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

NCT04939727 | Completed Results

• 2 other identifiers: A20-0423UG1DA040316-06S3
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Opioid-use Disorder; Suicide

Keywords

OUD; Opioid Use Disorder Treatment; Suicide prevention; Suicide risk

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

OUD-CDS + Suicide Risk Model associated CDS (Intervention arm)

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

OUD-CDS + Suicide Risk Model associated CDS OTHER

Access to OUD-CDS + Suicide Risk CDS

Also known as: Suicide Risk CDS

OUD-CDS + Suicide Risk Model associated CDS (Intervention arm)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active parenteral chemotherapy within the last year
• Stage 4 or equivalent cancer diagnoses
• Enrolled in hospice or palliative care programs.

Sponsors & Collaborators

• HealthPartners Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Hennepin Healthcare Research Institute: collaborator

Study Sites (1)

HealthPartners Institute

Bloomington, Minnesota, 55440, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Suicide; Suicide Prevention

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Rebecca Rossom
• Organization: HealthPartners Institute

Rebecca.C.Rossom@HealthPartners.com

952-883-5466

Study Officials

• Rebecca C Rossom, MD, MSCR

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: August 3, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 31, 2023
• Results First Posted: August 31, 2023

Record last verified: 2022-04

Locations

US (1)