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

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ClinicalTrials.gov Identifier: NCT02378181
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Treatment Research Institute

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Drug Use Behavioral: Health Education Toolkit Behavioral: Treatment-as-usual Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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).
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.
Behavioral: 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.




Primary Outcome Measures :
  1. 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).

  2. Increased satisfaction and acceptability, as measured by the Satisfaction Survey [ Time Frame: 3 months ]
    Satisfaction and acceptability of treatment sessions


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378181


Locations
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United States, Pennsylvania
Wedge Medical Center
Philadelphia, Pennsylvania, United States, 19126
Sponsors and Collaborators
Treatment Research Institute
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Adam C Brooks, PhD Treatment Research Institute

Additional Information:
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Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT02378181     History of Changes
Other Study ID Numbers: 1411
CDR-1310-07308 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Behavior, Addictive
Alcohol Drinking
Compulsive Behavior
Impulsive Behavior
Drinking Behavior