Table 2.

Study outcomes, descriptions and survey measure time points

Measure	Description	Measure time points
		Time 1	Time 2	Time 3	Time 4
Primary outcome
Mental and physical health outcomes
Distress29	Brief symptom inventory Global Severity Index of Global Distress: a validated scale of 53 questions that indicate the degree of stress the participant has experienced within the previous 7 days. Answers range on a 5-point Likert scale from 0=not at all to 4=extremely.	X	X	X	X
Secondary outcomes
Decision making outcomes
Perinatal grief30	Twenty-seven questions measuring grief, coping, and despair following the death of a child. Rated on a 5-point Likert scale that ranges from 1=strongly disagree to 5=strongly agree.				X
Decision quality (values)31	Six questions on parent’ decisional values (eg, ‘How important it is to you that your child have as little pain and discomfort from treatment as possible?’) rated on a 6-point Likert scale from 1=most important to 6=not as important.		X	X	X
Decision quality (knowledge)31	Twenty-six questions assessing the participants’ knowledge of treatment options for CHD in two domains. The first domain regards understanding about CHD diagnosis and what the heart does, the available options, and the outcomes of comfort care. The second domain regards understanding about the outcomes of surgery/intervention and the impact of CHD on family. 21 of the questions use a dichotomous response format (either ‘true/ false’ or ‘yes/no’); five questions are multiple choice.		X	X	X
Exploratory outcomes
Mental and physical health outcomes
Mental and physical functional health41	Short Form Health Survey (SF-12): Twelve items measuring the respondents’ health across multiple dimensions. Answers rated on a 5-point Likert scale ranging from 1=excellent to 5=poor for three questions; answers are given in a dichotomous (yes/no) format for four questions; answers are given on a 6-point Likert scale ranging from 1=all of the time to 6=none of the time for three questions; answers are given in a trichotomous format (yes, limited a little; yes, limited a lot; no, not limited at all) for the final two questions.	X			X
Parental quality of life42	Impact of Child with Congenital Anomalies on Parents (ICCAP) Questionnarie: Thirty-two questions to assess the impact on parental quality of life. Four questions ask about contact with caregivers, six ask about support from social networks, five ask about partner relationships, four ask about the participant’s state of mind, and the remaining thirteen ask about fear and anxiety. Answers range on a 4-point Likert scale that ranges from 1=strongly disagree to 4=strongly agree, with a ‘not applicable’ option.			X	X
Decision-making outcomes
Preference for SDM43	Adaption of Degner and Sloagan’s Control Preference Scale-A single question on how participants plan to make the decision. Responses include 1=My doctor(s) will make the decision with little input from me, 2=My doctor(s) will make the decision but will seriously consider my opinion, 3=My doctor(s) and I will make the decision together, 4=I will make the decision after seriously considering my doctor(s) opinion, 5=I will make the decision with little input from my doctor(s).	X	X	X
Preparation for decision making44	A validated scale which will assess participants' perspectives of the DA’s usefulness in preparing them to communicate with their clinicians and for SDM. These questions are answered on a Likert scale ranging from 1=not at all to 5=a great deal.		X
Decision self-efficacy45	Eleven questions to assess self-efficacy for making an informed choice (eg, getting needed information, asking questions, expressing opinions) using a 5-point Likert scale ranging from 0=not at all confident to 4=extremely confident.	X	X	X
Decision conflict46	Sixteen questions measuring: (1) perceptions of uncertainty in choosing options, (2) feelings of having adequate knowledge and clear values, and (3) effective decision making. All items use a 5-point Likert scale ranging from 0=strongly disagree to 4=strongly agree.		X	X	X
Decision regret47	Five questions asking participants to reflect on the decision they made about which treatment option they chose for their child. All questions assessed on a 5-point Likert scale from 1=strongly disagree to 5=strongly agree.				X
Use of information sources	Extent that participants consulted any of 11 sources of health information. Two sources are about personal relationships (ie, relatives and friends), three are about mass media (ie, exposure to television/movies, magazines and books about CHD), two are educational/research sources (eg, scientific journals) and the remaining four are about providers, support groups, other parents who have a child with CHD, and spiritual or religious advisor. Answers rated on a 5-point Likert scale ranging from 1=never to 5=a great deal.		X
Treatment choice	Treatment choice will be assessed by asking participants to identify which treatment they chose. Using electronic health records, we will record the child’s actual treatment in case of parental change of mind or misreport.		X	X	X
Acceptability of DA	Participants answered five questions about if they used the DA before their appointment or during their appointment, their likelihood to recommend the DA, the amount of information presented, and if the DA seemed biased.		X
Clinical encounter outcomes
Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE)48	Ten questions on 5-point scale (1=strongly disagree, 5=strongly agree) to evaluate the participant’s perspective of the effectiveness of risk communication and treatment decision making in clinician consultations.			X
Consultation quality49	Participants complete two questions that measure the quality of consultation. One measures the perceived usefulness of consultation on a seven point Likert scale that ranges from 0=not at all useful to 6=very useful. The second question measures participants’ perspective regarding whether the clinician was biased towards any certain treatment.	X		X
Parents’ characteristics and survey feedback
Demographics	Participants indicate their gender, education, race, ethnicity, number of children, religion, marital status and whether or not they have health insurance.	X
Literacy50	Three validated, brief questions identifying participants with inadequate health literacy.	X
Numeracy51	A validated scale of 8 questions that distinguish an individual’s quantitative ability without asking overly-invasive questions. Answers are rated on a 6-point Likert scale ranging from 1=not at all good/never to 6=extremely good/very often for six questions, 1=always prefer percentages to 6=always prefer numbers for one question, and 1=always prefer percentages to 6=always prefer words for one question.	X
Religiosity52	Two items asking ‘How often do you attend church or other religious meetings’ (1=Never to 6=More than once/week) and ‘How often do you spend time in private religious activities, such as prayer, meditation or Bible study’ (1=Rarely or never to 6=More than once a day)	X
Assessing Survey Burden	Six yes/no questions asked if the survey had burdensome questions, one 5-point Likert scale question asked about how useful the participant perceived the survey would be (1=not at all useful and 5=very useful), two 5-point Likert scale questions asked participants to rate how burdensome/time consuming the survey was from 1=time consuming/burdensome to 5=quick/easy.	X	X	X	X

Time 1=at diagnosis, Time 2=postreceipt of DA, Time 3=postdecision, Time 4=3 months postdecision.

CHD, congenital heart disease; DA, decision aid; SDM, shared decision making.