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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | Experimental | 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. |
|
| Enhanced Usual Care (EUC) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCP brief advice | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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PCP Inclusion Criteria
Patient Participant Inclusion Criteria
PCP Exclusion Criteria:
Patient Participant Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer McNeely, MD | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40457116 | Derived | Rostam-Abadi Y, Liebschutz JM, Subramaniam G, Stone R, Appleton N, Mazel S, Alexander K, Brill SB, Case A, Gelberg L, Gordon AJ, Hong H, Incze MA, Kawasaki SS, Kim T, Kline M, Lovejoy TI, McCormack J, Zhang S, McNeely J. Understanding the characteristics and comorbidities of primary care patients with risky opioid use: Baseline data from the multi-site "Subthreshold Opioid Use Disorder Prevention" (STOP) Trial. J Gen Intern Med. 2025 Sep;40(12):2906-2915. doi: 10.1007/s11606-025-09613-4. Epub 2025 Jun 2. | |
| 37980494 |
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All of the individual participant data collected during the trial, after deidentification, with permission from the lead investigator.
Data sets for CTN protocols will be available after (1) the primary paper has been accepted for publication, or (2) the data is locked for more than 18 months, whichever comes first
Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (https://datashare.nida.nih.gov/).
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Randomization occurred at the level of the PCP. Patients who were eligible and enrolled received the intervention according to the assignment of their PCP.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | STOP Intervention - Primary Care Providers (PCPs) | PCPs of participants in the STOP Intervention arm. |
| FG002 | 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. |
| FG003 | EUC - PCPs | PCPs of participants in the EUC arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | days | Up to Month 6 |
|
Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed among patient participants nor PCPs. All-cause mortality was assessed among patient participants, but not among PCPs.
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subthreshold Opioid Use Disorder Prevention(STOP) Intervention | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Stone | NYU Langone Health | 646-754-5322 | Rebecca.Stone@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2022 | Jun 12, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2025 | Jun 12, 2025 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2022 | May 25, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| Video doctor | Behavioral | 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. |
|
| Telephone health coaching | Behavioral | 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). |
|
| Nurse Care Manager (NCM) intervention | Behavioral | 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. |
|
| Month 7 up to Month 12 |
| 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). | Up to Month 6 |
| 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. | Month 7 up to Month 12 |
| 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). | Up to Month 6 |
| 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). | Month 7 up to Month 12 |
| 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). | Up to Month 6 |
| 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). | Month 7 up to Month 12 |
| 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). | Up to Month 6 |
| 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). | Month 7 up to Month 12 |
| 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. | Up to Month 6 |
| 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. | Month 7 up to Month 12 |
| 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). | Month 6 |
| 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). | Month 12 |
| 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). | Month 6 |
| 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). | Month 12 |
| Number of Participants With Alcohol Use Disorder | Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ). | Month 6 |
| Number of Participants With Alcohol Use Disorder | Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ). | Month 12 |
| 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. | Baseline, Month 6 |
| 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. | Baseline, Month 12 |
| Episodes of Non-Fatal Overdose | Number of non-fatal drug or alcohol overdoses per participant. | Month 6 |
| Episodes of Non-Fatal Overdose | Number of non-fatal drug or alcohol overdoses per participant. | Month 12 |
| 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. | Month 6 |
| 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. | Month 12 |
| 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. | Month 6 |
| 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. | Month 12 |
| 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. | Month 6 |
| 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. | Month 12 |
| 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. | Month 6 |
| 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. | Month 12 |
| 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. | Month 6 |
| 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. | Month 12 |
| 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. | Month 6 |
| 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. | Month 12 |
| Number of Acute Care Events | Measured as the total number of self-reported emergency department (ED) visits in the past six months. | Up to Month 6 |
| Number of Acute Care Events | Measured as the total number of self-reported emergency department (ED) visits in the past six months. | Month 7 up to Month 12 |
| Number of Acute Care Events (Self-Report) | Measured as the total number of self-reported hospital utilizations in the past six months. | Up to Month 6 |
| Number of Acute Care Events (Self-Report) | Measured as the total number of self-reported hospital utilizations in the past six months. | Month 7 up to Month 12 |
| Derived |
| Liebschutz JM, Subramaniam GA, Stone R, Appleton N, Gelberg L, Lovejoy TI, Bunting AM, Cleland CM, Lasser KE, Beers D, Abrams C, McCormack J, Potter GE, Case A, Revoredo L, Jelstrom EM, Kline MM, Wu LT, McNeely J. Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods. Addict Sci Clin Pract. 2023 Nov 18;18(1):70. doi: 10.1186/s13722-023-00424-8. |
| Unable to contact participant |
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| Practical problems (e.g., no childcare or transportation) |
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| Withdrawal by Subject |
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| PCP plans to leave practice |
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| Reduced panel |
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| No longer interested in participating |
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| BG001 | Subthreshold Opioid Use Disorder Prevention(STOP) Intervention - PCPs | PCPs of participants in the STOP arm. |
| BG002 | 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. |
| BG003 | Enhanced Usual Care (EUC) - PCPs | PCPs of participants in the EUC arm. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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. |
| OG001 | Enhanced Usual Care (EUC) | 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. |
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| 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. | Posted | Mean | Standard Deviation | days | Month 7 up to Month 12 |
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| 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). | Posted | Mean | Standard Deviation | days | Up to Month 6 |
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| 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. | Posted | Mean | Standard Deviation | days | Month 7 up to Month 12 |
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| 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). | Posted | Mean | Standard Deviation | days | Up to Month 6 |
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| 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). | Posted | Mean | Standard Deviation | days | Month 7 up to Month 12 |
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| 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). | Posted | Mean | Standard Deviation | days | Up to Month 6 |
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| 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). | Posted | Mean | Standard Deviation | days | Month 7 up to Month 12 |
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| 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). | Posted | Mean | Standard Deviation | days | Up to Month 6 |
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| 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). | Posted | Mean | Standard Deviation | days | Month 7 up to Month 12 |
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| 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. | Posted | Mean | Standard Deviation | days | Up to Month 6 |
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| 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. | Posted | Mean | Standard Deviation | days | Month 7 up to Month 12 |
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| 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). | Posted | Count of Participants | Participants | Month 6 |
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| 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). | Posted | Count of Participants | Participants | Month 12 |
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| 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). | Posted | Count of Participants | Participants | Month 6 |
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| 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). | Posted | Count of Participants | Participants | Month 12 |
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| Secondary | Number of Participants With Alcohol Use Disorder | Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ). | Posted | Count of Participants | Participants | Month 6 |
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| Secondary | Number of Participants With Alcohol Use Disorder | Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ). | Posted | Count of Participants | Participants | Month 12 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 12 |
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| Secondary | Episodes of Non-Fatal Overdose | Number of non-fatal drug or alcohol overdoses per participant. | Posted | Mean | Standard Deviation | episodes | Month 6 |
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| Secondary | Episodes of Non-Fatal Overdose | Number of non-fatal drug or alcohol overdoses per participant. | Posted | Mean | Standard Deviation | episodes | Month 12 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| 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. | Posted | Mean | Standard Deviation | T-score | Month 6 |
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| 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. | Posted | Mean | Standard Deviation | T-score | Month 12 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Month 12 |
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| Secondary | Number of Acute Care Events | Measured as the total number of self-reported emergency department (ED) visits in the past six months. | Posted | Mean | Standard Deviation | Events | Up to Month 6 |
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| Secondary | Number of Acute Care Events | Measured as the total number of self-reported emergency department (ED) visits in the past six months. | Posted | Mean | Standard Deviation | Events | Month 7 up to Month 12 |
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| Secondary | Number of Acute Care Events (Self-Report) | Measured as the total number of self-reported hospital utilizations in the past six months. | Posted | Mean | Standard Deviation | Events | Up to Month 6 |
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| Secondary | Number of Acute Care Events (Self-Report) | Measured as the total number of self-reported hospital utilizations in the past six months. | Posted | Mean | Standard Deviation | Events | Month 7 up to Month 12 |
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| 0 |
| 88 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Enhanced Usual Care (EUC) | 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. | 2 | 114 | 0 | 0 | 0 | 0 |
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