Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180811
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2023-12-06
Brief Title:
Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women
Sponsor:
Christiana Care Health Services
Organization:
Christiana Care Health Services
Study Overview
Official Title:
Evaluating the Effectiveness of a Food is Medicine Community Health Worker Program for Pregnant Women Addressing Social Needs and Improving Health Outcomes
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to conduct a pilot randomized controlled trial of a food is medicine community health worker intervention called the Womens Health Delaware Food Farmacy compared to the usual standard of care among pregnant ChristianaCare patients at risk for adverse clinical outcomes The pilot study has three specific aims
Aim 1 To assess the feasibility of the Womens Health Delaware Food Farmacy and refine the program as needed
Aim 2 To determine the prevalence of and change in social needs
Aim 3 To evaluate the effectiveness of the Womens Health Delaware Food Farmacy on maternal and child health healthcare utilization and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care
Aim 1 To assess the feasibility of the Womens Health Delaware Food Farmacy and refine the program as needed
Aim 2 To determine the prevalence of and change in social needs
Aim 3 To evaluate the effectiveness of the Womens Health Delaware Food Farmacy on maternal and child health healthcare utilization and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care
Detailed Description:
This study is a pilot randomized controlled trial where eligible pregnant ChristianaCare patients will be identified weekly through an automated list and patients who consent will be randomized to 1 of 2 arms Womens Health Delaware Food Farmacy vs usual standard of care Participants randomized to the Womens Health Delaware Food Farmacy program arm will receive medically tailored groceries that are high in micronutrients critical for a healthy pregnancy The food provided will be the equivalent of 10 meals per person in the household per week and will be delivered to participants weekly from enrollment to 4 weeks after giving birth Participants will receive culinary equipment and training recipes and educational nutrition videos and will interact weekly with their assigned Community Health Worker to address social needs and patient-centered goals Participants randomized to the usual standard of care arm will continue to receive their standard of care management
All participants will complete a questionnaire with patient-reported outcomes ie food insecurity dietary intake health-related quality of life and cost-related medication underuse at baseline and postpartum and a patient experience survey postpartum related to their experiences receiving prenatal care and giving birth at ChristianaCare In addition maternal and child health healthcare utilization and clinical event outcomes will be documented for all participants via electronic health records and assessed retrospectively Quantitative indicators related to feasibility ie acceptability demand and implementation will be collected such as program satisfaction program enrollment and retention meals provided to participants and their household food consumption and interactions with assigned Community Health Worker
Aim 1 To assess the feasibility of the Womens Health Delaware Food Farmacy and refine the program as needed
H1 Primary outcomes The investigators hypothesize that the Womens Health Delaware Food Farmacy will a prove acceptable to participants as measured by program satisfaction b meet demand as measured by project recruitment and retention number of meals provided to participants and their household and number of people providing food for and c prove implementable as measured by food consumption number of Community Health Worker interactions number of educational videos watched number of recipes reviewed and number of meal preparation sessions
Aim 2 To determine the prevalence of and change in social needs
H2 Primary outcome Social needs will be identified by administering the ChristianaCare Social Determinants of Health Screener and resource referrals will be sent on participants behalf to support their social needs both of which are the usual standard of care The investigators hypothesize that social needs will be identified through the ChristianaCare Social Determinants of Health Screener and that compared to baseline participants at postpartum will experience reductions in their social needs The investigators also hypothesize there will be some participants whose social needs will not be resolved due to a lack of community resources
Aim 3 To evaluate the effectiveness of the Womens Health Delaware Food Farmacy on maternal and child health healthcare utilization and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care
H3a Primary outcomes Maternal and child health outcomes The investigators hypothesize that compared to usual standard of care the Womens Health Delaware Food Farmacy group will demonstrate improvements in maternal and child health outcomes eg preeclampsia and small for gestational age from baseline to postpartum
H3b Primary outcomes Maternal and child healthcare utilization outcomes The investigators hypothesize that compared to usual standard of care the Womens Health Delaware Food Farmacy group will demonstrate reductions in maternal and child healthcare utilization outcomes eg neonatal intensive care unit NICU admission and maternal length of stay from baseline to postpartum
H3c Primary outcomes Maternal and child clinical event outcomes The investigators hypothesize that compared to usual standard of care the Womens Health Delaware Food Farmacy group will demonstrate reductions in maternal and child clinical event outcomes eg cesarean delivery and fetal death from baseline to postpartum
H3d Secondary outcomes Patient-reported outcomes The investigators hypothesize that compared to usual standard of care the Womens Health Delaware Food Farmacy group will demonstrate improvements in patient-reported outcomes ie food insecurity dietary intake health-related quality of life and cost-related medication underuse from baseline to postpartum
All participants will complete a questionnaire with patient-reported outcomes ie food insecurity dietary intake health-related quality of life and cost-related medication underuse at baseline and postpartum and a patient experience survey postpartum related to their experiences receiving prenatal care and giving birth at ChristianaCare In addition maternal and child health healthcare utilization and clinical event outcomes will be documented for all participants via electronic health records and assessed retrospectively Quantitative indicators related to feasibility ie acceptability demand and implementation will be collected such as program satisfaction program enrollment and retention meals provided to participants and their household food consumption and interactions with assigned Community Health Worker
Aim 1 To assess the feasibility of the Womens Health Delaware Food Farmacy and refine the program as needed
H1 Primary outcomes The investigators hypothesize that the Womens Health Delaware Food Farmacy will a prove acceptable to participants as measured by program satisfaction b meet demand as measured by project recruitment and retention number of meals provided to participants and their household and number of people providing food for and c prove implementable as measured by food consumption number of Community Health Worker interactions number of educational videos watched number of recipes reviewed and number of meal preparation sessions
Aim 2 To determine the prevalence of and change in social needs
H2 Primary outcome Social needs will be identified by administering the ChristianaCare Social Determinants of Health Screener and resource referrals will be sent on participants behalf to support their social needs both of which are the usual standard of care The investigators hypothesize that social needs will be identified through the ChristianaCare Social Determinants of Health Screener and that compared to baseline participants at postpartum will experience reductions in their social needs The investigators also hypothesize there will be some participants whose social needs will not be resolved due to a lack of community resources
Aim 3 To evaluate the effectiveness of the Womens Health Delaware Food Farmacy on maternal and child health healthcare utilization and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care
H3a Primary outcomes Maternal and child health outcomes The investigators hypothesize that compared to usual standard of care the Womens Health Delaware Food Farmacy group will demonstrate improvements in maternal and child health outcomes eg preeclampsia and small for gestational age from baseline to postpartum
H3b Primary outcomes Maternal and child healthcare utilization outcomes The investigators hypothesize that compared to usual standard of care the Womens Health Delaware Food Farmacy group will demonstrate reductions in maternal and child healthcare utilization outcomes eg neonatal intensive care unit NICU admission and maternal length of stay from baseline to postpartum
H3c Primary outcomes Maternal and child clinical event outcomes The investigators hypothesize that compared to usual standard of care the Womens Health Delaware Food Farmacy group will demonstrate reductions in maternal and child clinical event outcomes eg cesarean delivery and fetal death from baseline to postpartum
H3d Secondary outcomes Patient-reported outcomes The investigators hypothesize that compared to usual standard of care the Womens Health Delaware Food Farmacy group will demonstrate improvements in patient-reported outcomes ie food insecurity dietary intake health-related quality of life and cost-related medication underuse from baseline to postpartum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 90XP0484 | OTHER_GRANT | Administration for Children and Families | None |