Substance Use
Conditions
Keywords
Opioids, Telehealth, Police diversion program
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTelehealth
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Texas Christian University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The two-arm randomization has been discontinued with new consented participants joining the study in 2023.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Individuals interested in joining the study will be * Enrolled in the A Way Out Opioid Diversion Program (ODP), * At least 18 years of age, * Able to speak and understand English, * Have a history of opioid, alcohol, or other substance use within last 12 months, * Be willing to provide the research team with access to treatment records, * Have access to a phone, tablet or computer for the informed consent activity, and * Have a mailing address to receive a study phone issued to consented participants
Exclusion criteria
Individuals not eligible for the study are * Not currently enrolled in the A Way Out Opioid Diversion Program on the day of consent, * Under the age of 18 on the day of consent, * Unable to speak and understand English, * Have a history of past opioid, alcohol, or other substance use longer than 12 months ago with no use of opioids in the last 12 months, * Unwilling to authorize the research team to access treatment records, * Without access to a phone, tablet or computer to complete the informed consent activity, * Without a mailing address
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Received One or More Referrals During the 12-week Intervention. | 12-week intervention period | 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. |
| Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12 | Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Treatment Plus Telehealth |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of Participants Completing the Texas Christian University Drug Screen 5 Data | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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.
Time frame: 12-week intervention period
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Plus Telehealth | Percent of Participants Who Received One or More Referrals During the 12-week Intervention. | 4 Participants |
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.
Time frame: Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent.
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treatment Plus Telehealth | Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12 | TCU Drug Screen Baseline scores | 9.25 score on a scale |
| Treatment Plus Telehealth | Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12 | Post intervention TCU Drug Screen Scores | 9.75 score on a scale |