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| ID | Type | Description | Link |
|---|---|---|---|
| 3UG1DA040316-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Hennepin Healthcare Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waivered Providers Receive the Opioid Wizard | Experimental | All providers who have a buprenorphine waiver will receive the OUD clinical decision support tool (Opioid Wizard). |
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| Does not Receive the Opioid Wizard | No Intervention | 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. | |
| Non-Waivered Providers who receive Opioid Wizard | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Wizard | Other | The Opioid Wizard is an OUD clinical decision support tool for primary care providers. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intervention PCP Confidence in Assessing and Treating OUD | # of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD. | 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. | This was calculated after PCP surveys were completed, approximately month 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This was calculated at the end of the pilot study (month 8). |
| Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners | Bloomington | Minnesota | 55425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34130758 | Derived | Rossom RC, Sperl-Hillen JM, O'Connor PJ, Crain AL, Nightingale L, Pylkas A, Huntley KV, Bart G. A pilot study of the functionality and clinician acceptance of a clinical decision support tool to improve primary care of opioid use disorder. Addict Sci Clin Pract. 2021 Jun 15;16(1):37. doi: 10.1186/s13722-021-00245-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Waivered Providers Received the Opioid Wizard | 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. |
| BG001 | Non-Waivered Providers Who Received the Opioid Wizard |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention PCP Confidence in Assessing and Treating OUD | # of intervention PCPs who report feeling "moderately" or "very" confident in assessing and treating OUD. | 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. | Posted | Count of Participants | Participants | This outcome measure was calculated at approximately month 10 of the pilot study |
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These data were collected during the entire active intervention period, from 6/6/2018-12/6/2018
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Waivered Providers Who Received the Opioid Wizard | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca C Rossom | HealthPartners Institute | 952-883-5466 | Rebecca.C.Rossom@HealthPartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2018 | Feb 25, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2018 | Feb 25, 2020 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2018 | Feb 25, 2020 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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. |
| 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. | This was calculated at the end of the pilot study (month 8). |
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. |
| BG002 | Non-Waivered Providers Who do Not Receive the Opioid Wizard | These are non-buprenorphine waivered providers continued to treat their patients as usual. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | Non-Waivered Providers Who 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. |
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| Primary | 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. | One non-waivered intervention provider stopped working for the organization and two additional non-waivered intervention providers did not complete the follow-up survey. | Posted | Count of Participants | Participants | This was calculated after PCP surveys were completed, approximately month 10 |
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| Secondary | 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. | Posted | Number | OUD diagnosis per patient year | This was calculated at the end of the pilot study (month 8). |
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| Secondary | 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. | Posted | Number | pre/post ratio MAT Rx per patient year | This was calculated at the end of the pilot study (month 8). |
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| Secondary | 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. | Posted | Number | post/pre ratio of referral per pt. year | This was calculated at the end of the pilot study (month 8). |
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| 8 |
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| EG001 | Non-Waivered Providers Who Received the Opioid Wizard | Non-waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents the providers who received access to the opioid wizard. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Non-Waivered Providers Who Did Not Receive the Opioid Wizard | Non-waivered providers were randomized to receive/not receive the Opioid Wizard. This arm represents the providers who did not receive access to the opioid wizard.These providers continued to treat their patients as usual. | 0 | 23 | 0 | 23 | 0 | 23 |
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