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Nudges and Incentives to Enhance the Opioid Treatment Workforce

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ClinicalTrials.gov Identifier: NCT03834025
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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 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.


Condition or disease Intervention/treatment Phase
Opioid Abuse (Disorder) Behavioral: Phase 1 Condition 1 Behavioral: Phase 1 Condition 2 Behavioral: Phase 1 Condition 3 Behavioral: Phase 1 Condition 4 Behavioral: Phase 2 Condition 1 Behavioral: Phase 2 Condition 2 Behavioral: Phase 2 Condition 3 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Masking Description: Participants are unaware of other study arms.
Primary Purpose: Health Services Research
Official Title: Nudges and Incentives to Enhance the Opioid Treatment Workforce
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Phase 1 Condition 1, Phase 2 Condition 1
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 practice supports available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 1.
Behavioral: Phase 1 Condition 1
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 practice support available for participation.

Behavioral: Phase 2 Condition 1
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 1, Phase 2 Condition 2
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 practice supports available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 2.
Behavioral: Phase 1 Condition 1
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 practice support available for participation.

Behavioral: Phase 2 Condition 2
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 1, Phase 2 Condition 3
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 practice supports available for participation. If they enroll, in Phase 2 of the study these participants will be in condition 3.
Behavioral: Phase 1 Condition 1
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 practice support available for participation.

Behavioral: Phase 2 Condition 3
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 2, Phase 2 Condition 1
Providers assigned to this condition will be sent recruitment materials that include additional mention of practice 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.
Behavioral: Phase 1 Condition 2
Providers assigned to this condition will be sent recruitment materials that include an additional mention of practice support available for participation, but will not include prosocial messaging (Phase 1 Condition 2).

Behavioral: Phase 2 Condition 1
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 2, Phase 2 Condition 2
Providers assigned to this condition will be sent recruitment materials that include additional mention of practice 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.
Behavioral: Phase 1 Condition 2
Providers assigned to this condition will be sent recruitment materials that include an additional mention of practice support available for participation, but will not include prosocial messaging (Phase 1 Condition 2).

Behavioral: Phase 2 Condition 2
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 2, Phase 2 Condition 3
Providers assigned to this condition will be sent recruitment materials that include additional mention of practice 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.
Behavioral: Phase 1 Condition 2
Providers assigned to this condition will be sent recruitment materials that include an additional mention of practice support available for participation, but will not include prosocial messaging (Phase 1 Condition 2).

Behavioral: Phase 2 Condition 3
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 3, Phase 2 Condition 1
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of practice support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 1.
Behavioral: Phase 1 Condition 3
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of practice support available for participation (Phase 1 Condition 3).

Behavioral: Phase 2 Condition 1
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 3, Phase 2 Condition 2
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of practice support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 2.
Behavioral: Phase 1 Condition 3
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of practice support available for participation (Phase 1 Condition 3).

Behavioral: Phase 2 Condition 2
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 3, Phase 2 Condition 3
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of practice support available for participation (Phase 1 Condition 3). If they enroll, in Phase 2 of the study these participants will be in condition 3.
Behavioral: Phase 1 Condition 3
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of practice support available for participation (Phase 1 Condition 3).

Behavioral: Phase 2 Condition 3
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 4, Phase 2 Condition 1
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of practice support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 1.
Behavioral: Phase 1 Condition 4
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of practice support available for participation (Phase 1 Condition 4).

Behavioral: Phase 2 Condition 1
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 4, Phase 2 Condition 2
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of practice support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 2.
Behavioral: Phase 1 Condition 4
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of practice support available for participation (Phase 1 Condition 4).

Behavioral: Phase 2 Condition 2
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.

Experimental: Phase 1 Condition 4, Phase 2 Condition 3
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of practice support available for participation (Phase 1 Condition 4). If they enroll, in Phase 2 of the study these participants will be in condition 3.
Behavioral: Phase 1 Condition 4
Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of practice support available for participation (Phase 1 Condition 4).

Behavioral: Phase 2 Condition 3
Providers who enroll in the study and are assigned to this condition will be in this group. At this time the investigators are not disclosing the phase 2 conditions, and will disclose these at the end of the study.




Primary Outcome Measures :
  1. Number of recruited providers that enroll in the study [ Time Frame: From start of recruitment to enrollment fulfillment, up to 1 year ]
    Phase 1 recruitment interventions will be compared based on the number of recruited providers that enroll in the study.


Secondary Outcome Measures :
  1. Number of recruited providers that contact staff for information about 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.

  2. Number of recruited providers that complete MAT waiver training [ 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 subsequently complete MAT Waiver Training. MAT waiver training is an 8 hour course that is required for providers to prescribe and dispense MAT.

  3. Number of recruited providers that begin prescribing MAT [ 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 begin prescribing MAT.

  4. Number of UNC ECHO clinic sessions a participant attends [ Time Frame: Study follow up period (from enrollment to 6 months after enrollment) ]
    Phase 2 study interventions will be compared based on the number of UNC ECHO clinic sessions that a participant attends.

  5. Total amount of time a participant attends a UNC ECHO clinic session [ Time Frame: Study follow up period (from enrollment to 6 months after enrollment) ]
    Phase 2 study interventions will be compared based on the total amount of time that a participant attends a UNC ECHO clinic session (P2)

  6. Number of participants that complete MAT waiver training [ Time Frame: Study follow up period (from enrollment to 6 months after enrollment) ]
    Phase 2 study interventions will be compared based on the number of participants that complete MAT waiver training. MAT waiver training is an 8 hour course that is required for providers to prescribe and dispense MAT.

  7. Number of participants that begin prescribing MAT [ Time Frame: Study follow up period (from enrollment to 6 months after enrollment) ]
    Phase 2 study interventions will be compared based on the number of participants that begin prescribing MAT.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
    • 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
    • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834025


Contacts
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Contact: Marisa Domino, PhD (919)966-3891 domino@unc.edu

Locations
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United States, North Carolina
University of North Carolina At Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7411
Contact: Marisa Domino, PhD    919-966-3891    domino@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Marisa Domino, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03834025     History of Changes
Other Study ID Numbers: 18-2236
R21DA047286 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: 9 to 36 months following publication
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
Opioid Abuse Disorder

Additional relevant MeSH terms:
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Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents