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Table 1 Schedule of the enrollment, intervention, and assessments

From: Electronic health record nested pragmatic randomized controlled trial of a reminder system for serum lithium level monitoring in patients with mood disorder: KONOTORI study protocol

 Study periods
 EnrollmentAllocationPost-allocationClose-out
TimepointsT-1T0T1-AT1-BT2-AT2-BTxe
Trial programEnrollment       
ScreeningX      
Randomizationa X     
Intervention       
Reminder A  X X  
Reminder B   X X 
Assessments       
Baseline characteristicsbX      
Treating physicianEnrollment       
PRIME-MDcX      
Eligibility assessmentX      
Informed consentX      
Assessments       
Lithium concentrationdX     X
Liver functionX     X
Kidney functionX     X
Thyroid function      X
  1. PRIME-MD Primary Care Evaluation of Mental Disorders
  2. aStratified block randomization will be conducted if the candidate has a measurement of serum lithium within 7 days of giving informed consent and an appointment between 4 and 8 months after giving informed consent
  3. bBasic information includes gender, age, and concomitant medication
  4. cThe candidate will be classified as having major depression, bipolar I disorder, or bipolar II disorder
  5. dSerum lithium will be classified into three groups (between 0.4 mEq/L and 1.0 mEq/L inclusive; < 0.4 mEq/L; or > 1.0 mEq/L)
  6. eThe first scheduled visit is between 18 and 24 months after informed consent