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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DA048232-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program.
Participants in a police opioid diversion program will receive information about the research opportunity; those interested will be administered informed consent and randomized to either the (1) diversion program treatment as usual condition or (2) the enhanced condition, receiving the telehealth video call intervention with motivational interviewing and substance use treatment appointment reminders during the 12-week intervention. The study design has been modified to provide the enhanced condition with coaching and the T-CAP app to all individuals consented to the study beginning January 1, 2023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment plus telehealth | Experimental | Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth | Behavioral | The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Received One or More Referrals During the 12-week Intervention. | The number of participants who received one or more referrals to services made by the intervention coach. This measure is collected as evidence supporting participant utilization of the app and the coaching support model. | 12-week intervention period |
| Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12 | The Texas Christian University Drug Screen 5 is a 19-question survey that captures substance use during the past 12 months. Interpretation of the TCU Drug Screen 5 score for drug use severity corresponds with the Diagnostic and Statistical Manual of Mental Disorders 5 criteria for reporting three possible severity levels (mild, moderate, severe). A single level score is based on participant responses to 11 items (total range: 0 to 11) as such: the presence of 2 to 3 endorsed symptoms is scored as a mild disorder; 4 to 5 endorsed symptoms is scored as moderate disorder; and a severe disorder is scored with the presence of 6 or more symptoms of the 11 items; thus, more endorsed items means a more serious drug use problem. | Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent. |
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Inclusion Criteria:
Individuals interested in joining the study will be
Exclusion Criteria:
Individuals not eligible for the study are
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Pankow, PhD | Texas Christian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lake County Public Health Department | Waukegan | Illinois | 60085 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Plus Telehealth | Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. Telehealth: The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Overall consented sample is N=8. Two individuals did not participate in the telehealth intervention and have been excluded in the analysis dataset (N=6).
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Plus Telehealth | Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. Telehealth: The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percent of Participants Who Received One or More Referrals During the 12-week Intervention. | The number of participants who received one or more referrals to services made by the intervention coach. This measure is collected as evidence supporting participant utilization of the app and the coaching support model. | Six of eight consented participants (i.e., the intent-to-treat participants) completed calls with a coach, resulting in four participants (n=66.67%) who received referrals and two participants (n=33.33%) who did not receive a referral. The remaining two participants were not in the intent-to-treat group after randomization was discontinued. | Posted | Count of Participants | Participants | 12-week intervention period |
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Adverse event data were collected for a period of 3 months.
Definitions are consistent with Clinical Trials.
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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 | Treatment Plus Telehealth | Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. Telehealth: The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney stones | General disorders | Non-systematic Assessment | Participant reporting medical care for kidney stones. Participant confirmed that there was no inpatient care for this illness and no surgery needed. |
The T-CAP project explored the feasibility of implementing a telehealth model in a police diversion program that supports adults in recovery from opioid use disorder with treatment as an alternative to arrest. Inadequate data collection due to enrollment well below the target during the 2019 pandemic limits the ability to draw meaningful conclusions about the impact of the intervention to support people in recovery.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Jennifer Pankow | Texas Christian University Institute of Behavioral Research | 8172577226 | 6475 | j.pankow@tcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2022 | Dec 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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The two-arm randomization has been discontinued with new consented participants joining the study in 2023.
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| Participants |
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| Sex: Female, Male | 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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| Number of Participants Completing the Texas Christian University Drug Screen 5 Data | The Texas Christian University Drug Screen 5 (TCUDS 5) is a 19-question survey that captures substance use during the past 12 months. The instrument includes subscale that gauges the severity of drug use corresponding with the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria based on a single disorder measured on the following continuum from mild to severe: mild disorder (presence of 2-3 symptoms); moderate disorder (presence of 4-5 symptoms); and severe disorder: (presence of 6 or more symptoms). The total score range is 0 to 11. | The sample size at baseline (N=8) in the analysis reflects that number of participants in the group who experienced the telehealth plus coaching intervention (n=6) and participants (n=2) who did not receive the intervention. | Number | participants |
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| Primary | Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12 | The Texas Christian University Drug Screen 5 is a 19-question survey that captures substance use during the past 12 months. Interpretation of the TCU Drug Screen 5 score for drug use severity corresponds with the Diagnostic and Statistical Manual of Mental Disorders 5 criteria for reporting three possible severity levels (mild, moderate, severe). A single level score is based on participant responses to 11 items (total range: 0 to 11) as such: the presence of 2 to 3 endorsed symptoms is scored as a mild disorder; 4 to 5 endorsed symptoms is scored as moderate disorder; and a severe disorder is scored with the presence of 6 or more symptoms of the 11 items; thus, more endorsed items means a more serious drug use problem. | Four participants completed the Texas Christian University Drug Screen 5 at baseline and at the end of the intervention (12 weeks after consenting to the study). | Posted | Mean | Full Range | score on a scale | Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent. |
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| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
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| Medical procedure | General disorders | Non-systematic Assessment | Undetermined health issue reported by the participant that did not include an overnight hospital stay. |
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