Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction

Study Overview
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Brief Summary
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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
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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).

Official Title
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Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction

Conditions
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Alcohol Use, Drug Use

Intervention / Treatment
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* Behavioral: Health Education Toolkit
* Behavioral: Treatment-as-usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toolkit (TK)<br>Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK). | Behavioral: Health Education Toolkit<br>* 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.<br>|
| Active Comparator: Treatment-as-usual (TAU)<br>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. | Behavioral: Treatment-as-usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 months | 
| 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). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 months | 
| 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). | 6 weeks, 3 months | 
| 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). | 3 months |