NCT01859065

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

4 months

First QC Date

May 17, 2013

Last Update Submit

May 17, 2013

Conditions

Keywords

Non-urgent ED visitsNeonatesNewborn care

Outcome Measures

Primary Outcomes (1)

  • Non-urgent ED visits by neonates

    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 Outcomes (1)

  • Changes in caregivers' knowledge and attitude

    1 month

Study Arms (2)

Control

PLACEBO COMPARATOR

Mothers receive routine anticipatory guidance

Behavioral: Routine

Intervention

EXPERIMENTAL

Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance

Behavioral: Intensified anticipatory guidance

Interventions

Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance

Intervention
RoutineBEHAVIORAL

Routine anticipatory guidance (control)

Control

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mother of a newborn in the WBN of Bronx-Lebanon Hospital Center during the 4-month recruitment period of the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronx Lebanon Hospital Center

The Bronx, New York, 10457, United States

Location

Related Publications (9)

  • 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.

    PMID: 21272821BACKGROUND
  • 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.

    PMID: 15867120BACKGROUND
  • 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.

    PMID: 11115301BACKGROUND
  • 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.

    PMID: 16302840BACKGROUND
  • 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.

    PMID: 15232243BACKGROUND
  • 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.

    PMID: 12488831BACKGROUND
  • 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.

    PMID: 19382324BACKGROUND
  • 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.

    PMID: 20740085BACKGROUND
  • 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.

MeSH Terms

Conditions

BehaviorSneezingConstipationNasal ObstructionInflammation

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveNose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic DiseasesPathologic Processes

Study Officials

  • Ayoade Adeniyi, MD

    Bronx-Lebanon Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Pediatric Resident

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 21, 2013

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations