Trial Outcomes & Findings for Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program (NCT NCT04745065)
NCT ID: NCT04745065
Last Updated: 2024-01-31
Results Overview
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.
COMPLETED
NA
237 participants
baseline, 9 months
2024-01-31
Participant Flow
Participant milestones
| Measure |
Connect2BWell Condition
The Connect2BWell program delivers feedback on Substance Use Disorder 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.
Connect2BWell: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
118
|
|
Overall Study
COMPLETED
|
85
|
88
|
|
Overall Study
NOT COMPLETED
|
34
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Connect2BWell: An Evidence-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program
Baseline characteristics by cohort
| Measure |
Connect2BWell Condition
n=119 Participants
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.
Connect2BWell: Please see the description provided for arm 1.
|
Comparison Condition
n=118 Participants
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.
|
Total
n=237 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
43.3 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
84 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender or Other
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-White or Hispanic
|
67 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=5 Participants
|
118 participants
n=7 Participants
|
237 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 9 monthsDays 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.
Outcome measures
| Measure |
Connect2BWell Condition
n=85 Participants
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.
Connect2BWell: Please see the description provided for arm 1.
|
Comparison Condition
n=88 Participants
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.
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|---|---|---|
|
Change From Baseline in Days of Use of Most Problematic Drug at 9 Months
Baseline
|
17.3 days of use in previous 30 days
Interval 12.3 to 21.9
|
19.9 days of use in previous 30 days
Interval 15.0 to 23.9
|
|
Change From Baseline in Days of Use of Most Problematic Drug at 9 Months
9 Month Assessment
|
6.4 days of use in previous 30 days
Interval 3.4 to 11.0
|
14.5 days of use in previous 30 days
Interval 9.2 to 19.9
|
SECONDARY outcome
Timeframe: baseline, 9 monthsThe ASSIST yields drug-specific risk scores for 8 classes of drugs, including alcohol, plus ""Other"". The ASSIST score (range = 0 to 39) for the participant's most problematic drug identified at baseline will be examined. ASSIST scores are correlated with other measures of substance use, have predictive validity, and discriminate between non-problematic substance use. Change scores will range from -39 to +39, with lower scores indicating better outcomes.
Outcome measures
| Measure |
Connect2BWell Condition
n=85 Participants
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.
Connect2BWell: Please see the description provided for arm 1.
|
Comparison Condition
n=88 Participants
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.
|
|---|---|---|
|
Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months
Baseline
|
17.6 score on a scale
Interval 16.0 to 19.2
|
16.7 score on a scale
Interval 15.1 to 18.3
|
|
Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months
9 months
|
12.7 score on a scale
Interval 10.9 to 14.5
|
13 score on a scale
Interval 11.2 to 14.7
|
SECONDARY outcome
Timeframe: baseline, 9 monthsThis measure will be calculated by taking the sum of all items for all substances (excluding tobacco) assessed on the ASSIST (range = 0 to 351). Like drug-specific ASSIST scores, ASSIST total substance involvement scores are correlated with other measures of substance use, have predictive validity, and discriminate between non-problematic substance use. Change scores will range from -351 to + 351, with lower scores indicating better outcomes.
Outcome measures
| Measure |
Connect2BWell Condition
n=85 Participants
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.
Connect2BWell: Please see the description provided for arm 1.
|
Comparison Condition
n=88 Participants
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.
|
|---|---|---|
|
Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months
Baseline
|
36.9 score on a scale
Interval 33.5 to 40.3
|
34.1 score on a scale
Interval 30.7 to 37.5
|
|
Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months
9 months
|
33.4 score on a scale
Interval 29.7 to 37.1
|
35.7 score on a scale
Interval 32.1 to 39.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 9 monthsDepression assessed using Patient Health Questionnaire (PHQ-8), which consists of eight of the nine DSM-V (Diagnostic and Statistical Manual) diagnostic criteria for depression. Respondents indicate how many days in the past two weeks they experienced each of the 8 symptoms. Responses are summed to yield a severity score (0-24) and were then categorized into 5 categories of 1 = 'minimal depression, 0 to 4' 2 = 'mild depression, 5 to 9' 3 = 'moderate depression, 10 to 14' 4 = 'moderately severe depression, 15 to 19' 5 = 'severe depression, 20 to 24'. The estimates provided in the results table are the probability of mild or moderate depression relative to greater levels of depression, at both baseline and 9 months, calculated using ordinal logistic regression.
Outcome measures
| Measure |
Connect2BWell Condition
n=85 Participants
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.
Connect2BWell: Please see the description provided for arm 1.
|
Comparison Condition
n=88 Participants
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.
|
|---|---|---|
|
Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months
Baseline
|
.724 probability
Interval 0.348 to 0.928
|
.83 probability
Interval 0.439 to 0.968
|
|
Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months
9 months
|
.967 probability
Interval 0.807 to 0.995
|
.744 probability
Interval 0.296 to 0.953
|
Adverse Events
Connect2BWell Condition
Comparison Condition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place