Suicide Prediction and Prevention for People at Risk for Opioid Use Disorder: Supplement to COMPUTE 2.0

Study Overview
=================
Brief Summary
-----------------
This study integrates the Mental Health Research Network (MHRN) suicide risk models into Opioid Wizard, an electronic health record (EHR) clinical decision support (CDS) to identify and treat patients at high risk of opioid use disorder (OUD)/overdose or diagnosed with OUD, to alert primary care clinicians (PCCs) to patients at elevated risk for suicide and guide them through structured suicide risk assessment. In both intervention and control clinics, suicide risk scores will be calculated for all Opioid Wizard-eligible patients and relevant EHR data to inform analyses will be archived. In intervention clinics, Opioid Wizard will alert PCCs to Opioid Wizard-eligible patients who are at increased risk of suicide and coach them through use of the Columbia Suicide Severity Risk Scale (CSSRS), a structured tool in the EHR that will help PCCs assess immediate suicide risk. Based on the resulting CSSRS score, Opioid Wizard will provide EHR links for risk-based referrals and follow-up recommendations, including care as usual, routine or emergent referral to behavioral health, or transportation to the emergency department (ED) for further assessment. Primary outcome measures include completion of CSSRS assessments for at-risk patients and patient engagement in outpatient mental health care.

Detailed Description
-----------------
When a patient is at elevated risk of suicide, the PCC will be prompted by Opioid Wizard to complete the CSSRS, easily available to all PCCs in the EHR and saved as discrete data elements. Risk-based (depending on CSSRS score) referral and follow-up recommendations for suicide prevention will be given, with specific care recommendations ranging from care as usual (very low risk) to referral to behavioral health for evaluation and safety planning (moderate to high risk) to immediate evaluation in the emergency department and potential inpatient admission (very high risk), building on workflows developed for use by care managers in in our recently completed suicide prevention trial of over 19,000 people at elevated risk of suicide. (28) The MHRN suicide risk models will be programmed into the EHR, a rigorous process that will take approximately 6 months. This process includes building the model in a testing environment in the EHR, testing the model with fictitious patients in a EHR testing environment and conducting chart audits, revising as needed, testing the model in a different EHR testing environment with real patient data, revising as needed, testing the model by running it silently in the EHR production environment and conducting chart audits, and revising as needed. This is followed by testing in the EHR production environment with 5-15 physicians in 1-2 pilot clinics. Prior to the go-live date for the suicide risk calculator, training on use and interpretation of the suicide risk model and the CSSRS will be provided to all PCCs and their rooming staff in intervention clinics. Training for control clinics will be separate and will provide training on the use of the CSSRS.

Official Title
-----------------
Suicide Prediction and Prevention for People at Risk for Opioid Use Disorder: Supplement to COMPUTE 2.0

Conditions
-----------------
Opioid Use, Opioid-use Disorder, Suicide

Intervention / Treatment
-----------------
* Other: OUD-CDS + Suicide Risk Model associated CDS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be aged 18-75 years, inclusive, at the time of index visit Have an OUD diagnosis, be prescribed an active MOUD, or be identified by the opioid risk models as being at high risk of OUD or overdose Be identified at high risk of suicide by the suicide risk models Exclusion Criteria: Active parenteral chemotherapy within the last year Stage 4 or equivalent cancer diagnoses Enrolled in hospice or palliative care programs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OUD-CDS + Suicide Risk Model associated CDS (Intervention arm)<br>Providers that practice in the clinics in this intervention arm will receive access to the OUD-CDS + Suicide Risk Model associated CDS, for all eligible encounters. | Other: OUD-CDS + Suicide Risk Model associated CDS<br>* Access to OUD-CDS + Suicide Risk CDS<br>* Other names: Suicide Risk CDS;|
| No Intervention: Control<br>Providers that practice in the clinics in this control arm will not receive any access to the OUD-CDS + Suicide Risk Model associated CDS, however these clinical decision-support tools will run silently in the background, collecting data on eligible encounters. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With CSSRS Completion on the Same Day or in the 14 Days Following Any Outpatient Visit | EHR documentation of a completed Columbia Suicide Severity Rating Scale (CSSRS) on the same day or in the 14 days following any outpatient visit during the observation period. | Observation period (up to 12 months) | 
| Number of Outpatient Visits With Adequate Mental Health Engagement | Adequacy of engagement with mental health care following outpatient visits that occurred between the index visit and the end of the study period. Engagement was adequate if acute suicide risk was 1) documented as moderate or high and the patient had a follow-up mental health visit within 30 days, or 2) undocumented but the patient had a follow-up mental health visit within 30 days, or 3) documented as low. | Observation period (up to 12 months) | 
| Number of Participants With One or More Suicide Attempts | Identification of fatal or non-fatal suicide attempts, using ICD-10 diagnostic codes assigned at inpatient or outpatient visits during the outcome measure time frame | Two time periods: 1) 12 months prior to enrollment (index visit), and 2) between enrollment and end of observation period (up to 12 months) | 
| Number of Participants With One or More Opioid Overdoses | Identification of opioid overdoses, using ICD-10 diagnostic codes assigned at inpatient or outpatient visits during the outcome measure time frame | Two time periods: 1) 12 months prior to enrollment (index date), and 2) between enrollment and end of observation period (up to 12 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OUD, Opioid Use Disorder Treatment, Suicide prevention, Suicide risk