Mobile Technologies Extending Reach of Primary Care for Substance Use Disorders
NCT ID: NCT06208839
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-03-25
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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SBIRT/TAU for those with moderate risk drug or alcohol use
This moderate risk group will receive the standard Screening and Brief Intervention Treatment (SBIRT) along with Treatment as Usual (TAU) at the clinic.
SBIRT/TAU for those with moderate risk drug or alcohol use
Treatment as usual
SBIRT/eIntervention for those with moderate risk drug or alcohol use
Subjects assigned to this condition will be instructed by the research assistant in how to download and use the eIntervention app, which they will be free to use as they like for the duration of the study. The app will contain a personalized suite of programs and activities. Unlike the TAU condition, the patient's referral to treatment would be managed through eIntervention. For example, the app will show the patient their referral details (if a referral to treatment was made), including details on the provider, referred services, and contact information, and will offer them videos of peers and professionals educating them on addiction, treatment, and sharing personal stories of recovery.
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/TAU for those assessed with high risk.
This high risk group will receive the standard Screening and Brief Intervention Treatment (SBIRT) along with Treatment as Usual (TAU) at the clinic.
SBIRT/TAU for those assessed with high risk.
Treatment as usual for high risk group
SBIRT/eIntervention those assessed with high risk.
Subjects assigned to this condition will be instructed by the research assistant in how to download and use the eIntervention app, which they will be free to use as they like for the duration of the study. The app will contain a personalized suite of programs and activities. Unlike the TAU condition, the patient's referral to treatment would be managed through eIntervention. For example, the app will show the patient their referral details (if a referral to treatment was made), including details on the provider, referred services, and contact information, and will offer them videos of peers and professionals educating them on addiction, treatment, and sharing personal stories of recovery.
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.
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* receiving primary care at Western Michigan
* identified as having a substance-specific NIDA Modified Assist score of 27 or greater.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Western Michigan University
OTHER
Chess Mobile Health
INDUSTRY
Responsible Party
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Principal Investigators
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Hans Morefield
Role: PRINCIPAL_INVESTIGATOR
CHESS Health
Locations
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WMed Health Family Medicine
Kalamazoo, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Lisa Graves, MD
Role: primary
Other Identifiers
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2023-SBIR-ChessHealth
Identifier Type: -
Identifier Source: org_study_id
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