|
Field
Trial Status
|
Before
in_development
|
After
on_going
|
|
Field
Trial Start Date
|
Before
December 01, 2019
|
After
August 15, 2020
|
|
Field
Last Published
|
Before
November 22, 2019 10:05 PM
|
After
September 09, 2020 03:30 PM
|
|
Field
Intervention Start Date
|
Before
December 01, 2019
|
After
August 15, 2020
|
|
Field
Primary Outcomes (End Points)
|
Before
Duration of abstinence as measured by in-clinic urinalysis
|
After
Duration of abstinence as measured by in-clinic urinalysis, percentage of urine drug tests negative, enrollment rates
|
|
Field
Experimental Design (Public)
|
Before
To answer our research questions, we will conduct a randomized controlled trial of temporary incentives to encourage either abstinence, or inputs to abstinence, among 600 adults with opioid use disorders in Milwaukee, Wisconsin. Participants will be recruited from outpatients with substance use disorders in treatment at the Adult Behavioral Health Program within the Aurora Health Care System. Incentivized behaviors will be monitored and rewarded through a mobile application developed by our implementing technology partner, Dynamicare Management. We will evaluate the incentives using a combination of administrative data and surveys. In preparation for this experiment, we will conduct a Phase 1 pilot of 36-50 individuals to test and fine-tune our study protocols. In our pilot study, we will randomly assign individuals to either receive the mobile application to incentivize abstinence, a version of the application that has behavior monitoring but no incentives, or control. The full experimental design will be developed following this pilot.
|
After
To answer our research questions, we will conduct a randomized controlled trial of temporary incentives to encourage either abstinence, or inputs to abstinence, among 600 adults with opioid use disorders in Milwaukee, Wisconsin. Participants will be recruited from outpatients with substance use disorders in treatment at the Adult Behavioral Health Program within the Aurora Health Care System. Incentivized behaviors will be monitored and rewarded through a mobile application developed by our implementing technology partner, Dynamicare Management. We will evaluate the incentives using a combination of administrative data and surveys. In preparation for this experiment, we will conduct a Phase 1 pilot of 30 individuals to test and fine-tune our study protocols. The full experimental design will be developed following this pilot.
|
|
Field
Planned Number of Observations
|
Before
We aim to enroll approximately 36-50 individuals in the pilot.
|
After
We aim to enroll approximately 30 individuals in the pilot.
|
|
Field
Sample size (or number of clusters) by treatment arms
|
Before
The following treatment group distribution in the pilot is approximate, since enrollees will be assigned to treatments in a pre-determined order but may withdraw.
Treatment Groups:
T1 – Incentives: 1/3
T2 – Monitoring Only: 1/3
T3 – Control: 1/3
|
After
The following treatment group distribution in the pilot is approximate, since enrollees will be assigned to treatments in a pre-determined order but may withdraw.
Treatment Groups:
T1 – Inputs: 1/3
T2 – Outcomes: 1/3
T3 – Combined: 1/3
|
|
Field
Did you obtain IRB approval for this study?
|
Before
No
|
After
Yes
|