Clinical trial NCT06208839: Mobile Technologies Extending Reach of Primary Care for Substance Use Disorders
Official title: 1R44DA050214 - 01 Mobile Technologies Extending Reach of Primary Care for Substance Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Substance Use Disorder
Screening, Brief Intervention, Referral, and Treatment
Lead sponsor: Chess Mobile Health
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Western Michigan University
First posted: 2024-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial is to evaluate efficacy of our enhanced version of the CHESS Health eIntervention in a clinical setting for those with moderate risk drug or alcohol use and those at high risk or with Substance Use Disorder (SUD) as measured by the ASSIST and the AUDIT assessment tools. The clinical trial is designed to determine whether SBIRT/eIntervention is significantly more effective than SBIRT/Treatment as usual (TAU) as delivered in a primary care setting. While it is not feasible or practical to individually test all components and features of the planned eIntervention, this design will permit testing of efficacy for reduction of substance use in both risk groups and increased enrollment in treatment for the high risk/SUD group in the SBIRT/eIntervention cohorts compared to the SBIRT/TAU cohorts. Note that the investigators are not including a screening/assessment only or other control condition, as the purpose of this clinical trial is not to test the efficacy of SBIRT itself, but rather to test whether SBIRT/eIntervention improves outcomes and successful referral relative to SBIRT/TAU delivery alone.

Detailed description: The investigators will recruit and randomize 200 individuals screening positive on the NIDA Quick Screen.

All participants will receive SBIRT as currently implemented at Western Michigan and as described above. Adult patients would be asked prior to appointments at Western Michigan, either in-person when in a waiting room and/or via email for virtual appointments if they'd would be willing to answer a brief, anonymous online survey regarding their substance use as part of a research study. Upon completing the survey, the results of the survey would be displayed for the patient to see. If the patient's answers to the screening tool indicate their use may be risky or indicates a serious problem regarding assessment, then they would be asked if they would consider participating in a research study (the investigators would provide an online description of the requirements of the study and the payments for participation). If they click through as being interested, the investigators will display more detail about the research study, explain that they will need to review and sign a consent form, and would be required to speak with a research assistant in the coming days. The investigators would present them an electronic consent form and require them to scroll through and, if necessary, could ask them a question or two to confirm their understanding, before allowing them to electronically sign the consent. The investigators would advise them that their participation will not be anonymous. If the patient consents, then the investigators would have them to complete the longer NIDA ASSIST or AUDIT screening tool. If the patient's answers indicate a risk score in the low-risk range for either alcohol or illicit drugs, the investigators will exclude them from continuing in the study.

If the patient's answers indicate a risk score in the moderate to high range, then they would be randomized to the intervention group or the control group. As part of the randomization process, the SBIRT/TAU and the SBIRT/eIntervention groups will have two sub-groups each: (1) those with moderate risk drug or alcohol use and those at high risk or with SUD as measured by the ASSIST and the AUDIT assessment tools). Thus, participants will have been randomized into four cohorts of about 50 subjects each.

If the patient is randomized to the intervention group, then they would be presented a set of digital interventions for them to access then as well as to have access to in the coming weeks/months. If the patient is randomized to the control group, they will receive a 'brief intervention' based on the "Drinker's Checkup" licensed by CHESS Health from San Diego State University.

Whether in the intervention group or the control group, they would be recommended for a referral to treatment. If they're already in SUD treatment, then will exclude them from continuing in the study. If the patient is randomized to the intervention group, then in addition to the referral, they would be given use of the Envoy App with referral details and a TBD set of digital interventions for them to access then as well as to have access to in the coming weeks/months. If the patient is randomized to the control group, then they would only get the referral to treatment plus a basic version of the app that consists solely of the survey engine used for primary data collection. The investigators will conduct a 3-month randomized clinical trial, with a 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* adults aged 18 or over
* receiving primary care at Western Michigan
* identified as having a substance-specific NIDA Modified Assist score of 27 or greater.

Exclusion Criteria:

* non-English speaking
* cannot read at a 3rd grade level,
* have current participation in addiction treatment
* determined to be psychiatrically or medically unstable such that completion of the trial is unlikely.

Primary outcomes:
measure: NIDA Quick Screen
timeFrame: Screening
measure: The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: Screening, 3-month, and 6-month
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Screening, 3-month, and 6-month
measure: Demographics
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: TimeLine Follow-back method
timeFrame: Baseline, 3-month, and 6-month
measure: Healthcare utilization
timeFrame: Baseline, 3-month, and 6-month
measure: Contemplation ladder
timeFrame: Baseline, 3-month, and 6-month
measure: Satisfaction survey
timeFrame: 3-month, 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: WMed Health Family Medicine
state: Michigan
Study officials:
affiliation: CHESS Health
name: Hans Morefield
role: PRINCIPAL_INVESTIGATOR
References: