Alcohol Use, Drug Use
Conditions
Brief summary
This study deploys a strategy to develop and evaluate a training-efficient, multimedia patient-centered Health Education Toolkit to promote shared decision making between counselors and patients. An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum useful in group and individual counseling. The proven behavioral interventions will be augmented with health education material focused on medication assisted treatment (MAT). We will assess feasibility and acceptability, and pilot test whether exposure to the Toolkit (TK) can shared decision making conversations, reduce substance use, and increase engagement with MAT.
Detailed description
An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum useful in group and individual counseling. The proven behavioral interventions will be augmented with health education material focused on medication assisted treatment (MAT) and HIV risk reduction. Together, these materials will comprise the Health Education Toolkit. The Health Education Toolkit (TK) will employ a shared decision making model to encourage 1) increased recovery engagement by patients, and 2) patient engagement in deciding whether to initiate and adhere to MAT. We will conduct a randomized pilot trial of 50 patients with active alcohol substance use disorders (SUDs) enrolled in inpatient or outpatient treatment and will follow them over 3 months. We will test whether patients randomized to receive the TK curriculum will report increased shared decision making conversations, report greater satisfaction and acceptability of their treatment sessions, demonstrate larger reductions in substance use (drug and alcohol) and increases in abstinence, demonstrate improved alcohol severity scores, attend more attendance at specialty substance abuse intervention and treatment sessions, and demonstrate greater rates of initiating MAT for alcohol dependence over the 3-month follow-up period as compared to patients receiving treatment-as-usual (TAU).
Interventions
BEHAVIORALHealth Education Toolkit
An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum. The proven behavioral interventions will be augmented with health education material focused on MAT and HIV risk reduction. Together, these materials will comprise the Health Education Toolkit. The Health Education Toolkit (TK) will employ a shared decision making model to encourage 1) increased recovery engagement by patients, and 2) patient engagement in deciding whether to initiate and adhere to MAT.
BEHAVIORALTreatment-as-usual
Treatment-as-usual will consist of the same number of counseling sessions as the experimental TK condition, but the counselors working with patients in this condition will not be equipped with the TK materials.
Sponsors
Patient-Centered Outcomes Research Institute
Treatment Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Screening score of at least 16 on the AUDIT * Meets criteria for a DSM-V substance use disorder as assessed via the MINI Plus 5.0. * Reports at least two heavy drinking episodes in the previous 4 weeks
Exclusion criteria
* Reports plans to leave the Philadelphia greater metropolitan area within the next 6 months * Does not speak English * Unable to provide valid informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q) | 3 months | Shared decision making score, as measured by the Shared Decision Making Questionnaire (SDM-Q) which uses a 1-6 point scale with higher numbers indicating greater shared decision-making. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor). |
| Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey | 3 months | Satisfaction and acceptability of treatment sessions measured on a 1-5 scale with higher scores indicating greater satisfaction. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis | 3 months | Days substance use as measured by the Timeline Followback and confirmed by urinalysis. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor). |
| Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS) | 6 weeks, 3 months | Self-reported days attended treatment for alcohol or drug use issues as measured by the Non-Study Medical and Other Services (NSMOS). Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor). |
| Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review | 3 months | Initiation of MAT as measured by a chart utilization review. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from addiction treatment programs in the Philadelphia region between August 2016 and January 2017
Pre-assignment details
Participants were screened for eligibility using the AUDIT and Mini-International Neuropsychiatric Interview (MINI) for substance use disorders.
Participants by arm
| Arm | Count |
|---|---|
| Toolkit (TK) Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).
Health Education Toolkit: An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum. The proven behavioral interventions will be augmented with health education material focused on MAT and HIV risk reduction. Together, these materials will comprise the Health Education Toolkit. The Health Education Toolkit (TK) will employ a shared decision making model to encourage 1) increased recovery engagement by patients, and 2) patient engagement in deciding whether to initiate and adhere to MAT. | 21 |
| Treatment-as-usual (TAU) Patients in the treatment-as-usual (TAU) condition will receive the same number of counseling sessions as patients in the TK condition from participating counselors who have not been trained to use the Health Education Toolkit. Counselors working with patients in this condition will receive a control training of the same length and intensity on recovery topics that are covered in the Health Education Toolkit, but will not be equipped with the Toolkit.
Treatment-as-usual: Treatment-as-usual will consist of the same number of counseling sessions as the experimental TK condition, but the counselors working with patients in this condition will not be equipped with the TK materials. | 28 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incarcerated | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Toolkit (TK) | Treatment-as-usual (TAU) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 21 Participants | 28 Participants |
| Age, Continuous | 43.04 years STANDARD_DEVIATION 10.61 | 42.71 years STANDARD_DEVIATION 10.26 | 43.30 years STANDARD_DEVIATION 10.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 18 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 16 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 3 Participants | 9 Participants |
| Region of Enrollment United States | 49 Participants | 21 Participants | 28 Participants |
| Sex: Female, Male Female | 17 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 31 Participants | 15 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 28 |
| other Total, other adverse events | 0 / 21 | 0 / 28 |
| serious Total, serious adverse events | 0 / 21 | 1 / 28 |
Outcome results
Primary
Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q)
Shared decision making score, as measured by the Shared Decision Making Questionnaire (SDM-Q) which uses a 1-6 point scale with higher numbers indicating greater shared decision-making. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor).
Time frame: 3 months
Population: Patients who completed the 3-month follow-up at one research site.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toolkit (TK) | Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q) | 5.14 units on a scale | Standard Deviation 0.78 |
| Treatment-as-usual (TAU) | Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q) | 4.55 units on a scale | Standard Deviation 1.34 |
Primary
Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey
Satisfaction and acceptability of treatment sessions measured on a 1-5 scale with higher scores indicating greater satisfaction. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Toolkit (TK) | Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey | 3.95 units on a scale | Standard Deviation 0.86 |
| Treatment-as-usual (TAU) | Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey | 3.97 units on a scale | Standard Deviation 1.14 |
Secondary
Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review
Initiation of MAT as measured by a chart utilization review. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor).
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Toolkit (TK) | Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review | 0 percentage of participants |
| Treatment-as-usual (TAU) | Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review | 8.3 percentage of participants |
Secondary
Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS)
Self-reported days attended treatment for alcohol or drug use issues as measured by the Non-Study Medical and Other Services (NSMOS). Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor).
Time frame: 6 weeks, 3 months
Population: The number of participants analyzed for the 6 week follow-up differs from the overall number analyzed because some participants did not complete the 6 week follow-up, but did complete the 3 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Toolkit (TK) | Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS) | 6 week follow-up | 17.69 Days | Standard Deviation 11.56 |
| Toolkit (TK) | Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS) | 3 month follow-up | 10.69 Days | Standard Deviation 8.75 |
| Treatment-as-usual (TAU) | Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS) | 6 week follow-up | 15.60 Days | Standard Deviation 8.42 |
| Treatment-as-usual (TAU) | Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS) | 3 month follow-up | 12.83 Days | Standard Deviation 17.68 |
Secondary
Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis
Days substance use as measured by the Timeline Followback and confirmed by urinalysis. Results are presented for one research site only because of counselor randomization issues at the second site (i.e., the randomization was extremely unbalanced with 7 TAU counselors and 1 TK counselor).
Time frame: 3 months
Population: Participants who completed the 3-month follow-up at one research site
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Toolkit (TK) | Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis | Used Alcohol | 12.00 Days | Standard Deviation 14.53 |
| Toolkit (TK) | Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis | Used Drugs | 3.40 Days | Standard Deviation 5.77 |
| Treatment-as-usual (TAU) | Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis | Used Alcohol | 22.91 Days | Standard Deviation 27.08 |
| Treatment-as-usual (TAU) | Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis | Used Drugs | 1.27 Days | Standard Deviation 1.9 |