An interventional study of Multimedia Information and Printed Handout in Premature Birth, Counseling and Decision Making, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Other
This study evaluates the effectiveness of prenatal counseling when verbal counseling is supplemented with a multi-media mobile application versus a written gestational age handout.
Approximately 500,000 infants are born prematurely in the United States every year. Premature birth prior to 27 weeks gestation currently accounts for approximately 40% of infant mortality within the United States. When compared to full term infants, premature infants have a higher risk of physical or cognitive impairment and prematurity care accounts for over 26 billion dollars annually. Parents of premature infants are placed under significant emotional, financial, and personal stress. However, parental education about prematurity is often not evidenced based, varies significantly between OB and Neonatology providers, and lacks educational aids to help parents comprehend the information provided.
Several medical societies (American Academy of Pediatrics (AAP), American Congress of Obstetrics and Gynecology (ACOG), National Institute of Child Health and Human Development (NICHD)) and parental advocates have voiced concern that the current practice is sub-optimal. Several studies have looked at this challenging situation from the family's perspective and have shown that parents find this counseling to be helpful but rarely reassuring and often stressful. Cognitive science research has recommended the use of multimedia information to simultaneously use both text and visual cognitive channels to improve information uptake and retention. Policy statements from the AAP, ACOG, and NICHD have all emphasized the importance of improving the prenatal counseling process to give our parents the most information possible so that they can make the best choices possible for their vulnerable infant.
Potential study participants will be identified after hospitalization at Froedtert Hospital for premature labor. As per current clinical practice all mothers and their support person will have a neonatology consult requested by the obstetrician. These potential participants will be screened for eligibility in the study. Mothers and their support person will then be consented for participation and will be randomized to receive either verbal counseling with printed gestational age handout or verbal counseling with the multimedia information regarding prematurity. Participation of the pregnant woman's support person will be allowed by not required. If both mother and support person consent to participate, the support person will be will be assigned the same group as the mother. Participants will take a baseline STAI (State-Trait Anxiety Inventory) at time of randomization. After prenatal counseling has been completed by a neonatal provider (neonatology attending or fellow) the participants will be provided the validated questionnaire (previously developed) to assess their knowledge of prematurity based on the AAP recommended information for parents anticipating a premature birth. Participants will also retake the STAI.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 76 is close to the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
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Exclusion Criteria:
Participants in this arm will receive verbal prematurity counseling from a Neonatologist or Neonatal fellow as well as a printed gestational age specific handout about prematurity.
Other: Printed Handout
Participants in this arm will receive verbal prematurity counseling from a Neonatologist or Neonatal fellow as well as have bedside access to iPad multimedia information regarding prematurity.
Other: Multimedia Information
Is a multi-media mobile application that addresses information about prematurity, resuscitation, and NICU hospitalization.
Printed Handout is a gestational age specific handout that addresses resuscitation and prematurity information.
Overall knowledge of prematurity
Average of overall knowledge score
Time frame: within 24 hours of verbal counseling session
Gestational age sub-group knowledge scores
Comparison of average overall knowledge scores within gestational age groups 22-24 weeks and 25-29 weeks and 30-33 weeks gestation.
Time frame: within 24 hours of verbal counseling session
Sub-domain knowledge scores
Comparison of knowledge scores between groups for sub-domains of short-term outcomes, long-term outcomes, numerical information, and treatments
Time frame: within 24 hours of verbal counseling session
Anxiety
Comparison of change in participant anxiety as assessed by STAI
Time frame: within 24 hours of verbal counseling
Plan to share: No — There is no plan to share IPD.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin