Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction
|ClinicalTrials.gov Identifier: NCT02378181|
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : July 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Drug Use||Behavioral: Health Education Toolkit Behavioral: Treatment-as-usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction|
|Actual Study Start Date :||August 16, 2016|
|Actual Primary Completion Date :||April 15, 2017|
|Actual Study Completion Date :||April 15, 2017|
Experimental: 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).
Behavioral: 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.
Active Comparator: 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 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.
- Change in shared decision making conversations, as measured by the Shared Decision Making Questionnaire (SDM-Q) [ Time Frame: 6 weeks, 3 months ]Shared decision making score, as measured by the Shared Decision Making Questionnaire (SDM-Q).
- Increased satisfaction and acceptability, as measured by the Satisfaction Survey [ Time Frame: 3 months ]Satisfaction and acceptability of treatment sessions
- Change in substance use, as measured by the Timeline Followback and confirmed by urinalysis [ Time Frame: 6 weeks, 3 months ]Reduced substance use as measured by the Timeline Followback and confirmed by urinalysis
- Change in alcohol severity, as measured by the Addiction Severity Index (ASI) [ Time Frame: 6 weeks, 3 months ]Reduced Alcohol Severity Score, as measured by the Addiction Severity Index (ASI)
- Change in substance abuse treatment session attendance from baseline, as measured by the Non-Study Medical and Other Services (NSMOS) [ Time Frame: 6 weeks, 3 months ]Treatment sessions attended for alcohol or drug use issues as measured by the Non-Study Medical and Other Services (NSMOS)
- Change in medication assisted treatment (MAT) initiation from baseline, as measured by a utilization review [ Time Frame: 6 weeks, 3 months ]Initiation of MAT as measured by a chart utilization review
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378181
|United States, Pennsylvania|
|Wedge Medical Center|
|Philadelphia, Pennsylvania, United States, 19126|
|Principal Investigator:||Adam C Brooks, PhD||Treatment Research Institute|