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Table 1 Pragmatic trial examples

From: Principles and procedures for data and safety monitoring in pragmatic clinical trials

Reducing Cardiovascular Risk in Adults with Serious Mental Illness (SMI Wizard)
 • Design: Cluster-randomized pragmatic trial of decision support to reduce cardiovascular risk factors in adults with serious mental illness (SMI; psychotic disorder or bipolar disorder)
 • Setting: two integrated health systems
 • Participants: Adult outpatients aged 18 to 75 years who have SMI, have at least one cardiovascular risk factor not at goal at index visit, and make at least one follow-up visit to primary care
 • Intervention: Provider-facing and patient-facing decision support to identify, prioritize, and address specific cardiovascular risk factors
 • Comparator: Usual care (no decision support is provided, but no care is withheld or restricted)
 • Outcome: Reduction in Framingham 10-year cardiovascular event risk score
 • Safety monitoring plan: Local safety monitors reviewed any feedback on the clinical decision support provided by primary care providers during the intervention. A three-member DSMB reviewed study progress (including blinded review of interim analyses) twice per year. Safety outcomes assessed included differences between intervention and control groups in suicidal ideation, suicide attempt, psychiatric hospitalization, or emergency department visit rates.
 • Registration: ClinicalTrials.gov NCT02451670
 • Status: Enrollment, intervention, and outcome ascertainment completed (n = 8937); data analysis in progress
Safer Use of Antipsychotics in Youth (SUAY)
 • Design: Cluster-randomized pragmatic trial of multi-component intervention to reduce unnecessary antipsychotic medication use in children and adolescents with non-psychotic disorders
 • Setting: Three integrated health systems and one pediatric health system
 •Participants: Outpatients aged 3 to 17 for whom a mental health specialty or primary care provider initiates a prescription for antipsychotic medication in the absence of a diagnosis of psychotic disorder, mania, autism spectrum disorder, or intellectual disability
 • Intervention: Intervention program including:
   Decision support at time of initial prescription recommending alternative treatments
   Pro-active expert consultation to prescribing provider
   Care navigation for patients and families to promote and facilitate non-pharmacologic treatments
   Expedited access to psychosocial treatment via videoconferencing
 • Comparator: Augmented usual care (decision support only without consultation or care navigation)
 • Outcomes: Proportion using antipsychotic medication 6 months after enrollment AND person-months of antipsychotic medication use during 6 months after enrollment
 • Safety monitoring plan: Data regarding hospital admissions, emergency department visits, and self-harm diagnoses are extracted from health system records. A National Institute of Mental Health standing DSMB reviews study progress (including blinded interim analyses regarding potential harm) three times per year
 • Registration: ClinicalTrials.gov NCT03448575
 • Status: Enrollment in progress (401 enrolled as of April, 2019)
Suicide Prevention Outreach Trial (SPOT)
 • Design: Patient-randomized pragmatic trial of two population-based outreach programs to reduce suicide attempt or self-harm in adults at elevated risk
 • Setting: Four integrated health systems
 • Participants: Adult outpatients reporting frequent thoughts of death or self-harm on routinely administered depression questionnaires
 • Interventions: Two outreach interventions provided as supplements to usual care
   Outreach, risk assessment, and care management delivered primarily via online messaging
   Online training in Dialectical Behavior Therapy supported by online coaching
 •Comparator: Usual care (participants are not contacted, no care usually available is withheld or restricted)
 • Outcomes: Self-inflicted injury or poisoning over 18 months following randomization
 • Safety monitoring plan: Local safety monitors review study team responses to risk assessments indicating high risk or urgent need. National Institute of Mental Health standing DSMB reviews study progress (including blinded review of interim analyses) three times per year
 • Registration: ClinicalTrials.gov NCT02326883
 • Status: Enrollment completed (n = 18,887); intervention delivery and outcome ascertainment ongoing