Clinical trial NCT03225885: Counseling for Prematurity Using a Multimedia Education Tool
Official title: Effectiveness of Prenatal Counseling for Prematurity Using a Supplementary Multimedia Parent Education Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Counseling
Decision Making
Prenatal Care
Infant, Premature
Resuscitation
Keywords: gestational age
multi-media
mobile application
anxiety
clinical trial
random allocation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Marquette University
name: Children's National Research Institute
name: AMAG Pharmaceuticals, Inc.
First posted: 2017-07-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial where participants are assigned to 1 of 2 groups for the duration of the study. One group will receive verbal counseling and a printed gestational age handout. The other group will receive verbal counseling and a bedside iPad with the multimedia information about prematurity.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Admitted to Labor and Delivery unit due to concerns for premature delivery, gestational age of fetus between 22 weeks 0 days and 33 weeks 6 days

Exclusion Criteria:

* known significant genetic abnormality or congenital anomaly that would effect survival or counseling that parents receive
* participants will be excluded from analysis if delivery occurs prior to completion of questionnaires as other sources of information become available after birth

Primary outcomes:
measure: Overall knowledge of prematurity
timeFrame: within 24 hours of verbal counseling session
Secondary outcomes:
measure: Gestational age sub-group knowledge scores
timeFrame: within 24 hours of verbal counseling session
measure: Sub-domain knowledge scores
timeFrame: within 24 hours of verbal counseling session
measure: Anxiety
timeFrame: within 24 hours of verbal counseling
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Mir A Basir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cummings J; COMMITTEE ON FETUS AND NEWBORN. Antenatal Counseling Regarding Resuscitation and Intensive Care Before 25 Weeks of Gestation. Pediatrics. 2015 Sep;136(3):588-95. doi: 10.1542/peds.2015-2336.
citation: Raju TNK, Mercer BM, Burchfield DJ, Joseph GF Jr. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Obstet Gynecol. 2014 May;123(5):1083-1096. doi: 10.1097/AOG.0000000000000243.
citation: Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.
citation: Paivio A. Dual coding theory: Retrospect and current status. Can J Psychol. 45(3):255-87, 1991