NCT03834025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 20, 2021

Completed
Last Updated

August 20, 2021

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

January 29, 2019

Results QC Date

June 23, 2021

Last Update Submit

July 27, 2021

Conditions

Keywords

Opioid Abuse Disorder

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    From start of recruitment to enrollment fulfillment, up to 1 year

  • Total Amount of Time a Participant Attends a UNC ECHO Clinic Session

    From enrollment to 6 months afterwards, enrollment to 9 months afterwards.

  • Number of Participants That Receive a DATA 2000 Waiver

    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

    One year

Study Arms (12)

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.

Behavioral: Phase 1 Condition 1Behavioral: 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.

Behavioral: Phase 1 Condition 1Behavioral: 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.

Behavioral: Phase 1 Condition 1Behavioral: 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.

Behavioral: Phase 1 Condition 2Behavioral: 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.

Behavioral: Phase 1 Condition 2Behavioral: 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.

Behavioral: Phase 1 Condition 2Behavioral: 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.

Behavioral: Phase 1 Condition 3Behavioral: 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.

Behavioral: Phase 1 Condition 3Behavioral: 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.

Behavioral: Phase 1 Condition 3Behavioral: 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.

Behavioral: Phase 1 Condition 4Behavioral: 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.

Behavioral: Phase 1 Condition 4Behavioral: 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.

Behavioral: Phase 1 Condition 4Behavioral: Phase 2 Condition 3

Interventions

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 1, Phase 2 Condition 1Phase 1 Condition 1, Phase 2 Condition 2Phase 1 Condition 1, Phase 2 Condition 3

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 2, Phase 2 Condition 1Phase 1 Condition 2, Phase 2 Condition 2Phase 1 Condition 2, 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 financial support available for participation (Phase 1 Condition 3).

Phase 1 Condition 3, Phase 2 Condition 1Phase 1 Condition 3, Phase 2 Condition 2Phase 1 Condition 3, Phase 2 Condition 3

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 1 Condition 4, Phase 2 Condition 1Phase 1 Condition 4, Phase 2 Condition 2Phase 1 Condition 4, Phase 2 Condition 3

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 1 Condition 1, Phase 2 Condition 1Phase 1 Condition 2, Phase 2 Condition 1Phase 1 Condition 3, Phase 2 Condition 1Phase 1 Condition 4, Phase 2 Condition 1

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 1 Condition 1, Phase 2 Condition 2Phase 1 Condition 2, Phase 2 Condition 2Phase 1 Condition 3, Phase 2 Condition 2Phase 1 Condition 4, Phase 2 Condition 2

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.

Phase 1 Condition 1, Phase 2 Condition 3Phase 1 Condition 2, Phase 2 Condition 3Phase 1 Condition 3, Phase 2 Condition 3Phase 1 Condition 4, Phase 2 Condition 3

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +20 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27599-7411, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Marisa Domino, PhD
Organization
University of North Carolina at Chapel Hill

Study Officials

  • Marisa Domino, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants are unaware of other study arms.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

February 7, 2019

Study Start

February 12, 2019

Primary Completion

August 28, 2020

Study Completion

August 28, 2020

Last Updated

August 20, 2021

Results First Posted

August 20, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

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.

Locations