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| ID | Type | Description | Link |
|---|---|---|---|
| 22HERNPMI985239 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| ConnectionHealth | UNKNOWN |
| Memora Health | UNKNOWN |
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The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes.
Feasibility Study Aims
The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond. The objective of this pilot study is to determine if it is feasible to randomize and implement digital health and community health worker interventions.
Design Summary
The investigators will challenge existing care paradigms by testing the effectiveness of integrating innovative platforms into the existing healthcare system, including existing digital health and community health worker programs from within the EQUATE consortium, to eliminate critical barriers to equitable healthcare access. After seeking input from a Community Advisory Board, these interventions will be refined and deployed for pilot testing. Individuals in Non-Hispanic Black communities at the highest risk of adverse pregnancy outcomes which were historically underrepresented in clinical research due to structural racism will be included. The investigative team employs experts across the community, maternal, and infant health continuum.
For this pilot, 40 eligible participants will be randomized, 10 to usual care, 10 to DHI, 10 to CHW, and 10 to DHI + CHW
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Health Intervention | Experimental | This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower. |
|
| Community health worker (CHW) | Experimental | Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board. |
|
| DHI Plus CHW | Experimental | This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. |
|
| Usual Care | No Intervention | This group will receive routine prenatal care services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Health intervention | Behavioral | Health care information delivered via a link in a text message that is then opened in a secure browser. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Acceptance of Randomization Arm / Intervention | Participant acceptance is defined as a yes response to this question: "I would recommend the care I received to someone in a similar situation." | 6 weeks postpartum |
| Participant Use of Digital Health and/or Community Health Worker Interventions | Use of the intervention for the digital health arm(s) is defined as the % of opened text messages. Use of the intervention for the community health worker arm(s) is defined as the % of planned sessions in which the participant engages with the community health worker. | From randomization to 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Outpatient Perinatal Care Visits | Number of perinatal care visits | Randomization to study completion (up to 34 weeks) |
| Preterm Birth | Delivery of a neonate at less than 37 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Sinkey, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital Health Intervention (DHI) | This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower. |
| FG001 | Community Health Worker (CHW) | Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board. |
| FG002 | DHI Plus CHW | This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. |
| FG003 | Usual Care | This group will receive routine prenatal care services. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital Health Intervention (DHI) | This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Acceptance of Randomization Arm / Intervention | Participant acceptance is defined as a yes response to this question: "I would recommend the care I received to someone in a similar situation." | Posted | Count of Participants | Participants | 6 weeks postpartum |
|
Randomization to 6-weeks postpartum, up to 40 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digital Health Intervention (DHI) | This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Sinkey | University of Alabama at Birmingham | (205) 934-5612 | rsinkey@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2024 | Jun 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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Study is a pilot randomized trial (n=40) randomizing eligible participants to usual care (n=10), or usual care plus a digital health intervention (n=10), or usual care plus a community health worker intervention (n=10), or usual care plus both a digital health intervention and a community health worker intervention.
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| Community Health Worker | Behavioral | Health care information delivered via CHW. |
|
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| Digital Health Intervention plus Community Health Worker | Behavioral | Health care information delivered via DHI plus CHW |
|
| At birth |
| Neonatal Birthweight | Weight of neonate at birth | At birth |
| Cesarean Delivery | Occurrence of a cesarean birth | At birth |
| Maternal Blood Transfusion | Transfusion of blood products | At birth |
| Breastfeeding Intent | Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization | Upon admission to the delivery-associated hospitalization |
| Vaccination Rate | The number of mothers who received Tdap and infants who received the Hep B vaccine. | Pregnancy through 6 weeks postpartum / 6 weeks of life |
| Maternal Postpartum Readmission | Admission of the mother to the hospital after discharge from the delivery-associated hospitalization | From discharge from the delivery-associated hospitalization to 6 weeks postpartum |
| Neonatal Hospital Readmission | Answer to the question " How is your baby doing?" | Birth to 6 weeks of life |
| BG001 | Community Health Worker (CHW) | Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board. |
| BG002 | DHI Plus CHW | This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. |
| BG003 | Usual Care | This group will receive routine prenatal care services. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
| OG002 | DHI Plus CHW | This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. |
| OG003 | Usual Care | This group will receive routine prenatal care services. |
|
|
| Primary | Participant Use of Digital Health and/or Community Health Worker Interventions | Use of the intervention for the digital health arm(s) is defined as the % of opened text messages. Use of the intervention for the community health worker arm(s) is defined as the % of planned sessions in which the participant engages with the community health worker. | We did not collect data for this outcome as planned because the University legal department would not allow texting in the manner initially planned. | Posted | From randomization to 6 weeks postpartum |
|
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| Secondary | Outpatient Perinatal Care Visits | Number of perinatal care visits | Posted | Median | Inter-Quartile Range | Visits | Randomization to study completion (up to 34 weeks) |
|
|
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| Secondary | Preterm Birth | Delivery of a neonate at less than 37 weeks | Posted | Count of Participants | Participants | At birth |
|
|
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| Secondary | Neonatal Birthweight | Weight of neonate at birth | Posted | Median | Inter-Quartile Range | grams | At birth |
|
|
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| Secondary | Cesarean Delivery | Occurrence of a cesarean birth | Posted | Count of Participants | Participants | At birth |
|
|
|
| Secondary | Maternal Blood Transfusion | Transfusion of blood products | Posted | Count of Participants | Participants | At birth |
|
|
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| Secondary | Breastfeeding Intent | Participant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization | Posted | Count of Participants | Participants | Upon admission to the delivery-associated hospitalization |
|
|
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| Secondary | Vaccination Rate | The number of mothers who received Tdap and infants who received the Hep B vaccine. | Posted | Count of Participants | Participants | Pregnancy through 6 weeks postpartum / 6 weeks of life |
|
|
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| Secondary | Maternal Postpartum Readmission | Admission of the mother to the hospital after discharge from the delivery-associated hospitalization | Posted | Count of Participants | Participants | From discharge from the delivery-associated hospitalization to 6 weeks postpartum |
|
|
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| Secondary | Neonatal Hospital Readmission | Answer to the question " How is your baby doing?" | Posted | Count of Participants | Participants | Birth to 6 weeks of life |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Community Health Worker (CHW) | Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | DHI Plus CHW | This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Usual Care | This group will receive routine prenatal care services. | 0 | 10 | 0 | 10 | 0 | 10 |
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| No |
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| Missing |
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| Vaginal |
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| Missing |
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| No |
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| Missing |
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| Formula feed only |
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| Both breast and formula feed |
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| Do not know yet |
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| Missing |
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| Did not receive |
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| Newborn Death |
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| Newborn Hep. B |
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| No Readmission |
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| Some Illness (Hospitalization, Clinic, or ER) |
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| Baby Died |
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| Missing |
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