Stage-Based Intervention for Substance Use Disorders in Primary Care: Implementation and Clinical Trial
Phase: NA
Conditions: Substance Use Disorders
Sponsor: Pro-Change Behavior Systems

Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment 
(SBIRT) Program 
NCT04745065 
Unique Protocol ID: R44DA0448400 
09/16/2021 

This clinical trial evaluated Connect2BWell, a theoretically-grounded, mobile-optimized 
substance use risk intervention. Connect2BWell is a computer-tailored intervention (CTI) for 
adult primary care patients who misuse alcohol or other drugs. This program is tailored to each 
patient in the following ways: 
1.
Their most problematic drug (i.e., the drug with the highest risk score)
2.
Their risk severity (i.e., moderate or high) for their most problematic drug
3.
Their readiness to quit their most problematic drug or, for prescription drugs, to use as
prescribed
4.
Their readiness to seek treatment if their risk severity score is in the “high” range
The Connect2BWell program has many different components including: 
1. A CTI that delivers three online sessions with assessments, feedback, and guidance
matched to each patient on the dimensions above
2. Three one-on-one SBIRT brief intervention sessions delivered in person or via telehealth
by a healthcare provider trained in SBIRT and the Connect2BWell program
3. Clinical Dashboard that presents the patients’ results and responses from the CTI, to
guide “change talk” and the collaborative selection of action steps during the one-on-one
intervention sessions
4. Patient Portal that allows the patient to view and track their action steps, and that presents
online information and activities designed to increase key skills for reducing substance
use (e.g., dealing with cravings) and increase well-being
5. Daily text messages with stage and drug-matched messages to patients, to facilitate
change and increase well-being
6. PDFs with SBIRT screening and intervention session results that are sent to the patient’s
electronic health record (EHR)
ProChange collaborated with our partner the Community Health Center (CHC), the leading 
independent, non-profit healthcare provider in the state of Connecticut, providing comprehensive 
primary care services in medicine, dentistry, and behavioral health to more than 145,000 people. 
Two approaches were used to recruit patients to participate in the clinical trial: a “Universal 
Approach” and a “Targeted Approach,” as described below. 
Universal Approach: At the same time each day, the CHC Business Intelligence Department 
(BI) ran an automated query on CHC’s electronic data warehouse to identify patients who 
meet specified criteria. This list of patients and corresponding information was transmitted to 
a Pro-Change system that automatically sent each patient an email invitation in their 
preferred language. Patients who did not click on the link to start the study receive additional 
invitations at 1, 2, and 3 days’ follow-up, with a telephone call on day 4 from the CHC 
Project Manager to a random sample of non-respondents. After clicking on the email link and 
registering, patients saw a description of the study that presented many elements of informed 
consent and had the option to: 1) decline participation, 2) continue to the online screener, or 
3) simply close out of the program. Patients who begin the online screener but did not
complete it received up to five automatic reminders via email at 1, 2, 3, 5, and 6 days to
return to their session to complete it.

Targeted Approach. This approach targeted individuals who hadn’t completed the 
Connect2BWell-administered ASSIST measure before their scheduled medical appointment, 
and instead complete—and screened positive—on CHC’s standard care SBIRT screening 
administered during medical visits by a medical assistant. Each weekday, the CHC BI ran an 
automated query on CHC’s electronic data warehouse to identify patients who meet the study 
inclusion criteria, listed above, for the Universal Recruitment Approach AND who 
completed the DAST and AUDIT-C on the previous weekday and scored in the moderate- or 
high-risk range on either measure. The Project Manager took the list, removed any patients 
who declined participation in response to the original email and called the remaining at-risk 
patients to introduce the study and ask permission to send an email invitation with a link to 
the study website. The Project Manager confirmed the email address of the participants who 
agreed to be contacted. Each day the Project Manager sent Pro-Change a list of patients who 
agreed to be invited, and Pro-Change sent out the email invitations. 
Patients who complete the ASSIST via Connect2BWell fell into one of six groups 
•
Group 1 – Screened negative for Substance Use Disorder (SUD) on the ASSIST. A report of
the ASSIST results was assigned to their Primary Care Provider (PCP) through the Electronic
Medical Record (EMR).
•
Group 2 – Screened positive for SUD on the ASSIST but not enrolled in the study due to
screening out, not completing baseline, or not consenting. A report of the patient’s ASSIST
results was provided to the patient’s PCP through the EMR. The patient’s PCP’s nurse
contacted the patient to deliver a brief intervention and referred them to behavioral health or
specialty treatment if indicated.
•
Group 3 – Screened positive for SUD on the ASSIST and assigned to the Comparison
Condition. As in Group 2, a report of the patient’s ASSIST results was provided to their PCP
in the EMR. The PCP’s nurse contacted the patient to deliver a brief intervention and referral
to behavioral health or specialty treatment if indicated. These patients received an initial
email notification—with up to 9 email and text reminders, 5 calls, a mailed flyer, and calls to
collateral contacts—to complete additional study assessments.
•
Group 4 – Screened positive for SUD on the ASSIST and assigned to
the Connect2BWell Condition. The patient was transitioned seamlessly from the
online Connect2BWell screening questions and consent form to the intervention portion of
the session. After the session, a report of the patient’s ASSIST results was assigned to the
study’s Nurse Care Manager (NCM) in the EMR. The study’s NCM contacted the patient to
deliver a brief intervention guided by the Connect2BWell Clinical Dashboard and made a
referral to behavioral health or specialty treatment if indicated. The patient received
additional Connect2BWell online sessions at 1 and 3 months follow-up. Each online session
was followed by a Clinical Dashboard-guided one-on-one session with the study’s NCM.
The patient also received 6 months’ of stage-matched text messages and access to a patient
portal with tools and activities to support and facilitate change. These patients received an
initial email notification and the same schedule of reminders as the Comparison group to
complete additional study assessments.
•
Group 5 – Recruited via the Targeted Approach and assigned to the Comparison Condition.
These patients had already completed CHC’s standard SBIRT screening and brief
intervention.

•
Group 6 – Recruited via the Targeted Approach and assigned to
the Connect2BWell Condition. While these patients had already completed CHC’s standard
SBIRT screening and brief intervention, their ASSIST results were assigned to the study
NCM in the EMR and they received the study intervention.
•
Groups 3 and 5 comprise the Comparison group and groups 4 and 6 comprise
the Connect2BWell treatment group. Both groups are prompted to complete follow-up online
assessments 3, 6, and 9 months. Non-respondents received up to 9 email and text reminders,
5 calls, a mailed flyer, and calls to collateral contacts.
Analysis Plan 
The analysis will use mixed effects models that account for repeated measures within 
participants through a random intercept for participants. Fixed effects will include group 
(treatment vs control), time, and time-by-group interaction. Analyses will be conducted for the 
primary outcome measure of change from baseline in days of use of the most problematic drug in 
the previous 30 days at 9 Months. Secondary outcome measures include the change from 
baseline in ASSIST score for most problematic drug at 9 months and the change from baseline in 
ASSIST score for total substance involvement at 9 months as well as the change from baseline in 
depression at 9 months.