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

NCT04745065 | Completed Results DMC

• 1 other identifier: 4R44DA044840-02
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months

  baseline, 9 months

• Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months

  baseline, 9 months

Other Outcomes (1)

• Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months

  baseline, 9 months

Study Arms (2)

Connect2BWell Condition

EXPERIMENTAL

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

Comparison Condition

NO INTERVENTION

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.

Interventions

Connect2BWell BEHAVIORAL

Please see the description provided for arm 1.

Connect2BWell Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pro-Change Behavior Systems: lead
• Community Health Center, Inc.: collaborator

Study Sites (2)

Community Health Center, Inc.

Middletown, Connecticut, 06457-2718, United States

Location

Pro-Change Behavior Systems, Inc.

South Kingstown, Rhode Island, 02879, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Kerry E. Evers
• Organization: Pro-Change Behavior Systems, Inc.

kevers@prochange.com

401-360-2980

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 9, 2021
• Study Start: February 15, 2021
• Primary Completion: June 26, 2022
• Study Completion: June 26, 2022
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)