Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04575324 |
| Other study ID # |
1138-0420 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 24, 2020 |
| Est. completion date |
December 30, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Chestnut Health Systems |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Project STAMINA is a clinical trial that seeks to establish effectiveness of a telemedicine
approach for linking syringe exchange clients to medications for opioid use disorder. This
pilot study aims to recruit n=275 people and utilizes two study arms: (1) a treatment arm
consisting of immediate telemedicine linkage and (2) a control arm consisting of standard
referral to treatment. Half of the study participants will be randomly enrolled in each arm.
The study will utilize qualitative and quantitative data, including questionnaire data, drug
test results, and administrative treatment data, at multiple time points to determine what
effect telemedicine linkage has on clients in relation to the comparison group.
Description:
INTERVENTION DESCRIPTION:
Project STAMINA utilizes two study arms: (1) a treatment arm consisting of immediate
telemedicine linkage (2) a control arm consisting of standard referral to treatment. Half of
the study participants will be randomly enrolled in each arm. All enrollment and telemedicine
care will occur at one of three Chicago-based and university-affiliated syringe service
program (SSP) sites, where the primary purpose is providing free access to syringes for
people who inject drugs.
Intervention Arm (1): Participants enrolled into the telemedicine linkage intervention will
be immediately linked to telemedicine care provided by a university-affiliated federally
qualified health center (FQHC) that can prescribe buprenorphine and naltrexone and has a
relationship with a methadone treatment provider they can refer patients to as appropriate.
Study participants prescribed buprenorphine or naltrexone will be able to receive MOUD
treatment at any of the 6 FQHC locations across the city, three of which are in relatively
close proximity to the SSP sites, and a no-cost induction buprenorphine prescription can be
dispensed from their main office. The FQHC can also refer to a methadone provider with
various locations throughout the city. At the SSP, the participant will have their vitals
checked by a research team member and be connected with the FQHC provider via an iPad. The
research assistant will share the participant's vitals with the provider, and the provider
will complete a virtual treatment appointment. The research assistant will offer the
participant transportation assistance to pick up the first buprenorphine or naltrexone
prescriptions or to attend the first methadone referral appointment. Transportation to pick
up the prescription will be provided via a HIPAA compliant ride-share company, and a bus pass
will be provided to the participant for the return trip. Further, to support the
intervention, the research assistant will also provide a visual guide at enrollment (i.e.
picture directions) that describes how to navigate the FQHC pharmacy, as well as a scheduling
card that allows them to record any MOUD appointment dates. All follow-up OUD care and
prescribing will be conducted based on the provider's standards and may include in-person or
telemedicine appointments. Should the provider deem an in-person intake appointment
clinically necessary for any participant assigned to the treatment arm, the research
assistant will provide a full-day bus pass to assist with transportation.
Standard Care Arm (2): Participants enrolled in the control arm will receive a standard
referral to an in-person appointment, also with a provider from the same FQHC sites. This
appointment will involve an in-person meeting with the provider, which will occur within
24-72 hours of the enrollment time. After study enrollment, the research assistant will
utilize the FQHC electronic scheduling system to schedule this in-person appointment. The
research assistant will also provide the participant with an appointment reminder card for
this appointment and a full-day bus pass to cover the transportation to and from the
appointment, which aligns with standard care at the SSP. All follow-up OUD care and
prescribing will be conducted based on the provider's standards and may include in-person or
telemedicine appointments.
RESEARCH DESIGN:
Participants will be identified one of the following ways: (1) individuals will see the
STAMINA poster within the syringe exchange site and be able to ask staff where to get more
information, (2) individuals will inform syringe service staff that they are interested in
treatment for an opioid use disorder, and staff will inform them of the study opportunity,
(3) individuals will see a STAMINA flyer at another social service program in the city and be
able to call study personnel for more information on the study and how to get to syringe
exchange, (4) individuals will see marketing material distributed via social media platforms
by the TrialFacts company, contact the TrialFacts company, and then be put in touch with a
STAMINA research assistant, or (5) individuals will be introduced to the study by street
outreach staff.
Research personnel will be responsible for assessing SSP clients for eligibility. Using the
recruitment script, after providing an introduction to STAMINA and a reason for the
eligibility questions, the research assistant will begin to read the full script, which
includes an assessment of eligibility criteria. Any client who is eligible and interested in
participating will move forward with the statement of informed consent. Willing participants
will be asked to sign the consent form. Once the participant has been officially enrolled,
the onsite research assistant will notify an offsite research assistant of the enrollment so
that the participant can be randomized. This allows the onsite research assistant to move
forward in collecting data while blinded to the study arm assignment.
This offsite research assistant will use the pre-established random arm assignment list to
determine which arm the client has been randomly assigned, based on their study
identification number. Each identification number will include two stratified randomization
blocks: (1) one arm assignment will be for participants who are interested in receiving
buprenorphine or naltrexone, or open to considering these types, [Open MOUD Stratified Arm
Assignment] (2) one arm assignment will be for participants who are only interested in
receiving methadone [Methadone Only Stratified Arm Assignment]. Based on the participant's
interest in MOUD, which will have been clarified during the eligibility assessment and
entered into the data collection system, the offsite research assistant will then read the
appropriate random arm assignment from the list and record their random arm assignment in the
data collection system. If the participant is assigned to the telemedicine intervention arm,
the offsite research assistant will need to notify the FQHC of an upcoming virtual
appointment [the FQHC needs a one-hour notice of appointment]. At this time, the offsite
research assistant will not yet inform the onsite research assistant, or the participant, of
the arm assignment so that baseline data collection can be completed prior to notification.
The onsite research assistant will be responsible for data collection. The first step in data
collection will be to complete a questionnaire. The questionnaire will take approximately
45-60 minutes and be administered by research staff using the Research Electronic Data
Capture (REDCap) data collection system, which is a secure, HIPAA-compliant, web-based survey
instrument. The questionnaire will be administered in a standard manner, meaning: (1) all
questions will be asked, (2) all questions will be read as written, (3) research assistants
will not reword questions in any way, and (4) participants have the right to refuse to answer
any question.
This questionnaire will cover the following topics:
- Full name, Date of Birth, SSN, and UI Health Medical Record Number (MRN)
- Demographic information
- Social support
- Child welfare involvement
- Housing and homelessness
- Alcohol use
- Drug use
- Heroin cravings
- Opioid withdrawal symptoms
- Overdose experiences
- Physical and mental health
- Trauma exposure
- Criminal justice involvement
- Treatment motivation
- Quality of life
The questionnaire will also request participant contact information. This information will
not be used as research data, but rather, will aid the scheduling of research follow-up
visits. The form will ask participants for (1) their contact information, (2) the contact
information for others who might be able to help in reaching the participant, (3) the contact
information for providers whose services they utilize and might be able to help reach the
participant. The participants are reminded at the beginning of the form that they have the
right to refuse any question and only share what they want to share. Because of the transient
nature of the participant population, additional contacts are helpful in reaching the
participant should personal contact information change.
Participants will be asked to complete the REDCap questionnaire at baseline and 3 months
after baseline. Each questionnaire will take 45-60 minutes to complete. All questionnaires
(baseline & 3-months) will be completed at the SSP by a research team member. Though the
first questionnaire will be completed over video, the follow-up questionnaire will be
completed over telephone. Participants will be asked to return to the SSP, despite doing the
interview with via telephone because they will be asked to also complete a drug screen at
follow-up (described below).
Immediately following the questionnaire, all participants will be asked to submit a urine
drug screen, as a form of data collection. The drug screen will be completed on-site,
immediately following the REDCap questionnaire. The drug screen takes 1-2 minutes to
complete. This will also be completed at baseline and 3-months.
Once participants have completed all baseline data collection, they will be notified of their
random study arm assignment. At this time, participants randomized to the telemedicine
intervention arm would be connected via telemedicine to the FQHC provider and take part in
the intervention described above. Participants randomized to the control arm would receive a
scheduled in-person appointment at a FQHC location.
At the end of the visit with the research staff, all participants will receive materials that
aid follow-up data collection and prepare them for the data collection timeline. All
participants will be given a scheduling form that visually displays the data collection items
in the order of their occurrence. Participants will be offered a paper copy or invited to
take a picture of the schedule to store on their phone, if applicable. Participants will also
be provided with the STAMINA contact telephone number and asked to store it in their phone,
if applicable. They will be shown the STAMINA website and QR code.
SECONDARY DATA COLLECTION:
As a part of the consent and health information release process, we request to access
participant protected health information (PHI) from the four sources listed below.
(1) FQHC and (2) methadone provider We will request that the FQHC and methadone provider pull
treatment data, including dates of service, medications prescribed, and treatment details to
understand compliance.
(3) State Prescription Monitoring Program (PMP) records We will request the state
prescription monitoring program (PMP) data for the purpose of verifying the information
provided by the participant during the REDCap questionnaire. While we ask the participant to
self-report whether they have engaged in medication for opioid use disorder treatment, the
PMP data will allow us to verify whether they have been prescribed/dispensed any of the
prescriptions or prescriptions not mentioned during the interview.
(4) State Vital Records Similarly, we request state vital records data for the purpose of
verifying whether a participant passed away. We are obtaining this data to verify if a
participant disengaged from the study because of death and to understand whether that death
was caused by drug use.
