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| ID | Type | Description | Link |
|---|---|---|---|
| UG1DA013035 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this trial is to test the efficacy of a collaborative care intervention to address opioid- and/or stimulant-involved polysubstance use in adult primary care patients with moderate to severe substance use disorders (SUD). The primary aims are to reduce days of opioid use (illicit or nonmedical opioid use), days of illicit stimulant use (cocaine, methamphetamine), and days of heavy alcohol use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-Care | Experimental | Patient participants with providers will receive primary care treatment plus the full Co-Care intervention which includes: Nurse Care Manager (NCM) visits, Addiction specialist consultations through NCM if indicated, and Health coaching sessions. |
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| Enhanced Usual Care (EUC) | Active Comparator | Patient participants with providers will receive primary care treatment as usual plus educational materials. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education and support for primary care providers (PCPS) | Other | All PCPs in the EUC and Co-Care arms receive brief education on SUD treatment, including medications for OUD and AUD and contingency management for StUD, and recognizing and counteracting stigma while caring for patients with SUD. |
| Measure | Description | Time Frame |
|---|---|---|
| Total days of use of opioids, stimulants, and alcohol heavy drinking | Days of opioid use are defined as days with any use of heroin or synthetic opioids, or nonmedical use of prescription opioids. Nonmedical use includes using prescription opioids more than prescribed (e.g., taking two tablets when the prescription indicates a dose of one tablet) or taking pharmaceutical opioids that were not prescribed to the individual taking them. Days of stimulant use are defined as days with any use of cocaine or methamphetamine. Days of alcohol heavy drinking are defined as days with 5+ drinks/day for men, 4+ drinks/day for women. This outcome measure is collected using single item questions based on the Addiction Severity Index. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form. | Month 4-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Effectiveness Assessment (TEA) total score | The Treatment Effectiveness Assessment (TEA) is a 4-item patient-reported outcome measure of progress in treatment and recovery in the four following domains: substance use, health, lifestyle, and community involvement. Each domain is assessed with a single item and scored on a scale of 1-10 (higher scores indicate better progress). The total score is calculated using the sum of numerical responses for the four domains and can range from four (not well at all on all domains) to 40 (extremely well on all domains). |
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PCP Inclusion Criteria:
Patient Inclusion Criteria:
PCP Exclusion Criteria:
Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer McNeely, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States | ||
| NYU Langone Health |
This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm) and (for HEAL-funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy).
Primary data for this study will be available to the public in the NIDA data repository. For more details on data sharing please visit https://datashare.nida.nih.gov/.
The primary outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Anyone who wishes to access the data for any purpose can find that data is available indefinitely at (https://datashare.nida.nih.gov/).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 14, 2024 | May 5, 2026 |
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| Nurse Care Manager (NCM) visits | Other | A full-time clinic-embedded nurse care manager who works with patients and their PCPs to facilitate and support patient engagement in evidence-based treatment for polysubstance use and management of associated health conditions |
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| Addiction specialist consultant | Other | An addiction specialist consultant who supports the nurse care manager and PCP in formulating and adjusting treatment plans |
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| Health coaching sessions | Other | Health coaches who use motivational interviewing and cognitive behavioral therapy to motivate and support patients in behavior change to reduce polysubstance use-related harms. Patients may receive up to 12 health coaching sessions in total. The sessions will occur via phone and/or HIPAA compliant video chat software. |
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| Patient educational materials | Other | Patient participants receive an educational pamphlet addressing overdose prevention, information about accessing naloxone, and local SUD treatment options. |
|
| Baseline |
| Treatment Effectiveness Assessment (TEA) total score | The Treatment Effectiveness Assessment (TEA) is a 4-item patient-reported outcome measure of progress in treatment and recovery in the four following domains: substance use, health, lifestyle, and community involvement. Each domain is assessed with a single item and scored on a scale of 1-10 (higher scores indicate better progress). The total score is calculated using the sum of numerical responses for the four domains and can range from four (not well at all on all domains) to 40 (extremely well on all domains). | Month 3 |
| Treatment Effectiveness Assessment (TEA) total score | The Treatment Effectiveness Assessment (TEA) is a 4-item patient-reported outcome measure of progress in treatment and recovery in the four following domains: substance use, health, lifestyle, and community involvement. Each domain is assessed with a single item and scored on a scale of 1-10 (higher scores indicate better progress). The total score is calculated using the sum of numerical responses for the four domains and can range from four (not well at all on all domains) to 40 (extremely well on all domains). | Month 6 |
| Treatment Effectiveness Assessment (TEA) total score | The Treatment Effectiveness Assessment (TEA) is a 4-item patient-reported outcome measure of progress in treatment and recovery in the four following domains: substance use, health, lifestyle, and community involvement. Each domain is assessed with a single item and scored on a scale of 1-10 (higher scores indicate better progress). The total score is calculated using the sum of numerical responses for the four domains and can range from four (not well at all on all domains) to 40 (extremely well on all domains). | Month 12 |
| Total days of use of opioids, stimulants, and alcohol | Days of opioid use are defined as days with any use of heroin or synthetic opioids, or nonmedical use of prescription opioids. Nonmedical use includes using prescription opioids more than prescribed (e.g., taking two tablets when the prescription indicates a dose of one tablet) or taking pharmaceutical opioids that were not prescribed to the individual taking them. Days of stimulant use are defined as days with any use of cocaine or methamphetamine. Days of alcohol heavy drinking are defined as days with 5+ drinks/day for men, 4+ drinks/day for women. This outcome measure is collected using single item questions based on the Addiction Severity Index. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form. | Months 10-12 |
| Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol | Days of abstinence from substances of concern is measured as part of the Addiction Severity Index. At the end of the substance specific questions, patient participants who reported use of more than one substance of concern will be asked: "On how many days did you use none of these [insert names of all substances with 1+ days of use reported]?" (range is 0-30 days). For participants reporting use of 0-1 substances of concern, days of abstinence is calculated as 30 minus [number of days reported]. | Month 6 |
| Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol | Days of abstinence from substances of concern is measured as part of the Addiction Severity Index. At the end of the substance specific questions, patient participants who reported use of more than one substance of concern will be asked: "On how many days did you use none of these [insert names of all substances with 1+ days of use reported]?" (range is 0-30 days). For participants reporting use of 0-1 substances of concern, days of abstinence is calculated as 30 minus [number of days reported]. | Month 12 |
| Number of days of nonmedical benzodiazepine use | Nonmedical benzodiazepine use is defined as taking benzodiazepines that were not prescribed to the individual taking them. This outcome measure will be measured using single item questions based on the Addiction Severity Index. "During the past 30 days, on how many days did you use [substance name]?" The question will be asked separately for each substance type. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form. | Baseline |
| Number of days of nonmedical benzodiazepine use | Nonmedical benzodiazepine use is defined as taking benzodiazepines that were not prescribed to the individual taking them. This outcome measure will be measured using single item questions based on the Addiction Severity Index. "During the past 30 days, on how many days did you use [substance name]?" The question will be asked separately for each substance type. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form. | Months 4-6 |
| Number of days of nonmedical benzodiazepine use | Nonmedical benzodiazepine use is defined as taking benzodiazepines that were not prescribed to the individual taking them. This outcome measure will be measured using single item questions based on the Addiction Severity Index. "During the past 30 days, on how many days did you use [substance name]?" The question will be asked separately for each substance type. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form. | Months 10-12 |
| Proportion of patients with receipt of a prescription for a medication used for SUD treatment | Medication for SUD is defined as any medication for OUD, AUD, or StUD. This measures is collected from the electronic health record. | Baseline |
| Proportion of patients with receipt of a prescription for a medication used for SUD treatment | Medication for SUD is defined as any medication for OUD, AUD, or StUD. This measures is collected from the electronic health record. | Month 3 |
| Proportion of patients with receipt of a prescription for a medication used for SUD treatment | Medication for SUD is defined as any medication for OUD, AUD, or StUD. This measures is collected from the electronic health record. | Month 6 |
| Proportion of patients with receipt of a prescription for a medication used for SUD treatment | Medication for SUD is defined as any medication for OUD, AUD, or StUD. This measures is collected from the electronic health record. | Month 12 |
| Proportion of patients attending behavioral health visit(s) addressing substance use | This measure is based on behavioral health visits addressing substance use that occurred in the study clinic(s), as documented in the electronic health record. | Baseline |
| Proportion of patients attending behavioral health visit(s) addressing substance use | This measure is based on behavioral health visits addressing substance use that occurred in the study clinic(s), as documented in the electronic health record. | Month 3 |
| Proportion of patients attending behavioral health visit(s) addressing substance use | This measure is based on behavioral health visits addressing substance use that occurred in the study clinic(s), as documented in the electronic health record. | Month 6 |
| Proportion of patients attending behavioral health visit(s) addressing substance use | This measure is based on behavioral health visits addressing substance use that occurred in the study clinic(s), as documented in the electronic health record. | Month 12 |
| OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire | The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The OUD category in the questionnaire is comprised of 15 yes/no items. The OUD symptom score is calculated by finding the sum of the items marked "Yes". OUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder). | Baseline |
| OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire | The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The OUD category in the questionnaire is comprised of 15 yes/no items. The OUD symptom score is calculated by finding the sum of the items marked "Yes". OUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder). | Month 6 |
| StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire | The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The StUD category in the questionnaire is comprised of 15 yes/no items. The StUD symptom score is calculated by finding the sum of the items marked "Yes". StUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder). | Baseline |
| StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire | The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The StUD category in the questionnaire is comprised of 15 yes/no items. The StUD symptom score is calculated by finding the sum of the items marked "Yes". StUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder). | Month 6 |
| AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire | The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The AUD category in the questionnaire is comprised of 15 yes/no items. The AUD symptom score is calculated by finding the sum of the items marked "Yes". AUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder). | Baseline |
| AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire | The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The AUD category in the questionnaire is comprised of 15 yes/no items. The AUD symptom score is calculated by finding the sum of the items marked "Yes". AUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder). | Month 6 |
| Overdose Risk Behavior Questionnaire score | The Overdose Risk Behavior Questionnaire is a 9-item self-administered questionnaire. These questions measure the frequency, in the past 6 months, at which individuals used alone; used in a new place/environment; used other substances (alcohol, benzodiazepines, stimulants) within 2 hours of opioids; used more than one opioid; used more than the usual amount; and used inhaled or injected opioids. Response options were "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)," except for #6, which was "never (0)," "once (1)," or "more than once (2)." The total risk score is an aggregation of responses to the individual questions. Sum score range: 0-32, higher scores indicate greater risk of overdose. | Baseline |
| Overdose Risk Behavior Questionnaire score | The Overdose Risk Behavior Questionnaire is a 9-item self-administered questionnaire. These questions measure the frequency, in the past 6 months, at which individuals used alone; used in a new place/environment; used other substances (alcohol, benzodiazepines, stimulants) within 2 hours of opioids; used more than one opioid; used more than the usual amount; and used inhaled or injected opioids. Response options were "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)," except for #6, which was "never (0)," "once (1)," or "more than once (2)." The total risk score is an aggregation of responses to the individual questions. Sum score range: 0-32, higher scores indicate greater risk of overdose. | Month 6 |
| Overdose Risk Behavior Questionnaire score | The Overdose Risk Behavior Questionnaire is a 9-item self-administered questionnaire. These questions measure the frequency, in the past 6 months, at which individuals used alone; used in a new place/environment; used other substances (alcohol, benzodiazepines, stimulants) within 2 hours of opioids; used more than one opioid; used more than the usual amount; and used inhaled or injected opioids. Response options were "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)," except for #6, which was "never (0)," "once (1)," or "more than once (2)." The total risk score is an aggregation of responses to the individual questions. Sum score range: 0-32, higher scores indicate greater risk of overdose. | Month 12 |
| Number of episodes of a non-fatal overdose | Outcome measure is self reported on the Non-Fatal Overdose Questionnaire. | Baseline |
| Number of episodes of a non-fatal overdose | Outcome measure is self reported on the Non-Fatal Overdose Questionnaire. | Month 6 |
| Number of episodes of a non-fatal overdose | Outcome measure is self reported on the Non-Fatal Overdose Questionnaire. | Month 12 |
| World Health Organization Quality of Life (WHOQOL-BREF) score | The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. The mean score of items within each domain is used to calculate the domain score. After computed the scores, they transformed linearly to a 0-100-scale. Higher scores denote higher QOL. | Baseline |
| World Health Organization Quality of Life (WHOQOL-BREF) score | The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. The mean score of items within each domain is used to calculate the domain score. After computed the scores, they transformed linearly to a 0-100-scale. Higher scores denote higher QOL. | Month 3 |
| World Health Organization Quality of Life (WHOQOL-BREF) score | The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. The mean score of items within each domain is used to calculate the domain score. After computed the scores, they transformed linearly to a 0-100-scale. Higher scores denote higher QOL. | Month 6 |
| World Health Organization Quality of Life (WHOQOL-BREF) score | The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. The mean score of items within each domain is used to calculate the domain score. After computed the scores, they transformed linearly to a 0-100-scale. Higher scores denote higher QOL. | Month 12 |
| Single-item general health question (HRQOL-1) score | Questionnaire consist of one question 'Would you say that in general your health is' [scaled response ranges from (5)Excellent, (4)Very good, (3)Good, (2)Fair or (1)Poor]. The higher the score the better the patient's general health. | Baseline |
| Single-item general health question (HRQOL-1) score | Questionnaire consist of one question 'Would you say that in general your health is' [scaled response ranges from (5)Excellent, (4)Very good, (3)Good, (2)Fair or (1)Poor]. The higher the score the better the patient's general health. | Month 3 |
| Single-item general health question (HRQOL-1) score | Questionnaire consist of one question 'Would you say that in general your health is' [scaled response ranges from (5)Excellent, (4)Very good, (3)Good, (2)Fair or (1)Poor]. The higher the score the better the patient's general health. | Month 6 |
| Single-item general health question (HRQOL-1) score | Questionnaire consist of one question 'Would you say that in general your health is' [scaled response ranges from (5)Excellent, (4)Very good, (3)Good, (2)Fair or (1)Poor]. The higher the score the better the patient's general health. | Month 12 |
| Patient Health Questionnaire (PHQ-8) score | The Patient Health Questionnaire depression scale (PHQ-8) consists of 8 items. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. | Baseline |
| Patient Health Questionnaire (PHQ-8) score | The Patient Health Questionnaire depression scale (PHQ-8) consists of 8 items. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. | Month 3 |
| Patient Health Questionnaire (PHQ-8) score | The Patient Health Questionnaire depression scale (PHQ-8) consists of 8 items. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. | Month 6 |
| Patient Health Questionnaire (PHQ-8) score | The Patient Health Questionnaire depression scale (PHQ-8) consists of 8 items. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. | Month 12 |
| Percentage of participants with a negative suicidality screen | Outcome measured by Ask Suicide-Screening Questions (ASQ). The ASQ consists of four yes/no questions. If patient answers "No" to all questions 1 through 4, they are considered negative for suicidality. If patient answers "Yes" to any of questions 1 through 4, or refuses to answer, they are considered a positive screen. | Baseline |
| Percentage of participants with a negative suicidality screen | Outcome measured by Ask Suicide-Screening Questions (ASQ). The ASQ consists of four yes/no questions. If patient answers "No" to all questions 1 through 4, they are considered negative for suicidality. If patient answers "Yes" to any of questions 1 through 4, or refuses to answer, they are considered a positive screen. | Month 3 |
| Percentage of participants with a negative suicidality screen | Outcome measured by Ask Suicide-Screening Questions (ASQ). The ASQ consists of four yes/no questions. If patient answers "No" to all questions 1 through 4, they are considered negative for suicidality. If patient answers "Yes" to any of questions 1 through 4, or refuses to answer, they are considered a positive screen. | Month 6 |
| Percentage of participants with a negative suicidality screen | Outcome measured by Ask Suicide-Screening Questions (ASQ). The ASQ consists of four yes/no questions. If patient answers "No" to all questions 1 through 4, they are considered negative for suicidality. If patient answers "Yes" to any of questions 1 through 4, or refuses to answer, they are considered a positive screen. | Month 12 |
| Generalized Anxiety Disorder (GAD-7) score | The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The whole scale score can range from 0 to 21 Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety. | Baseline |
| Generalized Anxiety Disorder (GAD-7) score | The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The whole scale score can range from 0 to 21 Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety. | Month 3 |
| Generalized Anxiety Disorder (GAD-7) score | The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The whole scale score can range from 0 to 21 Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety. | Month 6 |
| Generalized Anxiety Disorder (GAD-7) score | The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The whole scale score can range from 0 to 21 Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety. | Month 12 |
| Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score | PC-PTSD-5 consists of 5-items. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0 meaning no trauma exposure. If a respondent endorses a trauma exposure, they can score a 0-5 on the PC-PTSD-5, which is a count of "yes" responses to the 5 questions about how the trauma has affected them in the past month. Higher scores indicate the trauma exposure has often affected them over the past month. | Baseline |
| Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score | PC-PTSD-5 consists of 5-items. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0 meaning no trauma exposure. If a respondent endorses a trauma exposure, they can score a 0-5 on the PC-PTSD-5, which is a count of "yes" responses to the 5 questions about how the trauma has affected them in the past month. Higher scores indicate the trauma exposure has often affected them over the past month. | Month 3 |
| Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score | PC-PTSD-5 consists of 5-items. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0 meaning no trauma exposure. If a respondent endorses a trauma exposure, they can score a 0-5 on the PC-PTSD-5, which is a count of "yes" responses to the 5 questions about how the trauma has affected them in the past month. Higher scores indicate the trauma exposure has often affected them over the past month. | Month 6 |
| Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score | PC-PTSD-5 consists of 5-items. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0 meaning no trauma exposure. If a respondent endorses a trauma exposure, they can score a 0-5 on the PC-PTSD-5, which is a count of "yes" responses to the 5 questions about how the trauma has affected them in the past month. Higher scores indicate the trauma exposure has often affected them over the past month. | Month 12 |
| Number of Patient Reported ED visits | Baseline |
| Number of Patient Reported ED visits | Month 6 |
| Number of Patient Reported ED visits | Month 12 |
| Number of patient reported hospital admissions | Baseline |
| Number of patient reported hospital admissions | Month 6 |
| Number of patient reported hospital admissions | Month 12 |
| Proportion of patients with a diagnosis of OUD receiving any medication for OUD treatment | Month 12 |
| Proportion of patients with a diagnosis of AUD receiving any medication for AUD treatment | Month 12 |
| PCPs Medical Condition Regard Scale (MCRS) score | Medical Condition Regard Scale (MCRS) is a self-administered instrument examines the degree to which 12 medical conditions (including alcohol dependence and intravenous drug use) are enjoyable, treatable, and worthy of medical resources. Responses were measured on a six-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = not sure but probably disagree, 4 = not sure but probably agree, 5 = agree, and 6 = strongly agree. A MCRS score of >57 correlates with high probability of desire to care for patients with with drug and alcohol use. | Baseline |
| PCPs Medical Condition Regard Scale (MCRS) score | Medical Condition Regard Scale (MCRS) is a self-administered instrument examines the degree to which 12 medical conditions (including alcohol dependence and intravenous drug use) are enjoyable, treatable, and worthy of medical resources. Responses were measured on a six-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = not sure but probably disagree, 4 = not sure but probably agree, 5 = agree, and 6 = strongly agree. A MCRS score of >57 correlates with high probability of desire to care for patients with with drug and alcohol use. | End of intervention period, up to 21 months |
| PCPs REDUCE-HARM instrument score | The REDUCE-HARM instrument is a 24-item scale to measure healthcare professional attitudes to work with people who inject drugs including self-reported skills in different aspects of substance use as well as attitudes towards individuals who use drugs. Each item is ranked from 1 = not at all important to 3 = very important. Higher scores indicate positive attitudes toward caring for patients with SUD. | Baseline |
| PCPs REDUCE-HARM instrument score | The REDUCE-HARM instrument is a 24-item scale to measure healthcare professional attitudes to work with people who inject drugs including self-reported skills in different aspects of substance use as well as attitudes towards individuals who use drugs. Each item is ranked from 1 = not at all important to 3 = very important. Higher scores indicate positive attitudes toward caring for patients with SUD. | End of intervention period, up to 21 months |
| PCPs Addictions Knowledge Questions score | The Addictions Knowledge Questions is a 6-question measure that asks basic knowledge questions about DSM-criteria for SUD, and pharmacological treatments for OUD and AUD. Each item is answered by the PCP with a choice of "Correct" or "Incorrect". The score is calculated by the adding the number of items that are answered with "Correct". Total scores range from 0-6, a higher score indicating better knowledge. | Baseline |
| PCPs Addictions Knowledge Questions score | The Addictions Knowledge Questions is a 6-question measure that asks basic knowledge questions about DSM-criteria for SUD, and pharmacological treatments for OUD and AUD. Each item is answered by the PCP with a choice of "Correct" or "Incorrect". The score is calculated by the adding the number of items that are answered with "Correct". Total scores range from 0-6, a higher score indicating better knowledge. | End of intervention period, up to 21 months |
| New York |
| New York |
| 10016 |
| United States |
| The Institute for Family Health | New York | New York | 10025 | United States |
| Winding Waters Medical Clinic | Enterprise | Oregon | 97828 | United States |
| Union Community Care | Lancaster | Pennsylvania | 17603 | United States |
| Harris Health | Houston | Texas | 77030 | United States |
| Sea Mar Community Health Centers | Bellingham | Washington | 98226 | United States |
| Wisconsin Research & Education Network | Madison | Wisconsin | 53705 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided