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

Primary Purpose

Alcohol Use, Drug Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Education Toolkit
Treatment-as-usual
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wedge Medical Center
  • Kirkbride Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Toolkit (TK)

Treatment-as-usual (TAU)

Arm Description

Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
February 26, 2015
Last Updated
October 21, 2022
Sponsor
Treatment Research Institute
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02378181
Brief Title
Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction
Official Title
Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2016 (Actual)
Primary Completion Date
April 15, 2017 (Actual)
Study Completion Date
April 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Drug Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toolkit (TK)
Arm Type
Experimental
Arm Description
Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).
Arm Title
Treatment-as-usual (TAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education Toolkit
Intervention 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. 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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-usual
Intervention Description
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 Measure Information:
Title
Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q)
Description
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
Title
Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey
Description
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
Secondary Outcome Measure Information:
Title
Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis
Description
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
Title
Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS)
Description
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
Title
Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam C Brooks, PhD
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wedge Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19126
Country
United States
Facility Name
Kirkbride Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.pcori.org/research-results/2014/testing-effectiveness-graphic-novel-health-education-curriculum-patients
Description
Patient-Centered Outcomes Research Institute (PCORI) Project Abstract

Learn more about this trial

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

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