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"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01859065
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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).


Condition or disease Intervention/treatment
Health Knowledge, Attitudes, Practice Sneezing Constipation Nasal Congestion and Inflammations Behavioral: Intensified anticipatory guidance Behavioral: Routine

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:

  1. Mothers selected for video-based anticipatory guidance that have a hearing/vision impairment.
  2. 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: "Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
Study Start Date : December 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Control
Mothers receive routine anticipatory guidance
Behavioral: Routine
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
Behavioral: Intensified anticipatory guidance
Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859065


Locations
United States, New York
Bronx Lebanon Hospital Center
Bronx, New York, United States, 10457
Sponsors and Collaborators
Bronx-Lebanon Hospital Center Health Care System
Investigators
Principal Investigator: Ayoade Adeniyi, MD Bronx-Lebanon Hospital Center
More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kelly Kamimura-Nishimura, MD, Pediatric Resident, Bronx-Lebanon Hospital Center Health Care System
ClinicalTrials.gov Identifier: NCT01859065     History of Changes
Other Study ID Numbers: 09 15 11 10
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Kelly Kamimura-Nishimura, Bronx-Lebanon Hospital Center Health Care System:
Non-urgent ED visits
Neonates
Newborn care

Additional relevant MeSH terms:
Inflammation
Emergencies
Constipation
Sneezing
Pathologic Processes
Disease Attributes
Signs and Symptoms, Digestive
Signs and Symptoms
Signs and Symptoms, Respiratory