Clinical Decision Support, Opioid Use Disorder
Conditions
Keywords
Opioid use disorder, clinical decision support
Brief summary
This study is stage 1 of a larger study which refines and optimizes the EMBED\* clinical decision support (CDS; see NCT03658642) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. In the current project, optimization phase, stage1 investigators will conduct a 2x2x2 factorial trial in which they expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment. Later study phases will include optimization phase, stage 2: rapid-cycle randomized testing, and evaluation phase: a randomized trial of the optimized package compared to the original EMBED and the evaluation phase in which investigators will compare the efficacy of the optimized, multicomponent CDS package to the original EMBED CDS on ED-initiation of buprenorphine rates in patients with OUD in a randomized trial. \*EMBED is a user centered, clinician facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community
Interventions
OTHERNurse prompt
Nurse prompt to complete COWS
OTHERProvider prompt
Provider prompt to use EMBED CDS
Patient materials provided at discharge from ED
OTHEREMBED
Original EMBED CDS
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible patients are randomized to a study arm during Emergency Department encounters at study sites. There is no open enrollment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Emergency department patient * 18 years of age or older * Moderate to severe opioid use disorder
Exclusion criteria
* Under 18 years of age * Pregnant * Currently receiving medication for opioid use disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of encounters with Buprenorphine initiation in the ED | Upon discharge from the ED, 1 day | Proportion of eligible encounters with buprenorphine administered in the Emergency Department (ED) and/or prescribed buprenorphine on discharge from the ED. Obtained from EHR data. |
| Proportion of alerted encounters with CDS engagement | Trial start to end up to 18 months | Proportion of eligible encounters in the Emergency Department with an alert fired (silent or active) with CDS engagement. CDS engagement is defined as: OUD diagnosis entered via CDS, withdrawal assessment, readiness assessment, buprenorphine order/prescription placed, referral placed, or any flowsheet item completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of encounters with Naloxone prescription upon ED discharge | Upon discharge from the ED, 1 day | Proportion of eligible encounters with naloxone prescribed on discharge from the Emergency Department (ED). Obtained from EHR data. |
| Proportion of encounters with patient referral to ongoing MOUD treatment | Upon discharge from the ED, 1 day | Proportion of eligible encounters with referral for ongoing MOUD treatment received on discharge from the Emergency Department (ED). Obtained from EHR data. |
| Proportion of encounters with patient receipt of appropriate opioid related discharge instructions | Upon discharge from the ED, 1 day | Proportion of encounters with appropriate opioid related discharge instructions. Obtained from EHR data. |
| Proportion of attending physicians initiating BUP in the ED for at least one eligible patient | Trial start to end up to 18 months | Proportion of attending physicians administered or prescribed Buprenorphine in the Emergency Department (ED) for at least one encounter. Obtained from EHR data. |
| Proportion of attending physician prescribing naloxone upon ED discharge | Trial start to end up to18 months | Proportion of attending physicians prescribing naloxone in the Emergency Department (ED) for at least one encounter. Obtained from EHR data. |
| Proportion of attending physician referral to ongoing MOUD treatment | Trial start to end up to 18 months | Proportion of attending physicians referring a patient to ongoing MOUD treatment on discharge from the Emergency Department (ED) for at least one encounter. Obtained from EHR data. |
| Proportion of attending physicians giving appropriate opioid related discharge instructions | Trial start to end up to 18 months | Proportion of attending physicians giving appropriate opioid related discharge instructions for at least one encounter. Obtained from EHR data. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREdward Melnick, MD, MHS
Yale University
Outcome results
None listed