Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Meharry Medical College
Phase 1: COVID-19 Breastfeeding Guideline Assessment Survey. 40 mothers who delivered during the period starting from January 1, 2020 to date will be recruited and consented to assess their exclusive breastfeeding (EBF) and COVID-19 breastfeeding patterns using a survey designed to be completed by interview on Zoom, phone, or any other social-distancing platform. Information to be collected in this survey will include: demography, medical history, COVID-19 status; COVID-19 breastfeeding guideline action; Stay-home pattern; Breastfeeding frequency and duration; Breastmilk expression frequency/duration; Frequency and volume of feeds with expressed breastmilk or formula. Phase 2: Intervention Development: Participating physicians will attend two 2-hour Zoom sessions, a 4-Module Online Breastfeeding Course, and a 1-hour orientation Zoom session in groups of not more than ten. The following presentations, course, surveys, other materials to be developed: 1. . Three presentations: i). Introduction: Healthy People 2020 Breastfeeding Objectives, Tennessee breastfeeding statistics, Breastfeeding role of physicians, nurses, and certified lactation consultants (CLC). ii). Breastfeeding Challenges Faced by Mothers. iii). Obstetrician Breastfeeding Promotion Challenges. 2. . Online Breastfeeding Promotion 101: A 10-hour course to be developed in partnership with Breastfeeding OUTLOOK, an online continuing education provider. 3. . Research Tools: COVID-19 Breastfeeding Guideline Assessment surveys; Pre- and Post-Intervention surveys for physicians; Pre- and Post-Intervention surveys for patients; Consent forms for physicians; Consent and HIPAA forms for patients; Recruitment flyer and Breastfeeding brochure for patients. 4. . Moderator Script for Community Engagement to guide the community-patient-provider stakeholder community advisory board (CAB) discussion sessions to review and make recommendations for revision to the following: intervention program, consent forms, surveys, brochure, COVID-19 related guidelines for pregnant and lactating mothers, and strategies to enhance participation. The 12-Person CAB of 4 mothers, 2 nurses/midwives, 2 CLCs, 2 physicians, a virologist, and a community leader. Investigator obstetrician Ladson, G. will be the moderator and the CAB recorder will be investigator Britt, A. Phase 3: Program Implementation Feasibility and Evaluation: 20 Obstetricians/Physicians will be consented and enrolled to participate as program providers, and expected to complete the following 5 tasks: 1. . Pre-Intervention Survey: This is 15-minute self-administered pre-test survey to capture breastfeeding promotion knowledge and practices, and COVID-19, other disease, and drug related breastfeeding guidelines. 2. . First In-Person Session: 2-hour Zoom session in groups of not more than 10 participants to disseminate Program introduction (20 minutes); Breastfeeding challenges faced by mothers (40 minutes); Obstetrician breastfeeding promotion challenges (40 minutes); Closing session (20 minutes) for Concerns, Q \& A. 3. . Online Breastfeeding Course 101: Participant physicians will enroll in Breastfeeding OUTLOOK and complete a 10-hour module over a two-week period. 4. . Second In-Person Session: 2-hour Zoom session in groups of 10 to provide intervention guidelines, research strategies and skills for participant recruitment, consenting, and survey administration by interview. 5. . Intervention Implementation: 20 physicians will each be expected to recruit 10 study participants in the third trimester of pregnancy from their prenatal clients over a period of two months. Physicians will complete a pre-intervention survey at enrollment and post-intervention survey 8 months after enrollment in the program. The physicians will receive intervention protocol, patient HIPPA \& consent forms, flyers, and survey booklet after signed consent received by email, and attend a one-hour program orientation in company of an office staff and/or resident physician scheduled in groups of four. The 200 study participants will sign informed consent, complete a pre-intervention patient survey, continue prenatal care, and will be followed up at 1-month and at 3-months postpartum to complete the post-intervention patient survey. Study Questionnaires. i) Mother COVID-19 Breastfeeding Guideline Assessment Survey: Demography, medical history, items from Centers for Disease Prevention and Control (CDC) \& Baby-Friendly Hospital Initiative (BFHI) breastfeeding surveys, EBF pattern since January 1, 2020, COVID-19 guideline items, COVID-19 status, Stay-home history. ii) Physician pre-intervention survey: Monthly prenatal volume, breastfeeding knowledge, and practices, CLC referral pattern, COVID-19 and other disease specific EBF guidelines. iii) Physician post-intervention survey: Breastfeeding knowledge and practices, COVID-19 and other disease specific EBF guidelines. Number of participants enrolled and number of CLC referrals. iv) Patient pre-intervention survey: Demography, medical history, CDC \& BFHI breastfeeding survey items, physician interaction items, previous CLC encounter, COVID-19 guideline items, COVID-19 status, Stay-home history. v) Patient post-intervention survey: CLC referral, CLC appointment and breastfeeding class attendance; COVID-19 guideline adherence; EBF initiation, frequency/duration of EBF; frequency and duration of breastmilk expression (manual or pump); frequency and volume of formula or breastmilk feeds. Infant feeding and growth pattern from medical records and growth charts. COVID-19 serology test (optional).
Age
18–45
Sex
FEMALE
Healthy volunteers
Accepted
