Trial Outcomes & Findings for Nudges and Incentives to Enhance the Opioid Treatment Workforce (NCT NCT03834025)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

From start of recruitment to end of data collection for last participant, up to 1.5 years

Results posted on

2021-08-20

Participant Flow

Recruitment materials were determined by the randomization of Phase 1. There were four types of recruitment materials: (1) recruitment as usual (no prosocial messaging, no reference to compensation); (2) no prosocial messaging, no reference to compensation; (3) prosocial messaging, reference to compensation; (4) prosocial messaging, reference to compensation.

Once a participant was enrolled, then they were randomized for Phase 2. Phase 2 involved three levels of compensation: no compensation, 30% compensation, 100% compensation. Participants were compensated for each learning collaborative attended based on the Phase 2 randomization.

Participant milestones

Participant milestones
Measure	Phase 1 Condition 1 (Recruitment as Usual) Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.	Phase 1 Condition 2 (no Prosocial Messaging, Compensation) 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 3 (Prosocial Messaging, no Compensation) 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 4 (Prosocial Messaging, Compensation) 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 2 Condition 1 (no Compensation) Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.	Phase 2 Condition 2 (30% Compensation) Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.	Phase 2 Condition 3 (100% Compensation) Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.
Sent Recruitment Letter (Phase 1) STARTED	4150	3871	4121	3693	0	0	0
Sent Recruitment Letter (Phase 1) Sent Letter	4150	3871	4121	3693	0	0	0
Sent Recruitment Letter (Phase 1) Responded to Letter	36	36	44	44	0	0	0
Sent Recruitment Letter (Phase 1) COMPLETED	36	36	44	44	0	0	0
Sent Recruitment Letter (Phase 1) NOT COMPLETED	4114	3835	4077	3649	0	0	0
Randomized to Payment Condition(Phase 2) STARTED	0	0	0	0	24	21	28
Randomized to Payment Condition(Phase 2) COMPLETED	0	0	0	0	24	21	27
Randomized to Payment Condition(Phase 2) NOT COMPLETED	0	0	0	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nudges and Incentives to Enhance the Opioid Treatment Workforce

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: From start of recruitment to end of data collection for last participant, up to 1.5 years

Population: This outcome is not relevant for Phase 2

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.

Outcome measures

Outcome measures
Measure	Phase 2 Condition 1 (no Compensation) Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.	Phase 2 Condition 2 (30% Compensation) Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.	Phase 2 Condition 3 (100% Compensation) Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.	Phase 1 Condition 1 (Recruitment as Usual) n=4150 Participants Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.	Phase 1 Condition 2 (no Prosocial Messaging, Compensation) n=3871 Participants 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 3 (Prosocial Messaging, no Compensation) n=4121 Participants 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 4 (Prosocial Messaging, Compensation) n=3693 Participants 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.
Number of Recruited Providers That Contact Staff for Information About Enrolling in the Study	—	—	—	36 Participants	36 Participants	44 Participants	44 Participants

PRIMARY outcome

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

Population: This outcome is only relevant to Phase 2 completers.

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.

Outcome measures

Outcome measures
Measure	Phase 2 Condition 1 (no Compensation) n=24 Participants Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.	Phase 2 Condition 2 (30% Compensation) n=21 Participants Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.	Phase 2 Condition 3 (100% Compensation) n=27 Participants Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.	Phase 1 Condition 1 (Recruitment as Usual) Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.	Phase 1 Condition 2 (no Prosocial Messaging, Compensation) 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 3 (Prosocial Messaging, no Compensation) 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 4 (Prosocial Messaging, Compensation) 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.
Mean Number of UNC ECHO Clinic Sessions a Participant Attends	1.00 Number of clinic sessions Standard Deviation 2.23	6.95 Number of clinic sessions Standard Deviation 8.60	12.04 Number of clinic sessions Standard Deviation 13.84	—	—	—	—

SECONDARY outcome

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

Population: This outcome is only relevant for Phase I participants

Phase 1 recruitment interventions will be compared based on the number of recruited providers that enroll in the Phase 2 study.

Outcome measures

Outcome measures
Measure	Phase 2 Condition 1 (no Compensation) Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.	Phase 2 Condition 2 (30% Compensation) Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.	Phase 2 Condition 3 (100% Compensation) Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.	Phase 1 Condition 1 (Recruitment as Usual) n=4150 Participants Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.	Phase 1 Condition 2 (no Prosocial Messaging, Compensation) n=3871 Participants 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 3 (Prosocial Messaging, no Compensation) n=4121 Participants 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 4 (Prosocial Messaging, Compensation) n=3693 Participants 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.
Number of Recruited Providers That Complete Enrollment in the Phase 2 Study	—	—	—	18 Participants	17 Participants	22 Participants	16 Participants

SECONDARY outcome

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

Population: This outcome is only relevant to those who completed the Phase 2 study

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.

Outcome measures

Outcome measures
Measure	Phase 2 Condition 1 (no Compensation) n=24 Participants Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.	Phase 2 Condition 2 (30% Compensation) n=21 Participants Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.	Phase 2 Condition 3 (100% Compensation) n=27 Participants Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.	Phase 1 Condition 1 (Recruitment as Usual) Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.	Phase 1 Condition 2 (no Prosocial Messaging, Compensation) 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 3 (Prosocial Messaging, no Compensation) 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 4 (Prosocial Messaging, Compensation) 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.
Total Amount of Time a Participant Attends a UNC ECHO Clinic Session	0.94 Hours Standard Deviation 2.03	6.61 Hours Standard Deviation 8.30	11.89 Hours Standard Deviation 13.80	—	—	—	—

SECONDARY outcome

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

Population: This outcome is only relevant for Phase 2 completers.

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.

Outcome measures

Outcome measures
Measure	Phase 2 Condition 1 (no Compensation) n=24 Participants Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.	Phase 2 Condition 2 (30% Compensation) n=21 Participants Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.	Phase 2 Condition 3 (100% Compensation) n=27 Participants Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.	Phase 1 Condition 1 (Recruitment as Usual) Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.	Phase 1 Condition 2 (no Prosocial Messaging, Compensation) 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 3 (Prosocial Messaging, no Compensation) 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 4 (Prosocial Messaging, Compensation) 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.
Number of Participants That Receive a DATA 2000 Waiver	16 Participants	11 Participants	11 Participants	—	—	—	—

SECONDARY outcome

Timeframe: One year

Population: This outcome is only relevant for Phase 2 completers.

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.

Outcome measures

Outcome measures
Measure	Phase 2 Condition 1 (no Compensation) n=24 Participants Providers enrolled in Phase 2 of the study randomized to Condition 1 will receive the opportunity to participate in a learning collaborative with no compensation.	Phase 2 Condition 2 (30% Compensation) n=21 Participants Providers enrolled in Phase 2 randomized to Condition 2 will receive the opportunity to participate in the learning collaborative at a reimbursement of 30% of the NC Medicaid rate for a patient visit up to a max of 24 sessions.	Phase 2 Condition 3 (100% Compensation) n=27 Participants Providers enrolled in Phase 2 randomized to Condition 3 will receive the opportunity to participate in the learning collaborative, participants receive a reimbursement at the NC Medicaid rate for a patient visit for their time participating in the learning collaborative, up to a max of 24 sessions.	Phase 1 Condition 1 (Recruitment as Usual) Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual'. These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.	Phase 1 Condition 2 (no Prosocial Messaging, Compensation) 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 3 (Prosocial Messaging, no Compensation) 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 4 (Prosocial Messaging, Compensation) 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.
Number of Participants That Begin Prescribing MAT Paid by Medicaid Within One Year of Phase 2 Start	8 Participants	7 Participants	5 Participants	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marisa Domino, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-3891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place