- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01859065
"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
Kennedy et al, in a study of pediatric Emergency Department (ED) use by newborns less than 14 days of age, revealed that half of all visits in this population were non-acute problems. Other pediatric ED utilization studies have shown similar findings in that 32% to 72% of all visits were for non-urgent problems.
Many studies have found that primiparity and young maternal age are associated with non-acute ED presentations. A recent factor that has been investigated is the effect of early neonatal discharge. Some other factors are nonwhite mothers and mothers on Medicaid. Zandieh et al, found additional predisposing determinants for non-urgent ED visits, such as single parenthood, Hispanic ethnicity, and having perceptions that their child's overall physical health was poor.
Paradis et al found that parents receiving a video intervention rated higher confidence with specific infant care skills and reported feeling better prepared to care for their baby, compared to parents receiving only handouts. However, there isn't any reported study that evaluates the benefits of receiving both, a video intervention along with handouts.
Aim: to demonstrate whether conducting anticipatory guidance related to non-urgent problems will reduce non-urgent ED visits, compared to care as usual (CAU) anticipatory guidance (Sudden Infant Death Syndrome and Shaken Baby Syndrome videos; and unstructured talk about jaundice, vaccinations, appointments, care of umbilical stump, normal urination and bowel movement, fever).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inclusion Criteria: Mother of a newborn in the Well Baby Nursery (WBN) of Bronx-Lebanon Hospital Center during the 4-month recruitment period of the study.
Exclusion Criteria:
- Mothers selected for video-based anticipatory guidance that have a hearing/vision impairment.
- Mothers selected for handout-based anticipatory guidance who speak a language other than Spanish or English.
Primary outcome measure: reduction in non-urgent ED visits in mothers who received the intervention (video-based and handout-based anticipatory guidance regarding non-urgent problems), compared to the control group (received CAU anticipatory guidance)
Secondary outcome measure: improvement in parental knowledge, attitude and behaviors related to non-urgent problems as a result of receiving anticipatory guidance (video and handouts) regarding non-urgent problems;
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10457
- Bronx Lebanon Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mother of a newborn in the WBN of Bronx-Lebanon Hospital Center during the 4-month recruitment period of the study
Exclusion Criteria:
- Mothers selected for video-based anticipatory guidance that have a hearing/vision impairment.
- Mothers selected for handout-based anticipatory guidance who speak a language other than Spanish or English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
Mothers receive routine anticipatory guidance
|
Routine anticipatory guidance (control)
|
|
Experimental: Intervention
Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance
|
Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-urgent ED visits by neonates
Time Frame: 1 month
|
Reduction in non-urgent ED visits in mothers who received the intervention (video-based and handout-based anticipatory guidance regarding non-urgent problems), compared to the control group (received CAU anticipatory guidance)
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in caregivers' knowledge and attitude
Time Frame: 1 month
|
Improvement in parental knowledge, attitude and behaviors related to non-urgent problems as a result of receiving anticipatory guidance (video and handouts) regarding non-urgent problems
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ayoade Adeniyi, MD, Bronx-Lebanon Hospital Center
Publications and helpful links
General Publications
- Paradis HA, Conn KM, Gewirtz JR, Halterman JS. Innovative delivery of newborn anticipatory guidance: a randomized, controlled trial incorporating media-based learning into primary care. Acad Pediatr. 2011 Jan-Feb;11(1):27-33. doi: 10.1016/j.acap.2010.12.005.
- Rosenthal MS, Lannon CM, Stuart JM, Brown L, Miller WC, Margolis PA. A randomized trial of practice-based education to improve delivery systems for anticipatory guidance. Arch Pediatr Adolesc Med. 2005 May;159(5):456-63. doi: 10.1001/archpedi.159.5.456.
- Schuster MA, Duan N, Regalado M, Klein DJ. Anticipatory guidance: what information do parents receive? What information do they want? Arch Pediatr Adolesc Med. 2000 Dec;154(12):1191-8. doi: 10.1001/archpedi.154.12.1191.
- Barkin SL, Scheindlin B, Brown C, Ip E, Finch S, Wasserman RC. Anticipatory guidance topics: are more better? Ambul Pediatr. 2005 Nov-Dec;5(6):372-6. doi: 10.1367/A04-2131R1.1.
- Kennedy TJ, Purcell LK, LeBlanc JC, Jangaard KA. Emergency department use by infants less than 14 days of age. Pediatr Emerg Care. 2004 Jul;20(7):437-42. doi: 10.1097/01.pec.0000132216.65600.1b.
- Pomerantz WJ, Schubert CJ, Atherton HD, Kotagal UR. Characteristics of nonurgent emergency department use in the first 3 months of life. Pediatr Emerg Care. 2002 Dec;18(6):403-8. doi: 10.1097/00006565-200212000-00001.
- Zandieh SO, Gershel JC, Briggs WM, Mancuso CA, Kuder JM. Revisiting predictors of parental health care-seeking behaviors for nonurgent conditions at one inner-city hospital. Pediatr Emerg Care. 2009 Apr;25(4):238-243. doi: 10.1097/pec.0b013e31819e350e.
- Rudominer A. Reducing Newborn Office Visits and Improving Satisfaction through Parent Education and Learning Communities. Perm J. 2009 Summer;13(3):25-30. doi: 10.7812/TPP/08-096. No abstract available.
- Kamimura-Nishimura K, Chaudhary V, Olaosebikan F, Azizi M, Galiveeti S, Adeniyi A, Neugebauer R, Hagmann SH. Does Nursery-Based Intensified Anticipatory Guidance Reduce Emergency Department Use for Nonurgent Conditions in the First Month of Life? A Randomized Controlled Trial. Int J Pediatr. 2016;2016:8356582. doi: 10.1155/2016/8356582. Epub 2016 Apr 24.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09 15 11 10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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