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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

     Others

  

       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

 

     Self-efficacy

  

       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.