RFA-DP21-001.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Pregnancy Risk Assessment Monitoring System (PRAMS)

RFA-DP-21-001

Application Due Date: 07/15/2020

Pregnancy Risk Assessment Monitoring System (PRAMS)

RFA-DP-21-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information

Participating Organization(s)

Centers for Disease Control and Prevention

Components of Participating Organizations

National Center for Chronic Disease Prevention and Health Promotion

Notice of Funding Opportunity (NOFO) Title

Pregnancy Risk Assessment Monitoring System (PRAMS)

Activity Code

U01

Amendment I. Made May 13, 2020

1. Revised application due date. Applications are due July 15, 2020.

2. Letter of Intent (LOI) due date is June 8, 2020.

3. Revised Section V.1 Criteria, Significance, Component A. How do outcomes compare to relevant national rates, the HRSA Maternal and Child Health Bureau indicators or Healthy People 2030 Objectives?

Notice of Funding Opportunity Type

New

Agency Notice of Funding Opportunity Number

RFA-DP-21-001

Assistance Listings (CFDA) Number(s)

93.946

Category of Funding Activity:

Health

NOFO Purpose

The purpose of this NOFO is to support collection of population-based data on maternal and child health indicators (MCH) of high scientific quality from vital records jurisdictions that can be used to monitor the prevalence of maternal behaviors and experiences to inform programs, research, and systems changes that influence maternal and infant health.

This will be accomplished through three Components:

1) Component A: Core Surveillance - To implement population-based surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy, including emerging issues, among women with a recent live birth, in up to 53 vital records jurisdictions.

2) Component B: Point-in-time Tribal Surveillance - To implement point-in-time (one time, one birth year) surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy among women with a recent live birth in up to 2 federally recognized American Indian Tribes, Alaska Native Villages, or Urban Indian Organizations (UIOs) with at least 1,000 live births annually or tribal organizations that support American Indian Tribes, Alaska Native Villages or Urban Indian Organizations with a project area that covers at least 1,000 live births annually.

3) Component C: Stillbirth Surveillance - To implement population-based surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy among women who recently experienced a stillbirth, in up to 2 vital records jurisdictions.

Key Dates

Publication Date: To receive notification of any changes to RFA-DP-21-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 06/08/2020

Application Due Date: 07/15/2020

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 09/07/2020

Secondary Review: 11/04/2020

Estimated Start Date: 05/01/2021

Expiration Date: 07/16/2020 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Applications should be submitted electronically.

Executive Summary

Purpose. This NOFO solicits applications to: 1) implement standardized surveillance of postpartum women with a recent live birth or fetal death on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy; 2) implement surveillance on emerging issues related to maternal and child health that arise during the data collection cycle including post-disaster or emergency surveillance; and 3) ensure collection of timely, high quality data for ongoing monitoring of maternal and infant health to inform programs, research, and system changes.

The activities will be conducted under three Components:

Component A: Core Surveillance - To implement population-based surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy, including emerging issues, among women with a recent live birth in up to 53 vital records jurisdictions.

Component B: Point-in-time Tribal Surveillance - To implement a point-in-time (one time, one birth year) surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy among women with a recent live birth in up to 2 federally recognized American Indian Tribes, Alaska Native Villages, or Urban Indian Organizations (UIOs) with at least 1,000 live births annually or tribal organizations that support American Indian Tribes, Alaska Native Villages or Urban Indian Organizations with a project area that covers at least 1,000 live births annually.

Component C: Stillbirth Surveillance - To implement population-based surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy among women who recently experienced a stillbirth in up to 2 vital records jurisdictions.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. The estimated total funding (direct and indirect) for entire period of performance is $41,200,000 to support up to 57 awards.

Component A: Core Surveillance Estimated Funding (per year): $8,000,000 Estimated Number of Awards: 53

Component B: Point–in–Time Tribal Surveillance Estimated Funding (per year): $200,000 Estimated Number of Awards: 2

Component C: Stillbirth Surveillance Estimated Funding (per year): $200,000 Estimated Number of Awards: 2

Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may vary. The total amount awarded and the number of awards will depend upon the number, quality, duration, and cost of the applications received.

Only one award within a defined vital records jurisdiction will be made for each Component of funding. Where there are multiple applicants within a jurisdiction, applicants are encouraged to coordinate on a single NOFO application per Component.

Budget and Period of Performance. The estimated total funding (direct and indirect) for the first budget period, 05/01/2021 to 04/30/2022, is $8,400,000. The estimated total funding (direct and indirect) for the entire period of performance, 05/01/2021 to 04/30/2026, is $41,200,000. The anticipated average award amount for the first budget period (direct and indirect) for each component is as follows:

Component A: Core Surveillance Period of Performance: 5 years (05/01/2021 to 04/30/2026) Estimated Funding (per year): $8,000,000

Average amount of each award: $150,000

Component B: Point–in–Time Tribal Surveillance Period of Performance: 3 years (05/01/2021 to 04/30/2024) Estimated Funding (per year): $200,000 Average amount of each award: $100,000

Component C: Stillbirth Surveillance Period of Performance: 3 years (05/01/2021 to 04/30/2024) Estimated Funding (per year): $200,000 Average amount of each award: $100,000

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A.

are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply through their organization.

Number of PDs/PIs. Applications may include more than one PI; however, the first PI listed on the application will be the “contact PI” for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

Number of Applications. One application per eligible institution (normally identified by having a unique DUNS number) is allowed for each Component of funding. Separate applications are required for each Component.

Application Type. New Special Date(s). None Application Materials. See Section IV.1 for application materials. Please note that Form F is to be used when downloading the application package https://grants.nih.gov /grants/how-to-apply-application-guide/forms-f/research-forms-f.pdf

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: 1- 888-232-6348.

A link to this NOFO on Grants.gov is available at https://www.cdc.gov/chronicdisease/progr ams-impact/nofo/index.htm

Part 2. Full Text

Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under Section 317K of the Public Health Service Act, [42 U.S.C.

247b-12], as amended, and Section 317 of the Public Health Service Act, 42 U.S.C. 247b.

1. Background and Purpose

Background

The Pregnancy Risk Assessment Monitoring System (PRAMS) was initiated in 1987 due to stagnant infant mortality rates [1]. PRAMS data are used to examine the associations between risk factors and outcomes, explore disparities by subpopulations, and compare health indicators across jurisdictions. The CDC PRAMS Program provides population-based and jurisdiction-specific estimates on a variety of maternal and infant health indicators that may not be available from any other data source. For example, PRAMS data have been used to monitor progress over time for safe infant sleep position, unintended births, and patterns of health insurance coverage.

PRAMS data are used to conduct research at the state and federal level.

PRAMS provides jurisdiction-specific and population-based data on women recently delivering a live birth or stillborn infant. Because less than 5% of the general population is pregnant at any time [2], there is a need for data that purposely samples from this population to provide stable estimates that can be stratified by population subgroup, as well as to provide jurisdiction-specific estimates of maternal experiences and behaviors that occur before, during, and shortly after pregnancy.

The data collection processes for PRAMS has been fine-tuned over time to achieve timely, high quality scientific data that meets the needs of various stakeholders by maximizing response rates, while minimizing respondent burden [3]. The CDC PRAMS Program continually assesses PRAMS methods and procedures through comparisons with industry standards, consultation with organizations funded to implement PRAMS, other experts in the field, and feedback from the PRAMS data collectors. A new version of the questionnaire, with potential adaptations to the existing PRAMS methodology (e.g., online data collection) will occur under this NOFO.

Questions included on the PRAMS questionnaire are cognitively tested to ensure respondents understand survey questions as intended. The core PRAMS surveillance methodology, including study design, data collection procedures, questionnaires and sampling, is documented in the PRAMS protocol [1, 3, 4].

The CDC PRAMS Program regularly collaborates with other federal agencies to identify other sources of maternal and infant data that may be duplicative and identify opportunities to leverage and learn from other data collection systems. In recent years, PRAMS has also proven to be a versatile system to address emerging health issues through the use of questionnaire supplements [3]. Leveraging the PRAMS infrastructure has allowed survey supplements on emerging topics to be quickly implemented across impacted funded sites to provide timely data for analysis and dissemination. To date, survey supplements have been developed and implemented for a variety of topics, including the H1N1 flu pandemic, family history of breast and ovarian cancer, e-cigarette use, Zika virus, marijuana and prescription opioid drug use, maternal disability, and disaster preparedness. The PRAMS methodology has been adapted to conduct surveillance among women with a recent stillbirth, and to conduct a telephone call-back survey at 9 months postpartum in jurisdictions with high rates of opioid-related overdose deaths [5]. The PRAMS surveillance system has also been leveraged to inform efforts of the Health Resources and Services Administration’s (HRSA) Maternal and Child Health Bureau by oversampling Healthy Start clients to allow comparisons with similar populations not participating in Healthy Start [6].

Purpose

The purpose of PRAMS is to collect vital records jurisdiction-specific and population-based data on maternal and child health indicators (MCH) of high scientific quality that can be used to monitor the prevalence of maternal behaviors and experiences to inform programs and systems changes that influence maternal and infant health, as well as conduct research.

The intent of this NOFO is to collect PRAMS data that can be used by federal agencies, states, jurisdictions, clinical groups, policymakers, and researchers to monitor the prevalence of maternal behaviors and experiences and to assess progress on maternal and infant health indicators (e.g., Healthy People 2030 targets, Health Resources and Services Administration’s (HRSA) Title V Maternal and Child Health Program performance measures) [7-9]; to investigate emerging issues in maternal and infant health; to support research; and to assess impacts of programs and system changes aimed at improving the health of mothers and infants.

Researchers have used PRAMS data to answer research and programmatic questions of interest to the field of maternal and child health using analytical techniques, such as econometric and epidemiological modeling. Findings from PRAMS data collection are also used to inform programs and policies that improve maternal and child health as described in CDC PRAMS Data to Action Success Stories [10] collected from exisiting and previous awardees. Results are translated into useable information for public health action, including fact sheets, presentations, and educational materials. The CDC PRAMS Program releases reports on surveillance topics and key indicators and highlight new publications on the CDC PRAMS website (https://www.cdc.gov/prams/) [1].

Healthy People 2020 and other National Strategic Priorities

PRAMS data will be used to monitor progress towards four HP2030 objectives related to Maternal, Infant, and Child Health (3 of which are developmental) [9]:

1. Increase the proportion of infants who are put to sleep on their backs.

2. (Developmental) Increase the proportion of infants who are put to sleep in a safe sleep environment.

3. (Developmental) Increase the percentage of women who are screened for postpartum depression at their postpartum checkup.

4. (Developmental) Decrease the proportion of pregnant women who use illicit opioid pain relievers during pregnancy.

Public Health Impact

PRAMS surveillance data will be used to establish an evidence base for data-driven public health decision making and program development. Data will be used to: 1) document estimates and trends in maternal and infant indicators; 2) identify subpopulations at greatest risk for the adverse birth outcomes and inform prevention strategies; 3) inform the HRSA Title V needs assessment process to help jurisdictions plan for and allocate MCH block grant funds; 4) develop programs and system changes that support improvement of maternal and infant health;

5) investigate emerging issues in maternal and infant health; and 6) support health professionals to incorporate the latest research findings into their standards of practice.

Relevant Work

Historically, the PRAMS surveillance project has been a collaboration between the Centers for Disease Control and Prevention (CDC) and health departments, which were funded to collect jurisdiction-specific, population-based data on maternal behaviors and experiences before, during, and shortly after pregnancy to provide information on a wide range of risk factors that influence maternal and infant health.

PRAMS has collected information from women with a recent live birth since inception of the project, but there has been a data gap for women who have a pregnancy that results in a loss, such as a stillbirth, defined as a fetal death at 20 weeks of gestation or more. In 2016, CDC funded one site to adapt PRAMS methodology and data collection tools to assess maternal behaviors and experiences before, during and shortly after pregnancy among women with a recent stillbirth [5, 11]. Essential data for monitoring stillbirth and related factors such as periconceptional, antenatal, and postpartum health care after a pregnancy loss were obtained.

PRAMS data has been used in the assessment of CDC Winnable Battles (https://www.cdc.gov /winnablebattles/) [12] as they relate to maternal and infant health:

Opioids HIV elimination Vaccine Preventable Disease

Other ongoing CDC activities in the National Center for Chronic Disease Prevention and Health Promotion’s Division of Reproductive Health that complement this activity include the Maternal and Child Health Epidemiology Program (MCHEP), Enhancing Reviews and Surveillance to Eliminate Maternal Mortality Program (ERASE MM), Perinatal Quality Collaboratives (PQCs), CDC’s Opioid Response Coordination Unit activities that encompass Rapid Assessment of Maternal Opioid Use and Overdose to Improve Outcomes and Save Lives.

PRAMS data support these activities by providing population-based information on jurisdiction-level MCH priorities to help inform the initiatives and programs of the MCHEP, PQCs, and Maternal Mortality Review Committees (MMRCs) [13-16].

2. Approach

The Pregnancy Risk Assessment Monitoring System collects jurisdiction- and population-based information on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy. Awardees will implement major project components, including representative sampling, data collection operations, project staffing, convening of a steering committee, data analysis, and data translation according to the PRAMS protocol. The expected outcomes are to produce high quality data representative of the awardee’s population that can be used to monitor prevalence of maternal behaviors and experiences to inform programs, research, and system changes that influence maternal and infant health.

This announcement includes 3 separate funding components:

Component A: Core Surveillance Component B: Point-in-time Tribal Surveillance Component C: Stillbirth Surveillance

Applicants may apply for Component A or B, but not both. To be funded for Component C, applicants must also apply for and receive funding for Component A. Separate applications are required for each Component.

Component A: Core Surveillance 5-year Period of Performance

Component A is to conduct standardized ongoing core PRAMS surveillance, using a core survey with approximately 55-questions, among women with a recent live birth. Sites conducting PRAMS surveillance may adapt methods and implement survey supplements to respond to emerging issues that arise during the data collection cycle including response to post-disaster or emergency surveillance needs.

Requirements for Component A are listed below:

Data Collection

1. Collaborate with the Office of Vital Records, the official office to record all births within the jurisdiction to ensure availability of data for monthly sampling, data quality checks, an accurate sampling frame, and final year birth files.

2. Develop and implement a sampling stratification plan that addresses data collection among subpopulations that are disproportionately affected by adverse maternal and infant health outcomes (e.g., based on race, ethnicity, or geography).

3. Adhere to data collection procedures as documented in the current CDC PRAMS protocol or any future updates of the protocol, including closing and submitting of each monthly batch of data to CDC within the 95-day data collection period and maintaining telephone operations with maximum recommended calls to each sampled woman throughout the data collection process. All monthly batches for the entire year should be submitted to CDC by June 30 of the year following the data collection year.

4. Achieve the minimum annual response rate set by CDC, which is currently 55%

5. Use data collection software provided by CDC for PRAMS operations.

6. Maintain adequate staffing to conduct data collection activities and project operations, including a suggested minimum of 2 full-time equivalents, between CDC funded and in-kind support, committed to working on daily operations and project coordination, and a PD/PI dedicating at least 10% time to the project to support the PD/PI responsibilities outlined in Section VI.4. Cooperative Agreement Terms and Conditions of Award.

7. Submit final year birth files to CDC by September 1 of the year following the data collection year (i.e., 9/1/22 for 2021 data collection); the birth file must include all the elements required by CDC for data weighting.

8. Provide input into the development of a new version of the PRAMS questionnaire, and implement the new questionnaire within the specified timeline with potential adaptations to the existing PRAMS methodology (e.g., online data collection).

Data Analysis and Research

1. Form a Steering Committee as outlined in the PRAMS protocol to advise the jurisdiction’s PRAMS project in the development and selection of questions for the survey and on the use, dissemination, and application of findings; steering committees are expected to meet annually beginning during the first year post-award.

2. Develop an analysis plan by the 8th month post award to be updated annually at the end of each calendar year that reflects the jurisdiction’s priorities for PRAMS analyses.

3. Analyze and disseminate jurisdiction-specific PRAMS results annually, within 1 year of receiving a weighted dataset from CDC.

4. Sign a data sharing agreement that will be provided by CDC, to allow CDC to release a pre-determined, restricted set of birth certificate variables to share with internal and external stakeholders and researchers for analytic purposes, per terms of the data sharing agreement between CDC and awardees for the duration of the period of performance.

CDC will provide one standard PRAMS Data Sharing Agreement at the time of award as opposed to separate agreements for resource purposes and to facilitate data sharing on behalf of awardees. Compliance with this data sharing agreement is required to ensure that the objectives of the NOFO are met.

Data Translation

1. Collaborate with the maternal and child health (MCH) unit of the applicant jurisdiction’s approved Title V recipient to identify contact information for sampled women and to assist with the selection of questions for the survey and on the use, dissemination, and application of findings.

2. Document two data-to-action examples using the CDC-provided template annually and submit to CDC with the yearly continuation application.

Capacity Building

1. Participate in routine conference calls to discuss operational and analytic activities with CDC; participate in webinars and conference calls organized by CDC to discuss issues that affect all awardees; and attend in-person awardee meetings hosted by CDC.

Component B: Point-in-Time Surveillance Tribal Surveillance 3-year period of performance

Component B is to conduct point-in-time (one time, one birth year) PRAMS surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy among women with a recent live birth for federally-recognized American Indian Tribes, Alaska Native Villages, or Urban Indian Organizations (UIOs) with at least 1,000 live births annually or tribal organizations that support American Indian Tribes, Alaska Native Villages or Urban Indian Organizations. To provide reliable statistical estimates, the proposed project should cover an area with at least 1,000 live births annually to American Indian/Alaska Native women.

Requirements for Component B are listed below:

Data Collection

1. Collaborate with the Office of Vital Records, the official office to record all births within the jurisdiction to ensure availability of data for monthly sampling, data quality checks, and final year birth files.

2. Develop and implement a sampling stratification plan that addresses data collection among subpopulations that are disproportionately affected by adverse maternal and infant health outcomes (e.g., based on race, ethnicity, or geography).

3. Adhere to data collection procedures as documented in the CDC PRAMS protocol, including closing and submitting of each monthly batch of data to CDC within the 95-day data collection period and maintaining telephone operations with maximum recommended calls to each sampled woman throughout the data collection process. All monthly batches for the entire year should be submitted to CDC by June 30 of the year following the data collection year.

4. Achieve the minimum annual response rate set by CDC, which is currently 55%

5. Use data collection software provided by CDC for PRAMS operations.

6. Maintain adequate staffing to conduct data collection activities and project operations, including a suggested minimum of 2 full-time equivalents, between CDC funded and in-kind support, committed to working on daily operations and project coordination, and a PD/PI dedicating at least 10% time to the project to support the PD/PI responsibilities outlined in Section VI.4. Cooperative Agreement Terms and Conditions of Award.

7. Submit final year birth files to CDC by September 1 of the year following the data collection year (i.e., 9/1/22 for 2021 data collection); the birth file must include all the elements required by CDC for data weighting.

Data Analysis and Research

1. Form a Steering Committee, as outlined in the PRAMS protocol, to advise the awardee’s PRAMS project in the development and selection of questions for the survey and on the use, dissemination, and application of findings; steering committees are expected to meet annually beginning during the first year post-award.

2. Develop an analysis plan by the 8th month post award that reflects the jurisdiction’s priorities for PRAMS analyses.

3. Analyze and disseminate jurisdiction-specific PRAMS results beginning within 1 year of receiving a weighted dataset from CDC.

4. Sign a data sharing agreement that will be provided by CDC, to allow CDC to release a pre-determined, restricted set of birth certificate variables to share with internal and external stakeholders and researchers for analytic purposes, per terms of the data sharing agreement between CDC and awardees for the duration of the period of performance.

CDC will provide one standard PRAMS Data Sharing Agreement at the time of award as opposed to separate agreements for resource purposes and to facilitate data sharing on behalf of awardees. Compliance with this data sharing agreement is required to ensure that the objectives of the NOFO are met.

Data Translation

1. Collaborate with the maternal and child health (MCH) unit of the applicant jurisdiction’s approved Title V recipient to identify contact information for sampled women and to assist with the use, dissemination, and application of findings.

2. Document two data-to-action examples using the CDC-provided template within 1 year of receiving a weighted dataset from CDC.

Capacity Building

1. Participate in routine conference calls to discuss operational and analytic activities with CDC; participate in webinars and conference calls organized by CDC to discuss issues that affect all awardees; and attend in-person awardee meetings hosted by CDC.

Component C: Stillbirth Surveillance 3-year period of performance

Component C is to conduct standardized PRAMS surveillance among women who recently experienced a stillbirth. PRAMS stillbirth surveillance is a stand-alone project with a separate survey (approximately 60 questions) that will be used to gather data for monitoring stillbirth occurrence and related factors such as periconceptional, antenatal, and postpartum health care after a stillbirth. The information collected will fill data gaps and inform efforts to help prevent the occurrence of stillbirth and improve care and provide support to women who experience stillbirth.

Requirements for Component C are listed below:

Data Collection

1. Collaborate with the Office of Vital Records, the official office to record all fetal deaths within the jurisdiction to ensure availability of data for monthly sampling, data quality checks, and final year fetal death files.

2. Develop and implement a sampling stratification plan that addresses data collection among subpopulations that are disproportionately affected by stillbirth (e.g., based on race, ethnicity, or geography).

3. Adhere to data collection procedures as documented in the CDC PRAMS Stillbirth protocol, including closing and submitting of each monthly batch of data to CDC within the 95-day data collection period and maintaining telephone operations with maximum recommended calls to each sampled woman throughout the data collection process. All monthly batches for the entire year should be submitted to CDC by June 30 of the year following the data collection year.

4. Achieve the minimum annual response rate set by CDC, which is currently 55%.

5. Use data collection software provided by CDC for PRAMS operations.

6. Maintain adequate staffing to conduct data collection activities and project operations, including a suggested minimum of 2 full-time equivalents, between CDC funded and in-kind support, committed to working on daily operations and project coordination, and a PD/PI dedicating at least 10% time across components A and C to support the PD/PI responsibilities outlined in Section VI.4. Cooperative Agreement Terms and Conditions of Award.

7. Submit final year fetal death files to CDC by December 1 of the year following the data collection year (i.e.,12/1/22 for 2021 data collection); the fetal death file must include all the elements required by CDC for data weighting.

Data Analysis and Research

1. Form a Steering Committee, as outlined in the PRAMS protocol, to advise the jurisdiction’s PRAMS project in the development and selection of questions for the survey and on the use, dissemination, and application of findings.

2. Develop an analysis plan by the 8th month post award to be updated annually at the end of each calendar year that reflects the jurisdiction’s priorities for PRAMS analyses;

steering committees are expected to meet annually beginning during the first year post-award.

3. Analyze and disseminate jurisdiction-specific PRAMS results within 1 year of receiving a weighted dataset from CDC.

4. Sign a data sharing agreement that will be provided by CDC, to allow CDC to release a pre-determined, restricted set of birth certificate variables to share with internal and external stakeholders and researchers for analytic purposes, per terms of the data sharing agreement between CDC and awardees for the duration of the period of performance.

CDC will provide one standard PRAMS Data Sharing Agreement at the time of award as opposed to separate agreements for resource purposes and to facilitate data sharing on behalf of awardees. Compliance with this data sharing agreement is required to ensure that the objectives of the NOFO are met.

Data Translation

1. Collaborate with the maternal and child health (MCH) unit of the applicant jurisdiction’s approved Title V recipient to identify contact information for sampled women and to assist with the selection of questions for the survey and on the use, dissemination, and application of findings.

2. Document two data-to-action examples using the CDC-provided template within 1 year of receiving a weighted dataset from CDC.

Capacity Building

1. Participate in routine conference calls to discuss operational and analytic activities with CDC; participate in webinars and conference calls organized by CDC to discuss issues that affect all awardees; and attend in-person awardee meetings hosted by CDC.

Objectives/Outcomes

Component A: Core Surveillance

Objectives:

1. To implement population-based surveillance within a defined vital records jurisdiction on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy among women with a recent live birth, including emerging issues and post-disaster surveillance needs, as they arise.

2. To ensure data is of high scientific quality and comparable to other jurisdictions by following the methodology documented in the CDC PRAMS protocol.

3. To conduct comprehensive analyses of PRAMS data based on a written jurisdiction-specific analysis plan designed to inform programmatic activities, research, and public health practice.

4. To translate and disseminate analytic results into useable information for public health action that can guide program development and evaluation, in collaboration with a jurisdiction-level steering committee.

Expected outcomes:

1. Produce timely, high quality data representative of the jurisdiction’s population to monitor risk factors for maternal and infant health.

2. Analyze and disseminate PRAMS data on a variety of MCH topics to inform public health programs, research and system changes, and health care system changes.

3. Document efforts to translate data into useable information for public health action.

4. Make PRAMS data available to stakeholders including public health agencies, clinical providers, health systems, and researchers for studies to inform knowledge gaps in maternal and infant health.

Component B: Point-in-Time Surveillance Tribal Surveillance

Objectives:

1. To implement point-in-time (one time, one birth year) PRAMS surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy among women with a recent live birth for federally-recognized American Indian Tribes, Alaska Native Villages, or Urban Indian Organizations (UIOs) with at least 1,000 live births annually or tribal organizations that support American Indian Tribes, Alaska Native Villages or Urban Indian Organizations with a project area that covers at least 1,000 live births annually.

2. To ensure data is of high scientific quality and comparable to other jurisdictions by following the methodology documented in the CDC PRAMS protocol.

3. To conduct comprehensive analyses of PRAMS data based on a written project-specific analysis plan designed to inform programmatic activities and public health practice.

4. To translate and disseminate analytic results into useable information for public health action that can guide program development and evaluation, in collaboration with a project-level steering committee.

Expected outcomes:

1. Produce timely, high quality data representative of awardee’s population to monitor risk factors for maternal and infant health.

2. Analyze and disseminate PRAMS data on a variety of MCH topics to inform public health programs, research and system changes, and health care system changes.

3. Document efforts to translate data into useable information for public health action.

4. Make PRAMS data available to stakeholders, including tribes, tribal organizations, public health agencies, clinical providers, health systems, and researchers for studies to inform knowledge gaps in maternal and infant health.

Objectives:

1. To implement population-based surveillance within a defined vital records jurisdiction on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy among women who recently experienced a stillbirth.

2. To ensure data is of high scientific quality by using the standardized CDC PRAMS stillbirth protocol.

3. To conduct comprehensive analyses of PRAMS stillbirth data based on a written jurisdiction-specific analysis plan designed to inform programmatic activities, research, and public health practice related to stillbirth.

4. To translate and disseminate analytic results into useable information for public health action that can guide program development and evaluation in collaboration with a jurisdiction-level steering committee.

Expected outcomes:

1. Produce timely, high quality data representative of the vital records jurisdiction population, to monitor risk factors for stillbirth occurrence.

2. Analyze and disseminate PRAMS data on a variety of MCH topics to inform prevention efforts and clinical practice to prevent stillbirths.

3. Document efforts to translate stillbirth data into useable information for public health action.

4. Make PRAMS data available to stakeholders including federal, state, and local public health agencies, clinical providers, health systems, and researchers for studies to inform knowledge gaps in stillbirth research.

Target Population

Component A: Core Surveillance - This NOFO component addresses the population of women with a recent live birth in a defined vital records jurisdiction. This group will benefit directly from implementation of programs, research, and system changes aimed at improving the health of mothers and infants jurisdiction-wide.

Components B: Point-in-Time Tribal Surveillance - This NOFO component addresses the population of American Indian or Alaska Native women with a recent live birth in a defined area with at least 1,000 live births to American Indian or Alaska Native women annually. This group will benefit directly from implementation of programs, research, and system changes aimed at improving the health of American Indian and Alaska Native mothers and infants.

Component C: Stillbirth Surveillance - This NOFO component addresses the population of women experiencing a recent stillbirth in a defined vital records jurisdiction. This group will benefit directly from implementation of programs, research, and system changes aimed at reducing fetal deaths at 20 weeks of gestation or more.

Collaboration/Partnerships

Component A: Core Surveillance Awardees are required to collaborate with the Office of Vital Records, the official office to record all births within the jurisdiction. This collaboration is critical to conducting PRAMS.

Implementation of the activities under this funding announcement requires ongoing timely access to vital records information for monthly sampling, as well as timely availability of final year birth files for data weighting. The final vital statistics birth files are needed for weighting the annual data set. The final birth file is to be available to CDC by September 1 of the year following data collection and must include all the elements required by CDC for data weighting.

Awardees are required to collaborate with the maternal and child health (MCH) unit of the jurisdiction’s approved Title V recipient. This is necessary since PRAMS data will be used to monitor jurisdiction-specific and national performance objectives for the Title V Maternal and Child Health (MCH) Program, a federal block grant which serves as a key source of support for promoting and improving the health and well-being of the nation’s mothers, children, including children with special needs, and their families. The PRAMS data will serve to benchmark select Title V performance measures and enable jurisdictions to demonstrate the impacts of Title V on selected health outcomes within the jurisdiction. This collaboration is critical to ensuring that the PRAMS project collects the data that are needed to support the jurisdiction’s MCH Title V grant reporting requirements, emerging issues, and other jurisdictional priorities in MCH. In addition, implementation of PRAMS activities requires access to jurisdiction-level maternal and child health data sources, many of which are funded, maintained, or accessible through partnership with the jurisdiction’s Title V recipient. These data sources, such as high-risk infant screening, newborn metabolic screening, Sudden Unexpected Infant Death (SUID), and birth defects programs, Medicaid, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) [17], or others are needed in order to locate participant contact information for the target population.

Awardees are required to form a Steering Committee to advise the jurisdiction’s PRAMS project on the development and selection of questions for the survey and on the use, dissemination, and application of findings. The committee should include a multi-disciplinary mixture of individuals from the public and private sector, as well as from the academic community. Steering Committees should include a representative from the Vital Registrars, jurisdiction-level health department maternal and child health unit. Other members may include stakeholders in maternal and infant health such as family planning, substance abuse prevention, oral health, behavioral health, SUID, epidemiology units, state Medicaid programs, state Special Supplemental Program for Women, Infants, and Children (WIC) programs, hospital associations, state chapters of professional medical organizations, perinatal quality collaboratives, regional/local health departments, tribes or tribal organizations, foundations, and public health departments of state and/or local universities.

Awardees whose vital records jurisdiction includes tribal populations that are served by a Tribal Epidemiology Center (TEC) are encouraged, but not required, to work with the TEC on surveillance of their American Indian/Alaska Native (AI/AN) populations. The activities of TECs consist of surveillance to develop and evaluate MCH programmatic activities in coordination with tribes and urban AI/AN communities. In addition, they serve as liaisons with counties, states, the Indian Health Service (IHS), and other Federal public health authorities, in order to improve public health capacity for surveillance and research within AI/AN communities.

Awardees are expected to leverage funding or other in-kind resources to maximize project outcomes. Recipients should consider collaborating with relevant state and local agencies, community-based organizations, and national, non-governmental organizations external to CDC that have similar interests in the health and well-being of mothers and infants.

Awardees may volunteer to be part of the PRAMS Coordinating Committee. The PRAMS Coordinating Committee (CC) will be comprised of CDC Project Scientists and awardees. The PRAMS Coordinating Committee will help with project planning and to promote exchange of information and best practices for program development and evaluation.

Component B: Point-in-Time Tribal Surveillance

Awardees are required to collaborate with the Office of Vital Records, the official office to record all births within the jurisdiction. This collaboration is critical to conducting PRAMS.

Implementation of the activities under this funding announcement requires ongoing timely access to vital records information for monthly sampling, as well as timely availability of final year birth files for data weighting. The final vital statistics birth files are needed for weighting the annual data set. The final birth file is to be available to CDC by September 1 of the year following data collection and must include all the elements required by CDC for data weighting.

Awardees are required to collaborate with the maternal and child health (MCH) unit of the jurisdiction’s approved Title V recipient. This is necessary since PRAMS data will be used to monitor jurisdiction-specific and national performance objectives for the Title V Maternal and Child Health (MCH) Program, a federal block grant which serves as a key source of support for promoting and improving the health and well-being of the nation’s mothers, children, including children with special needs, and their families. The PRAMS data will serve to benchmark select Title V performance measures and enable jurisdictions to demonstrate the impacts of Title V on selected health outcomes within the jurisdiction. This collaboration is critical to ensuring that the PRAMS project collects the data that are needed to support the jurisdiction’s MCH Title V grant reporting requirements, emerging issues, and other jurisdictional priorities in MCH. In addition, implementation of PRAMS activities requires access to jurisdiction-level maternal and child health data sources, many of which are funded, maintained, or accessible through partnership with the jurisdiction’s Title V recipient. These data sources, such as high-risk infant screening, newborn metabolic screening, Sudden Unexpected Infant Death (SUID), and birth defects programs, Medicaid, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) [17], or others are needed in order to locate participant contact information for the target population.

Awardees are required to form a Steering Committee to advise the PRAMS project on the development and selection of questions for the survey and on the use, dissemination, and application of findings. The committee should include a multi-disciplinary mixture of individuals from the public and private sector, as well as from the academic community.

Steering Committees should include tribal representatives, tribal organizations, and a representative from the Vital Registrars, jurisdiction-level health department maternal and child health unit. Other members may include stakeholders in maternal and infant health such as family planning, substance abuse prevention, oral health, behavioral health, SUID, epidemiology units, state Medicaid programs, state Special Supplemental Program for Women, Infants, and Children (WIC) programs, hospital associations, state chapters of professional medical organizations, perinatal quality collaboratives, regional/local health departments, foundations, tribal organizations, and public health departments of state and/or local universities.

Awardees whose project area includes tribal populations that are served by a Tribal Epidemiology Center (TEC) are encouraged, but not required, to work with the TEC on surveillance of their American Indian/Alaska Native (AI/AN) populations. The activities of TECs consist of surveillance to develop and evaluate MCH programmatic activities in coordination with tribes and urban AI/AN communities. In addition, they serve as liaisons with counties, states, the Indian Health Service (IHS), and other Federal public health authorities, in order to improve public health infrastructure within AI/AN communities.

Awardees are expected…