Baby Steps to Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Care Box.
- Who it may be relevant to
- Registry conditions: Prenatal Follow Up Care. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Baby Steps to Care - Improving Access to Prenatal Care From the Emergency Department
Overview
The purpose of this research study is to understand if receipt of extra prenatal resources from the ED visit improves i) the patient's ability to engage in prenatal services after the ED visit, and ii) how it impacts the patient's pregnancy knowledge and confidence. If participant's consent to this study, the participants will receive standard of care and additionally be randomized, like flipping a coin, to receive either i) extra prenatal care resources in the form of a 'care box' during this ED visit, or ii) the extra prenatal care resources in the form of a 'care box" two weeks from today. All participants will also receive a follow-up survey asking about the patient's engagement in prenatal services following ED visit, perceptions of pregnancy knowledge and confidence, the usefulness of the resources received, and what additional resources might have been helpful during the early stages of pregnancy. Participation in this study will not require any additional clinic or hospital visits. The total time involved is approximately 20 minutes during the initial ED visit and less than 20 minutes to complete the follow-up survey. Investigators hope to enroll a total of 50 participants in this study.
Interventions
- Behavioral Care Box
The resources in the care box include a water bottle, pocket calendar (monthly planner) and pen, recorder in the shape of a heart, bus pass, mini stuffed animal, and a welcome insert (includes descriptions for the items and a QR code with additional resources) additionally, the QR code will be on the inside of the box's top as well as on the insert.
Primary outcome measures
- Change in number of OBGYN follow up appointments as measured by medical record review [Time frame: 1 week, 1 month, 3 months, 6 months, 9 months]
Secondary outcome measures (6)
- Number of participants with a pregnancy outcome of 1 as measured by medical record review [Time frame: Up to 9 months]
- Number of participants with a pregnancy outcome of 2 as measured by medical record review [Time frame: Up to 9 months]
- Number of participants with a pregnancy outcome of 3 as measured by medical record review [Time frame: Up to 9 months]
- Number of participants with a pregnancy outcome of 4 as measured by medical record review [Time frame: Up to 9 months]
- Number of participants with a pregnancy outcome of 5 as measured by medical record review [Time frame: Up to 9 months]
- Number of participants who affirmed the care box supported the pregnancy as measured by patient survey [Time frame: Up to 1 week]
Eligibility criteria
Inclusion criteria
- Found to be pregnant in the CMC Emergency Department through serum or urine pregnancy testing (hcg) or point of care (POC) urine testing
- Ability to provide verbal consent to this study
Exclusion criteria
- Prisoners
- Non-Ohio residents
- Serious medical conditions (severe cardiovascular disease, infections, trauma) or critical illness requiring urgent hospitalization
- Nonpregnant persons including men
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University University Cleveland Medical Center — Cleveland
Identifiers
NCT: NCT07499648 · STUDY20251517