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Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial
Elliott Mark Weiss1,2, Aleksandra E Olszewski1,2, Katherine F Guttmann3
1Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.
Insights
Parental trust in researchers and perception of infant illness influence neonatal clinical trial enrollment. Demographic factors like race and income also play a role, highlighting the need for strategies to reduce research disparities.
Area of Science:
- Neonatal research
- Clinical trial recruitment
- Health disparities
Background:
- Parental decision-making for neonatal clinical trials is not well understood, particularly for minority populations.
- Understanding enrollment factors can improve recruitment and reduce research participation disparities.
Purpose of the Study:
- To identify differences in parental factors between those who enrolled and those who declined neonatal randomized clinical trials.
- To explore demographic characteristics, illness perception, study comprehension, and trust in researchers as factors in enrollment decisions.
Main Methods:
- A survey study was conducted in 12 US neonatal intensive care units (July 2017-October 2019).
- Parents of infants enrolled or eligible but declined from the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial were included.
- Data were analyzed using percentages and odds ratios, comparing enrolled and declined groups across four categories.
Main Results:
- Parents who enrolled infants had lower Medicaid participation and higher incomes compared to those who declined.
- Black parents had lower enrollment rates than White parents (OR, 0.35).
- Greater perceived infant illness severity (OR, 5.7) and higher trust in researchers were associated with enrollment; study comprehension was not.
Conclusions:
- Demographic factors (race/ethnicity, income, Medicaid status), illness perception, and trust in researchers are associated with neonatal clinical trial enrollment.
- Findings suggest strategies are needed to engage underrepresented groups and reduce enrollment disparities.
- Further research is warranted to confirm these findings and explore underlying reasons for enrollment decisions.
Importance:
It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations. Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation.
Objective:
To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial.
Design, Setting, And Participants:
This survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020.
Exposure:
Parental choice of enrollment in neonatal clinical trial.
Main Outcomes And Measures:
Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers.
Results:
Of a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment.
Conclusions And Relevance:
In this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and reported income), perception of illness, and trust in medical researchers. Future work to confirm these findings and explore the reasons behind them may lead to strategies for better engaging underrepresented groups in neonatal clinical research to reduce enrollment disparities.
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