Background
Methods
Overview
-
A Care Management intervention including: systematic outreach to assess risk of suicidal behavior, EHR-based tools to implement risk-based care pathways, and care management to facilitate and monitor recommended follow-up care
-
A Skills Training intervention including: interactive online training in DBT skills [12], supported by reminder and reinforcement messages from a skills coach
Study settings
Eligibility
-
Completion of a PHQ9 questionnaire [20] at an outpatient mental health or general medical visit
-
Age 18 years or older on the visit date
-
Response of “more than half the days” or “nearly every day” to item 9 of the PHQ9
-
Use of EHR patient portal secure messaging during the prior year
-
Currently enrolled in participating health system insurance plan (to ensure adequate ascertainment of subsequent suicide attempts)
-
Recorded diagnosis of dementia or developmental delay in the previous 2 years
-
Limited English proficiency (as indicated by “need for interpreter” recorded in the EHRs)
-
Previous request to be excluded from research invitations
-
Already enrolled and randomized via a previous visit
Enrollment and randomization
Invitation and consent
Care Management intervention
Rationale
Assessment tools
Follow-up algorithms
Care manager role
-
Initial and follow-up invitations to all participants assigned to be offered Care Management
-
Periodic outreach to assess current risk (using an online version of the CSSRS)
-
Application of follow-up algorithms, supported by informatics tools (see below)
-
Regular feedback to treating providers regarding risk assessments and follow-up plans
-
As-needed communication with participants and providers to facilitate follow-up care
Informatics tools
-
Online administration of structured questionnaires such as the CSSRS
-
Secure provider-to-provider messaging for care managers’ communications with primary care and mental health specialty providers
-
Population management and reporting tools to apply follow-up algorithms and deliver algorithm-based recommendations to care managers regarding outreach and follow-up
Engagement with health system stakeholders
-
Language for outreach messages
-
Recommended follow-up intervals
-
Criteria for referral from primary care to mental health specialty care
-
Processes for communicating with primary care and mental health specialty providers
-
Procedures for urgent assessment and referral
Training and supervision
-
6 h of clinical training regarding suicide risk assessment
-
2 h of general orientation to project aims and procedures
-
6 h of specific training regarding care management aims, tools, and procedures
Skills Training intervention
Rationale
Specific skills content
-
Mindfulness – Introduction to mindfulness skills, emphasizing nonjudgmental observation
-
Mindfulness of Current Emotion – Nonjudgmental observation of sensations associated with difficult or painful emotions
-
Opposite Action – Acting in opposition to urges associated with painful or difficult emotions
-
Paced Breathing – Use of breathing techniques to manage overwhelming emotions or crises
Adaptation for online delivery
-
A brief video introduction to the skill concept
-
A longer teaching video describing the skill, including in vivo practice
-
Example videos of peers (see below) describing use of the skill in daily life
-
Interactive exercises for use during the online session
-
Customizable worksheets to support between-session practice
Skills coach role
-
Initial and follow-up invitations to all participants assigned to be offered Skills Training
-
For participants visiting the online program, messages to reinforce use of the program and practice of specific skills
-
For participants not visiting the program, periodic outreach messages to encourage return visits
-
As-needed communication with treating providers regarding participants’ progress
Informatics tools
Engagement with patient stakeholders
Training and supervision
-
6 h of clinical training regarding suicide risk assessment
-
2 h of general orientation to project aims and procedures
-
6 h of specific training regarding skills coaching aims, tools, and procedures
Outcome definitions
-
Any outpatient or inpatient diagnosis of definite self-inflicted injury or poisoning
-
Any outpatient or inpatient diagnosis of possible self-inflicted injury or poisoning
-
Any outpatient or inpatient diagnosis of other injury or poisoning associated with a diagnosis of suicidal ideation during the same encounter
Analysis plan
Sample size
Enrollment progress
Ethical and regulatory approval
Waiver of informed consent
Defining minimal risk
-
Research risk versus preexisting risk – Given that the trial enrolls patients who are at risk of suicide attempt, we encountered concern that study procedures could not be classified as having minimal risk. To address this concern, we relied on regulatory guidance distinguishing between preexisting risk due to a research participant’s health state (i.e., increased risk of suicide attempt) and incremental risk created by study procedures. This distinction led to the appreciation of this trial as evaluating minimal-risk interventions in a high-risk population
-
Risk of assignment to continued usual care – We also encountered concern regarding the ethical acceptability of randomly assigning patients who are at risk of suicide attempt to a usual care control condition. We clarified that a participant assigned to usual care will, by definition, receive the same treatment that she or he would have received if the study were not occurring
-
Risk of assignment to offer of intervention programs – We also encountered concern that assignment to either intervention group might increase risk. Both intervention programs are based on effective interventions and are intended to reduce risk of suicide attempt. Participants are free to receive any other services that are normally available. Nevertheless, it is possible that some participants will experience negative effects from either program. We addressed this concern by clarifying that participants are assigned to the offer of an intervention, with no obligation to participate. Invitation messages clearly identify intervention programs as research activities, make no promise of benefit, and advise that participation is completely voluntary
-
Intrusiveness or invasion of privacy – Different stakeholders expressed concern regarding both inappropriate intrusiveness of repeated outreach and inadequate vigor of outreach given the known increased risk of suicide attempt. In consultation with peer experts, we designed the outreach strategy described above, including up to three cycles of invitation, as a reasonable compromise between these two concerns.
Monitoring for adverse events
Interim analyses of benefit or harm
Data and resource sharing
Discussion
PRECIS criteria for pragmatic trials | Design of suicide prevention outreach trial | |
---|---|---|
Participants | All eligible participants enrolled, regardless of risk, responsiveness, comorbidities or past compliance | Adult health plan members reporting frequent suicidal ideation on routine depression questionnaires are automatically enrolled |
Intervention condition | Interventions are highly flexible, offering providers leeway in formulation and application | Both interventions allow personalization to patients’ needs and preferences. Varying levels of participation are expected |
Intervention practitioners | Interventions are applied by the full range of practitioners in the full range of settings with only ordinary attention to dose and side effects | Intervention clinicians will be recruited from existing local workforces. Each site will be responsible for selection and supervision of clinicians (using standard quality control tools) |
Comparison condition | “Usual practice” (or the best alternative), offering practitioners considerable leeway in application | Each prevention program will be compared to usual care |
Comparison practitioners | The control intervention is applied by the full range of clinicians in the full range of settings, with only ordinary attention to training, experience, and performance | Usual care will be provided by real-world providers (mental health and general medical clinicians) under usual practice conditions – with no additional training or supervision |
Follow-up assessments | There are no research assessments; administrative databases are searched for outcomes | All outcome data are collected from EHR, insurance claim data, and death certificate data |
Outcome definition | The primary outcome is objectively measured, meaningful to study participants, and does not depend on central adjudication | Primary and secondary outcomes are defined by specific ICD-9/ICD-10 diagnosis codes – no clinical assessment is required |
Intervention compliance | There are no special strategies to improve compliance, and compliance is unobtrusively measured | Patients assigned to interventions are free to participate (or not participate) at any level. Participation or compliance is assessed passively using EHRs and online intervention databases |
Practitioner adherence | There are no special strategies to maintain practitioner adherence, and adherence is unobtrusively measured | Care managers and skills coaches work independently at each site, but receive initial training and regular supervision from study investigators |
Primary comparison | The analysis includes all patients regardless of compliance, eligibility, or others | All outcomes will be analyzed according to initial assignment – regardless of intervention participation or compliance |
-
Population-based enrollment – If we hope to inform policy or implementation decisions by health system leaders, then it is necessary to evaluate program effectiveness in the full population of those to whom the program would eventually be offered
-
Allowing variable participation or compliance – Restricting enrollment to those willing to participate in outreach or prevention programs would not allow a valid assessment of program effectiveness. Low participation or high rates of dropout should be considered essential indicators of effectiveness rather than threats to internal validity
-
Analysis by intent-to-treat – A valid evaluation of prevention program effectiveness must examine risk among all those offered the prevention service, rather than those who accept or participate. Any “as treated” or “completers” analysis (limited to those who participate in prevention services) would certainly be biased