Health EducationNCT01014169
Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance
A study testing Note taking in people with Health Education and Sudden Infant Death, run by Boston Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Education, Sudden Infant Death
- What is being tested?
- Note taking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- newborn gestational age greater than 35 weeks
- maternal spoken fluency in either English or Spanish
- a working telephone in the home.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 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.
Read the detailed description
The importance of communicating effectively with families and children is not unique to medicine. In the field of child music education, research has shown that effective parental involvement is linked to musical achievement [1]. The Suzuki method of music education in particular emphasizes this involvement and regards an effective teacher-child-parent relationship as fundamental to learning [2]. Parental engagement both during the music lesion and at home is key, and parents are routinely encouraged to take notes during the lesson so they can accurately recall the instruction for practice at home [1]. The Suzuki method is based on the idea that this model of education can be used with any family in any environment [3]. We are interested to learn whether a similar approach can be applied to pediatric anticipatory guidance in an urban population.
Note taking has been shown to improve both memory and comprehension in a number of settings. In a study of memory aids, participants taking notes exhibited higher levels of accurate recall of information than participants using other techniques [4]. Another study demonstrated that participants who took notes and then had the notes to review had improved recall of information when compared to participants who were given written information to study but did not take notes themselves [5]. Even doodling has been shown to lead to improved memory and to aid with concentration [6]. Interestingly, patient or family note taking for retention of medical information has not been extensively studied.
A number of studies have been done to look at interventions to improve both the delivery of health information and the retention of the information provided. Randomized controlled trials have looked at the impact of specific training programs for providers [7] and at practice-wide changes in office systems [8], and have shown improvements in the amount and quality of guidance provided. A study looking at the impact of physician advice on behavior change found that patients who had received counseling by their physician prior to receiving related written materials had better recall of information and were more likely to share the materials with others when compared to patients who only received the written material with no counseling [9]. A study on information recall of instructions given in the emergency department for otitis media care showed that parents retained more information at one and three days after the encounter when they received either standardized verbal or written instructions, as opposed to the usual verbal instructions [10].
The effective delivery of health information plays a central role in pediatric primary care. In 1990, the Federal Maternal and Child Health Bureau, along with the American Academy of Pediatrics, launched Bright Futures, a set of health supervision guidelines for pediatric patients aged birth to 21 [11]. The guidelines, which provide a framework for well-patient care, emphasize a partnership between the healthcare team, the family, and the child and highlight a number of recommended topics to be covered at routine visits [12]. This is a standard curriculum for primary care in many pediatric residencies, including the Boston Combined Residency Program.
For many families, the first interaction with a healthcare provider for their child occurs during the newborn evaluation prior to discharge from the hospital. The newborn anticipatory guidance recommended by Bright Futures is divided into the five categories of family readiness, infant behaviors, feeding, safety, and routine newborn care [12]. Included in these topics are recommendations for counseling on prone sleeping position, or "back to sleep," breast feeding support, and car seat use, all of which have been shown to improve infant health and safety [13,14,15]. Despite the recommendations for newborn anticipatory guidance, a national survey of parents with young children showed that 38% of parents reported never having discussed newborn care with a healthcare provider [16]. The authors of the study comment that it is difficult to know whether a portion of these families received information but were unable to remember it at the time of the survey. In the same study, a perceived lack of information was correlated with decreased satisfaction with care. The parents who reported discussing fewer anticipatory guidance topics gave their providers lower overall ratings.
A survey of sleep position of infants seen at an urban primary care center in Washington DC showed that 34.1% of infants were sleeping in the recommended supine position [17]. A subsequent study of sleep position reported by parents of black infants at a WIC clinic in Washington DC showed that 57.7% of the infants were sleeping in the supine position [13]. While there are many factors that impact parental behaviors around sleep position, the most common reasons given for supine sleeping position in this study were concern for SIDS and advice from a health care professional. These findings indicate that improved delivery of anticipatory guidance may play a role in increasing the proportion of infants sleeping on their backs.
At Boston Medical Center (BMC), a group of three nurse practitioners split full-time coverage of the newborn nursery and are responsible for doing a great deal of the newborn teaching with parents. Prior to discharge from the hospital, each infant is evaluated and teaching on newborn care is done using both verbal instruction and written handouts. This teaching, which is based on the Bright Futures recommendations, covers topics including feeding, diaper care, bathing, dressing, umbilical cord care, circumcision care, safety, sleeping, and crying. The providers also review warning signs that may indicate that an infant is sick. At the time this teaching is done, each mother is given a large envelope containing the discharge documents. On the outside of the envelope is a section designated for taking notes, although this is not currently used by the providers or parents.
In our study, a randomized controlled trial, we will draw on the techniques promoted by the Suzuki method of music education to see if the principles of increased parental involvement and parental note taking can improve information retention and impact behavior change. We 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. Our specific aims are as follows:
Specific Aim 1: To evaluate the impact of note taking during the delivery of newborn anticipatory guidance on maternal behavior. 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.
Specific Aim 2: To evaluate the impact of note taking on mothers' knowledge of recommended practices related to newborn care.
Specific Aim 3: To evaluate the impact of note taking during health information delivery on mothers' satisfaction with the guidance received.
- Conditions
- Health Education, Sudden Infant Death
- Being tested
- Note taking
- Keywords
- Health education, Sudden Infant Death, Breast Feeding, Infant Equipment
- Medical subject headings
- Health Education, Sudden Infant Death, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Note takingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | 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. |
| Note taking | Experimental | 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. Receives: Behavioral: Note taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.
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.
Measured: two days after discharge
Secondary outcomes (2)
Maternal Practice Related to Breastfeeding Initiation
This measure assesses maternal report of breastfeeding. The number analyzed is the number who reported any breastfeeding.
Measured: two days after discharge
Maternal Practice Related to Correct Car Seat Use
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.
Measured: two days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Health EducationStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Joel and Barbara Alpert Endowment For The Children of The City
- Responsible party
- Sponsor
- Investigators
- C. Jason Wang, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014169
- Sponsor's protocol ID
- H-28356
- Status last verified
- Sep 2012
- First submitted
- 13 Nov 2009
- Last updated
- 19 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kendall J. Suzuki's Mother Tongue Method. Music Educators Journal. 1986;72:47-50
Creech A and Hallam S. Parent-teacher-pupil interactions in instrumental music tuition: a literature review. B.J. Music Ed. 2003;20:29-44.
Grilli S. An interview with Dr. Shin'ichi Suzuki at the Talent Education Institute. International Review of Education. 1992; 38: 547-551.
Intons-Peterson MJ, Fournier J. External and Internal Memory Aids: When and How Often Do We Use Them? Journal of Experimental Psychology: General. 1986;115:267-280.
Kiewra KA DuBois NF, McShane CD, et al. Note-taking functions and techniques. Journal of Educational Psychology. 1991;83:240-245.
Andrade J. What Does Doodling Do? Appl Cognit Psychol.2009;23:1-7.
Gielen AC, Wilson ME, McDonald EM, Serwint JR, Andrews JS, Hwang WT, Wang MC. Randomized trial of enhanced anticipatory guidance for injury prevention. Arch Pediatr Adolesc Med. 2001 Jan;155(1):42-9. doi: 10.1001/archpedi.155.1.42.
PubMed 11177061Rosenthal 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 15867120Kreuter MW, Chheda SG, Bull FC. How does physician advice influence patient behavior? Evidence for a priming effect. Arch Fam Med. 2000 May;9(5):426-33. doi: 10.1001/archfami.9.5.426.
PubMed 10810947Isaacman DJ, Purvis K, Gyuro J, Anderson Y, Smith D. Standardized instructions: do they improve communication of discharge information from the emergency department? Pediatrics. 1992 Jun;89(6 Pt 2):1204-8.
PubMed 1594378Green M, Kessel SS. Diagnosing and treating health: bright futures. Pediatrics. 1993 May;91(5):998-1000. No abstract available.
PubMed 84748272008. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Third Edition. Elk Grove Village, IL: American Academy of Pediatrics.
Moon RY, Oden RP, Grady KC. Back to Sleep: an educational intervention with women, infants, and children program clients. Pediatrics. 2004 Mar;113(3 Pt 1):542-7. doi: 10.1542/peds.113.3.542.
PubMed 14993547United States Preventative Services Task Force: Recommendations of Breastfeeding Counseling. www.ahrq.gov/clinic/uspstf/uspsbrfd.htm. Accessed on 11/25/08.
Zaza S, Sleet DA, Thompson RS, Sosin DM, Bolen JC; Task Force on Community Preventive Services. Reviews of evidence regarding interventions to increase use of child safety seats. Am J Prev Med. 2001 Nov;21(4 Suppl):31-47. doi: 10.1016/s0749-3797(01)00377-4.
PubMed 11691560
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01014169
- Acronym / sponsor ID
- H-28356
- Conditions
- Health Education, Sudden Infant Death
- Keywords
- Health education, Sudden Infant Death, Breast Feeding, Infant Equipment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- The Joel and Barbara Alpert Endowment For The Children of The City
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Nov 2009 (estimated)
- Results
- Posted 19 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The importance of communicating effectively with families and children is not unique to medicine. In the field of child music education, research has shown that effective parental involvement is linked to musical achievement [1]. The Suzuki method of music education in particular emphasizes this involvement and regards an effective teacher-child-parent relationship as fundamental to learning [2]. Parental engagement both during the music lesion and at home is key, and parents are routinely encouraged to take notes during the lesson so they can accurately recall the instruction for practice at home [1]. The Suzuki method is based on the idea that this model of education can be used with any family in any environment [3]. We are interested to learn whether a similar approach can be applied to pediatric anticipatory guidance in an urban population.
Note taking has been shown to improve both memory and comprehension in a number of settings. In a study of memory aids, participants taking notes exhibited higher levels of accurate recall of information than participants using other techniques [4]. Another study demonstrated that participants who took notes and then had the notes to review had improved recall of information when compared to participants who were given written information to study but did not take notes themselves [5]. Even doodling has been shown to lead to improved memory and to aid with concentration [6]. Interestingly, patient or family note taking for retention of medical information has not been extensively studied.
A number of studies have been done to look at interventions to improve both the delivery of health information and the retention of the information provided. Randomized controlled trials have looked at the impact of specific training programs for providers [7] and at practice-wide changes in office systems [8], and have shown improvements in the amount and quality of guidance provided. A study looking at the impact of physician advice on behavior change found that patients who had received counseling by their physician prior to receiving related written materials had better recall of information and were more likely to share the materials with others when compared to patients who only received the written material with no counseling [9]. A study on information recall of instructions given in the emergency department for otitis media care showed that parents retained more information at one and three days after the encounter when they received either standardized verbal or written instructions, as opposed to the usual verbal instructions [10].
The effective delivery of health information plays a central role in pediatric primary care. In 1990, the Federal Maternal and Child Health Bureau, along with the American Academy of Pediatrics, launched Bright Futures, a set of health supervision guidelines for pediatric patients aged birth to 21 [11]. The guidelines, which provide a framework for well-patient care, emphasize a partnership between the healthcare team, the family, and the child and highlight a number of recommended topics to be covered at routine visits [12]. This is a standard curriculum for primary care in many pediatric residencies, including the Boston Combined Residency Program.
For many families, the first interaction with a healthcare provider for their child occurs during the newborn evaluation prior to discharge from the hospital. The newborn anticipatory guidance recommended by Bright Futures is divided into the five categories of family readiness, infant behaviors, feeding, safety, and routine newborn care [12]. Included in these topics are recommendations for counseling on prone sleeping position, or "back to sleep," breast feeding support, and car seat use, all of which have been shown to improve infant health and safety [13,14,15]. Despite the recommendations for newborn anticipatory guidance, a national survey of parents with young children showed that 38% of parents reported never having discussed newborn care with a healthcare provider [16]. The authors of the study comment that it is difficult to know whether a portion of these families received information but were unable to remember it at the time of the survey. In the same study, a perceived lack of information was correlated with decreased satisfaction with care. The parents who reported discussing fewer anticipatory guidance topics gave their providers lower overall ratings.
A survey of sleep position of infants seen at an urban primary care center in Washington DC showed that 34.1% of infants were sleeping in the recommended supine position [17]. A subsequent study of sleep position reported by parents of black infants at a WIC clinic in Washington DC showed that 57.7% of the infants were sleeping in the supine position [13]. While there are many factors that impact parental behaviors around sleep position, the most common reasons given for supine sleeping position in this study were concern for SIDS and advice from a health care professional. These findings indicate that improved delivery of anticipatory guidance may play a role in increasing the proportion of infants sleeping on their backs.
At Boston Medical Center (BMC), a group of three nurse practitioners split full-time coverage of the newborn nursery and are responsible for doing a great deal of the newborn teaching with parents. Prior to discharge from the hospital, each infant is evaluated and teaching on newborn care is done using both verbal instruction and written handouts. This teaching, which is based on the Bright Futures recommendations, covers topics including feeding, diaper care, bathing, dressing, umbilical cord care, circumcision care, safety, sleeping, and crying. The providers also review warning signs that may indicate that an infant is sick. At the time this teaching is done, each mother is given a large envelope containing the discharge documents. On the outside of the envelope is a section designated for taking notes, although this is not currently used by the providers or parents.
In our study, a randomized controlled trial, we will draw on the techniques promoted by the Suzuki method of music education to see if the principles of increased parental involvement and parental note taking can improve information retention and impact behavior change. We 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. Our specific aims are as follows:
Specific Aim 1: To evaluate the impact of note taking during the delivery of newborn anticipatory guidance on maternal behavior. 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.
Specific Aim 2: To evaluate the impact of note taking on mothers' knowledge of recommended practices related to newborn care.
Specific Aim 3: To evaluate the impact of note taking during health information delivery on mothers' satisfaction with the guidance received.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –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. |
| Note taking | Experimental | Behavioral: Note takingThe 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- newborn gestational age greater than 35 weeks
- maternal spoken fluency in either English or Spanish
- a working telephone in the home.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Note takingThe 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. | Behavioural | Note taking |
Primary outcome
The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.
Time frame: two days after discharge
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.
2 secondary outcomes
Maternal Practice Related to Breastfeeding Initiation
Time frame: two days after discharge
Maternal Practice Related to Correct Car Seat Use
Time frame: two days after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundKendall J. Suzuki's Mother Tongue Method. Music Educators Journal. 1986;72:47-50
- BackgroundCreech A and Hallam S. Parent-teacher-pupil interactions in instrumental music tuition: a literature review. B.J. Music Ed. 2003;20:29-44.
- BackgroundGrilli S. An interview with Dr. Shin'ichi Suzuki at the Talent Education Institute. International Review of Education. 1992; 38: 547-551.
- BackgroundIntons-Peterson MJ, Fournier J. External and Internal Memory Aids: When and How Often Do We Use Them? Journal of Experimental Psychology: General. 1986;115:267-280.
- BackgroundKiewra KA DuBois NF, McShane CD, et al. Note-taking functions and techniques. Journal of Educational Psychology. 1991;83:240-245.
- BackgroundAndrade J. What Does Doodling Do? Appl Cognit Psychol.2009;23:1-7.
- Background: PubMed 11177061Gielen AC, Wilson ME, McDonald EM, Serwint JR, Andrews JS, Hwang WT, Wang MC. Randomized trial of enhanced anticipatory guidance for injury prevention. Arch Pediatr Adolesc Med. 2001 Jan;155(1):42-9. doi: 10.1001/archpedi.155.1.42.
- 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 10810947Kreuter MW, Chheda SG, Bull FC. How does physician advice influence patient behavior? Evidence for a priming effect. Arch Fam Med. 2000 May;9(5):426-33. doi: 10.1001/archfami.9.5.426.
- Background: PubMed 1594378Isaacman DJ, Purvis K, Gyuro J, Anderson Y, Smith D. Standardized instructions: do they improve communication of discharge information from the emergency department? Pediatrics. 1992 Jun;89(6 Pt 2):1204-8.
- Background: PubMed 8474827Green M, Kessel SS. Diagnosing and treating health: bright futures. Pediatrics. 1993 May;91(5):998-1000. No abstract available.
- Background2008. Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Third Edition. Elk Grove Village, IL: American Academy of Pediatrics.
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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.
C. Jason Wang, MD principal investigator
Boston Medical 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 Note taking in people with Health Education and Sudden Infant Death, run by Boston Medical Center 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 3 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 19 Oct 2012. 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. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position. (time frame: two days after discharge). 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 NCT01014169, which also lists 17 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 19 Oct 2012.