Suicide Prediction and Prevention for People at Risk for Opioid Use Disorder: Supplement to COMPUTE 2.0
Primary Purpose
Opioid Use, Opioid-use Disorder, Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OUD-CDS + Suicide Risk Model associated CDS
Sponsored by
About this trial
This is an interventional other trial for Opioid Use focused on measuring OUD, Opioid Use Disorder Treatment, Suicide prevention, Suicide risk
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.
Sites / Locations
- HealthPartners Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
OUD-CDS + Suicide Risk Model associated CDS (Intervention arm)
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04939727
First Posted
June 17, 2021
Last Updated
August 9, 2023
Sponsor
HealthPartners Institute
Collaborators
National Institute on Drug Abuse (NIDA), Hennepin Healthcare Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04939727
Brief Title
Suicide Prediction and Prevention for People at Risk for Opioid Use Disorder: Supplement to COMPUTE 2.0
Official Title
Suicide Prediction and Prevention for People at Risk for Opioid Use Disorder: Supplement to COMPUTE 2.0
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
National Institute on Drug Abuse (NIDA), Hennepin Healthcare Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid-use Disorder, Suicide
Keywords
OUD, Opioid Use Disorder Treatment, Suicide prevention, Suicide risk
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OUD-CDS + Suicide Risk Model associated CDS (Intervention arm)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
OUD-CDS + Suicide Risk Model associated CDS
Other Intervention Name(s)
Suicide Risk CDS
Intervention Description
Access to OUD-CDS + Suicide Risk CDS
Primary Outcome Measure Information:
Title
Number of Participants With CSSRS Completion on the Same Day or in the 14 Days Following Any Outpatient Visit
Description
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.
Time Frame
Observation period (up to 12 months)
Title
Number of Outpatient Visits With Adequate Mental Health Engagement
Description
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.
Time Frame
Observation period (up to 12 months)
Title
Number of Participants With One or More Suicide Attempts
Description
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
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)
Title
Number of Participants With One or More Opioid Overdoses
Description
Identification of opioid overdoses, using ICD-10 diagnostic codes assigned at inpatient or outpatient visits during the outcome measure time frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca C Rossom, MD, MSCR
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55440
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Suicide Prediction and Prevention for People at Risk for Opioid Use Disorder: Supplement to COMPUTE 2.0
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