The COPE-Trial—Communicating prognosis to parents in the neonatal ICU: Optimistic vs. PEssimistic: study protocol for a randomized controlled crossover trial using two different scripted video vignettes to explore communication preferences of parents of preterm infants

Table 1 Overview of time points of exposure to interventions and data acquisition

	Enrolment	Baseline questionnaire	Post-intervention questionnaire
Time point	t₋₁	t₀		t₁		t₂	t_end
Enrolment
Eligibility feedback to RT	●
Informed consent (electronic)	●
Randomization
Group allocation	●
Baseline data
Sociodemographics		●
Prematurity as special life event		●
Relevant psychological characteristics		●
Interventions^a			Video A/B		Video B/A
Primary outcome
1 Preference video A or B						●
Secondary outcomes
1 State-anxiety				●		●
2 Satisfaction (framing)				●
3 Realism of prognosis evaluation				●
a Severity of prognosis				●
b Recall of prognostic information				●
4 Future optimism				●
5 Future hope				●
6 Preparedness for decision-making				●
7 Physician general impression				●
8 Physician professionalism				●
9 Physician compassion				●
Further outcomes
10 Perception of framing				●		●
11 Preference gradation of framing						●
12 Importance of communication							●
13 Burden by study							●

Notes. RT: Research team. ^aThe interventions video A and B are embedded in the post-intervention questionnaire. Prior to exposure to the first video (A or B, depending on study group) participants watch a short explanatory film

ISSN: 1745-6215