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| ID | Type | Description | Link |
|---|---|---|---|
| CDR-1310-07308 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toolkit (TK) | Experimental | Patients in the TK condition will receive counseling sessions from participating counselors who have been trained to use the Health Education Toolkit (TK). |
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| Treatment-as-usual (TAU) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education Toolkit | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam C Brooks, PhD | Treatment Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wedge Medical Center | Philadelphia | Pennsylvania | 19126 | United States | ||
| Kirkbride Center |
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| Label | URL |
|---|---|
| Patient-Centered Outcomes Research Institute (PCORI) Project Abstract | View source |
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Participants were screened for eligibility using the AUDIT and Mini-International Neuropsychiatric Interview (MINI) for substance use disorders.
Participants were recruited from addiction treatment programs in the Philadelphia region between August 2016 and January 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who completed the baseline assessment and randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Patients who completed the 3-month follow-up at one research site. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam C. Brooks, Ph.D. | Public Health Management Corporation | 215-399-0636 | abrooks@tri.phmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2017 | Dec 29, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2017 | Dec 29, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| Treatment-as-usual | Behavioral | 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. |
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| 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 |
| 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 |
| Philadelphia |
| Pennsylvania |
| 19139 |
| United States |
| Incarcerated |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Number analyzed differs from overall because one participant's sex is unknown | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| OG001 | 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. |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| 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). | Participants who completed the 3-month follow-up at one research site | Posted | Mean | Standard Deviation | Days | 3 months |
|
|
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| 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). | 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. | Posted | Mean | Standard Deviation | Days | 6 weeks, 3 months |
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| 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). | Posted | Number | percentage of participants | 3 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. | 0 | 28 | 1 | 28 | 0 | 28 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Used Drugs |
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| 3 month follow-up |
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