Opioid Use DisorderTalkAboutItNCT06527820
Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation
A study testing Talk About It (conversation aid) in people with Opioid Use Disorder, run by Baystate Medical Center at 1 site in United States.
Trial summary
The increasing morbidity and mortality of the opioid epidemic has necessitated a reevaluation of current addiction treatment paradigms: medications for opioid use disorder, such as buprenorphine and methadone, are effective in decreasing one's risk of death and disability from opioid use, but are underutilized and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Talk About It (conversation aid)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 16 and older
- presenting with indications for Medications for Opioid Use Disorder (MOUD) initiation (opioid overdose, opioid withdrawal, complications of injection opioid use, untreated OUD)
- not currently on buprenorphine or methadone (in the past 7 days).
- (Buprenorphine is FDA approved for patients aged 16 and older, so 16- and 17-year-olds may be included with parental consent.)
Who cannot join
- No Opioid Use Disorder (OUD)
- already on MOUD
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baystate Medical Center
Springfield, Massachusetts, 01199
Jillian Tozloski, Jillian.Tozloski@baystatehealth.org
About this study
Official title: Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation (TALK ABOUT It)
The increasing morbidity and mortality of the opioid epidemic has necessitated a reevaluation of current addiction treatment paradigms: medications for opioid use disorder, such as buprenorphine and methadone, are effective in decreasing one's risk of death and disability from opioid use, but are underutilized and often difficult to access. The 5000 Emergency Departments (EDs) in the US are potential additional locales for medication initiation, but currently only a small minority of ED patients with opioid use disorder are started on medications. This study will refine and pilot an intervention called Talk About It which aims to foster patient-centered care, 'meet patients where they are' for addiction treatment, and increase treatment initiation and adherence via facilitating Shared Decision-Making in the ED around these potentially life-saving options.
Read the detailed description
Participants (ED patients with untreated opioid use disorder) will be enrolled and followed prospectively before and after an ED-wide intervention training clinicians to use "Talk About It," a paper-based conversation aid designed to foster shared decision-making about the decision to start methadone and buprenorphine.
Outcomes will include the initiation of medications, treatment adherence, and patient-reported outcomes.
- Conditions
- Opioid Use Disorder
- Being tested
- Talk About It (conversation aid)
- Keywords
- shared decision-making, decision aid, conversation aid, patient-centered care, addiction, emergency medicine
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talk About It (conversation aid)Behavioural
"Talk About It" is a conversation aid aimed to increase awareness of options and prompt discussion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of Talk About It (1)
Clinician report of number of times they utilized the Talk About It Tool in preceding 12 months
Measured: At 18 months
Uptake of Talk About It (2)
Number of paper versions of Talk About It tool shared with patients each month as monitored by research staff
Measured: At 6-18 months
Uptake of Talk About It (3)
Number of times the digital version of Talk About It is accessed for clinical care each month (webpage use monitoring software)
Measured: At 6-18 months
Uptake of Talk About It (4)
Number of times patient reports using Talk About It on follow-up survey
Measured: At 6-18 months
Medications for Opioid Use Disorder (MOUD) initiation
- Rate of Methadone or buprenorphine started in ED (via EHR)
- Rate of Prescription written for buprenorphine
Measured: From 0-24 months
Recruitment: Clinician enrollment
Average number of eligible clinicians who complete training and survey instruments
Measured: From 0-12 months
Recruitment: Patient enrollment
Average number of eligible patients who are enrolled each month
Measured: From 0-24 months
Acceptability/Feasibility of Talk About It
The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM) scales are brief, validated scales that clinicians will answer regarding acceptability, appropriateness, and feasibility of the intervention. Trained clinicians will complete these scales twice (once immediately after training and once 12 months after training. Range 1-5 with higher meaning better
Measured: At 6 and 18 months
Secondary outcomes (12)
Knowledge/Awareness
Patients will complete a post-ED knowledge test developed by Steering Committee
Measured: From 0-24 months
Perception of clinicians' compassion
Patients will complete the Sinclair Compassion Questionnaire (SCQ) which assessed their perception of their clinician's compassion (5 questions, range 1-5, higher = better)
Measured: From 0-24 months
Perceived Stigma
Patients will complete a Modified Perceived Stigma of Addiction Scale (PSAS) which assess their perception of their clinician's stigma (Q1 binary, Q2-4, range 1-5 with higher = more stigma)
Measured: From 0-24 months
Attitudes towards methadone
Patients will complete the Attitudes About Methadone (OAM-5) to assess whether the intervention has changed negative attitudes about methadone
Measured: From 0-24 months
Attitudes towards buprenorphine
Patients will complete the Attitudes About Buprenorphine (modified OAM-5) to assess whether the intervention has changed negative attitudes about buprenorphine
Measured: From 0-24 months
Engagement/SDM
Patients will complete the Shared Decision-Making Process Scale (SDM-P) to assess their perceived involvement in decision-making (4 questions, scored 0/1 with higher = more engagement)
Measured: From 0-24 months
Trust
Patients will complete the validated 5-item Trust in Physician Scale to assess their trust in the physician (5 questions, 1-5, with higher = more trust; 1 question reverse coded)
Measured: From 0-24 months
Readiness to change
Patients will fill out the Contemplation ladder scale (1-7), a validated tool to assess readiness for drug abstinence
Measured: From 0-24 months
Stigma
Clinicians will complete the Opening Minds Stigma Scale for Health Care Providers (OMS-HC) twice to assess for changes in stigma (19 questions, each 1-5, lower scrore = less stigma)
Measured: From 0-24 months
Self-efficacy for conversations about MOUD
Clinicians will complete the Self-efficacy in clinical communication scale (SE-12) to assess for changes in self-efficacy around communication (12 questions, response options 1-10, higher score = more self efficacy
Measured: From 0-24 months
Adherence to MOUD
Patients will report their 14- and 30- day use of MOUD, which will be confirmed in the EHR; 60 day adherence will be obtained from EHR and methadone clinics
Measured: From 0-24 months
Illegal opioid use
Patients will report their 14- and 30- day use of illegal opioids
Measured: From 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jun 2024
- Primary completion31 May 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after trial. ED patients will be enrolled and followed before and after the intervention is delivered to clinicians. Clinicians at one site will receive the intervention and clinicians at control sites will complete outcome collection without receiving the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Schoenfeld, MD, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527820
- Sponsor's protocol ID
- BH-24-001
- Acronym
- TalkAboutIt
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation (TALK ABOUT It)
- ClinicalTrials.gov ID
- NCT06527820
- Acronym / sponsor ID
- TalkAboutIt / BH-24-001
- Conditions
- Opioid Use Disorder
- Keywords
- shared decision-making, decision aid, conversation aid, patient-centered care, addiction, emergency medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The increasing morbidity and mortality of the opioid epidemic has necessitated a reevaluation of current addiction treatment paradigms: medications for opioid use disorder, such as buprenorphine and methadone, are effective in decreasing one's risk of death and disability from opioid use, but are underutilized and often difficult to access. The 5000 Emergency Departments (EDs) in the US are potential additional locales for medication initiation, but currently only a small minority of ED patients with opioid use disorder are started on medications. This study will refine and pilot an intervention called Talk About It which aims to foster patient-centered care, 'meet patients where they are' for addiction treatment, and increase treatment initiation and adherence via facilitating Shared Decision-Making in the ED around these potentially life-saving options.
Detailed description
Participants (ED patients with untreated opioid use disorder) will be enrolled and followed prospectively before and after an ED-wide intervention training clinicians to use "Talk About It," a paper-based conversation aid designed to foster shared decision-making about the decision to start methadone and buprenorphine.
Outcomes will include the initiation of medications, treatment adherence, and patient-reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Model description
- Before and after trial. ED patients will be enrolled and followed before and after the intervention is delivered to clinicians. Clinicians at one site will receive the intervention and clinicians at control sites will complete outcome collection without receiving the intervention.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 16 and older
- presenting with indications for Medications for Opioid Use Disorder (MOUD) initiation (opioid overdose, opioid withdrawal, complications of injection opioid use, untreated OUD)
- not currently on buprenorphine or methadone (in the past 7 days).
- (Buprenorphine is FDA approved for patients aged 16 and older, so 16- and 17-year-olds may be included with parental consent.)
Key exclusion criteria (2 listed)
- No Opioid Use Disorder (OUD)
- already on MOUD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talk About It (conversation aid)"Talk About It" is a conversation aid aimed to increase awareness of options and prompt discussion. | Behavioural | – |
Primary outcome
Uptake of Talk About It (1)
Time frame: At 18 months
Clinician report of number of times they utilized the Talk About It Tool in preceding 12 months
Uptake of Talk About It (2)
Time frame: At 6-18 months
Number of paper versions of Talk About It tool shared with patients each month as monitored by research staff
Uptake of Talk About It (3)
Time frame: At 6-18 months
Number of times the digital version of Talk About It is accessed for clinical care each month (webpage use monitoring software)
Uptake of Talk About It (4)
Time frame: At 6-18 months
Number of times patient reports using Talk About It on follow-up survey
Medications for Opioid Use Disorder (MOUD) initiation
Time frame: From 0-24 months
1. Rate of Methadone or buprenorphine started in ED (via EHR) 2. Rate of Prescription written for buprenorphine
Recruitment: Clinician enrollment
Time frame: From 0-12 months
Average number of eligible clinicians who complete training and survey instruments
Recruitment: Patient enrollment
Time frame: From 0-24 months
Average number of eligible patients who are enrolled each month
Acceptability/Feasibility of Talk About It
Time frame: At 6 and 18 months
The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM) scales are brief, validated scales that clinicians will answer regarding acceptability, appropriateness, and feasibility of the intervention. Trained clinicians will complete these scales twice (once immediately after training and once 12 months after training. Range 1-5 with higher meaning better
12 secondary outcomes
Knowledge/Awareness
Time frame: From 0-24 months
Perception of clinicians' compassion
Time frame: From 0-24 months
Perceived Stigma
Time frame: From 0-24 months
Attitudes towards methadone
Time frame: From 0-24 months
Attitudes towards buprenorphine
Time frame: From 0-24 months
Engagement/SDM
Time frame: From 0-24 months
Trust
Time frame: From 0-24 months
Readiness to change
Time frame: From 0-24 months
Stigma
Time frame: From 0-24 months
Self-efficacy for conversations about MOUD
Time frame: From 0-24 months
Adherence to MOUD
Time frame: From 0-24 months
Illegal opioid use
Time frame: From 0-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talk About It (conversation aid) in people with Opioid Use Disorder, run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Schoenfeld, MD, MS (4137940000, elizschoen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of Talk About It (1) (time frame: At 18 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.