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

NCT ID: NCT04745065

Last Updated: 2024-01-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-06-26

Brief Summary

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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

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Conditions

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Substance Use Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Connect2BWell Condition

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.

Group Type EXPERIMENTAL

Connect2BWell

Intervention Type BEHAVIORAL

Please see the description provided for arm 1.

Comparison Condition

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Connect2BWell

Please see the description provided for arm 1.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Community Health Center, Inc.

INDUSTRY

Sponsor Role collaborator

Pro-Change Behavior Systems

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Community Health Center, Inc.

Middletown, Connecticut, United States

Site Status

Pro-Change Behavior Systems, Inc.

South Kingstown, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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4R44DA044840-02

Identifier Type: NIH

Identifier Source: org_study_id

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