Opioid-use Disorder
Conditions
Keywords
CDS, Medication Assisted Therapy
Brief summary
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.
Interventions
OTHEROpioid Wizard
The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
Sponsors
National Institute on Drug Abuse (NIDA)
Hennepin Healthcare Research Institute
HealthPartners Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Be an MD, Doctor of Osteopathy, Nurse Practitioner or Physician's Assistant engaged in independent primary care of adults at HealthPartners or Park Nicollet * Have at least schedule 3 DEA prescribing privileges * Voluntarily provide written informed consent to participate in this study
Exclusion criteria
* Less than half-time clinical primary care responsibilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention PCP Confidence in Assessing and Treating OUD | This outcome measure was calculated at approximately month 10 of the pilot study | \# of intervention PCPs who report feeling moderately or very confident in assessing and treating OUD. |
| Intervention PCP Likeliness to Recommend Use of the OUD-CDS | This was calculated after PCP surveys were completed, approximately month 10 | \# 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients. | 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. |
| Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use. | 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. |
| Compare Post-intervention Referral Patterns Between Intervention and Control Groups | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Non-Waivered Providers Who Received the Opioid Wizard 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. | 24 |
| Non-Waivered Providers Who do Not Receive the Opioid Wizard These are non-buprenorphine waivered providers continued to treat their patients as usual. | 23 |
| Total | 55 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 23 Participants | 23 Participants | 54 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 19 Participants | 18 Participants | 42 Participants |
| Sex: Female, Male Female | 4 Participants | 13 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 7 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 24 | 0 / 23 |
| other Total, other adverse events | 0 / 8 | 0 / 24 | 0 / 23 |
| serious Total, serious adverse events | 0 / 8 | 0 / 24 | 0 / 23 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Waivered Providers Received the Opioid Wizard | Intervention PCP Confidence in Assessing and Treating OUD | # of INT PCPs reporting confidence assessing OUD | 6 Participants |
| Waivered Providers Received the Opioid Wizard | Intervention PCP Confidence in Assessing and Treating OUD | # of INT PCPs reporting confidence treating OUD | 8 Participants |
| Non-Waivered Providers Who Received the Opioid Wizard | Intervention PCP Confidence in Assessing and Treating OUD | # of INT PCPs reporting confidence treating OUD | 1 Participants |
| Non-Waivered Providers Who Received the Opioid Wizard | Intervention PCP Confidence in Assessing and Treating OUD | # of INT PCPs reporting confidence assessing OUD | 11 Participants |
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.
Time frame: This was calculated after PCP surveys were completed, approximately month 10
Population: One non-waivered intervention provider stopped working for the organization and two additional non-waivered intervention providers did not complete the follow-up survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Waivered Providers Received the Opioid Wizard | Intervention PCP Likeliness to Recommend Use of the OUD-CDS | 6 Participants |
| Non-Waivered Providers Who Received the Opioid Wizard | Intervention PCP Likeliness to Recommend Use of the OUD-CDS | 13 Participants |
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.
Time frame: This was calculated at the end of the pilot study (month 8).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Waivered Providers Received the Opioid Wizard | Compare Post-intervention Referral Patterns Between Intervention and Control Groups | 0.99 post/pre ratio of referral per pt. year |
| Non-Waivered Providers Who Received the Opioid Wizard | Compare Post-intervention Referral Patterns Between Intervention and Control Groups | 1.21 post/pre ratio of referral per pt. year |
| Did Not Receive the Opioid Wizard | Compare Post-intervention Referral Patterns Between Intervention and Control Groups | 1.04 post/pre ratio of referral per pt. year |
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.
Time frame: This was calculated at the end of the pilot study (month 8).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Waivered Providers Received the Opioid Wizard | Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use. | 1.4 pre/post ratio MAT Rx per patient year |
| Non-Waivered Providers Who Received the Opioid Wizard | Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use. | 1.1 pre/post ratio MAT Rx per patient year |
| Did Not Receive the Opioid Wizard | Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use. | 1.03 pre/post ratio MAT Rx per patient year |
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.
Time frame: This was calculated at the end of the pilot study (month 8).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Waivered Providers Received the Opioid Wizard | Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients. | 11.3 OUD diagnosis per patient year |
| Non-Waivered Providers Who Received the Opioid Wizard | Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients. | 28.54 OUD diagnosis per patient year |
| Did Not Receive the Opioid Wizard | Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients. | 7.87 OUD diagnosis per patient year |