Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance
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Purpose
The delivery of anticipatory guidance is an essential component of pediatric practice. Given the large amount of information to be shared during each encounter and the limited time available, there is a need for an effective and efficient means of communication between health care providers and families. The investigators hypothesize that more active parental participation in the form of note taking during the delivery of anticipatory guidance will lead to increased knowledge, higher levels of satisfaction with the encounter, and increased adoption of recommended parenting practices.
In this study, the investigators propose a randomized controlled trial of the impact of note taking during the delivery of newborn anticipatory guidance on maternal practices related to newborn care. The investigators plan to compare a control group of mothers receiving standard of care anticipatory guidance with an intervention group of mothers who are encouraged to take written notes while receiving the anticipatory guidance. The primary outcome of interest is maternal practice related to infant sleep position, and the secondary outcomes of interest are maternal practice related to breastfeeding initiation and car seat use. The investigators also plan to evaluate the impact of note taking on mothers' knowledge of recommended practices related to newborn care and on mothers' satisfaction with the guidance received.
| Condition | Intervention |
|---|---|
|
Health Education Sudden Infant Death |
Behavioral: Note taking |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | A Randomized Controlled Trial of The Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance: the Suzuki Music Model Applied to Urban Pediatrics |
- The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position. [ Time Frame: two days after discharge ] [ Designated as safety issue: Yes ]This measure assesses maternal report of placing the infant on the back to sleep (supine sleep position) as opposed to putting the infant on its side or stomach.
- Maternal Practice Related to Breastfeeding Initiation [ Time Frame: two days after discharge ] [ Designated as safety issue: No ]This measure assesses maternal report of breastfeeding. The number analyzed is the number who reported any breastfeeding.
- Maternal Practice Related to Correct Car Seat Use [ Time Frame: two days after discharge ] [ Designated as safety issue: Yes ]Correct car seat use by all subjects who use cars was defined as placing the car seat in the back seat facing backwards and using the car seat every time the infant travels by car. The number reported is the number who report using the car seat correctly.
| Enrollment: | 126 |
| Study Start Date: | December 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Usual care
Mothers in the control group will receive the nursing discharge newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
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|
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Experimental: Note taking
The mothers in the intervention group will be given a pen and encouraged to take written notes in the notes section of the discharge envelope using their language of preference when receiving the standard newborn information.
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Behavioral: Note taking
The mothers in the intervention group will be given a pen and encouraged to take written notes in the notes section of a discharge envelope using their language of preference when receiving standard newborn discharge information.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- newborn gestational age greater than 35 weeks
- maternal spoken fluency in either English or Spanish
- a working telephone in the home.
Exclusion Criteria:
- either the newborn or the mother has a medical condition requiring hospitalization for longer than 4 days after a cesarean section or 2 days after a vaginal delivery
- mother not expected to retain custody of the infant at the time of discharge
Contacts and Locations| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: | C. Jason Wang, MD | Boston Medical Center |
More Information
Publications:
| Responsible Party: | Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT01014169 History of Changes |
| Other Study ID Numbers: | H-28356 |
| Study First Received: | November 13, 2009 |
| Results First Received: | August 20, 2012 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston Medical Center:
|
Health education Sudden Infant Death Breast Feeding Infant Equipment |
Additional relevant MeSH terms:
|
Death Sudden Infant Death Pathologic Processes Death, Sudden |
ClinicalTrials.gov processed this record on May 22, 2013