Trial Outcomes & Findings for Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance (NCT NCT01014169)
NCT ID: NCT01014169
Last Updated: 2012-10-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
two days after discharge
Results posted on
2012-10-19
Participant Flow
Mothers on the postpartum ward of an urban safety-net hospital were recruited. Inclusion criteria included gestational age \> 35 weeks, fluency in English or Spanish, and access to a telephone. Mothers were excluded if there was prolonged hospitalization of the mother or the infant or if they were not expected to retain custody of the infant.
Participant milestones
| Measure |
Usual Care
Mothers in the control group received 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
The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
61
|
|
Overall Study
COMPLETED
|
58
|
48
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance
Baseline characteristics by cohort
| Measure |
Usual Care
n=65 Participants
Mothers in the control group received 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
n=61 Participants
The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
27.8 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
28.9 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
28.3 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Language
English
|
37 participants
n=5 Participants
|
36 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Language
Spanish
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Number of pregnancies
|
2 Pregnancies
n=5 Participants
|
2 Pregnancies
n=7 Participants
|
2 Pregnancies
n=5 Participants
|
|
Number of Children
|
2 Children
n=5 Participants
|
2 Children
n=7 Participants
|
2 Children
n=5 Participants
|
|
Type of delivery
Vaginal
|
46 participants
n=5 Participants
|
46 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Type of delivery
Cesarean section
|
19 participants
n=5 Participants
|
15 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Type of Insurance
Medicaid
|
52 participants
n=5 Participants
|
46 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Type of Insurance
Free Care
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Type of Insurance
Private
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Type of Insurance
None
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Highest Education Level
Less than/some high school
|
24 participants
n=5 Participants
|
14 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Highest Education Level
High school graduate
|
15 participants
n=5 Participants
|
21 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Highest Education Level
Vocational/trade school
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Highest Education Level
Some college
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Highest Education Level
Associates degree
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Highest Education Level
Bachelors degree
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Highest Education Level
Graduate/professional degree
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Received prenatal care
Yes
|
65 participants
n=5 Participants
|
61 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Received prenatal care
No
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Attended Childbirth Classes
Yes
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Attended Childbirth Classes
No
|
55 participants
n=5 Participants
|
49 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Other Adults in the Home
No other adult in home
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Other Adults in the Home
Spouse/partner
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Other Adults in the Home
Baby's grandmother
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Other Adults in the Home
Baby's grandfather
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Other Adults in the Home
Baby's uncles or aunts
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Other Adults in the Home
Other adult
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Nurse Practitioner
Patients Seen By Nurse Practitioner # 1
|
37 participants
n=5 Participants
|
34 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Nurse Practitioner
Patients Seen By Nurse Practitioner # 2
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Nurse Practitioner
Patients Seen By Nurse Practitioner # 3
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: two days after dischargeThis 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.
Outcome measures
| Measure |
Usual Care
n=58 Participants
Mothers in the control group received 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
n=48 Participants
The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
|
|---|---|---|
|
The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.
|
45 participants who report supine position
|
42 participants who report supine position
|
SECONDARY outcome
Timeframe: two days after dischargeThis measure assesses maternal report of breastfeeding. The number analyzed is the number who reported any breastfeeding.
Outcome measures
| Measure |
Usual Care
n=58 Participants
Mothers in the control group received 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
n=48 Participants
The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
|
|---|---|---|
|
Maternal Practice Related to Breastfeeding Initiation
|
50 participants who report breastfeeding
|
46 participants who report breastfeeding
|
SECONDARY outcome
Timeframe: two days after dischargeCorrect 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.
Outcome measures
| Measure |
Usual Care
n=55 Participants
Mothers in the control group received 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
n=46 Participants
The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
|
|---|---|---|
|
Maternal Practice Related to Correct Car Seat Use
|
48 participants with correct car seat use
|
46 participants with correct car seat use
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Note Taking
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Caroline Kistin
Boston University School of Medicine/Boston Medical Center
Phone: 617-414-3642
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place