Mobile Technologies Extending Reach of Primary Care for Substance Use Disorders

Substance-Related Disorders Clinical Trial

Official title:

1R44DA050214 - 01 Mobile Technologies Extending Reach of Primary Care for Substance Use

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06208839
• Other study ID #: 2023-SBIR-ChessHealth
• Secondary ID: 1R44DA050214-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: April 2027

Study information

• Verified date: January 2024
• Source: Chess Mobile Health
• Contact: Andrew Quanbeck, PhD
• Phone: 6086097308
• Email: andrew.quanbeck[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Device:
• SBIRT/eIntervention for those with moderate risk drug or alcohol use
The Connections App is available on iOS or Android and will be offered to the patient during the referral process and contains the following functionalities: Online view of the referrals made for them e.g. to healthcare provider Secure messaging with the referring provider Secure messaging with the destination provider(s) to support them to adhere to the referral, and/or the patient can seek assistance with the destination provider, Informative multimedia content filtered from a library to fit the patient including testimonial content from peers thus showing the patient that others like them have shared their addiction experience and successfully received treatment and achieved recovery, Capture structured feedback from the patient The patient may access more functionality within the Connections App for those who wish to modify behavior using eTherapy and eRecovery. eRecovery includes ecological momentary assessments (EMA) selected by the provider.
• SBIRT/eIntervention those assessed with high risk.
The Connections App is available on iOS or Android and will be offered to the patient during the referral process and contains the following functionalities: Online view of the referrals made for them e.g. to healthcare provider Secure messaging with the referring provider Secure messaging with the destination provider(s) to support them to adhere to the referral, and/or the patient can seek assistance with the destination provider, Informative multimedia content filtered from a library to fit the patient including testimonial content from peers thus showing the patient that others like them have shared their addiction experience and successfully received treatment and achieved recovery, Capture structured feedback from the patient The patient may access more functionality within the Connections App for those who wish to modify behavior using eTherapy and eRecovery. eRecovery includes ecological momentary assessments (EMA) selected by the provider.

Other:
• SBIRT/TAU for those with moderate risk drug or alcohol use
Treatment as usual
• SBIRT/TAU for those assessed with high risk.
Treatment as usual for high risk group

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Chess Mobile Health	National Institute on Drug Abuse (NIDA), Western Michigan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIDA Quick Screen	The NIDA Quick Screen is a validated instrument designed to assist providers in screening adults for substance use. The screen simply inquires whether a participant has used drugs (mood-altering, illegal, or prescription for nonmedical reasons), alcohol, or tobacco products within the past year and how often these substances have been used.	Screening
Primary	The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)	The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed for the World Health Organization (WHO) by an international group of researchers and clinicians as a technical tool to assist with early identification of substance use related health risks and substance use disorders in primary health care, general medical care and other settings	Screening, 3-month, and 6-month
Primary	The Alcohol Use Disorders Identification Test (AUDIT)	The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems. We will also administer the AUDIT for patients who screen positive for alcohol via the NIDA Quick Screen.	Screening, 3-month, and 6-month
Primary	Demographics	Participant Age	Baseline
Primary	Demographics	Participant Race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White)	Baseline
Primary	Demographics	Participant Biological Sex (Male/Female)	Baseline
Primary	Demographics	Participant Ethnicity (Hispanic/Latino vs. non-Hispanic/Latino)	Baseline
Primary	TimeLine Follow-back method	Self-reports are collected using the TimeLine Follow-back method, a widely used and well-validated technique for collecting information on all types of substance use on a day-by day basis for the full period of each participants trial involvement (covering the 3 months prior to baseline through the end of the follow-up).	Baseline, 3-month, and 6-month
Primary	Healthcare utilization	Self reported treatment utilization (including emergency department visits, hospitalization, specialty care visits, attendance at self-help meetings) in all conditions.	Baseline, 3-month, and 6-month
Primary	Contemplation ladder	To assess patient motivation	Baseline, 3-month, and 6-month
Primary	Satisfaction survey	Evaluate patients' satisfaction with treatment and interventions	3-month, 6 month