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

Drug Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378181
• Other study ID #: 1411
• Secondary ID: CDR-1310-07308
• Status: Completed
• Phase: N/A
• Start date: August 16, 2016
• Est. completion date: April 15, 2017

Study information

• Verified date: October 2022
• Source: Public Health Management Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 15, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use
• Behavior, Addictive
• Drug Use

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kirkbride Center	Philadelphia	Pennsylvania
United States	Wedge Medical Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Treatment Research Institute	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Patient-Centered Outcomes Research Institute (PCORI) Project Abstract