Table 2.

Primary and secondary outcome measures and covariates and fidelity assessments completed at baseline and follow-up visits in the engaging caregivers and providers of children with sickle cell anemia in shared decision making for hydroxyurea trial.

Construct			Measure		Brief description		Baseline		Follow-up
Primary outcomes
	Caregiver-reported decisional uncertainty	Decisional conflict scale [15]–effectiveness		Measures uncertainty experienced when feeling uninformed about options, unclear about personal values, or unsupported in making a choice		✓a		N/Ab
	Caregiver-reported perception of shared decision making	Dyadic OPTION [16]–effectiveness		Describes clinician behaviors to involve a patient or caregiver in decision making		✓		N/A
Secondary outcomes
	Caregiver-reported satisfaction with decision making	6-item survey [17,44]–effectiveness		Three items adapted from the empirical research related to procedural justice and 3 items assessing the influence of faith on decision making		✓		✓
	Caregiver-reported hydroxyurea knowledge	8-item survey–effectiveness		Hydroxyurea knowledge survey (8 items): developed based on the existing literature, the Ottawa Knowledge User Manual, and it was used by caregiver and clinician stakeholders in our pilot work		✓		✓
	Caregiver report of SCDc-specific quality of life and pain	PedsQLd SCD module [18]–effectiveness		Measures several domains of health-related quality of life including pain impact, fatigue, pain management, emotions, communication, and treatment adherence		✓		✓
	Caregiver report of neurocognitive functioning	Ages and stages questionnaire [45]–effectiveness		Reliable, accurate developmental and social emotional screener for children aged between 2 and 60 months		✓		✓
	Caregiver report of hydroxyurea adherence	Medical adherence measure subscale [46]–effectiveness		A 9-item survey that measures adherence problems and the extent of nonadherence in pediatric populations		N/A		✓
	Caregiver report of continued use of decision aids	H-SDMe follow-up survey		For the H-SDM condition, caregiver report of continued use of decision aids: previsit brochure, postvisit booklet, and narrative videos, including sharing information with others		N/A		✓
	Hydroxyurea uptake	Active hydroxyurea prescription–effectiveness		One item reported by the research coordinator. They report whether patients enrolled in the study have an active prescription for hydroxyurea using the EMRf (prescription in the last 6 months)		✓		✓
	Hydroxyurea adherence	Lab values and pharmacy refill records–effectiveness		Labs reported by the research coordinator based on the EMR (past 12 months): HbFg level, which increases when taking hydroxyurea as prescribed, ANCh, which decreases when taking hydroxyurea as prescribed, and MCVi, which increases when taking hydroxyurea as prescribed		✓		✓
	Hydroxyurea offered	1 item reported by research coordinator–reach		1 of 3 responses completed by the research coordinator based on a review of EMR data: hydroxyurea was not offered, offered, or previously prescribed. If not offered, coordinators choose a reason why (ie, not eligible because the patient is on transfusions)		✓		✓
	Health care utilization	Hospitalizations, emergency room visits, and ill visits–effectiveness		EMR data on the number of hospitalizations, ill visits, and emergency room visits in the 6 months before enrollment (if possible, some participants may be 9 months of age) and the 6 months after enrollment		✓		✓
Covariates
	Demographics	Demographics survey		10-item survey assessing family demographics including patient and caregiver age, gender, race and ethnicity, socioeconomic status, insurance (public vs private), and caregiver highest level of education completed		✓		N/A
	Health literacy	Newest vital sign [19]		Newest vital sign (3 min): tests literacy skills for both numbers and words		✓		N/A
	Caregiver report of the effects of COVID-19	CEFISj [47]		The CEFIS was designed to be used in ongoing and new studies where COVID-19 may impact study outcomes. It conceptualizes the exposure to potentially traumatic aspects of COVID-19 and assesses the pandemic's impact on the family		✓		✓
	Caregiver report of telemedicine use	COVID-19 and telemedicine use survey [48]		Items from the telemedicine usability questionnaire assess the impact of telemedicine on care		✓		✓
Fidelity
	Caregiver-reported fidelity	H-SDM toolkit parent checklist		Checklist to assess the toolkit components that were used during the hydroxyurea discussion with the clinician		✓		N/A
	Research coordinator observation of decision making	Observer OPTION scale [20]–implementation		Observer quantifies clinician behaviors to involve a caregiver in decision making. A total score is calculated, ranging from 0 (no involvement) to 100 (exemplary involvement)		✓		N/A
	Intervention fidelity	Intervention fidelity checklist–implementation		Checklist to assess if the clinician used the intervention materials		✓		N/A
	Study site report of continued use of intervention	Follow-up survey–maintenance		Survey to assess the continued implementation of the sites' guidelines and clinical characteristics to understand barriers and facilitators to maintain implementation		N/A		1-3 months after enrollment ends

^aThe check mark indicates that participants completed the measure either at baseline, follow-up, or both.

^bN/A: not applicable.

^cSCD: sickle cell disease.

^dPedsQL: Pediatric Quality of Life.

^eH-SDM: hydroxyurea shared decision making.

^fEMR: emergency medical record.

^gHbF: fetal hemoglobin.

^hANC: absolute neutrophil count.

ⁱMCV: mean corpuscular volume.

^jCEFIS: COVID-19 Exposure and Family Impact Survey.