Trial Outcomes & Findings for Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction (NCT NCT02378181)
NCT ID: NCT02378181
Last Updated: 2023-09-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
3 months
Results posted on
2023-09-01
Participant Flow
Participants were recruited from addiction treatment programs in the Philadelphia region between August 2016 and January 2017
Participants were screened for eligibility using the AUDIT and Mini-International Neuropsychiatric Interview (MINI) for substance use disorders.
Participant milestones
| Measure |
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).
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 (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: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
28
|
|
Overall Study
6 Week Assessment
|
18
|
16
|
|
Overall Study
3 Month Assessment
|
18
|
21
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
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).
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 (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: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Incarcerated
|
0
|
1
|
Baseline Characteristics
Number analyzed differs from overall because one participant's sex is unknown
Baseline characteristics by cohort
| Measure |
Toolkit (TK)
n=21 Participants
Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).
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 (TAU)
n=28 Participants
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: 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.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=49 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=21 Participants
|
28 Participants
n=28 Participants
|
49 Participants
n=49 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=49 Participants
|
|
Age, Continuous
|
42.71 years
STANDARD_DEVIATION 10.26 • n=21 Participants
|
43.30 years
STANDARD_DEVIATION 10.63 • n=28 Participants
|
43.04 years
STANDARD_DEVIATION 10.61 • n=49 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=21 Participants • Number analyzed differs from overall because one participant's sex is unknown
|
11 Participants
n=27 Participants • Number analyzed differs from overall because one participant's sex is unknown
|
17 Participants
n=48 Participants • Number analyzed differs from overall because one participant's sex is unknown
|
|
Sex: Female, Male
Male
|
15 Participants
n=21 Participants • Number analyzed differs from overall because one participant's sex is unknown
|
16 Participants
n=27 Participants • Number analyzed differs from overall because one participant's sex is unknown
|
31 Participants
n=48 Participants • Number analyzed differs from overall because one participant's sex is unknown
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=21 Participants
|
2 Participants
n=28 Participants
|
5 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=21 Participants
|
24 Participants
n=28 Participants
|
42 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
2 Participants
n=28 Participants
|
2 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=21 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=21 Participants
|
14 Participants
n=28 Participants
|
30 Participants
n=49 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=21 Participants
|
9 Participants
n=28 Participants
|
12 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=21 Participants
|
3 Participants
n=28 Participants
|
4 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=21 Participants
|
2 Participants
n=28 Participants
|
3 Participants
n=49 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=21 Participants
|
28 Participants
n=28 Participants
|
49 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Patients who completed the 3-month follow-up at one research site.
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).
Outcome measures
| Measure |
Toolkit (TK)
n=17 Participants
Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).
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 (TAU)
n=12 Participants
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: 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.
|
|---|---|---|
|
Shared Decision Making Conversations, as Measured by the Shared Decision Making Questionnaire (SDM-Q)
|
5.14 units on a scale
Standard Deviation 0.78
|
4.55 units on a scale
Standard Deviation 1.34
|
PRIMARY outcome
Timeframe: 3 monthsSatisfaction 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).
Outcome measures
| Measure |
Toolkit (TK)
n=17 Participants
Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).
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 (TAU)
n=13 Participants
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: 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.
|
|---|---|---|
|
Treatment Satisfaction and Acceptability, as Measured by the Satisfaction Survey
|
3.95 units on a scale
Standard Deviation .86
|
3.97 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants who completed the 3-month follow-up at one research site
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).
Outcome measures
| Measure |
Toolkit (TK)
n=16 Participants
Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).
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 (TAU)
n=11 Participants
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: 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.
|
|---|---|---|
|
Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis
Used Alcohol
|
12.00 Days
Standard Deviation 14.53
|
22.91 Days
Standard Deviation 27.08
|
|
Substance Use, as Measured by the Timeline Followback and Confirmed by Urinalysis
Used Drugs
|
3.40 Days
Standard Deviation 5.77
|
1.27 Days
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: 6 weeks, 3 monthsPopulation: The number of participants analyzed for the 6 week follow-up differs from the overall number analyzed because some participants did not complete the 6 week follow-up, but did complete the 3 month follow-up.
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).
Outcome measures
| Measure |
Toolkit (TK)
n=17 Participants
Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).
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 (TAU)
n=13 Participants
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: 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.
|
|---|---|---|
|
Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS)
6 week follow-up
|
17.69 Days
Standard Deviation 11.56
|
15.60 Days
Standard Deviation 8.42
|
|
Substance Abuse Treatment Session Attendance, as Measured by the Non-Study Medical and Other Services (NSMOS)
3 month follow-up
|
10.69 Days
Standard Deviation 8.75
|
12.83 Days
Standard Deviation 17.68
|
SECONDARY outcome
Timeframe: 3 monthsInitiation 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).
Outcome measures
| Measure |
Toolkit (TK)
n=17 Participants
Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).
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 (TAU)
n=13 Participants
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: 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.
|
|---|---|---|
|
Medication Assisted Treatment (MAT) Initiation, as Measured by a Utilization Review
|
0 percentage of participants
|
8.3 percentage of participants
|
Adverse Events
Toolkit (TK)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment-as-usual (TAU)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Toolkit (TK)
n=21 participants at risk
Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK).
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 (TAU)
n=28 participants at risk
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: 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.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization for Suicidal Ideation
|
0.00%
0/21 • Adverse event data were collected from each participant over a 6-month period of time.
The study serious adverse event (SAE) definition did not consider pre-planned elective procedures and unrelated medical events that require hospitalization SAEs. Adverse events (AEs) that were not clinically significant (e.g., colds, other medical conditions not related to drug use) were not considered AEs. This reporting strategy was approved by the Institution Review Board overseeing the study and the funding agency.
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected from each participant over a 6-month period of time.
The study serious adverse event (SAE) definition did not consider pre-planned elective procedures and unrelated medical events that require hospitalization SAEs. Adverse events (AEs) that were not clinically significant (e.g., colds, other medical conditions not related to drug use) were not considered AEs. This reporting strategy was approved by the Institution Review Board overseeing the study and the funding agency.
|
Other adverse events
Adverse event data not reported
Additional Information
Adam C. Brooks, Ph.D.
Public Health Management Corporation
Phone: 215-399-0636
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place