How Parents Weigh Clinical Trials Participation

How Parents Weigh Clinical Trials Participation
Income, education, and race shown to influence decision to enroll.

A new study clarifies the fears and worries that dispose parents of a newborn to either enroll their child in a clinical trial or to decline enrollment, says Uche Anani, M.D., a neonatologist at Monroe Carell Jr. Children’s Hospital at Vanderbilt. The study appeared in JAMA Network Open.

“Parents who agreed [to participate] were likelier to identify the child’s condition as serious and to worry about long-term effects,” Anani said. “Those who declined were more likely to say that they felt overwhelmed, to perceive the trial as demanding a lot of work, and to worry about their baby being experimented upon.”

Insight into Parents’ Real Thinking

Most prior studies in this area have examined parents’ reasoning when faced with a hypothetical situation, Anani said. “Our study examined a real decision made by parents in real time in an actual NICU setting. To my knowledge, nothing like this has been done before.”

“Our study examined a real decision made by parents in real time in an actual NICU setting.”

The multi-institution decision study was developed around enrollment in the HEAL trial (High- dose Erythropoietin for Asphyxia and encephaLopathy), a randomized, controlled trial of erythropoietin as a neuroprotectant in infants with hypoxic-ischemic encephalopathy.

The decision study involved Vanderbilt and 11 other institutions participating in the HEAL trial and was led by Elliott M. Weiss, M.D., a neonatologist and bioethicist at Seattle Children’s Hospital.

Influences on Consent

At Vanderbilt, either Anani or Erin Havrilla, R.N., a nurse manager in neonatal services, approached parents of neonates eligible for the HEAL trial. They asked for the parent’s enrollment decision soon after the child’s birth, generally a time of great distress for new parents with sick infants. The HEAL trial required consent within 24 hours, while the decision study portion allowed for consent in 5 to 7 days.

Researchers surveyed parents either by phone or face to face. The survey included seven questions. Six used a five-point Likert scale (with “1” meaning “not at all” and “5” meaning “very much”). One question (“Did you think your infant was likely to die?”) received a “yes” or “no” answer. They administered one survey for each child.

 

At Vanderbilt, 18 parents completed the survey. Among them, 16 enrolled in the HEAL trial. Across 12 sites, 269 parents completed the survey. There were no differences in the clinical severity of the child’s illness between those who enrolled and those who refused. Two-thirds of respondents were mothers answering by themselves; the other third were fathers or couples.

Important demographic differences emerged. Parents who declined to enroll in the trial were more likely to be of lower socioeconomic status, on Medicaid, and self-identify as Black than parents who enrolled their child.

Better Serving Diverse Families

Anani says the findings highlight the need to communicate effectively with parents of all backgrounds about the value of clinical trials.

“Our findings can help us learn to better communicate with and educate families about their infants’ health, and also build rapport and trust,” Anani said. “It’s important for parents to enroll their children to improve the likelihood that minority communities will benefit from new discoveries and treatments.”

“Our findings can help us learn to better communicate with and educate families about their infants’ health, and also build rapport and trust.”