Health Knowledge, Attitudes, PracticeNCT01859065
"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
A study testing Intensified anticipatory guidance and Routine in people with Health Knowledge, Attitudes, Practice and Sneezing, run by Bronx-Lebanon Hospital Center Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Sneezing, Constipation
- What is being tested?
- Intensified anticipatory guidance and Routine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother of a newborn in the WBN of Bronx-Lebanon Hospital Center during the 4-month recruitment period of the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bronx Lebanon Hospital Center
The Bronx, New York, 10457
About this study
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.
Read more
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).
Read the 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;
- Conditions
- Health Knowledge, Attitudes, Practice, Sneezing, Constipation, Nasal Congestion and Inflammations
- Being tested
- Intensified anticipatory guidance, Routine
- Keywords
- Non-urgent ED visits, Neonates, Newborn care
- Medical subject headings
- Behavior, Sneezing, Constipation, Nasal Obstruction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified anticipatory guidanceBehavioural
Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance
RoutineBehavioural
Routine anticipatory guidance (control)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Mothers receive routine anticipatory guidance Receives: Behavioral: Routine |
| Intervention | Experimental | Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance Receives: Behavioral: Intensified anticipatory guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month
Secondary outcomes (1)
Changes in caregivers' knowledge and attitude
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startDec 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bronx-Lebanon Hospital Center Health Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Kamimura-Nishimura, Bronx-Lebanon Hospital Center Health Care System
- Investigators
- Ayoade Adeniyi, MD, Principal investigator, Bronx-Lebanon Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859065
- Sponsor's protocol ID
- 09 15 11 10
- Status last verified
- May 2013
- First submitted
- 17 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21272821Rosenthal 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.
PubMed 15867120Schuster 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.
PubMed 11115301Barkin 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.
PubMed 16302840Kennedy 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.
PubMed 15232243Pomerantz 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.
PubMed 12488831Zandieh 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.
PubMed 19382324Rudominer 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.
PubMed 20740085Kamimura-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.
PubMed 27212955
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
- ClinicalTrials.gov ID
- NCT01859065
- Acronym / sponsor ID
- 09 15 11 10
- Conditions
- Health Knowledge, Attitudes, Practice, Sneezing, Constipation, Nasal Congestion and Inflammations
- Keywords
- Non-urgent ED visits, Neonates, Newborn care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Bronx-Lebanon Hospital Center Health Care SystemUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: RoutineMothers receive routine anticipatory guidance |
| Intervention | Experimental | Behavioral: Intensified anticipatory guidanceMothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mother of a newborn in the WBN of Bronx-Lebanon Hospital Center during the 4-month recruitment period of the study
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensified anticipatory guidanceMothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance | Behavioural | Intervention |
| RoutineRoutine anticipatory guidance (control) | Behavioural | Control |
Primary outcome
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 secondary outcome
Changes in caregivers' knowledge and attitude
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Background: PubMed 21272821Paradis 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.
- Background: PubMed 15867120Rosenthal 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.
- Background: PubMed 11115301Schuster 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.
- Background: PubMed 16302840Barkin 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.
- Background: PubMed 15232243Kennedy 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.
- Background: PubMed 12488831Pomerantz 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.
- Background: PubMed 19382324Zandieh 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.
- Background: PubMed 20740085Rudominer 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.
- Derived from this study: PubMed 27212955Kamimura-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayoade Adeniyi, MD principal investigator
Bronx-Lebanon Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensified anticipatory guidance and Routine in people with Health Knowledge, Attitudes, Practice and Sneezing, run by Bronx-Lebanon Hospital Center Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-urgent ED visits by neonates (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859065, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.