Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04982627 |
| Other study ID # |
2000030168 |
| Secondary ID |
R43DA051267 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
March 31, 2022 |
Study information
| Verified date |
July 2021 |
| Source |
Center for Progressive Recovery, LLC |
| Contact |
Michael V Pantalon, PhD |
| Phone |
2035063134 |
| Email |
mvpantalon[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Primary Objective:
Conduct pilot study to assess effects of brief negotiation interview (BNI) Chatbot among
individuals involved in the Connecticut criminal justice system with opioid use disorder
(OUD).
Study Duration:
Approximately 2 years (1 year for study activities, 1 year for data analysis)
Study Design:
This is a prospective, randomized study to evaluate the effectiveness of a BNI Chatbot on
patients with OUD compared with Standard Care (SC).
Number of Study Sites:
The offices of the Center for Progressive Recovery, LLC and the New Haven Police Department
Detention Center (NHPD).
Study Population:
The study population includes adult individuals with OUD who are involved in the Connecticut
criminal justice system and not currently receiving medication-assisted treatment for their
OUD.
Number of Participants:
Sixty participants
Primary Outcome Variable:
Attendance at participants first treatment appointment within four weeks of referral among
participants in the BNI Chatbot vs. Standard Care (SC) groups.
Secondary Outcome and Exploratory Outcome Variables:
Secondary outcomes include readiness and intention to engage in buprenorphine (bup)
treatment, and urine toxicology test-confirmed drug use at four weeks among participants in
BNI Chatbot vs. SC groups. Exploratory outcomes include ratings of feasibility, acceptability
and satisfaction between study groups, and a comparison of study findings to engagement data
from previous in-person studies, including BNI+bup, and other digital programs, such as
reSET-O, and DynamiCare.
Description:
Enrollment and Randomization:
Individuals meeting inclusion/exclusion criteria with the research associate (RA), who will
be following a "Recruitment Script" (see below) will be offered participation and written
informed consent will be obtained. Participants will be randomly assigned (via
http://www.randomization.com) to receive either the BNI Chatbot or Standard Care (SC).
- SC: The RA will provide participants with an electronic link, which provides OUD and bup
education, and lists OUD treatment options and descriptions and locations, including bup
prescribers. After reviewing, participants will be asked to choose from among the list
of and a referral will be made based on the receiving treatment providers' procedures.
These participants will not have access to the BNI chatbot. However, the referral
facilitation, the electronic link will direct participants to a short Feasibility,
Acceptability and Satisfaction (FAS) Assessment to obtain feedback on the process.
- BNI Chatbot: Participants will receive a link to register for the chatbot. Following
registration, they will complete the initial chat, which includes instructions for the
entire study. The chatbot will then guide the participant through multiple BNIs focused
on the goal of bup engagement, with the following steps: 1) Raise the Subject/Establish
Rapport; 2) Enhance Motivation; 3) Provide & Elicit Feedback; and 4) Negotiate a Plan.
The chatbot then reminds the participant of their reasons why they might engage in OUD
treatment based on their responses to Steps 2 & 3, and their negotiated plan. The
chatbot will electronically connect participants to a treatment provider of their
choice, based on available options. Based on their choice, individuals in the BNI
Chatbot group choosing to engage in bup treatment will be assessed by the Clinical
Opiate Withdrawal Scale (COWS) and those in active withdrawal may be offered a
telehealth appointment immediately (to the extent possible), which would occur during
the enrollment and help facilitate a prescription for bup. The telehealth appointment
may be with a different treatment provider than the one that they choose to meet with
post-enrollment. If the participant is prescribed bup during this telehealth
appointment, the RA will pick up the prescription for participant and deliver it to the
participant immediately upon release from the police, courthouse or probation office (to
the extent possible). At the end of the encounter, participants will be prompted to
complete the feasibility, acceptability and satisfaction (FAS) assessment electronically
to obtain feedback on the process.
Note: While participants are financially responsible for their own healthcare, we will only
refer them to treatment options that are listed as being covered by their health insurance.
Baseline Assessment: Demographics and status of the participant's case in the criminal
justice system will be collected by the RA via a mobile tablet.
One Month Assessment: At four weeks post-randomization, we will collect the following data:
- Patient-facing assessment: Participants will complete a brief follow-up assessment to
collect information on readiness and intention to engage in bup treatment and ratings of
satisfaction regarding their assigned intervention (BNI chatbot or Web-based OUD &
Treatment Referral Resources). Additionally, they will be contacted by phone 1-month
post-randomization to assess self-reported treatment attendance and drug use.
- Treatment providers: The RA will call treatment providers to collect information
regarding participants' attendance and record urine toxicology results during the one
month post-randomization, as well as any treatment/prescriptions provided for their
opioid use disorder. Information will be provided to the RA over the phone and recorded
in the electronic study database.
Participant Payments:
Participants will receive a $25 gift card after the completing the initial enrollment,
including their first use of whichever web application the are assigned (BNI Chatbot or SC).
Participants will receive an additional $25 gift card following completion of the one-month
follow-up assessment.
Study Schedule:
Participants will participate in two visits, including 1) enrollment, randomization, and
baseline assessment, web application completion (BNI Chatbot or SC, both of which are
delivered via the web) and 2) one-month follow-up. The initial visit will take up to 45
minutes and the follow-up assessment will take up to 15 minutes.
Informed Consent:
An in-person recruitment/written consent has been submitted with this protocol, which
describes in detail the study intervention, study procedures, and risks. The consent will be
given to the participant via a mobile tablet and paper (if they request), and participants
will be given as much time as needed to review the information and ask any questions they may
have. will be answered by the RA in a way that does not reveal, or ask the individual to
reveal, any PHI. If the individual's questions have been satisfactorily answered or if they
have no questions, then they are given the option of signing the consent form on the tablet.
If they sign the consent form, a copy of it will be emailed to them. They are then asked to
sign a release of information allowing us to contact the substance use disorder treatment
center that has appointments available at that time to confirm attendance and treatment one
month later. If the individual signs the release of information, then we will email them a
copy. Randomization and study interventions are then completed as outlined in the protocol.
Written documentation of informed consent is required prior to enrollment and randomization.
Screening & Recruitment:
Below is a detailed outline of how recruitment, enrollment/informed consent and data
collection will occur throughout the study. Overall, the NHPD's only involvement in this
study is to provide space and access for recruitment and enrollment, and they will not
provide or receive any study data.
1. The NHPD detention center (i.e., "lockup") at 1 Union Ave, New Haven, CT, provides space
for the study's RA to sit during set hours.
2. NHPD shares with the RA which cells have nonviolent offenders (i.e., offenses in the
past 5 years will not have been violent in nature) and can be approached.
3. All nonviolent offenders will be given a Study Flyer by RA and then asked if they are
willing to hear more about a research study.
4. If yes, the prospective individual will be handed a study mobile tablet and a pair of
disposable headphones so that they may hear the RA read the "Recruitment Script" (see
attached), which will guide the RA through describing the study and answering any
questions from the prospective participant in such a way as not to reveal any protected
health information (PHI).
5. Following the reading of the script, the prospective participant is handed a mobile
tablet (e.g., iPad) where they can note their interest by clicking one of several
options, including "I want to answer eligibility questions," which then provides the
questions for the patient to read and answer on the tablet. The individual also has the
option of having the RA read the questions but still provide the answers on the tablet.
6. If the individual is eligible, then they can note their interest in participating by
clicking one of several options, including "I want to read the Consent Form" or "I want
the RA to review the Consent Form without revealing any private information".
The RA will enroll subjects in the study after they have been referred, screened for
eligibility criteria, and provided informed consent. If screening/enrollment is completed in
person, written informed consent will be collected. If screening/enrollment is completed by
phone or video chat, a copy of the consent form will be emailed to the participant and the
time/date of verbal consent will be documented and retained for study records.
On Study Visits:
1. Baseline visit (30-45 minutes, depending on group)
- Consent
- Randomization
- SC: The RA will provide participants with an electronic link, which provides
OUD and bup education, and lists OUD treatment options and descriptions and
locations, including bup prescribers. After reviewing, The RA will ask
participants to choose a treatment option and, if the participant so chooses,
a referral will be made based on the receiving treatment providers'
procedures. These participants will not have access to the BNI chatbot but
will be prompted to complete a brief FAS assessment electronically.
- BNI Chatbot: Participants will receive a link to register for the chatbot.
Following registration, they will complete the initial chat, which includes
instructions for the entire study. The chatbot will then guide the participant
through multiple BNIs focused on the goal of bup engagement and electronically
connect participants to the treatment provider of their choice. They may be
offered and connected with a telehealth appointment immediately, as outlined
above, and may receive the physical prescriptions immediately once released
from police, probation or the courthouse. After the encounter, participants
will be prompted to complete a brief FAS assessment electronically.
- Baseline Assessment - Demographics and status of case in criminal justice system,
provided by the participant.
- Participant payment ($25 gift card)
2. One-month assessment (5-15 minutes, depending on group)
- At 4 weeks post-randomization, participants will complete a brief follow-up
assessment to collect information on satisfaction of the treatment referral
process. Participants in the BNI Chatbot group will also provide feedback on
feasibility, acceptability and satisfaction of the chatbot and participants in the
SC group will provide feedback on feasibility, acceptability and satisfaction of
the electronic education and referral process. Assessments will be conducted via
the chatbot (BNI Chatbot group only) or in-person or by phone. To facilitate
scheduling, the RA will have access to all participants' scheduled probation
appointments during the study.
- Participant payment ($25 gift card)
End of Study and Follow-up:
Following completion of study procedures, the research team will review data for completeness
and attempt to complete any missing data, as possible. If patients withdraw from the study
early, investigators will retain data collected up until discontinuation of the study.
