Trial Outcomes & Findings for Subthreshold Opioid Use Disorder Prevention (STOP) Trial (NCT NCT04218201)

NCT ID: NCT04218201

Last Updated: 2025-06-19

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 321 participants
• Primary outcome timeframe: Up to Month 6
• Results posted on: 2025-06-19

Participant Flow

Randomization occurred at the level of the PCP. Patients who were eligible and enrolled received the intervention according to the assignment of their PCP.

Participant milestones

Measure	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.	STOP Intervention - Primary Care Providers (PCPs) PCPs of participants in the STOP Intervention arm.	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.	EUC - PCPs PCPs of participants in the EUC arm.
Overall Study STARTED	88	58	114	61
Overall Study COMPLETED	79	49	109	55
Overall Study NOT COMPLETED	9	9	5	6

Reasons for withdrawal

Measure	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.	STOP Intervention - Primary Care Providers (PCPs) PCPs of participants in the STOP Intervention arm.	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.	EUC - PCPs PCPs of participants in the EUC arm.
Overall Study Death	0	0	2	0
Overall Study Unable to contact participant	4	0	3	0
Overall Study Practical problems (e.g., no childcare or transportation)	3	0	0	0
Overall Study Withdrawal by Subject	2	0	0	0
Overall Study PCP plans to leave practice	0	8	0	5
Overall Study Reduced panel	0	0	0	1
Overall Study No longer interested in participating	0	1	0	0

Baseline Characteristics

Subthreshold Opioid Use Disorder Prevention (STOP) Trial

Baseline characteristics by cohort

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention - Patients n=88 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.	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention - PCPs n=58 Participants PCPs of participants in the STOP arm.	Enhanced Usual Care (EUC) - Patients n=114 Participants 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.	Enhanced Usual Care (EUC) - PCPs n=60 Participants PCPs of participants in the EUC arm.	Total n=320 Participants Total of all reporting groups
Age, Continuous	54.1 years STANDARD_DEVIATION 13.31 • n=93 Participants	41.4 years STANDARD_DEVIATION 7.6 • n=4 Participants	56.9 years STANDARD_DEVIATION 12.09 • n=27 Participants	43.3 years STANDARD_DEVIATION 12.23 • n=483 Participants	55.7 years STANDARD_DEVIATION 12.68 • n=36 Participants
Sex/Gender, Customized Male	23 Participants n=93 Participants	16 Participants n=4 Participants	51 Participants n=27 Participants	26 Participants n=483 Participants	116 Participants n=36 Participants
Sex/Gender, Customized Female	65 Participants n=93 Participants	38 Participants n=4 Participants	63 Participants n=27 Participants	34 Participants n=483 Participants	200 Participants n=36 Participants
Sex/Gender, Customized Unknown or Not Reported	0 Participants n=93 Participants	4 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	4 Participants n=36 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants	8 Participants n=4 Participants	0 Participants n=27 Participants	13 Participants n=483 Participants	22 Participants n=36 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race/Ethnicity, Customized Black or African American	21 Participants n=93 Participants	1 Participants n=4 Participants	22 Participants n=27 Participants	1 Participants n=483 Participants	45 Participants n=36 Participants
Race/Ethnicity, Customized White	60 Participants n=93 Participants	38 Participants n=4 Participants	83 Participants n=27 Participants	41 Participants n=483 Participants	222 Participants n=36 Participants
Race/Ethnicity, Customized More than one race	3 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	9 Participants n=36 Participants
Race/Ethnicity, Customized Other	3 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	0 Participants n=483 Participants	9 Participants n=36 Participants
Race/Ethnicity, Customized Unknown or refused to answer	0 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants	9 Participants n=36 Participants
Race/Ethnicity, Customized Missing	0 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	12 Participants n=36 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	86 Participants n=93 Participants	51 Participants n=4 Participants	109 Participants n=27 Participants	55 Participants n=483 Participants	301 Participants n=36 Participants
Race/Ethnicity, Customized Unknown or Refused to Answer	0 Participants n=93 Participants	4 Participants n=4 Participants	0 Participants n=27 Participants	3 Participants n=483 Participants	7 Participants n=36 Participants
Region of Enrollment United States	88 participants n=93 Participants	58 participants n=4 Participants	114 participants n=27 Participants	60 participants n=483 Participants	316 participants n=36 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=75 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.	Enhanced Usual Care (EUC) n=101 Participants 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.
Days of Risky Opioid Use in Past 180 Days	12.2 days Standard Deviation 27.73	15.5 days Standard Deviation 32.64

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=78 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Days of Risky Opioid Use in Past 180 Days	10.7 days Standard Deviation 30.14	10.1 days Standard Deviation 27.75

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=75 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Days of Benzodiazepine Use in Past 180 Days	2.4 days Standard Deviation 11.05	4 days Standard Deviation 18.66

SECONDARY outcome

Timeframe: Month 7 up to Month 12

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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=79 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Days of Benzodiazepine Use in Past 180 Days	2.9 days Standard Deviation 10.8	3 days Standard Deviation 16.36

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Days of Stimulant Use in Past 180 Days	1.2 days Standard Deviation 8.10	0.6 days Standard Deviation 3.54

SECONDARY outcome

Timeframe: Month 7 up to Month 12

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).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=79 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Days of Stimulant Use in Past 180 Days	2.0 days Standard Deviation 15.41	0.9 days Standard Deviation 4.30

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=75 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Days of Marijuana Use in Past 180 Days	34.3 days Standard Deviation 61.47	31.0 days Standard Deviation 55.19

SECONDARY outcome

Timeframe: Month 7 up to Month 12

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).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=79 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Days of Marijuana Use in Past 180 Days	33.2 days Standard Deviation 61.19	34.0 days Standard Deviation 58.38

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=82 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.	Enhanced Usual Care (EUC) n=108 Participants 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.
Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.	0.0 days Standard Deviation 0.25	0.1 days Standard Deviation 0.69

SECONDARY outcome

Timeframe: Month 7 up to Month 12

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).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=82 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.	Enhanced Usual Care (EUC) n=108 Participants 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.
Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.	0.0 days Standard Deviation 0.11	0.0 days Standard Deviation 0.35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=76 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Days of Binge Alcohol Use in Past 180 Days	7.3 days Standard Deviation 18.06	9.9 days Standard Deviation 23.01

SECONDARY outcome

Timeframe: Month 7 up to Month 12

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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=79 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Days of Binge Alcohol Use in Past 180 Days	7.0 days Standard Deviation 21.76	11.2 days Standard Deviation 28.47

SECONDARY outcome

Timeframe: Month 6

Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=104 Participants 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.
Number of Participants With Opioid Use Disorder	1 Participants	13 Participants

SECONDARY outcome

Timeframe: Month 12

Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=71 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Number of Participants With Opioid Use Disorder	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Month 6

Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=101 Participants 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.
Number of Participants With Drug (Other Than Opioid) Use Disorder	6 Participants	25 Participants

SECONDARY outcome

Timeframe: Month 12

Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Number of Participants With Drug (Other Than Opioid) Use Disorder	8 Participants	22 Participants

SECONDARY outcome

Timeframe: Month 6

Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=101 Participants 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.
Number of Participants With Alcohol Use Disorder	10 Participants	26 Participants

SECONDARY outcome

Timeframe: Month 12

Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Number of Participants With Alcohol Use Disorder	9 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=72 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Change in Overdose Risk Behavior Questionnaire Score	-1.43 score on a scale Standard Deviation 2.75	-1.25 score on a scale Standard Deviation 3.03

SECONDARY outcome

Timeframe: Baseline, Month 12

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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=99 Participants 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.
Change in Overdose Risk Behavior Questionnaire Score	-1.61 score on a scale Standard Deviation 3.37	-1.15 score on a scale Standard Deviation 3.07

SECONDARY outcome

Timeframe: Month 6

Number of non-fatal drug or alcohol overdoses per participant.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Episodes of Non-Fatal Overdose	0.7 episodes Standard Deviation 5.85	0.7 episodes Standard Deviation 4.53

SECONDARY outcome

Timeframe: Month 12

Number of non-fatal drug or alcohol overdoses per participant.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=100 Participants 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.
Episodes of Non-Fatal Overdose	0.3 episodes Standard Deviation 1.66	0.3 episodes Standard Deviation 1.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity	4.46 score on a scale Standard Deviation 2.2	4.34 score on a scale Standard Deviation 2.56

SECONDARY outcome

Timeframe: Month 12

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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity	4.46 score on a scale Standard Deviation 2.29	3.98 score on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference	4.38 score on a scale Standard Deviation 2.91	4.32 score on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: Month 12

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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference	4.14 score on a scale Standard Deviation 2.79	3.87 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score	9.99 T-score Standard Deviation 8.59	9.66 T-score Standard Deviation 7.78

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
PROMIS Anxiety Short Form Score	10.27 T-score Standard Deviation 8.91	9.63 T-score Standard Deviation 7.83

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=104 Participants 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.
Patient Health Questionnaire-8 (PHQ-8) Score	5.77 score on a scale Standard Deviation 5.16	6.53 score on a scale Standard Deviation 5.63

SECONDARY outcome

Timeframe: Month 12

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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=72 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Patient Health Questionnaire-8 (PHQ-8) Score	6.39 score on a scale Standard Deviation 5.69	5.68 score on a scale Standard Deviation 4.68

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)	39.43 score on a scale Standard Deviation 10.63	40.45 score on a scale Standard Deviation 11.48

SECONDARY outcome

Timeframe: Month 12

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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)	39.51 score on a scale Standard Deviation 10.99	41.84 score on a scale Standard Deviation 11.84

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)	46.56 score on a scale Standard Deviation 12.32	47.01 score on a scale Standard Deviation 11.26

SECONDARY outcome

Timeframe: Month 12

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.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=102 Participants 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.
Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)	46.11 score on a scale Standard Deviation 11.59	46.05 score on a scale Standard Deviation 9.32

SECONDARY outcome

Timeframe: Up to Month 6

Measured as the total number of self-reported emergency department (ED) visits in the past six months.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Number of Acute Care Events	0.37 Events Standard Deviation 0.76	0.36 Events Standard Deviation 0.81

SECONDARY outcome

Timeframe: Month 7 up to Month 12

Measured as the total number of self-reported emergency department (ED) visits in the past six months.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=100 Participants 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.
Number of Acute Care Events	0.45 Events Standard Deviation 0.76	0.30 Events Standard Deviation 0.73

SECONDARY outcome

Timeframe: Up to Month 6

Measured as the total number of self-reported hospital utilizations in the past six months.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=73 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.	Enhanced Usual Care (EUC) n=103 Participants 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.
Number of Acute Care Events (Self-Report)	0.26 Events Standard Deviation 0.91	0.12 Events Standard Deviation 0.38

SECONDARY outcome

Timeframe: Month 7 up to Month 12

Measured as the total number of self-reported hospital utilizations in the past six months.

Outcome measures

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n=74 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.	Enhanced Usual Care (EUC) n=100 Participants 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.
Number of Acute Care Events (Self-Report)	0.28 Events Standard Deviation 0.96	0.20 Events Standard Deviation 0.92

Adverse Events

Subthreshold Opioid Use Disorder Prevention(STOP) Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Usual Care (EUC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rebecca Stone

NYU Langone Health

Phone: 646-754-5322

Email: Rebecca.Stone@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place