Supporting
Statement for
Healthy Start Program and Evaluation:
Justification
Supporting Statement
Healthy Start Evaluation and Quality Improvement
OMB Control No. 0915-0338
Highlighted text is the information changed from the last request.
Terms of Clearance: None
This statement from the Health Resources and Services Administration’s (HRSA) Maternal and Child Health Bureau (MCHB) requests Office of Management and Budget (OMB) approval for data collection to support monitoring and evaluation of the Healthy Start program. The information collection is a revision to OMB# 0915–0338 and is authorized under the Healthy Start Reauthorization Act 2007 (Public Health Law No. 110-339), which includes appropriations for the Healthy Start initiative and its evaluation (Attachment A).
The revision includes a significant reduction in the number as well as length of the forms that grantees are required to submit. The current OMB approval [OMB# 0915–0338] included six forms, which in this approval request, have been consolidated into three forms to eliminate redundancy: (1) Background Information Form; (2) Prenatal Form; and (3) Parent/Child Form. In addition to consolidating questions across tools, many individual items have been eliminated or in some cases reworded in order to focus the evaluation more clearly on program progress with regard to the performance measures. In the process, this will ensure that collected data are meaningful for monitoring and evaluation, and that previously separate data systems can be streamlined, thus improving efficiency and accuracy. HRSA/MCHB has also added questions that allow the Forms to be used as all-inclusive data collection instruments for HRSA/MCHB and Healthy Start grantees. The other currently approved data collection instruments – the National Healthy Start Program Survey, Community Action Network Survey, Healthy Start Site Visit Protocol, and Healthy Start Participant Focus Group Protocol – will no longer be used as part of the evaluation, as these data collection instruments no longer align with future evaluation design, and so will no longer be used as part of any planned evaluation.
The purpose of the ongoing data collection is to assess Healthy Start progress towards meeting its performance goals and other key indicators central to the program’s mission. Results from monitoring and evaluation efforts will provide actionable evidence to support the improvement of the program. In addition, monitoring and evaluation of the Healthy Start program are consistent with the needs of HRSA/MCHB to meet its Government Performance and Results Act requirements.
The data collection effort to support monitoring and evaluation is of interest to HRSA/MCHB as the federal agency for promoting and improving the health of women and children. HRSA/MCHB will use the results of the data collection to improve guidance for Healthy Start grantees funded to serve reproductive age women, their children, and families, and to help reduce health disparities, decrease infant mortality, and improve perinatal health outcomes.
The national Healthy Start program aims to reduce disparities in infant mortality and other adverse perinatal outcomes. The program began as a demonstration project with 15 grantees in 1991 and expanded over the past three decades to 101 grantees currently serving communities in 34 states, Washington, D.C., and Puerto Rico. Today, Healthy Start has evolved from a program framework of nine service and systems core components to four approaches to reduce infant mortality through individual services and community support to women, infants, and families: 1) improve women’s health, 2) improve family health and wellness, 3) promote systems change, and 4) assure impact and effectiveness.1
The 2014 transformation of Healthy Start necessitated revised methods for monitoring and program assessment. Information from an ongoing data collection effort will contribute to the program’s continued evolution and improvement by informing key programmatic decisions. In addition, results from monitoring and evaluation can be used to meet Government Performance and Results Act requirements.
Healthy Start benefits from more than three decades of experience, including multiple small scale program evaluations; however, program evaluations prior to 2014 were limited by a lack of consistently collected and high-quality data. 2 Although grantees collected administrative data on all of their clients at the individual level, their data collection was not standardized and only reported in the aggregate to HRSA/MCHB.
Considering the lessons learned from the previous funding cycles of the Healthy Start program and its evaluations, HRSA/MCHB seeks to continue to conduct uniform individual-level data collection across grantees for programmatic monitoring purposes, for assessing overall progress towards meeting Healthy Start performance goals, and for improving accuracy and efficiency in reporting. This information can in turn be used to inform future program efforts.
The Revised Client-Level Forms (Background, Prenatal, Parent/Child, Attachments B1 – B3) will collect uniform information at the individual program participant level about women, their children 0-18 months old, and other caregivers who have primary responsibility for an enrolled child participating in Healthy Start. These data have traditionally been collected by Healthy Start grantees at the individual level within their own administrative data systems and have been reported to HRSA/MCHB only in the aggregate. Data collection using standardized formats began only in the past few years. A final report on analyzed 2017 data is anticipated in Spring 2020. This revision will continue that effort and, based on grantee feedback, will reduce overall burden while focusing greater attention on quality improvement and on grantee progress in relation to program performance measures and other key indicators central to Heathy Start’s mission. The revised forms will streamline reporting efforts in such a way that the aggregate data reporting will build upon the client-level data collection, thus promoting greater efficiency, accuracy, and accountability.
The purposes of this data collection are aligned with Healthy Start program needs and goals for accountability, programmatic decision making, and ongoing quality assessment at the grantee and national levels. The monitoring and evaluation of the Healthy Start program are focused on the goal of providing information to enable identification of issues at the earliest possible stages to help allow for midcourse corrections among individual grantees and for the program as a whole. In addition, the extent to which individual grantees and the program as a whole are meeting and/or improving their progress towards number of clients served, and other program goals and key indicators is essential to data collection.
The redesigned client-level forms (Attachments A, B, and C) are intended to collect information about Healthy Start participants/clients across all Healthy Start grantee sites. Additionally, the forms include items that prompt provision of staff records that are designed to bring client-level data directly into alignment with grantee reporting requirements. The revised forms also continue to facilitate rough benchmarking and comparison with national databases on various health behaviors and perinatal outcomes. The wording of individual items was standardized to align with existing national surveys, including the Health Resources and Services Administration’s (HRSA) National Survey of Children’s Health (NSCH) and CDC’s Pregnancy Risk Assessment Monitoring System (PRAMS).
These three data collection forms will comply with the Government Paperwork Elimination Act (Public Law 105-277, Title XVII) by efficiently employing technology in an effort to reduce burden on respondents. HRSA/MCHB will use an online, web-based application to obtain information from respondents for all three forms. The application will include automated range checks and branching and will enforce consistency among critical questions to optimize resources and facilitate collection of high quality data. The application will also allow respondents to stop and return to the instrument so that they can complete it at their convenience. The instruments solicit only information that corresponds to the specific research items discussed above. No superfluous or unnecessary information is being requested of respondents. In addition to the web-based application for the redesigned forms, grantees requiring a paper form will also have the option to use PDF forms. Grantees using the PDF forms may save these forms locally and can complete them for clients on a laptop or other device in the field, saving them for upload later when an internet connection is available.
These three revised forms constitute a smaller and more focused extension of the currently authorized (0915-0338) HRSA/MCHB data collection activities for monitoring and evaluating the Healthy Start program. Aside from this current effort, the information proposed for collection in this OMB package is not available elsewhere.
This activity does not impact small businesses or other small entities.
The requested data collection activity does not result in less frequent collection of data. The Background Information form will be administered to all clients upon enrollment in the program, and updated when the enrolled woman enters a new reproductive phase (e.g., preconception to prenatal, or prenatal to postpartum, etc.), or annually, as long as the client is enrolled in Healthy Start. The Prenatal form will be administered when an enrolled woman is pregnant, and the Parent/Child form will be administered when a program participant has a live birth, updated when the enrolled child is 6 months old, and/or when the child exits the program (if that exit is at least 3 months beyond the previous data collection point). This will facilitate tracking participant outcomes across the full time horizon of the Healthy Start program.
This request fully complies with 5 CFR 1320.5. There are no special circumstances.
The 60-day Federal Register Notice required in 5 CFR 1320.8(d) was published in the Federal Register on Jan 31, 2019, Volume 84, Number 21, Page Numbers 753-754. Public comments were received. The vast majority of the public comments were incorporated into the revised forms. These revisions resulted in the reworking of a few items deemed confusing, and the addition of several items needed to streamline reporting requirements, as well as reinstatement of a few items that had been eliminated initially. Please see Attachment C for a summary matrix of public comments and how they are addressed/resolved, as well as a crosswalk between 2016 and 2019 versions.
Healthy Start participants will not be compensated for completing the three revised forms, as information will be collected as part of the enrollment and participation process and will be essential for providing, targeting, and improving services for these women.
The information collection will fully comply with all aspects of the Privacy Act I and agencies will be assured of the privacy of their replies under Section 934(c) of the Public Health Service Act, 42 USC 299c-3(c). All participants will be told that the information they provide will be treated in a secure manner to the extent allowed by law. Participants also will be informed that they may refuse to answer any question, and that they can stop at any time without risk to any Healthy Start benefits or services they receive. In addition, participant names and dates of birth will not be provided to the federal government, nor will any other PII be uploaded to HRSA/MCHB during the data collection process. Thus, HRSA/MCHB will not be collecting any PII from these data collection forms. A unique ID will be assigned to each participating woman as well as participating children and fathers/partners.
At Healthy Start sites, individuals must have a form recorded in the data collection system to be considered a program participant. The form can be incomplete if the individual refuses to provide all information requested; however, without a form in the data collection system, grantees will not have a means of accounting for individuals recruited (and Healthy Start services provided) in reporting to HRSA/MCHB.
In addition, any/all contractor employees will sign a pledge that data will be kept private to the extent allowed by law and respondent identity. Breaking that pledge is grounds for immediate dismissal and possible legal action.
The revised forms are designed to provide data on individual-level socio-demographics (e.g., education, race, ethnicity), and to track outcomes and progress at the subgroup and participant levels. The forms also facilitate aggregate benchmarking and comparison with national databases on various health behaviors and perinatal outcomes.
While numerous potentially sensitive questions have been eliminated from the three revised forms, in addition to socio-demographic information, several items remain that refer to behaviors and/or circumstances that may be of a personal nature for respondents. Examples of potentially sensitive questions include: those related to behaviors including smoking, alcohol, and drug use; family planning goals; and, pregnancy loss or infant death. As Healthy Start provides services to promote healthy behaviors and link participants to critical resources in the face of challenging circumstances, it is necessary to collect information on related topics given the association between these factors and perinatal outcomes. Finally, as noted in #10 above, women will be assured that they do not have to respond to any questions that they do not want to answer, and that all information they provide will be kept confidential and private. No PII will be uploaded to HRSA/MCHB.
Section 12A:
This information collection request contains three forms: the Background Information form (see Attachment A); the Prenatal Form (see Attachment B); and the Parent/Child form (see Attachment C). The Background Information form will be administered to each Healthy Start participant upon enrollment and updated with each reproductive phase change. The Prenatal form will be administered to pregnant women, and the Parent/Child form will be administered to participants who have a child 0-18 months enrolled in Healthy Start.
The annualized frequency of the data collection will include one response per respondent for each data collection form. Respondents include pregnant women, women of reproductive age, and the primary custodial parent of children who are served by the Healthy Start program, as well as any spouses/partners who are participating with them in relevant Healthy Start activities. HRSA estimates 116,150 total responses and an average time per response of 0.39 hours. The estimated annualized burden hours is 45,652 hours. Table A1 presents the annual burden hour estimates for this data collection. These estimates were derived through nine pilot administrations conducted with Healthy Start clients across 9 Healthy Start sites, and represent the longer end of the range of times we found in these administrations; as such, these time estimates are conservative in that they are more likely to over than to underestimate the actual time burden.
Table A1 – Estimates of annualized burden hours:
Type of Collection |
Number of Respondents |
Number of Responses per Respondent |
Total Responses |
Average Burden per Response (in hours) |
Total Burden Hours |
Background Information Form |
55,550* |
1 |
55,550* |
.50 |
27,775 |
Prenatal Form
|
30,300* |
1 |
30,300* |
.17 |
5,151 |
Parent/Child Form
|
30,300* |
1 |
30,300* |
.42 |
12,726 |
Total |
116,150 |
|
116,150 |
.39 |
45,652 |
* All participants (55,550) complete the Background form, and a subset of these same individuals (30,300) also complete the Prenatal or Parent/Child forms for total of 116,150 responses.
Section 12B:
For each data collection effort, we use dollar per hour estimates to generate the estimated annualized burden costs. For Healthy Start participants, we used the median wage ($18.58) estimated by the Department of Labor, Bureau of Labor Statistics (BLS), Occupational Employment Statistics for all occupations in 2018 (http://www.bls.gov/oes/current/oes_nat.htm).
Table A2 – Estimates of annualized burden costs:
Type of Collection |
Total Burden Hours |
Wage Rate Participants |
Total Burden Cost |
Background Information Form |
27,775 |
$18.58 |
$516,059 |
Prenatal Form
|
5,151 |
$18.58 |
$95,706 |
Parent/Child Form
|
12,726 |
$18.58 |
$236,449 |
Total |
45,652 |
|
$848,214 |
There are no capital and start-up costs to respondents associated with this data collection.
The approximate annualized cost to the government for this data collection effort is $209,023. These costs are comprised of: federal employee salaries, contractor staff salaries, and operational expenses (e.g., equipment, printing, and postage). Table A3 below provides the cost breakdown for the annualized cost to the federal government.
Table A3. Estimates of annualized cost to the Federal Government
Item |
Grade/Salary
|
Percent Effort |
Annualized Cost |
HRSA/MCHB Healthy Start Project Staff/Oversight |
GS-14-5 ($104,246) |
50% |
$52,123 |
HRSA/MCHB Healthy Start Project Staff/Oversight |
GS-13-5 ($88,215) |
50% |
$44,108 |
Contractor Staff (Project Manager) |
$147,999* |
28% |
$41,412 |
Contractor Staff (Architect) |
$130,000 |
22% |
$28,600 |
Contractor Staff (Software Engineer) |
$89,000 |
27% |
$24,030 |
Contract Staff (Analyst) |
$71,000 |
25% |
$17,750 |
Operational Costs for Data Collection Activities (e.g., printing, postage, equipment), non-labor |
|
|
$1,000 |
Total |
|
|
$209,023 |
*Contractor salaries are loaded and include fringe benefits (e.g., costs for health insurance, travel, paid vacation). The fringe rate is 38% for full-time staff.
The previous burden hour approval was entered in error as 31,145 but should have been 92,156 as indicated in the September 13, 2016 30-day Federal Register Notice published for the last submission of this information collection request. As this revised request is for 45,652 hours, this represents an actual decrease of approximately 46,504 hours.
The proposed revisions include a significant reduction in the number as well as length of the forms that grantees are required to submit. The current OMB approval [OMB# 0915–0338] included six forms, which have been consolidated to three: (1) Background Information; (2) Prenatal; and (3) Parent/Child. The purpose of this consolidation is to reduce the burden of data collection on grantees, case workers who administer the interviews, and participants, as well as to focus the evaluation more clearly on progress towards meeting program performance goals. HRSA/MCHB consolidated questions that were redundant across the six forms into the single Background form, and deleted questions that are neither critical for evaluation nor programmatic purposes. HRSA/MCHB has also added questions that allow the forms to be used as all-inclusive data collection instruments for HRSA/MCHB and Healthy Start grantees. These changes will ensure that collected data are meaningful for monitoring and evaluation, and that previously separate data systems can be streamlined and more efficient.
Finally, piloting occurred with participants across nine Healthy Start grantees in August 2019. HRSA/MCHB incorporated key feedback from these pilots into the three revised forms. Based on the feedback obtained through the piloting, HRSA/MCHB was able to better ensure that the questions used were understandable to the intended population, and allowed grantees an opportunity to provide input into whether the content of the questions was aligned with grantee reporting requirements.
Results from monitoring will be synthesized annually to assess trends and changes in participant characteristics and outcomes, allowing for program adjustments throughout the grant period. It is estimated that final data collection results from the evaluation will become available in December 2024 or early 2025.
Analyses of program progress spanning five years will allow HRSA/MCHB to examine short- and long-term outcomes as the program matures throughout the grant cycle. It is important to assess the program effects on outcomes at multiple points in time to identify when the changes in outcomes occur and link the changes to the maturity of the program; information that can be used in program improvement and replication. In addition, it is important to assess progress towards performance goals over a relatively long period of time (in this case, five years) to give the program time to affect long-term gains, which are typically difficult to change and observe at the population-level in a short period of time
Funding for the Healthy Start grantees began in June 2019, and will end in March 2024. After the receipt of funding, grantees began recruiting and/or providing services. HRSA/MCHB expects the data system to collect information via the revised forms will be fully updated by the summer of 2020. The estimated schedule for the project is presented in Table A.5 for key data collection, analysis, and reporting tasks relevant to this request for OMB approval. The maximum three years of clearance is requested with the intent that an extension for OMB clearance will be requested to continue data collection if needed.
Table A5. Estimated time schedule for data collection, analysis, and reports
Task |
Time Schedule |
Prepare data collection tools |
January 2019 – August 2019 |
Receive OMB approval |
February 2020 |
Update data collection systems |
February 2020 – August 2020 |
Administer Background Information, Prenatal, Parent/Child Forms |
|
Train staff on data collection/new data collection system |
February 2020– August 2020 |
Collect individual-level data for monitoring (Healthy Start grantees) |
September 2020–June 2024* |
Conduct Analyses and Reporting |
|
Analyze and synthesize data annually and at project end |
January 2022–June 2024 |
Develop Final report |
June 2024–December 2024 |
Final study briefing |
December 2024 |
There are no exceptions to the certification; the expiration date will be displayed. To continue data collection in the last two years of the grant, an extension or revision to this package will be submitted for OMB clearance.
There are no exceptions to the certification.
1 The nine previous Healthy Start components included five service and four systems components. Service components included direct outreach services and client recruitment, case management, health education services, screening and referral for perinatal depression, and interconception continuity of care through the infant’s second year of life. Systems components included utilization of community consortia and provider councils to mobilize key stakeholders and advise local grantees, development of a local health system action plan, collaboration and coordination with Title V services, and development of a sustainability plan for continuation of services and project work beyond the grant period.
2OMB numbers for the previous national evaluations are 0915-0287 and 0915-0300 for the first national evaluation and 0915–0338 for the second national evaluation.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Instructions for writing Supporting Statement A |
| Author | Jodi.Duckhorn |
| File Modified | 0000-00-00 |
| File Created | 2021-01-15 |