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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04939727
• Other study ID #: A20-042
• Secondary ID: 3UG1DA040316-06S
• Status: Completed
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2022
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Be aged 18-75 years, inclusive, at the time of index visit

2. 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

3. Be identified at high risk of suicide by the suicide risk models

Exclusion Criteria:

1. Active parenteral chemotherapy within the last year

2. Stage 4 or equivalent cancer diagnoses

3. Enrolled in hospice or palliative care programs.

Related Conditions & MeSH terms

• Opioid Use
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders
• Suicide

Intervention

Other:
• OUD-CDS + Suicide Risk Model associated CDS
Access to OUD-CDS + Suicide Risk CDS

Locations

Country	Name	City	State
United States	HealthPartners Institute	Bloomington	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	Hennepin Healthcare Research Institute, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)