Clinical trial NCT04745065: Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program
Official title: Stage-Based Intervention for Substance Use Disorders in Primary Care: Implementation and Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
Collaborators: name: Community Health Center, Inc.
First posted: 2021-02-09
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Days of Use of Most Problematic Drug at 9 Months
timeFrame: baseline, 9 months
Secondary outcomes:
measure: Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months
timeFrame: baseline, 9 months
measure: Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months
timeFrame: baseline, 9 months
Other outcomes:
measure: Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months
timeFrame: baseline, 9 months
Locations:
city: Middletown
country: United States
facility: Community Health Center, Inc.
state: Connecticut
city: South Kingstown
country: United States
facility: Pro-Change Behavior Systems, Inc.
state: Rhode Island
Study officials:
References: