An interventional study of Opioid Wizard in Opioid-use Disorder, sponsored by HealthPartners Institute. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-03-17.
Sponsored by HealthPartners Institute · Not applicable, Interventional, and Other
The primary objective of this pilot study is to program an opioid use disorder (OUD) clinical decision support (CDS) tool for use in an electronic medical record (EMR) and obtain high primary care physician (PCP) usability and acceptability. The OUD-CDS is based on the NIDA-Blending Initiative white paper, "Clinical Decision Support for Opioid Use Disorders: Working Group Report," which itself is based on national evidence-based guidelines (American Society of Addiction Medicine (ASAM 2015), VA (VA 2015). As such, this pilot study aims to help PCPs achieve accepted standards of care in OUD treatment. The secondary objectives of this pilot study are to evaluate the usefulness of the tool by comparing OUD case-finding, medication-assisted therapy (MAT) and referral patterns pre- and post-CDS deployment for PCPs with and without CDS access.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 55 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All providers who have a buprenorphine waiver will receive the OUD clinical decision support tool (Opioid Wizard).
Other: Opioid Wizard
All non-buprenorphine waivered providers will be randomized to receive or not receive the Opioid Wizard. This arm of providers will continue to treat their patients as usual.
All non-buprenorphine waivered providers will be randomized to receive or not receive the Opioid. This arm of providers will receive the OUD clinical decision support tool (Opioid Wizard).
Other: Opioid Wizard
The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
Intervention PCP Confidence in Assessing and Treating OUD
# of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD.
Time frame: This outcome measure was calculated at approximately month 10 of the pilot study
Intervention PCP Likeliness to Recommend Use of the OUD-CDS
# 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.
Time frame: This was calculated after PCP surveys were completed, approximately month 10
Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients.
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.
Time frame: This was calculated at the end of the pilot study (month 8).
Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use.
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.
Time frame: This was calculated at the end of the pilot study (month 8).
Compare Post-intervention Referral Patterns Between Intervention and Control Groups
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.
Time frame: This was calculated at the end of the pilot study (month 8).
| Milestone | Waivered Providers Received the Opioid Wizard | Non-Waivered Providers Received The Opioid Wizard | Non-Waivered Providers Who Did Not Receive the Opioid Wizard |
|---|---|---|---|
| Started | 8 | 24 | 23 |
| Completed | 8 | 23 | 23 |
| Not completed | 0 | 1 | 0 |
# of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD.
| Participants | Waivered Providers Received the Opioid Wizard | Non-Waivered Providers Who Received the Opioid Wizard |
|---|---|---|
| # of INT PCPs reporting confidence assessing OUD | 6 | 11 |
| # of INT PCPs reporting confidence treating OUD | 8 | 1 |
# 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.
| Participants | Waivered Providers Receive the Opioid Wizard | Non-Waivered Providers Who Receive Opioid Wizard |
|---|---|---|
| Intervention PCP Likeliness to Recommend Use of the OUD-CDS | 6 | 13 |
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.
| OUD diagnosis per patient year | Waivered Providers Received the Opioid Wizard | Non-Waivered Providers Who Received Opioid Wizard | Did Not Receive the Opioid Wizard |
|---|---|---|---|
| Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients. | 11.3 | 28.54 | 7.87 |
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.
| pre/post ratio MAT Rx per patient year | Waivered Providers Received the Opioid Wizard | Non-Waivered Providers Who Receive the Opioid Wizard | Non-Waivered Providers Who do Not Receive the Opioid Wizard |
|---|---|---|---|
| Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use. | 1.4 | 1.1 | 1.03 |
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.
| post/pre ratio of referral per pt. year | Waivered Providers Received the Opioid Wizard | Non-Waivered Providers Who Received the Opioid Wizard | Non-Waivered Providers Who Did Not Receive the Opioid Wizard |
|---|---|---|---|
| Compare Post-intervention Referral Patterns Between Intervention and Control Groups | 0.99 | 1.21 | 1.04 |
Collected over These data were collected during the entire active intervention period, from 6/6/2018-12/6/2018. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Waivered Providers Who Received the Opioid Wizard | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Non-Waivered Providers Who Received the Opioid Wizard | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Non-Waivered Providers Who Did Not Receive the Opioid Wizard | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Categorical(Participants) | Waivered Providers Received the Opioid Wizard | Non-Waivered Providers Who Received the Opioid Wizard | Non-Waivered Providers Who do Not Receive the Opioid Wizard | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 23 | 23 | 54 |
| >=65 years | 0 | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Waivered Providers Received the Opioid Wizard | Non-Waivered Providers Who Received the Opioid Wizard | Non-Waivered Providers Who do Not Receive the Opioid Wizard | Total |
|---|---|---|---|---|
| Female | 4 | 13 | 16 | 33 |
| Male | 4 | 11 | 7 | 22 |
| Race/Ethnicity, Customized(Participants) | Waivered Providers Received the Opioid Wizard | Non-Waivered Providers Who Received the Opioid Wizard | Non-Waivered Providers Who do Not Receive the Opioid Wizard | Total |
|---|---|---|---|---|
| White | 5 | 19 | 18 | 42 |
| Black | 1 | 1 | 1 | 3 |
| Asian | 0 | 4 | 2 | 6 |
| Multiple | 1 | 0 | 1 | 2 |
| Unknown | 1 | 0 | 1 | 2 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HealthPartners Institute