Subthreshold Opioid Use Disorder Prevention (STOP) Trial

NYU Langone Health

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Behavioral: Video doctor; Behavioral: PCP brief advice; Behavioral: Telephone health coaching; Behavioral: Nurse Care Manager (NCM) intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04218201

19-00535

Details and patient eligibility

About

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.

Full 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.

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

PCP 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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321 participants in 2 patient groups

Subthreshold Opioid Use Disorder Prevention(STOP) Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Nurse Care Manager (NCM) intervention

Behavioral: Telephone health coaching

Behavioral: PCP brief advice

Behavioral: Video doctor

Enhanced Usual Care (EUC)

No Intervention group

Description:

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.