- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02378181
Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction
October 21, 2022 updated by: Treatment Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19126
- Wedge Medical Center
-
Philadelphia, Pennsylvania, United States, 19139
- Kirkbride Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q)
Time Frame: 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).
|
3 months
|
Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey
Time Frame: 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).
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis
Time Frame: 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).
|
3 months
|
Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS)
Time Frame: 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).
|
6 weeks, 3 months
|
Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review
Time Frame: 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).
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Adam C Brooks, PhD, Treatment Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2016
Primary Completion (Actual)
April 15, 2017
Study Completion (Actual)
April 15, 2017
Study Registration Dates
First Submitted
February 26, 2015
First Submitted That Met QC Criteria
February 26, 2015
First Posted (Estimated)
March 4, 2015
Study Record Updates
Last Update Posted (Actual)
September 1, 2023
Last Update Submitted That Met QC Criteria
October 21, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1411
- CDR-1310-07308 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Use
-
Women's College HospitalRecruitingAlcohol; Harmful Use | Tobacco Use | Tobacco Use Cessation | Alcohol Use, UnspecifiedCanada
-
University of Colorado, DenverUnknownAlcohol Use Disorders | Unhealthy Alcohol UseUnited States
-
Université du Québec à Trois-RivièresCompletedAlcohol Use, Unspecified | Alcohol Use Disorder, MildCanada
-
University of Central FloridaEnrolling by invitationAlcohol Use, Underage | Harmful; Use, AlcoholUnited States
-
University of North Carolina, Chapel HillCompletedAlcohol Use Disorder, Mild | Alcohol Use Disorder, ModerateUnited States
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
University of VirginiaNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Minnesota and other collaboratorsRecruitingSexual Behavior | Alcohol Use, Unspecified | Alcohol Exposed Pregnancy | Unplanned Pregnancy | Contraception UseUnited States
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA)CompletedAlcohol Drinking | Alcohol Use Norms | Alcohol Use Among ART ClientsVietnam
-
Washington State UniversityRecruitingNicotine Use Disorder | Alcohol Use Disorder (AUD)United States
-
H. Lee Moffitt Cancer Center and Research InstituteNational Institutes of Health (NIH); National Center for Complementary and...CompletedTobacco Use | Alcohol Use, UnspecifiedUnited States
Clinical Trials on Health Education Toolkit
-
Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation TrustActive, not recruitingOsteo Arthritis Knee | Osteoarthritis, HipUnited Kingdom
-
University of Wisconsin, MadisonCompletedIntellectual Disability | Developmental Disability | Chronic Conditions, MultipleUnited States
-
Weill Medical College of Cornell UniversityNational Institute on Aging (NIA)RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Caregiver Burden | Pain, ChronicUnited States
-
Hospices Civils de LyonNot yet recruitingAcute Decompensated Heart Failure | Acute Myocardial InfarctionFrance
-
Federal University of PelotasRecruiting
-
University of PretoriaUnknown
-
Universiti Sains MalaysiaNot yet recruitingKnowledge, Attitudes, Practice | Early Childhood Caries
-
Junyan ZhaoActive, not recruitingTumor Chemotherapy PatientsChina
-
Tianjin HospitalCompletedLumbar Disc HerniationChina
-
Federal University of PelotasRecruitingBreast Cancer FemaleBrazil