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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Northwestern University | OTHER |
| University of Chicago | OTHER |
| Rush University |
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The purpose of this study is to identify whether adding clinically integrated breastfeeding peer counseling (ci-BPC) to standard lactation care is associated with a reduction in disparities in breastfeeding intensity and duration for Black and Hispanic/Latine families.
FEEDS is a randomized control trial comparing standard lactation care to standard lactation care plus a ci-BPC. This trial will take place at three hospitals in the Chicago land area, Swedish Hospital, Highland Park Hospital, and University of Chicago Medicine Hospital. The aims of the study are: (1) To determine whether ci-BPC reduces disparities in breastfeeding outcomes for Black and Hispanic/Latine participants, (2)To determine whether ci-BPC improves breastfeeding knowledge, attitude, access to support, and empowerment, (3) To understand implementation outcomes, facilitators, and barriers, and (4) To identify associated patient centered costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | Standard lactation care is provided by postpartum RNs on the inpatient unit and RNs who are board certified in lactation (IBCLCs).Postpartum RNs provide support to all patients post delivery with direct breastfeeding, breast pump use, and addressing routine breastfeeding concerns. IBCLCs provide direct lactation care for more complicated lactation problems and is delivered in a dosed manner based on the nature of the lactation problem, with low-risk patients often having no encounters. | |
| ci-BPC with Standard of Care | Active Comparator | In addtion to normal standard of care (as described above), patients will also receive clinically-integrated breastfeeding peer counseling (ci-BPC) from a Peer Counselor at four timepoints throughout the perinatal period. The encounters will take place either in person or virtually and include: an intake encounter between 2- and 30 weeks gestation, a dedicated prenatal infant feeding education encounter, at least one inpatient encounter post-delivery during the delivery admission, and at least one postpartum encounter. Patients will also have access to a "warmline" that will include phone follow up by the next business day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ci-BPC with Standard of Care (SOC) | Behavioral | Clinically-integrated breastfeeding peer counseling (ci-BPC) is a practice that, supports the patient and the clinical care team by delivering culturally-appropriate breastfeeding help to motivate breastfeeding initiation, intensity, and duration, inspiring confidence for patients to set breastfeeding goals and meet them. ci-BPC is delivered by community health workers who have breastfed an infant, and have received basic training in breastfeeding support through a qualified BPC training organization. For this project, the Peer Counselor will make initial contact to patients randomized into the treatment arm via phone to schedule the Intake Encounter between 20 and 30 weeks gestation. Subsequently, each patient will receive a minimum of 3 additional encounters which can occur virtually or in-person. Patients randomized to the ci-BPC arm are additionally offered access to a "warmline" where messages will be returned by the next business day. |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding duration | Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report. | 6 weeks postpartum |
| Breastfeeding duration | Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report. | 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding intensity-inpatient | Proportion of infant feedings during the delivery admission that are breastmilk only. Number of breastmilk feeds will be divided by the total number of infant feedings. | During Delivery Admission |
| Breastfeeding intensity-post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding knowledge | Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding | Baseline 12-20 weeks |
| Breastfeeding knowledge | Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Keenan-Devlin, MPH, PhD | Contact | 8475701971 | lkeenan-devlin@northshore.org | |
| Ashley B Walther, MS | Contact | 8475702652 | awalther@northshore.org |
| Name | Affiliation | Role |
|---|---|---|
| Ann Borders, MD, MS | Endeavor Health (NorthShore University HealthSystem) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Hospital | Recruiting | Chicago | Illinois | 60625 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37494586 | Derived | Keenan-Devlin LS, Smart BP, Hirschhorn L, Meier P, Jefferson U, Solomonides A, Wang CE, Handler A, Silver RK, Borders AEB. Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity. Am J Perinatol. 2024 May;41(S 01):e2313-e2325. doi: 10.1055/s-0043-1771255. Epub 2023 Jul 21. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
Patients will be randomized 1:1 to either standard lactation care or to standard lactation care plus clinically-integrated breastfeeding peer counseling
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Proportion of infant feedings that are breastmilk only. Intensity will be calculated as # breastmilk feeds/day divided by total number of infant feedings/day as recorded in the infant feeding logs completed by study participants. |
| 6 weeks postpartum |
| Breastfeeding intensity-post discharge | Proportion of infant feedings that are breastmilk only. Intensity will be calculated as # breastmilk feeds/day divided by total number of infant feedings/day as recorded in the infant feeding logs completed by study participants. | 6 months postpartum |
| 6 weeks postpartum |
| Breastfeeding knowledge | Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding | 6 months postpartum |
| Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS) | The Iowa Infant Feeding Attitudes Scale; 26 items with a 5 point likert scale, half of which measure favorability towards breastfeeding and the remaining half measuring favorability towards formula feeding, higher scores reflect positive attitudes towards breastfeeding and lower scores reflect positive attitudes towards formula. | Baseline 12-20 weeks |
| Ci-BPC related costs | The time spent in BPC inpatient encounters, outpatient/telehealth appointments and support group sessions, travel time for BPC appointments, transportation for BPC appointments, and cellular data for telehealth BPC appointments. | 6 weeks postpartum |
| Out of pocket cost | Supplies purchased for infant feeding, including breastfeeding supplies (e.g., pump and parts, storage, contained, bras, breast pads, billows), bottles, formula, and addition food cost (including supplements) | 6 weeks postpartum |
| Feeding related opportunity costs | Time spent feeding infants (preparation, feeding, and clean up) for type of feeding (breast milk at breast, breast milk by bottle, formula) | 6 weeks postpartum |
| Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS) | The Iowa Infant Feeding Attitudes Scale; 26 items with a 5 point likert scale, half of which measure favorability towards breastfeeding and the remaining half measuring favorability towards formula feeding, higher scores reflect positive attitudes towards breastfeeding and lower scores reflect positive attitudes towards formula. | 6 weeks postpartum |
| Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS) | The Iowa Infant Feeding Attitudes Scale; 26 items with a 5 point likert scale, half of which measure favorability towards breastfeeding and the remaining half measuring favorability towards formula feeding, higher scores reflect positive attitudes towards breastfeeding and lower scores reflect positive attitudes towards formula. | 6 months postpartum |
| UChicago Medicine Hospital (University of Chicago) | Recruiting | Chicago | Illinois | 60637 | United States |
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| Endeavor Health (NorthShore University HealthSystem) | Not yet recruiting | Evanston | Illinois | 60201 | United States |
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| Highland Park Hospital | Recruiting | Highland Park | Illinois | 60035 | United States |
|