Substance Use Disorders
Conditions
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.
Interventions
BEHAVIORALConnect2BWell
Please see the description provided for arm 1.
Sponsors
Community Health Center, Inc.
Pro-Change Behavior Systems
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Days of Use of Most Problematic Drug at 9 Months | baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months | baseline, 9 months | The 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. |
| Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months | baseline, 9 months | This 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months | baseline, 9 months | Depression 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Connect2BWell: Please see the description provided for arm 1. | 119 |
| 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. | 118 |
| Total | 237 |
Baseline characteristics
| Characteristic | Connect2BWell Condition | Comparison Condition | Total |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 13.7 | 43.0 years STANDARD_DEVIATION 13.2 | 43.1 years STANDARD_DEVIATION 13.4 |
| Race/Ethnicity, Customized non-White or Hispanic | 67 Participants | 66 Participants | 133 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 52 Participants | 52 Participants | 104 Participants |
| Region of Enrollment United States | 119 participants | 118 participants | 237 participants |
| Sex/Gender, Customized Female | 84 Participants | 82 Participants | 166 Participants |
| Sex/Gender, Customized Male | 29 Participants | 32 Participants | 61 Participants |
| Sex/Gender, Customized Transgender or Other | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 118 |
| other Total, other adverse events | 0 / 119 | 0 / 118 |
| serious Total, serious adverse events | 0 / 119 | 0 / 118 |
Outcome results
Primary
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.
Time frame: baseline, 9 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Connect2BWell Condition | Change From Baseline in Days of Use of Most Problematic Drug at 9 Months | Baseline | 17.3 days of use in previous 30 days |
| Connect2BWell Condition | 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 |
| Comparison Condition | Change From Baseline in Days of Use of Most Problematic Drug at 9 Months | Baseline | 19.9 days of use in previous 30 days |
| Comparison Condition | Change From Baseline in Days of Use of Most Problematic Drug at 9 Months | 9 Month Assessment | 14.5 days of use in previous 30 days |
Secondary
Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months
The 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.
Time frame: baseline, 9 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Connect2BWell Condition | Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months | Baseline | 17.6 score on a scale |
| Connect2BWell Condition | Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months | 9 months | 12.7 score on a scale |
| Comparison Condition | Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months | Baseline | 16.7 score on a scale |
| Comparison Condition | Change From Baseline in ASSIST Score for Most Problematic Drug at 9 Months | 9 months | 13 score on a scale |
Secondary
Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months
This 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.
Time frame: baseline, 9 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Connect2BWell Condition | Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months | Baseline | 36.9 score on a scale |
| Connect2BWell Condition | Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months | 9 months | 33.4 score on a scale |
| Comparison Condition | Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months | Baseline | 34.1 score on a scale |
| Comparison Condition | Change From Baseline in ASSIST Score for Total Substance Involvement at 9 Months | 9 months | 35.7 score on a scale |
Other Pre-specified
Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months
Depression 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.
Time frame: baseline, 9 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Connect2BWell Condition | Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months | Baseline | .724 probability |
| Connect2BWell Condition | Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months | 9 months | .967 probability |
| Comparison Condition | Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months | Baseline | .83 probability |
| Comparison Condition | Probability of Mild or Moderate Depression Relative to Greater Levels of Depression at Baseline Compared to 9 Months | 9 months | .744 probability |