A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial

Table 1 Study schedule for data collection measures and time points

Study variable	Sample	Measure	Baseline	clinic visit	4 weeks	LT F/U^g
Eligibility	All subjects	Eligibility assessment	Prior to enrollment
Non-participation		Recruitment issues	Prior to enrollment
Demographics		Participant characteristics^c	X
Mental health		MINI^{c, d}	X
Mental health		EPDS^{b, e} and STAI^{b, f}	X		X	X
Decisional conflict		Decisional Conflict Scale^b	X		X
Knowledge		Knowledge Questionnaire^b	X		X
Adherence		Website use and Chart review^a			X	X
Patient-provider		Audiotaped clinic visit^b		X
Decision		Health Service Questionnaire^c	X		X	X
Participant views	PDA only	Acceptability Questionnaire^a			X
Provider views	Providers	Provider Perspective Survey^a				X^h

^aFeasibility; ^bEfficacy; ^cCovariate; ^dMini Neuropsychiatric Interview; ^eEdinburgh Postnatal Depression Scale; ^fState-Trait Anxiety Inventory; ^gLT F/U = long-term follow-up: at 12 weeks postpartum (for women enrolled while pregnant) or 6 months after baseline assessment (for women enrolled while planning a pregnancy); ^hCollected only after all other subject data collection is complete. PDA patient decision aid

ISSN: 1745-6215