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Table 1 RCT Sub-studies and Process and Outcome Measures

From: Targeted versus tailored multimedia patient engagement to enhance depression recognition and treatment in primary care: randomized controlled trial protocol for the AMEP2 study

  Measurement points Method(s) of measurement
  Immediately after index office visit 12 week follow-up  
Sub-study 1: patients with clinically significant depressive symptoms (baseline PHQ-9 ≥ 5)    
   Process of care    
     Key outcome - components of initial depression care (CIDC): antidepressant prescription and/or mental health referral among participants with baseline PHQ-9 ≥ 10* X   PQ, PCPQ, MRR
       Antidepressant prescription and/or mental health referral among all sub-study participants* X  
       Follow-up with PCP at an appropriate interval† X  
       Inquiry regarding self-harm/suicidal thoughts X  
   Patient function    
     PHQ-8 score X X PQ
     SF-12 Mental Component Summary score   X
     SF-12 Physical Component Summary score   X
   Patient engagement in depression care    
     Readiness    PQ
       To discuss depression (in general) with PCP X  
       To discuss depression treatment with PCP X  
       For recognizing depression X X
       For discussing depression with PCP X X  
     Provider-patient interaction    PQ, PCPQ, MRR
       Discussion of depression X  
       Patient request for depression treatment X  
   Patient perceived depression stigma X X PQ
Sub-study 2: patients without clinically significant depressive symptoms (baseline PHQ-9 < 5)    
   Process of care    
     Antidepressant prescription (over-treatment) X   PQ, PCPQ, MRR
     Distraction effects   
       Index office visit length X  
       Patient request for depression treatment X  
       Physician visit effort X   
   Patient function    
     SF-12 Physical Component Summary score (potential toxicity, i.e. reduced function)   X PQ
     Patient perceived depression stigma (potential reduction) X X PQ
  1. * Sub-study 1 primarily powered to examine this outcome; research evidence indicates PHQ-9 scores ≥ 10 are associated with significant life impairment (e.g. reduced functional abilities) and a strong likelihood of clinical depression, while scores of 5–9 are more equivocal in this regard.
  2. Not an evidence-based element of care, but endorsed in prevailing clinical practice guidelines.
  3. Includes all PHQ-9 items except the item concerning self-harm thoughts.
  4. Abbreviations:
  5. AMEP2, Activating Messages for Enhancing Primary Care Practice; MRR, medical record review; NA, not applicable (participants in this sub-study are not followed up); PCP, primary care provider; PCPQ, PCP questionnaire; PHQ, Patient Health Questionnaire; PQ, patient questionnaire.