Trial Outcomes & Findings for Clinical Decision Support for Opioid Use Disorders in Medical Settings: Usability Testing in an EMR (NCT NCT03559179)
NCT ID: NCT03559179
Last Updated: 2020-03-17
Results Overview
\# of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
This outcome measure was calculated at approximately month 10 of the pilot study
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
Waivered Providers Received the Opioid Wizard
All Buprenorphine-Waivered providers received the OUD clinical decision support tool (Opioid Wizard).
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
|
Non-Waivered Providers Received The Opioid Wizard
Non-buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents providers who received the Opioid Wizard.
|
Non-Waivered Providers Who Did Not Receive the Opioid Wizard
Non-Buprenorphine waivered providers are randomized to receive/not receive the Opioid Wizard. This arm represents providers who did not receive the Opioid Wizard. These providers continued to treat their patients as usual.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
24
|
23
|
|
Overall Study
COMPLETED
|
8
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Decision Support for Opioid Use Disorders in Medical Settings: Usability Testing in an EMR
Baseline characteristics by cohort
| Measure |
Waivered Providers Received the Opioid Wizard
n=8 Participants
These providers received the OUD clinical decision support tool (Opioid Wizard).
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
|
Non-Waivered Providers Who Received the Opioid Wizard
n=24 Participants
Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents non-waivered providers who received the OUD clinical decision support tool (Opioid Wizard).
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
|
Non-Waivered Providers Who do Not Receive the Opioid Wizard
n=23 Participants
These are non-buprenorphine waivered providers continued to treat their patients as usual.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: This outcome measure was calculated at approximately month 10 of the pilot studyPopulation: This outcome was to help show proof of the OUD-CDS concept using responses from intervention PCPs. One intervention provider stopped working for the organization during the intervention. Two additional intervention providers in the "Non-Waivered providers who received the Opioid Wizard" arm did not complete follow-up surveys.
\# of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD.
Outcome measures
| Measure |
Waivered Providers Received the Opioid Wizard
n=8 Participants
All Buprenorphine-Waivered providers received the OUD clinical decision support tool (Opioid Wizard).
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
|
Non-Waivered Providers Who Received the Opioid Wizard
n=21 Participants
Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents providers who received the Opioid Wizard.
|
Did Not Receive the Opioid Wizard
All non-buprenorphine waivered providers were randomized to receive or not receive the Opioid Wizard. This arm of providers continued to treat their patients as usual.
|
|---|---|---|---|
|
Intervention PCP Confidence in Assessing and Treating OUD
# of INT PCPs reporting confidence assessing OUD
|
6 Participants
|
11 Participants
|
—
|
|
Intervention PCP Confidence in Assessing and Treating OUD
# of INT PCPs reporting confidence treating OUD
|
8 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: This was calculated after PCP surveys were completed, approximately month 10Population: One non-waivered intervention provider stopped working for the organization and two additional non-waivered intervention providers did not complete the follow-up survey.
\# of PCPs with CDS access who rate the OUD-CDS \>4 on a 5-point Likert scale of likeliness to recommend use of the tool to their colleagues. The scale ranges from 1-"not at all likely" to 5-"very likely," with higher values representing a higher likelihood of recommending the OUD-CDS to other colleagues.
Outcome measures
| Measure |
Waivered Providers Received the Opioid Wizard
n=8 Participants
All Buprenorphine-Waivered providers received the OUD clinical decision support tool (Opioid Wizard).
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
|
Non-Waivered Providers Who Received the Opioid Wizard
n=21 Participants
Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents providers who received the Opioid Wizard.
|
Did Not Receive the Opioid Wizard
All non-buprenorphine waivered providers were randomized to receive or not receive the Opioid Wizard. This arm of providers continued to treat their patients as usual.
|
|---|---|---|---|
|
Intervention PCP Likeliness to Recommend Use of the OUD-CDS
|
6 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: This was calculated at the end of the pilot study (month 8).Calculate and compare the number of patients diagnosed with OUD pre- and post-intervention. This will be presented as rate of OUD diagnoses per patient year.
Outcome measures
| Measure |
Waivered Providers Received the Opioid Wizard
n=8 Participants
All Buprenorphine-Waivered providers received the OUD clinical decision support tool (Opioid Wizard).
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
|
Non-Waivered Providers Who Received the Opioid Wizard
n=24 Participants
Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents providers who received the Opioid Wizard.
|
Did Not Receive the Opioid Wizard
n=23 Participants
All non-buprenorphine waivered providers were randomized to receive or not receive the Opioid Wizard. This arm of providers continued to treat their patients as usual.
|
|---|---|---|---|
|
Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients.
|
11.3 OUD diagnosis per patient year
|
28.54 OUD diagnosis per patient year
|
7.87 OUD diagnosis per patient year
|
SECONDARY outcome
Timeframe: This was calculated at the end of the pilot study (month 8).Calculate and compare the rate of MAT use among patients with OUD pre- and post-intervention. This is presented as a pre/post ratio of MAT rx per patient year.
Outcome measures
| Measure |
Waivered Providers Received the Opioid Wizard
n=8 Participants
All Buprenorphine-Waivered providers received the OUD clinical decision support tool (Opioid Wizard).
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
|
Non-Waivered Providers Who Received the Opioid Wizard
n=24 Participants
Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents providers who received the Opioid Wizard.
|
Did Not Receive the Opioid Wizard
n=23 Participants
All non-buprenorphine waivered providers were randomized to receive or not receive the Opioid Wizard. This arm of providers continued to treat their patients as usual.
|
|---|---|---|---|
|
Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use.
|
1.4 pre/post ratio MAT Rx per patient year
|
1.1 pre/post ratio MAT Rx per patient year
|
1.03 pre/post ratio MAT Rx per patient year
|
SECONDARY outcome
Timeframe: This was calculated at the end of the pilot study (month 8).Calculate and compare how often patients diagnosed with OUD are referred to specialty care or inpatient treatment post-intervention. Compare these rates between intervention and control groups.
Outcome measures
| Measure |
Waivered Providers Received the Opioid Wizard
n=8 Participants
All Buprenorphine-Waivered providers received the OUD clinical decision support tool (Opioid Wizard).
Opioid Wizard: The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
|
Non-Waivered Providers Who Received the Opioid Wizard
n=24 Participants
Non-Buprenorphine waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents providers who received the Opioid Wizard.
|
Did Not Receive the Opioid Wizard
n=23 Participants
All non-buprenorphine waivered providers were randomized to receive or not receive the Opioid Wizard. This arm of providers continued to treat their patients as usual.
|
|---|---|---|---|
|
Compare Post-intervention Referral Patterns Between Intervention and Control Groups
|
0.99 post/pre ratio of referral per pt. year
|
1.21 post/pre ratio of referral per pt. year
|
1.04 post/pre ratio of referral per pt. year
|
Adverse Events
Waivered Providers Who Received the Opioid Wizard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Waivered Providers Who Received the Opioid Wizard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Waivered Providers Who Did Not Receive the Opioid Wizard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place