NIDA CTN Protocol 0139: Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 301
- 试验地点
- 8
- 主要终点
- Total days of use of opioids, stimulants, and alcohol heavy drinking
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PCP Inclusion Criteria:
- •Licensed medical professional (MD, DO, NP, PA) who is able to prescribe controlled substances (Schedule III), or medical trainee meeting the requirements below.
- •Serves as a primary care provider to adult patients (18 years of age and over) of the study clinic(s) during direct patient care sessions.
- •Willing to be randomized to either of the study conditions. a. Medical trainees (physicians who are residents or fellows), are eligible if they have at least one continuity clinic session per week on average in the study clinic. Trainees must have plans to be working in a study clinic for approximately 8 months or longer. They must be able to provide prescriptions for controlled substances (Schedule III) either directly or through their preceptor(s).
- •Patient Inclusion Criteria:
- •The participant's PCP is enrolled in the study.
- •Age 18 years or older.
- •Spoken and written proficiency in language of study materials, as determined by patient self-report and research staff evaluation.
- •Moderate to severe substance use disorder for opioids, stimulants, and/or alcohol, (defined as meeting four or more DSM-5 criteria per substance as measured on the CIDI-adapted for DSM-5).
- •a) Patients having alcohol use disorder without an opioid or stimulant SUD are required to have current opioid or stimulant use, as measured on the TAPS tool or baseline monthly survey.
- •Current polysubstance use, defined as self-reported use of two or more substances of concern in the past 30 days, at least one of which is required to be an opioid or stimulant. Substances of concern include opioids (illicit opioids, nonmedical use of prescription opioids), stimulants (cocaine, methamphetamine), alcohol (heavy drinking defined as more than 5 for men and 4 for women drinks on a single occasion), and benzodiazepines (nonmedical use). Nonmedical use includes using prescription medications more than prescribed, or that were not prescribed to the individual taking them.
- •Patients must report on the baseline monthly survey use in the past 30 days of at least one substance at or above the following thresholds: >10 days for opioids; >10 days for alcohol heavy drinking; >7 days for stimulants. These minimum thresholds reflect levels of use that are typical for individuals with moderate to severe SUD, and are lower for stimulants than for opioids and alcohol to reflect the different patterns of use that are observed in prior trials.
- •Access to a reliable cell phone or willing to accept a phone as part of the incentive for completing the baseline visit (as determined by patient self-report).
- •Able to provide sufficient contact information (minimum of one locator).
- •Willing and able to provide written informed consent.
排除标准
- •Definite plan to resign from the clinic in the next eight months, per PCP self-report. Residents and fellows will need at least eight months before training completion to enroll.
- •Patient Exclusion Criteria:
- •Currently being treated with medication for OUD (MOUD), and do not have moderate to severe AUD or StUD
- •Initiated MOUD treatment (buprenorphine, methadone, or XR-NTX) within the 30 days prior to screening, per patient self-report. Because substance use may fall rapidly with the initiation of MOUD, patients who recently started MOUD may already be in the process of making changes to their substance use that are not attributable to the intervention.
- •a) Initiation is defined as starting a new MOUD treatment episode, after not receiving MOUD treatment in the prior 30 days
- •Initiated a SUD treatment program within the 30 days prior to screening, per patient self-report. Because substance use may fall rapidly with the initiation of a treatment program, patients who recently initiated treatment may already be making changes to their substance use that are not attributable to the intervention. SUD treatment program includes outpatient or residential programs for alcohol/drug treatment; does not include detox or short-term inpatient episodes (<15 days), or peer support (e.g., 12-Step Program such as AA/NA, Smart Recovery)
- •a) Initiation is defined as starting a new treatment episode, after not being in a SUD treatment program in the prior 30 days
- •Pregnancy, as determined by patient self-report.
- •Are currently in jail, prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities
- •Definite plan to leave the area or the clinical practice within the next six months, per patient self-report.
- •Other factors that may cause harm or increased risk to the participant or close contacts or preclude the patient's full adherence with or completion of the study (e.g. unstable/severe acute mental illness).
研究组 & 干预措施
Co-Care
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.
干预措施: Education and support for primary care providers (PCPS) (Other)
Co-Care
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.
干预措施: Addiction specialist consultant (Other)
Enhanced Usual Care (EUC)
Patient participants with providers will receive primary care treatment as usual plus educational materials.
干预措施: Patient educational materials (Other)
Co-Care
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.
干预措施: Nurse Care Manager (NCM) visits (Other)
Co-Care
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.
干预措施: Health coaching sessions (Other)
Enhanced Usual Care (EUC)
Patient participants with providers will receive primary care treatment as usual plus educational materials.
干预措施: Education and support for primary care providers (PCPS) (Other)
结局指标
主要结局
Total days of use of opioids, stimulants, and alcohol heavy drinking
时间窗: Month 4-6
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.
次要结局
- Proportion of patients with receipt of a prescription for a medication used for SUD treatment(Month 12)
- Proportion of patients attending behavioral health visit(s) addressing substance use(Month 12)
- StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire(Month 6)
- Overdose Risk Behavior Questionnaire score(Month 12)
- Generalized Anxiety Disorder (GAD-7) score(Month 12)
- Number of days of nonmedical benzodiazepine use(Months 10-12)
- Treatment Effectiveness Assessment (TEA) total score(Month 12)
- Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol(Month 12)
- Number of patient reported hospital admissions(Month 12)
- Single-item general health question (HRQOL-1) score(Month 12)
- Percentage of participants with a negative suicidality screen(Month 12)
- Total days of use of opioids, stimulants, and alcohol(Months 10-12)
- Number of episodes of a non-fatal overdose(Month 12)
- World Health Organization Quality of Life (WHOQOL-BREF) score(Month 12)
- Patient Health Questionnaire (PHQ-8) score(Month 12)
- Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score(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)
- OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire(Month 6)
- AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire(Month 6)
- Number of Patient Reported ED visits(Month 12)
- PCPs Medical Condition Regard Scale (MCRS) score(End of intervention period, up to 21 months)
- PCPs Addictions Knowledge Questions score(End of intervention period, up to 21 months)
- PCPs REDUCE-HARM instrument score(End of intervention period, up to 21 months)
- Treatment Effectiveness Assessment (TEA) total score(Baseline)
- Treatment Effectiveness Assessment (TEA) total score(Month 3)
- Treatment Effectiveness Assessment (TEA) total score(Month 6)
- Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol(Month 6)
- Number of days of nonmedical benzodiazepine use(Baseline)
- Number of days of nonmedical benzodiazepine use(Months 4-6)
- Proportion of patients with receipt of a prescription for a medication used for SUD treatment(Baseline)
- Proportion of patients with receipt of a prescription for a medication used for SUD treatment(Month 3)
- Proportion of patients with receipt of a prescription for a medication used for SUD treatment(Month 6)
- Proportion of patients attending behavioral health visit(s) addressing substance use(Baseline)
- Proportion of patients attending behavioral health visit(s) addressing substance use(Month 3)
- Proportion of patients attending behavioral health visit(s) addressing substance use(Month 6)
- OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire(Baseline)
- StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire(Baseline)
- AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire(Baseline)
- Overdose Risk Behavior Questionnaire score(Baseline)
- Overdose Risk Behavior Questionnaire score(Month 6)
- Number of episodes of a non-fatal overdose(Baseline)
- Number of episodes of a non-fatal overdose(Month 6)
- World Health Organization Quality of Life (WHOQOL-BREF) score(Baseline)
- World Health Organization Quality of Life (WHOQOL-BREF) score(Month 3)
- World Health Organization Quality of Life (WHOQOL-BREF) score(Month 6)
- Single-item general health question (HRQOL-1) score(Baseline)
- Single-item general health question (HRQOL-1) score(Month 3)
- Single-item general health question (HRQOL-1) score(Month 6)
- Patient Health Questionnaire (PHQ-8) score(Baseline)
- Patient Health Questionnaire (PHQ-8) score(Month 3)
- Patient Health Questionnaire (PHQ-8) score(Month 6)
- Percentage of participants with a negative suicidality screen(Baseline)
- Percentage of participants with a negative suicidality screen(Month 3)
- Percentage of participants with a negative suicidality screen(Month 6)
- Generalized Anxiety Disorder (GAD-7) score(Baseline)
- Generalized Anxiety Disorder (GAD-7) score(Month 3)
- Generalized Anxiety Disorder (GAD-7) score(Month 6)
- Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score(Baseline)
- Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score(Month 3)
- Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score(Month 6)
- Number of Patient Reported ED visits(Baseline)
- Number of Patient Reported ED visits(Month 6)
- Number of patient reported hospital admissions(Baseline)
- Number of patient reported hospital admissions(Month 6)
- PCPs Medical Condition Regard Scale (MCRS) score(Baseline)
- PCPs REDUCE-HARM instrument score(Baseline)
- PCPs Addictions Knowledge Questions score(Baseline)