N/A
N=237
Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program
Substance Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04745065 ↗Enrolled (actual)
237
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Change From Baseline in Days of Use of Most Problematic Drug at 9 Months — 17.3; 19.9; 6.4; 14.5 days of use in previous 30 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Connect2BWell (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pro-Change Behavior Systems
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Days of Use of Most Problematic Drug at 9 Months |
17.3; 19.9; 6.4; 14.5 | — |
| SECONDARY Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months |
17.6; 16.7; 12.7; 13 | — |
| SECONDARY Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months |
36.9; 34.1; 33.4; 35.7 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT04745065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.