Table 1 PRECIS domains defining pragmatic trials

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