Opioid Abuse (Disorder)NCT03834025
Nudges and Incentives to Enhance the Opioid Treatment Workforce
A study testing Phase 1 Condition 1, Phase 1 Condition 2 and Phase 1 Condition 3 in people with Opioid Abuse (Disorder), run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This project seeks to examine a critical barrier to optimizing the health care workforce for the treatment of opioid use disorders. Without a dramatic increase in the number of primary care providers trained and comfortable with the many nuances of prescribing medication-assisted treatment (MAT), the staggering… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse (Disorder)
- What is being tested?
- Phase 1 Condition 1, Phase 1 Condition 2 and Phase 1 Condition 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 28 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Licensed Primary Care Provider (Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Physician Assistant (PA), Nurse Practitioner (NP))
- Currently practice in North Carolina
- For Nurse practitioners, the following specialties were included:
- Addiction Psychiatry
- Addiction/Chemical Dependency
- Adolescent Medicine
Show all 35Show fewer
- Emergency Medicine
- Family Practice
- Family Practice, Geriatric
- General Practice
- General Preventive Medicine
- Geriatrics
- Gerontology
- Gynecology
- Infectious Disease
- Internal Medicine
- Internal Medicine/Immunology Diagnostic
- Internal Medicine/Pulmonary Dis. \& Crit
- Medicine/Pediatrics
- Medicine/Psychiatry
- Obstetrics
- Obstetrics and Gynecology/Critical Care
- Obstetrics/Gynecology
- Other Specialty
- Pain Management (phys med)
- Pain Medicine
- Pediatrics
- Psychiatry
- Psychiatry, Child
- Psychiatry/Geriatric
- Public Health
- Unspecified
- Hospitalist
- For MD/DOs practitioners that were considered primary by the medical board care were included except those specializing in sports, addiction, alcohol, and surgery
- For PAs practitioners were included that are considered primary care by the medical board
Who cannot join
- Another member of the same practice is already enrolled in the study (one provider per practice in Phase 2)
- Active participation in University of North Carolina at Chapel Hill (UNC) ECHO Collaborative at beginning of study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599-7411
About this study
This project seeks to examine a critical barrier to optimizing the health care workforce for the treatment of opioid use disorders. Without a dramatic increase in the number of primary care providers trained and comfortable with the many nuances of prescribing medication-assisted treatment (MAT), the staggering increases in opioid overdose deaths will continue to skyrocket. However, Drug Addiction Treatment Act (DATA) 2000 waiver training alone is not enough to facilitate prescribing for patients who desperately need services; an estimated 40% of physicians with waivers do not initiate MAT prescriptions. To address this problem, North Carolina developed a learning collaborative framework to promote MAT training. Learning collaboratives have been shown to be an efficacious approach to increase utilization of MAT, but engagement among providers in North Carolina has been low. To date, the need to encourage provider collaborative participation at scale has not been addressed. This is the critical problem focused on in this proposal.
The death rate from accidental opioid overdoses continues to climb at an alarming rate, with overdose deaths in 2016 almost five times the number from 1999. The daily death rate from opioid overdoses in the U.S. alone is now estimated at 115, so every day that evidence-based treatment is not available leads to more preventable deaths. North Carolina is one of the states with both an opioid overdose death rate greater than the national average (11.9 vs 10.4 deaths per 100,000, age-adjusted) and a rate of increase in opioid overdose deaths greater than the national average (19% vs. 16%). North Carolina is also one of four states with an Agency for Healthcare Research and Quality (AHRQ) funded Extension for Community Healthcare Outcomes (ECHO) MAT learning collaborative available to primary care practices, but engagement among providers is low. While the main barriers to engagement are incompletely understood, recent evidence from provider interviews conducted by the study team in December 2017 and January 2018 suggest that one substantial barrier is the time required for weekly ECHO clinics.
Read the detailed description
This study is designed to assess how to effectively recruit and enroll primary care providers into participation into an ECHO MAT learning collaborative. For study participants that enroll in the learning collaborative, the study team will track participation over 6 months.
The study is designed to be implemented in two phases. Phase 1 is the recruitment phase. Providers will be randomized to receive recruitment letters and emails from 1 of 4 conditions. Randomization for this phase will occur at the practice level, as determined by provider address.
Participants that contact the study team and enroll in the study will begin Phase 2 of the study. In Phase 2 of the study participants will be randomly assigned to rewards for participation in ECHO MAT learning collaborative. Their participation in the learning collaborative will be tracked. Phase 2 of the study is a pilot.
Recruitment:
Primary care providers will receive recruitment letters, and may receive emails and phone calls based on the recruitment condition they are assigned to.
Informed Consent:
Since it is not possible to consent before recruitment, participants will complete the informed consent process at the beginning of Phase 2 of the study. The consent form will be shared with eligible participants when they contact the study team to enroll. Before enrolling in the ECHO MAT learning collaborative, participants will be asked to provide consent in order to enroll in the study.
Randomization:
Phase 1: Primary care providers will be randomized by practice to 1 of 4 study arms. Computerized randomization will assign practices to study arms, practices and primary care providers will have an equal chance of being randomized to each study arm .
Phase 2: Eligible participants will be randomized to the Phase 2 study arm upon enrollment in the study. Randomization will be assigned using a predetermined randomly ordered list of study condition assignments. Upon enrolling in the study, the participants will be assigned to the condition that is next on the list. Participants will have an equal chance of being randomized to each study arm.
Assessment:
Assessment for Phase 1 will occur when participants contact study staff with interest in the study or to enroll. Any primary care providers that are sent letters but do not contact study staff will be included in study analyses as 'No' for outcomes for Phase 1.
Assessment for Phase 2 will occur throughout the 6 months after participants enroll in the study. Outcomes for this study phase are related to participation in ECHO MAT learning collaboratives, which is tracked for each training by study staff.
Detailed Description of the Intervention:
Phase 1 recruitment letters are designed in a 2 (prosocial mention of need for primary care providers trained in opioid use disorder treatment vs. none) x 2 (mention of additional practice supports available for participation in training vs. none). This yields 4 study conditions for recruitment letters: 1) Letter including prosocial messages and additional mention of practice supports available for participation, 2) Letter including prosocial messages but no additional mention of practice support available for participation, 3) Letter including an additional mention of practice support available for participation but no prosocial messages, and 4) Recruitment as usual letter that does not include prosocial messages or an additional mention of practice support available for participation.
Phase 2 examines participation in the learning community by group. Participants will be randomly assigned to 1 of 3 groups. At this time the investigators are not disclosing the Phase 2 conditions, and will disclose these at the end of the study, as approved by UNC's institutional review board (IRB).
- Conditions
- Opioid Abuse (Disorder)
- Being tested
- Phase 1 Condition 1, Phase 1 Condition 2, Phase 1 Condition 3, Phase 1 Condition 4, Phase 2 Condition 1
- Keywords
- Opioid Abuse Disorder
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1 Condition 1Behavioural
Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.
Phase 1 Condition 2Behavioural
Providers assigned to this condition will be sent recruitment materials that include an additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2).
Phase 1 Condition 3Behavioural
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3).
Phase 1 Condition 4Behavioural
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4).
Phase 2 Condition 1Behavioural
Providers who enroll in the study and are assigned to this condition will be in this group. Other than the opportunity to participate in a learning collaborative, participants receive no compensation.
Phase 2 Condition 2Behavioural
Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 30% of the NC Medicaid rate for a patient visit.
Phase 2 Condition 3Behavioural
Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 100 percent of the NC Medicaid rate for a patient visit for their time participating in the learning collaborative.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Condition 1, Phase 2 Condition 1 | Experimental | Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 1. Receives: Behavioral: Phase 1 Condition 1; Behavioral: Phase 2 Condition 1 |
| Phase 1 Condition 1, Phase 2 Condition 2 | Experimental | Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 2. Receives: Behavioral: Phase 1 Condition 1; Behavioral: Phase 2 Condition 2 |
| Phase 1 Condition 1, Phase 2 Condition 3 | Experimental | Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 3. Receives: Behavioral: Phase 1 Condition 1; Behavioral: Phase 2 Condition 3 |
| Phase 1 Condition 2, Phase 2 Condition 1 | Experimental | Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 1. Receives: Behavioral: Phase 1 Condition 2; Behavioral: Phase 2 Condition 1 |
| Phase 1 Condition 2, Phase 2 Condition 2 | Experimental | Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 2. Receives: Behavioral: Phase 1 Condition 2; Behavioral: Phase 2 Condition 2 |
| Phase 1 Condition 2, Phase 2 Condition 3 | Experimental | Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 3. Receives: Behavioral: Phase 1 Condition 2; Behavioral: Phase 2 Condition 3 |
| Phase 1 Condition 3, Phase 2 Condition 1 | Experimental | Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 1. Receives: Behavioral: Phase 1 Condition 3; Behavioral: Phase 2 Condition 1 |
| Phase 1 Condition 3, Phase 2 Condition 2 | Experimental | Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 2. Receives: Behavioral: Phase 1 Condition 3; Behavioral: Phase 2 Condition 2 |
| Phase 1 Condition 3, Phase 2 Condition 3 | Experimental | Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 3. Receives: Behavioral: Phase 1 Condition 3; Behavioral: Phase 2 Condition 3 |
| Phase 1 Condition 4, Phase 2 Condition 1 | Experimental | Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 1. Receives: Behavioral: Phase 1 Condition 4; Behavioral: Phase 2 Condition 1 |
| Phase 1 Condition 4, Phase 2 Condition 2 | Experimental | Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 2. Receives: Behavioral: Phase 1 Condition 4; Behavioral: Phase 2 Condition 2 |
| Phase 1 Condition 4, Phase 2 Condition 3 | Experimental | Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 3. Receives: Behavioral: Phase 1 Condition 4; Behavioral: Phase 2 Condition 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Recruited Providers That Contact Staff for Information About Enrolling in the Study
Phase 1 recruitment interventions will be compared based on the number of recruited providers that reach out to study staff via email, phone, or any other method.
Measured: From start of recruitment to end of data collection for last participant, up to 1.5 years
Mean Number of UNC ECHO Clinic Sessions a Participant Attends
Phase 2 study interventions will be compared based on the number of UNC ECHO clinic sessions that a participant attends.
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.
Measured: From enrollment to 6 months afterwards, enrollment to 9 months afterwards.
Secondary outcomes (4)
Number of Recruited Providers That Complete Enrollment in the Phase 2 Study
Phase 1 recruitment interventions will be compared based on the number of recruited providers that enroll in the Phase 2 study.
Measured: From start of recruitment to enrollment fulfillment, up to 1 year
Total Amount of Time a Participant Attends a UNC ECHO Clinic Session
Phase 2 study interventions will be compared based on the total amount of time that a participant attends a UNC ECHO clinic session (P2).
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.
Measured: From enrollment to 6 months afterwards, enrollment to 9 months afterwards.
Number of Participants That Receive a DATA 2000 Waiver
Phase 2 study interventions will be compared based on the number of participants that receive a DATA 2000 waiver. MAT waiver training is an 8 hour course for physicians and a 24 hour course for advanced practitioners that is required for providers to prescribe and dispense MAT.
Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.
Measured: From enrollment to 6 months afterwards, enrollment to 9 months afterwards.
Number of Participants That Begin Prescribing MAT Paid by Medicaid Within One Year of Phase 2 Start
Phase 2 study interventions will be compared based on the number of participants that begin prescribing MAT paid by Medicaid within one year of enrolling in Phase 2.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start12 Feb 2019
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Abuse (Disorder)Studies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Marisa Domino, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834025
- Sponsor's protocol ID
- 18-2236
- Other IDs
- R21DA047286
- Status last verified
- Jun 2021
- First submitted
- 29 Jan 2019
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication. Some of the outcomes proposed by the study are covered by data use agreements, we will not share measures restricted by data use agreements. We will share data, as allowed, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudges and Incentives to Enhance the Opioid Treatment Workforce
- ClinicalTrials.gov ID
- NCT03834025
- Acronym / sponsor ID
- 18-2236
- Conditions
- Opioid Abuse (Disorder)
- Keywords
- Opioid Abuse Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Posted 20 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project seeks to examine a critical barrier to optimizing the health care workforce for the treatment of opioid use disorders. Without a dramatic increase in the number of primary care providers trained and comfortable with the many nuances of prescribing medication-assisted treatment (MAT), the staggering increases in opioid overdose deaths will continue to skyrocket. However, Drug Addiction Treatment Act (DATA) 2000 waiver training alone is not enough to facilitate prescribing for patients who desperately need services; an estimated 40% of physicians with waivers do not initiate MAT prescriptions. To address this problem, North Carolina developed a learning collaborative framework to promote MAT training. Learning collaboratives have been shown to be an efficacious approach to increase utilization of MAT, but engagement among providers in North Carolina has been low. To date, the need to encourage provider collaborative participation at scale has not been addressed. This is the critical problem focused on in this proposal.
The death rate from accidental opioid overdoses continues to climb at an alarming rate, with overdose deaths in 2016 almost five times the number from 1999. The daily death rate from opioid overdoses in the U.S. alone is now estimated at 115, so every day that evidence-based treatment is not available leads to more preventable deaths. North Carolina is one of the states with both an opioid overdose death rate greater than the national average (11.9 vs 10.4 deaths per 100,000, age-adjusted) and a rate of increase in opioid overdose deaths greater than the national average (19% vs. 16%). North Carolina is also one of four states with an Agency for Healthcare Research and Quality (AHRQ) funded Extension for Community Healthcare Outcomes (ECHO) MAT learning collaborative available to primary care practices, but engagement among providers is low. While the main barriers to engagement are incompletely understood, recent evidence from provider interviews conducted by the study team in December 2017 and January 2018 suggest that one substantial barrier is the time required for weekly ECHO clinics.
Detailed description
This study is designed to assess how to effectively recruit and enroll primary care providers into participation into an ECHO MAT learning collaborative. For study participants that enroll in the learning collaborative, the study team will track participation over 6 months.
The study is designed to be implemented in two phases. Phase 1 is the recruitment phase. Providers will be randomized to receive recruitment letters and emails from 1 of 4 conditions. Randomization for this phase will occur at the practice level, as determined by provider address.
Participants that contact the study team and enroll in the study will begin Phase 2 of the study. In Phase 2 of the study participants will be randomly assigned to rewards for participation in ECHO MAT learning collaborative. Their participation in the learning collaborative will be tracked. Phase 2 of the study is a pilot.
Recruitment:
Primary care providers will receive recruitment letters, and may receive emails and phone calls based on the recruitment condition they are assigned to.
Informed Consent:
Since it is not possible to consent before recruitment, participants will complete the informed consent process at the beginning of Phase 2 of the study. The consent form will be shared with eligible participants when they contact the study team to enroll. Before enrolling in the ECHO MAT learning collaborative, participants will be asked to provide consent in order to enroll in the study.
Randomization:
Phase 1: Primary care providers will be randomized by practice to 1 of 4 study arms. Computerized randomization will assign practices to study arms, practices and primary care providers will have an equal chance of being randomized to each study arm .
Phase 2: Eligible participants will be randomized to the Phase 2 study arm upon enrollment in the study. Randomization will be assigned using a predetermined randomly ordered list of study condition assignments. Upon enrolling in the study, the participants will be assigned to the condition that is next on the list. Participants will have an equal chance of being randomized to each study arm.
Assessment:
Assessment for Phase 1 will occur when participants contact study staff with interest in the study or to enroll. Any primary care providers that are sent letters but do not contact study staff will be included in study analyses as 'No' for outcomes for Phase 1.
Assessment for Phase 2 will occur throughout the 6 months after participants enroll in the study. Outcomes for this study phase are related to participation in ECHO MAT learning collaboratives, which is tracked for each training by study staff.
Detailed Description of the Intervention:
Phase 1 recruitment letters are designed in a 2 (prosocial mention of need for primary care providers trained in opioid use disorder treatment vs. none) x 2 (mention of additional practice supports available for participation in training vs. none). This yields 4 study conditions for recruitment letters: 1) Letter including prosocial messages and additional mention of practice supports available for participation, 2) Letter including prosocial messages but no additional mention of practice support available for participation, 3) Letter including an additional mention of practice support available for participation but no prosocial messages, and 4) Recruitment as usual letter that does not include prosocial messages or an additional mention of practice support available for participation.
Phase 2 examines participation in the learning community by group. Participants will be randomly assigned to 1 of 3 groups. At this time the investigators are not disclosing the Phase 2 conditions, and will disclose these at the end of the study, as approved by UNC's institutional review board (IRB).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Condition 1, Phase 2 Condition 1 | Experimental | Behavioral: Phase 1 Condition 1, Behavioral: Phase 2 Condition 1Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 1. |
| Phase 1 Condition 1, Phase 2 Condition 2 | Experimental | Behavioral: Phase 1 Condition 1, Behavioral: Phase 2 Condition 2Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 2. |
| Phase 1 Condition 1, Phase 2 Condition 3 | Experimental | Behavioral: Phase 1 Condition 1, Behavioral: Phase 2 Condition 3Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 3. |
| Phase 1 Condition 2, Phase 2 Condition 1 | Experimental | Behavioral: Phase 1 Condition 2, Behavioral: Phase 2 Condition 1Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 1. |
| Phase 1 Condition 2, Phase 2 Condition 2 | Experimental | Behavioral: Phase 1 Condition 2, Behavioral: Phase 2 Condition 2Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 2. |
| Phase 1 Condition 2, Phase 2 Condition 3 | Experimental | Behavioral: Phase 1 Condition 2, Behavioral: Phase 2 Condition 3Providers assigned to this condition will be sent recruitment materials that include additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). If they enroll, in Phase 2 of the study these participants will be in condition 3. |
| Phase 1 Condition 3, Phase 2 Condition 1 | Experimental | Behavioral: Phase 1 Condition 3, Behavioral: Phase 2 Condition 1Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 1. |
| Phase 1 Condition 3, Phase 2 Condition 2 | Experimental | Behavioral: Phase 1 Condition 3, Behavioral: Phase 2 Condition 2Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 2. |
| Phase 1 Condition 3, Phase 2 Condition 3 | Experimental | Behavioral: Phase 1 Condition 3, Behavioral: Phase 2 Condition 3Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 3. |
| Phase 1 Condition 4, Phase 2 Condition 1 | Experimental | Behavioral: Phase 1 Condition 4, Behavioral: Phase 2 Condition 1Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 1. |
| Phase 1 Condition 4, Phase 2 Condition 2 | Experimental | Behavioral: Phase 1 Condition 4, Behavioral: Phase 2 Condition 2Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 2. |
| Phase 1 Condition 4, Phase 2 Condition 3 | Experimental | Behavioral: Phase 1 Condition 4, Behavioral: Phase 2 Condition 3Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 3. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Licensed Primary Care Provider (Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Physician Assistant (PA), Nurse Practitioner (NP))
- Currently practice in North Carolina
- For Nurse practitioners, the following specialties were included:
- For MD/DOs practitioners that were considered primary by the medical board care were included except those specializing in sports, addiction, alcohol, and surgery
- For PAs practitioners were included that are considered primary care by the medical board
Key exclusion criteria (2 listed)
- Another member of the same practice is already enrolled in the study (one provider per practice in Phase 2)
- Active participation in University of North Carolina at Chapel Hill (UNC) ECHO Collaborative at beginning of study
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 |
|---|---|---|
| Phase 1 Condition 1Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation. | Behavioural | Phase 1 Condition 1, Phase 2 Condition 1, Phase 1 Condition 1, Phase 2 Condition 2, Phase 1 Condition 1, Phase 2 Condition 3 |
| Phase 1 Condition 2Providers assigned to this condition will be sent recruitment materials that include an additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2). | Behavioural | Phase 1 Condition 2, Phase 2 Condition 1, Phase 1 Condition 2, Phase 2 Condition 2, Phase 1 Condition 2, Phase 2 Condition 3 |
| Phase 1 Condition 3Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3). | Behavioural | Phase 1 Condition 3, Phase 2 Condition 1, Phase 1 Condition 3, Phase 2 Condition 2, Phase 1 Condition 3, Phase 2 Condition 3 |
| Phase 1 Condition 4Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4). | Behavioural | Phase 1 Condition 4, Phase 2 Condition 1, Phase 1 Condition 4, Phase 2 Condition 2, Phase 1 Condition 4, Phase 2 Condition 3 |
| Phase 2 Condition 1Providers who enroll in the study and are assigned to this condition will be in this group. Other than the opportunity to participate in a learning collaborative, participants receive no compensation. | Behavioural | Phase 1 Condition 1, Phase 2 Condition 1, Phase 1 Condition 2, Phase 2 Condition 1, Phase 1 Condition 3, Phase 2 Condition 1, Phase 1 Condition 4, Phase 2 Condition 1 |
| Phase 2 Condition 2Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 30% of the NC Medicaid rate for a patient visit. | Behavioural | Phase 1 Condition 1, Phase 2 Condition 2, Phase 1 Condition 2, Phase 2 Condition 2, Phase 1 Condition 3, Phase 2 Condition 2, Phase 1 Condition 4, Phase 2 Condition 2 |
| Phase 2 Condition 3Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 100 percent of the NC Medicaid rate for a patient visit for their time participating in the learning collaborative. | Behavioural | Phase 1 Condition 1, Phase 2 Condition 3, Phase 1 Condition 2, Phase 2 Condition 3, Phase 1 Condition 3, Phase 2 Condition 3, Phase 1 Condition 4, Phase 2 Condition 3 |
Primary outcome
Number of Recruited Providers That Contact Staff for Information About Enrolling in the Study
Time frame: From start of recruitment to end of data collection for last participant, up to 1.5 years
Phase 1 recruitment interventions will be compared based on the number of recruited providers that reach out to study staff via email, phone, or any other method.
Mean Number of UNC ECHO Clinic Sessions a Participant Attends
Time frame: From enrollment to 6 months afterwards, enrollment to 9 months afterwards.
Phase 2 study interventions will be compared based on the number of UNC ECHO clinic sessions that a participant attends. Subsequent to COVID-19, the number of ECHO clinic sessions was decreased and the assessment period was extended by 3 additional months for those who had not completed the Follow up period as of 3/9/2020.
4 secondary outcomes
Number of Recruited Providers That Complete Enrollment in the Phase 2 Study
Time frame: From start of recruitment to enrollment fulfillment, up to 1 year
Total Amount of Time a Participant Attends a UNC ECHO Clinic Session
Time frame: From enrollment to 6 months afterwards, enrollment to 9 months afterwards.
Number of Participants That Receive a DATA 2000 Waiver
Time frame: From enrollment to 6 months afterwards, enrollment to 9 months afterwards.
Number of Participants That Begin Prescribing MAT Paid by Medicaid Within One Year of Phase 2 Start
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication. Some of the outcomes proposed by the study are covered by data use agreements, we will not share measures restricted by data use agreements. We will share data, as allowed, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Related trials for Opioid Abuse (Disorder)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Recruiting
Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes
Opioid Abuse (Disorder)
Not yet recruitingPhase 1
Cannabis Effects on Opioid Self-Administration
Opioid Use Disorder, Cannabis Use
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.
Marisa Domino, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 1 Condition 1, Phase 1 Condition 2 and Phase 1 Condition 3 in people with Opioid Abuse (Disorder), run by University of North Carolina, Chapel Hill 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 35 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: finished, as of the sponsor's last update on 20 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Recruited Providers That Contact Staff for Information About Enrolling in the Study (time frame: From start of recruitment to end of data collection for last participant, up to 1.5 years). The study lists 2 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 20 Aug 2021.