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Purpose
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.
Conditions
- Infant Death
- Sudden Infant Death
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- Female
- Accepts 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- 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.
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
- Masking Description
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental New low touch (LT) hospital implementation strategy |
This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm mothers will be attracted to TodaysBaby through direct-to-consumer marketing and sign themselves up using a QR code. These mothers will also receive standard postpartum care. |
|
Active Comparator Original high touch (HT) hospital implementation strategy |
This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm hospital staff will help mothers sign up and view the first 2 TodaysBaby in a one-on-one conversation format. These mothers will also receive standard postpartum care. |
|
No Intervention Control- Standard of Care |
During the 3 months immediately prior to the first intervention time period, hospitals will recruit approximately 100 mothers to complete surveys regarding infant care practices. These mothers will also receive postpartum standard of care. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Virginia