Infant Death, Sudden Infant Death
Conditions
Keywords
Safe Sleep, Mobile Messaging
Brief summary
This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention.
Interventions
BEHAVIORALTodaysBaby
The TodaysBaby intervention is comprised of: 1) Text message-delivered, short educational videos in the first 2 months after birth, with each video timed to match content addressing anticipated barriers and facilitators to adhering to guidelines (e.g. parental concerns that infant will choke while supine). Participants will also have access to a web portal where intervention videos will be maintained. 2) Text queries regarding safe sleep practices, which collect data on sleep practices in near real-time and provide reinforcement of adherence. Mothers will receive 1-2 text message questions weekly that assess sleep practices in near real-time .
Sponsors
Washington University School of Medicine
Boston Medical Center
Boston University
University of Massachusetts, Worcester
Columbia University
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
None (Open Label)
Intervention model description
This is a hybrid type 3 implementation-effectiveness cluster randomized trial at 20 US birth hospitals. In a crossover design separated by a 1-month washout period, we will test 2 strategies for recruitment of mothers into the 2-month-long TodaysBaby mobile safe sleep education program: 1) The original TodaysBaby implementation strategy (HT), in which hospital staff recruit mothers and view the first 2 videos with them; and 2) A new low-touch (LT) hospital implementation strategy, in which mothers are attracted to TodaysBaby through direct-to-consumer marketing and sign themselves up using a QR code.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Must speak English or Spanish * Must live in the United States * Must have given birth to a healthy, term infants (37 weeks or greater) and be discharged within 7 days of birth * Must plan to care for infant and live in the same household as infant after birth * Must enroll in the TodaysBaby program by the time their infant is 7 days of age
Exclusion criteria
* A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penetration of sign up for TodaysBaby | First week after birth | Rate of sign up for TodaysBaby among mothers that sign up during the different implementation strategies |
| Equity of sign up for TodaysBaby | First week after birth | Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustainability | Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods | Staff perception that the implementation strategies could continue to be delivered after the end of the study (measured through semi-structured interviews); monthly penetration rates |
| Fidelity | First 60 days after birth | Number of videos viewed by mother, divided by total videos among mothers enrolled in the different implementation strategies |
| Feasibility of implementation | Within a year of participant enrollment (qualitative) and >60 day after birth survey | Staff perception that the implementation strategies were successfully used or carried out (measured through semi-structured interviews; Rate of maternal report that signing up for TodaysBaby was simple and fast |
| Program cost of TodaysBaby | 60-180 days during the program sign up periods. | Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies |
| Effectiveness of TodaysBaby on safe sleep practices | 60-180 days (average 80 days) after birth survey | We will measure 4 sleep practices in the past 2 weeks among mothers enrolled in the different implementation strategies: Sleep position: % reporting supine position only Sleep location: % reporting roomsharing not bedsharing only Soft bedding: % reporting no soft bedding in sleep space Pacifier: % reporting usual pacifier use when infant sleeping |
| Acceptability | Within a year of participant enrollment | Staff perception that the delivery of the implementation strategies was satisfactory (measured through semi-structured interviews) |
Countries
United States
Contacts
Primary ContactSarah Roth, MPH
Outcome results
None listed