Subthreshold Opioid Use Disorder Prevention (STOP) Trial

Not Applicable

Active, not recruiting

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: PCP brief advice; Behavioral: Video doctor; Behavioral: Telephone health coaching; Behavioral: Nurse Care Manager (NCM) intervention

• Registration Number: NCT04218201
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-06
• Study Start: 2020-03-25
• Status Verified: 2023-11
• Primary Completion: 2023-11-15
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Not provided

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subthreshold Opioid Use Disorder Prevention(STOP) Intervention	Video doctor	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	PCP brief advice	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	Telephone health coaching	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	Nurse Care Manager (NCM) 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.

Primary Outcome Measures

Name	Time	Method
Days of Risky Opioid Use in Past 180 Days	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).

Secondary Outcome Measures

Name	Time	Method
Days of Risky Opioid Use in Past 180 days	Month 12	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).
Days of Benzodiazepine Use in Past 180 days	Month 12	Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Days of Stimulant Use in Past 180 days	Month 12	Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Days of Marijuana Use in Past 180 days	Month 12	Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Days of Other Drug Use (not including opioids, benzodiazepines, stimulants, and marijuana) in Past 180 days.	Month 12	Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Days of Binge Alcohol Use in Past 180 days	Month 12	Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days (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.
Number of Participants with Opioid Use Disorder	Month 12	Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI).
Number of Participants with Drug (other than Opioid) Use Disorder	Month 12	Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Number of Participants with Alcohol Use Disorder	Month 12	Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Change in Overdose Risk Behavior Questionnaire Score	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.
Episodes of Non-Fatal Overdose	Month 12
Brief Pain Inventory (BPI) Short Form Modified Score	Month 12	Items 3-6 and 9A-9G from the BPI short form will be assessed. Items 3-6 are rated on a Likert scale from 0 (no pain) to 10 (pain as bad as you can imagine). 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 severity/interreference.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score	Month 6	The PROMIS Anxiety Short Form comprises 8 questions; each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses and is converted to a standardized t-score ranging from 0-100; higher scores indicate greater levels of anxiety.
PROMIS Anxiety Short Form Score	Month 12	The PROMIS Anxiety Short Form comprises 8 questions; each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses and is converted to a standardized t-score ranging from 0-100; higher scores indicate greater levels of anxiety.
Patient Health Questionnaire-8 (PHQ-8) Score	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.
Health-Related Quality of Life (SF-12) Score	Month 12	Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The raw score is the sum of responses and is converted into a total score ranging from 0-100; higher scores indicate a better health condition.
Number of Acute Care Events	Month 12	Measured as number of emergency department (ED) or hospital utilizations.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States