Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of the digital + telehealth Connect2BWell program among 336 safety net patients. Adults patients with an upcoming medical medical visit, and/or who screen positive for substance use disorder (SUD) during routine SBIRT screening during their visit, will receive an email invitation from the research team to complete an online risk assessment to assess study eligibility. The assessment will include the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Patients scoring in the moderate- or high-risk range for one or more drugs--including alcohol, excluding tobacco--and who meet all other study inclusion criteria, will alternately be assigned to the Connect2BWell Condition or a Comparison Condition. ASSIST scores will be sent to the patient's EHR. Patients assigned to the Treatment Condition will receive three brief online intervention sessions followed by dashboard-guided telehealth sessions with a study nurse, text messages, and access to a patient portal. Patients assigned to the Comparison Condition will receive an SBIRT session delivered via telehealth by a member of their clinic care team. Outcomes, assessed at baseline, 3, 6 and 9 months, include days of use of most problematic drug during the past 30 days, the ASSIST risk score of the most problematic drug, depression, well-being, satisfaction with care, and treatment uptake, if indicated. All patient-facing materials are available in English and Spanish.

Official Title
-----------------
Stage-Based Intervention for Substance Use Disorders in Primary Care: Implementation and Clinical Trial

Conditions
-----------------
Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Connect2BWell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate/high risk use of at least 1 substance (identified using the ASSIST) Can receive text messages Can access Internet via smartphone, tablet, or computer Exclusion Criteria: Pregnant Admitted to inpatient psychiatric hospital or substance use treatment program, past 30 days Has serious medical condition that could impede study participating, next 9 months Receiving treatment with goal of quitting or reducing use of substances

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connect2BWell Condition<br>The Connect2BWell program delivers feedback on SUD risk, 3 brief online intervention sessions over 3 months, and text messages for 6 months. Sessions and text messages are tailored to the patient's most problematic drug based on the ASSIST; stage of change for quitting or reducing use of that drug; and stage of change for seeking treatment, if indicated. Online sessions are followed by a dashboard-guided telehealth session with a nurse care manager. The dashboard summarizes the patient's ASSIST risk scores and stage of change data; presents patients' responses to key questions in the online session; and provides tools for collaborating with the patient to select action steps matched to risk level and stage and stage of change for seeking treatment, if indicated. The program provides a patient portal with activities, resources, and tools for tracking progress on action steps. | Behavioral: Connect2BWell<br>* Please see the description provided for arm 1.<br>|
| No Intervention: Comparison Condition<br>Patients assigned to the Comparison Condition will receive a brief SBIRT session delivered via telehealth by a member of their clinic care team. The session will include the clinic's standard scripted feedback matched to level of risk for alcohol use and for other drug use; encouragement to quit; and referral to specialty treatment, if indicated. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in days of use of most problematic drug at 9 months | Days of use will be assessed using the Timeline Followback (TLFB) method, which includes a calendar for indicating each day of use during the past 30 days. The approach has been validated for alcohol use, other drug use, and for administration by telephone and computer. The online assessment will present an interactive calendar showing the past 30 days, and ask participants to mark each day that they used their most problematic drug. Total days marked will represent days of use. Change scores will range from -30 to + 30, with lower scores indicating better outcomes. | baseline, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ASSIST score for most problematic drug at 9 months | The ASSIST yields drug-specific risk scores for 8 classes of drugs, including alcohol, plus Other. The ASSIST score (range = 0 to 39) for the participant's most problematic drug identified at baseline will be examined. ASSIST scores are correlated with other measures of substance use, have predictive validity, and discriminate between non-problematic substance use. Change scores will range from -39 to +39, with lower scores indicating better outcomes. | baseline, 9 months | 
| Change from baseline in ASSIST score for total substance involvement at 9 months | This measure will be calculated by taking the sum of all items for all substances (excluding tobacco) assessed on the ASSIST (range = 0 to 351). Like drug-specific ASSIST scores, ASSIST total substance involvement scores are correlated with other measures of substance use, have predictive validity, and discriminate between non-problematic substance use. Change scores will range from -351 to + 351, with lower scores indicating better outcomes. | baseline, 9 months | 
| Rate of drug abstinence based on self-report | Individuals who answered Never to all ASSIST questions assessing frequency of use in the past three months (i.e., How often have you used [drug] in the last 3 months?) will be considered abstinent. | 9 months | 
| Change in treatment uptake among high-risk patients | Treatment uptake will be assessed using seven questions from the Global Appraisal of Individual Needs (GAIN). The seven questions assess the last time the patient received treatment and how many days/nights/times in the past 90 days the patient was in residential treatment, intensive outpatient treatment, outpatient treatment, took a medication like methadone or Antabuse, or went to any other kind of treatment for a drug or alcohol problem. A final question asks whether the patient is currently being treated regularly for alcohol or other drug problems. Whether a participant has received any form of treatment (yes/no) will be computed. | 9 months |