Clinical trial NCT02378181: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use
Drug Use
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-03-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q)
timeFrame: 3 months
measure: Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey
timeFrame: 3 months
Secondary outcomes:
measure: Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis
timeFrame: 3 months
measure: Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS)
timeFrame: 6 weeks, 3 months
measure: Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wedge Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kirkbride Center
state: Pennsylvania
Study officials:
affiliation: Treatment Research Institute
name: Adam C Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
References: