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

Not Applicable

Completed

Conditions: Substance Use Disorders

Registration Number: NCT04745065

Lead Sponsor: Pro-Change Behavior Systems

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 Electronic Health Record (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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 237

Inclusion Criteria

Moderate/high risk use of at least 1 substance (identified using the ASSIST)
Can receive text messages
Can access Internet via smart phone, 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Days of Use of Most Problematic Drug at 9 Months	baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months	baseline, 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.
Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months	baseline, 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.

Trial Locations

Locations (2): Community Health Center, Inc.
🇺🇸
Middletown, Connecticut, United States
Pro-Change Behavior Systems, Inc.
🇺🇸
South Kingstown, Rhode Island, United States
Community Health Center, Inc.
🇺🇸Middletown, Connecticut, United States