Subthreshold Opioid Use Disorder Prevention (STOP) Trial

  • STATUS
    Recruiting
  • End date
    May 22, 2023
  • participants needed
    300
  • sponsor
    NYU Langone Health
Updated on 22 March 2022

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.

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.

Details
Condition Opioid-use Disorder
Treatment Telephone Health Coaching, PCP brief advice, Video doctor, Nurse Care Manager (NCM) intervention
Clinical Study IdentifierNCT04218201
SponsorNYU Langone Health
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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

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
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
Plan to leave the area or the clinical practice within the next 12 months, per patient self-report
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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