Subthreshold Opioid Use Disorder Prevention (STOP) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- Days of Risky Opioid Use in Past 180 Days
研究概览
简要总结
The Subthreshold Opioid Use Disorder Prevention (STOP) trial will test the efficacy of a primary care intervention to reduce opioid use and overdose risk, and prevent progression to OUD, in adults with unhealthy use of illicit or prescribed opioids. STOP is a collaborative care model. A cluster-randomized trial, conducted in 5 primary care sites, with 100 PCPs and 300adult primary care patients, will test the efficacy of STOP versus enhanced usual care (EUC). The STOP intervention, if proven efficacious, will provide a solution to preventing OUD among patients who are most at risk, thus addressing a key aspect of the current opioid crisis.
详细描述
This cluster randomized trial, conducted in primary care clinics and randomized at the level of the PCP, will compare the STOP intervention to enhanced usual care (EUC) for 12 months. Patients who are eligible and enroll will receive the intervention according to the assignment of their PCP. In the EUC arm, PCPs conduct primary care as usual, without support of the nurse care manager. Patient participants receive an educational pamphlet about overdose prevention and watch a brief video on "healthy living" that is not specific to substance use. In the STOP arm, PCPs and their enrolled patient participants receive the STOP intervention, consisting of a NCM, brief advice about health risks of opioid misuse, and telephone health coaching. Patient participants in either arm who are found by clinical providers to have developed a moderate-severe OUD at any time during the study can be offered medication for OUD and linked to treatment by clinical staff in the EUC arm, and the NCM in the STOP arm, to formal assessment and MOUD treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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, PA, NP).
- •Currently providing care to approximately 4 or more adult patients (18 years or older) who are receiving chronic opioid treatment and/or have risky opioid use.
- •Total patient volume is approximately 40 or more adult patients (18 years or older) per week on a typical week
- •Willing to be randomized to either of the two study conditions
- •Patient Participant Inclusion Criteria
- •PCP is enrolled in the study.
- •Age 18 years or older at time of prescreening.
- •Proficient in spoken and written English, as determined by patient self-report and research staff evaluation.
- •Risky opioid use in the past 90 days from date of prescreening, as determined by a TAPS score >1 for heroin and/or prescription opioids and/or a positive response (>Never) to any of the three COMM items indicating taking more opioid medication than prescribed
- •Access to phone that can receive text messages, and access to internet (via smartphone, tablet, or computer), per patient self-report.
- •Able to provide informed consent.
排除标准
- •Planning to resign from the clinic in the next 24 months, per PCP self-report.
- •Planning to change their schedule in the next 24 months such that they would no longer meet the inclusion criteria for patient volume, per PCP self-report.
- •Patient Participant Exclusion Criteria:
- •Patients with moderate-severe OUD, defined as meeting 4 or more DSM-5 criteria for OUD at screening, as assessed by research staff using the modified-CIDI opioid items.
- •Receiving MOUD or engaged in an opioid treatment program in the past 30 days from screening date, per patient self-report.
- •Receiving opioids for end of life care, per patient self-report.
- •Pregnancy (females age 18-50), as determined by patient self-report at the time of screening.
- •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.
- •Plan to leave the area or the clinical practice within the next 12 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.
研究组 & 干预措施
Subthreshold Opioid Use Disorder Prevention(STOP) Intervention
At baseline, patient participants in the STOP arm will receive the intervention components of brief advice from their PCP and a video doctor , printed educational materials, interaction with the NCM, and telephone health coaching. Brief advice will be delivered by the patient participant's PCP as part of the medical visit or via phone call. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the research staff. During the baseline visit, patient participants also meet with the research staff to view a video on tablet or desktop computer that reinforces the PCP's counseling.
干预措施: PCP brief advice (Behavioral)
Subthreshold Opioid Use Disorder Prevention(STOP) Intervention
At baseline, patient participants in the STOP arm will receive the intervention components of brief advice from their PCP and a video doctor , printed educational materials, interaction with the NCM, and telephone health coaching. Brief advice will be delivered by the patient participant's PCP as part of the medical visit or via phone call. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the research staff. During the baseline visit, patient participants also meet with the research staff to view a video on tablet or desktop computer that reinforces the PCP's counseling.
干预措施: Video doctor (Behavioral)
Subthreshold Opioid Use Disorder Prevention(STOP) Intervention
At baseline, patient participants in the STOP arm will receive the intervention components of brief advice from their PCP and a video doctor , printed educational materials, interaction with the NCM, and telephone health coaching. Brief advice will be delivered by the patient participant's PCP as part of the medical visit or via phone call. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the research staff. During the baseline visit, patient participants also meet with the research staff to view a video on tablet or desktop computer that reinforces the PCP's counseling.
干预措施: Telephone health coaching (Behavioral)
Subthreshold Opioid Use Disorder Prevention(STOP) Intervention
At baseline, patient participants in the STOP arm will receive the intervention components of brief advice from their PCP and a video doctor , printed educational materials, interaction with the NCM, and telephone health coaching. Brief advice will be delivered by the patient participant's PCP as part of the medical visit or via phone call. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the research staff. During the baseline visit, patient participants also meet with the research staff to view a video on tablet or desktop computer that reinforces the PCP's counseling.
干预措施: Nurse Care Manager (NCM) intervention (Behavioral)
Enhanced Usual Care (EUC)
PCPs will conduct primary care as usual, without the support of the NCM. At the baseline visit, patient participants receive an educational pamphlet and view a short video on overdose and cancer screening. The pamphlet includes information about preventing opioid-related overdose, including how to obtain a naloxone kit. The video content will feature the health benefits of exercise. It will be viewed on a tablet or desktop computer and will be approximately 2 minutes long. All EUC patient participants receive the same video, which is not tailored to the responses given on their questionnaires. There is no study intervention after the baseline visit.
结局指标
主要结局
Days of Risky Opioid Use in Past 180 Days
时间窗: 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).
次要结局
- Days of Risky Opioid Use in Past 180 Days(Month 7 up to Month 12)
- Days of Benzodiazepine Use in Past 180 Days(Month 7 up to Month 12)
- Days of Stimulant Use in Past 180 Days(Month 7 up to Month 12)
- Days of Marijuana Use in Past 180 Days(Month 7 up to Month 12)
- Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.(Month 7 up to Month 12)
- Days of Binge Alcohol Use in Past 180 Days(Month 7 up to Month 12)
- Number of Participants With Opioid Use Disorder(Month 12)
- Number of Participants With Drug (Other Than Opioid) Use Disorder(Month 12)
- Number of Participants With Alcohol Use Disorder(Month 12)
- Change in Overdose Risk Behavior Questionnaire Score(Baseline, Month 12)
- Episodes of Non-Fatal Overdose(Month 12)
- Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity(Month 12)
- Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference(Month 12)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score(Month 6)
- PROMIS Anxiety Short Form Score(Month 12)
- Patient Health Questionnaire-8 (PHQ-8) Score(Month 12)
- Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)(Month 12)
- Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)(Month 12)
- Number of Acute Care Events(Month 7 up to Month 12)
- Number of Acute Care Events (Self-Report)(Month 7 up to Month 12)
- Days of Benzodiazepine Use in Past 180 Days(Up to Month 6)
- Days of Stimulant Use in Past 180 Days(Up to Month 6)
- Days of Marijuana Use in Past 180 Days(Up to Month 6)
- Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.(Up to Month 6)
- Days of Binge Alcohol Use in Past 180 Days(Up to Month 6)
- Number of Participants With Opioid Use Disorder(Month 6)
- Number of Participants With Drug (Other Than Opioid) Use Disorder(Month 6)
- Number of Participants With Alcohol Use Disorder(Month 6)
- Change in Overdose Risk Behavior Questionnaire Score(Baseline, Month 6)
- Episodes of Non-Fatal Overdose(Month 6)
- Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity(Month 6)
- Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference(Month 6)
- Patient Health Questionnaire-8 (PHQ-8) Score(Month 6)
- Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)(Month 6)
- Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)(Month 6)
- Number of Acute Care Events(Up to Month 6)
- Number of Acute Care Events (Self-Report)(Up to Month 6)