Counseling for Prematurity Using a Multimedia Education Tool
Primary Purpose
Premature Birth, Counseling, Decision Making
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multimedia Information
Printed Handout
Sponsored by

About this trial
This is an interventional other trial for Premature Birth focused on measuring gestational age, multi-media, mobile application, anxiety, clinical trial, random allocation
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
Sites / Locations
- Froedtert Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Printed Handout
Multimedia Information
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Overall knowledge of prematurity
Average of overall knowledge score
Secondary Outcome Measures
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.
Sub-domain knowledge scores
Comparison of knowledge scores between groups for sub-domains of short-term outcomes, long-term outcomes, numerical information, and treatments
Anxiety
Comparison of change in participant anxiety as assessed by STAI
Full Information
NCT ID
NCT03225885
First Posted
July 20, 2017
Last Updated
February 26, 2019
Sponsor
Medical College of Wisconsin
Collaborators
Marquette University, Children's National Research Institute, AMAG Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03225885
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
January 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Marquette University, Children's National Research Institute, AMAG Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Counseling, Decision Making, Prenatal Care, Infant, Premature, Resuscitation
Keywords
gestational age, multi-media, mobile application, anxiety, clinical trial, random allocation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Printed Handout
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Multimedia Information
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multimedia Information
Intervention Description
Is a multi-media mobile application that addresses information about prematurity, resuscitation, and NICU hospitalization.
Intervention Type
Other
Intervention Name(s)
Printed Handout
Intervention Description
Printed Handout is a gestational age specific handout that addresses resuscitation and prematurity information.
Primary Outcome Measure Information:
Title
Overall knowledge of prematurity
Description
Average of overall knowledge score
Time Frame
within 24 hours of verbal counseling session
Secondary Outcome Measure Information:
Title
Gestational age sub-group knowledge scores
Description
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
Title
Sub-domain knowledge scores
Description
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
Title
Anxiety
Description
Comparison of change in participant anxiety as assessed by STAI
Time Frame
within 24 hours of verbal counseling
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir A Basir, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.
Citations:
PubMed Identifier
26324869
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.
Results Reference
background
PubMed Identifier
24785861
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.
Results Reference
background
PubMed Identifier
22492766
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.
Results Reference
background
Citation
Paivio A. Dual coding theory: Retrospect and current status. Can J Psychol. 45(3):255-87, 1991
Results Reference
background
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Counseling for Prematurity Using a Multimedia Education Tool
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