patient Health Questionnaire-8 (PHQ-8) Score | 6.53 score on a scale | Standard Deviation 5.63 |
Secondary
Patient Health Questionnaire-8 (PHQ-8) Score
The Patient Health Questionnaire-8 (PHQ-8) is a self-reported questionnaire that measures depressive symptoms. The PHQ-8 score is calculated by adding up the scores from each of the eight items on the questionnaire. The score ranges from 0 to 24, with higher scores indicating more severe depression.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Patient Health Questionnaire-8 (PHQ-8) Score | 6.39 score on a scale | Standard Deviation 5.69 |
| Enhanced Usual Care (EUC) | Patient Health Questionnaire-8 (PHQ-8) Score | 5.68 score on a scale | Standard Deviation 4.68 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score
The PROMIS Anxiety Short Form comprises 8 questions assessing anxiety. Each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses and ranges from 8 to 40. The raw score is converted to a standardized t-score ranging from 0-100 with a mean of 50 and a standard deviation of 10. Higher t-scores indicate greater levels of anxiety.
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score | 9.99 T-score | Standard Deviation 8.59 |
| Enhanced Usual Care (EUC) | Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score | 9.66 T-score | Standard Deviation 7.78 |
Secondary
PROMIS Anxiety Short Form Score
The PROMIS Anxiety Short Form comprises 8 questions assessing anxiety. Each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses and ranges from 8 to 40. The raw score is converted to a standardized t-score ranging from 0-100 with a mean of 50 and a standard deviation of 10. Higher t-scores indicate greater levels of anxiety.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | PROMIS Anxiety Short Form Score | 10.27 T-score | Standard Deviation 8.91 |
| Enhanced Usual Care (EUC) | PROMIS Anxiety Short Form Score | 9.63 T-score | Standard Deviation 7.83 |