Justification for 0915-0338 NSC

5600 Fishers Lane

Rockville, MD 20857

DATE: February 20, 2024

TO: Dan Cline, OMB Desk Officer

FROM: [Name], HRSA Information Collection Clearance Officer

______________________________________________________________________________

Request: The Health Resources and Services Administration (HRSA) Maternal and Child Health Bureau (MCHB) requests approval for changes to the Healthy Start Evaluation and Quality Improvement information collection (OMB No. 0915-0338 expiration date 09/30/2026).

Purpose: The purpose of this request is to make changes to the three Healthy Start participant-level data collection tools to improve the quality of the instruments and underlying data structure, make it easier for respondents to complete the forms, and to align the tools with the most recent program reporting requirements set out in the latest Healthy Start Notice of Funding Opportunity. Collection of this information will provide more accurate data reporting across program performance measures, allowing HRSA to better track the impact of the program on participant outcomes, and inform future programmatic decisions while reducing burden overall.

This memo explains the changes and supporting rationale.

Changes: Instruments:

Table A includes the type of instrument that received the change, the variable name which was altered/added, a description of the change, and the rationale for the change. Attached are the Demographic Form (Attachment 1), Background Form (Attachment 2), Prenatal Form (Attachment 3), and Parent/Child Form (Attachment 4) with the changes tracked, for reference. The overall scope of change to the data collection tools is minimal, representing an update of existing content, except for the addition of the Demographic Form (which is comprised of seven questions previously in the Background Form), the removal of 34 questions, and the addition of 15 new questions across the forms. All edits are to address updates to program reporting requirements and feedback from Healthy Start grant recipients.

Time Sensitivity: The data collection changes must be completed in a timely manner to ensure that the tools are available to Healthy Start grant recipients at the start of the next 5-year project period. Approval of these changes is needed by March 15, 2024, to implement the changes in the data collection tools and to prepare for the timely collection of data critical to program monitoring and evaluation.

Burden: These changes included herein are expected to decrease reporting burden for Healthy Start grant recipients. The number of questions across the revised data collection forms reduces from 110 to 91 total. As a result, the burden is expected to decrease.

PROPOSED CLARIFICATIONS AND NON-SUBSTANTIVE CHANGES:

Table A

*Please note that “Q” refers to “Question”, for example “Q1” is “Question 1”

Instrument	Variable	Change implemented	Rationale
Demographic, Background, Prenatal, Parent/Child Form	Correction Checkbox	A correction checkbox was added to all forms.	The addition of a correction checkbox allows program to better delineate between forms that are corrections (contained incorrect information) and forms that are updates (the data has changed over time). Tracking the difference is critical to understanding the underlying longitudinal data.
Background, Prenatal, Parent/Child Form	General Instructions	The general instructions and instructions for making form updates on page 2 of the forms were revised.	The edits to “General Instructions” better convey the intended respondents of the form, clarify the process for linking participant data, and reduce the overall length of the original instructions. The edits to form update instructions align with revised question numbering, and better clarify the process for making form updates (based on the type of individual screened and the form version).
Background Form	G1, G6, G10, 1, 2, 3, 4	These questions were moved to the new Demographic Form. G1 response options were revised. G6 question text and response options were revised. G10 response type was changed from single-select to free text. Q1 question text was revised. Q3 and Q4 response options were revised.	The Demographic form was introduced to provide a minimum level of data collection for a new category of program participants outlined in the FY24-FY29 Healthy Start Notice of Funding Opportunity (group-based health education participants). Edits to G1 (Demographic Form G2) now reflect the three categories of desired respondents: Case management/care coordination participants, group-based health education participants, and “other adults”. Edits to G6 (Demographic Form Q1) reduce the length and complexity of responses. Edits to G10 (Demographic Form Q2) more accurately collect participant age. Edits to Q1 (Demographic Form Q4) align responses with HRSA/BPHC Uniform Data System reporting standards. Edits to Q3 (Demographic Form Q5), and Q4 (Demographic Form Q6) align responses with HHS standards for collecting race/ethnicity data.
Background Form	G7, G8, G9	These questions were combined: G7, G8, and G9 became new G4 Question 12 and 13 were combined and became new Question 7	These questions were combined to improve the underlying data structure.
Background Form	10,14, 25, 27	These questions were re-ordered in the Background form: Question 10 was moved to Question 3 Question 14 was moved to Question 2 Question 25 was moved to Question 19 and response option “Married or Partnered” was added Question 27 was moved to Question 1	Re-ordering the questions improves the overall flow of data collection: The edit to Q10 ensures all questions in the section that ask for information through the same time period (12 months) appear together. The edit to Q14 allows the interviewer to better plan their data collection time and approach as the question helps determine which additional forms respondents must complete The edit to Q25 better delineates between birth control methods and STI/STD prevention, and allows respondents to specify if they are married or partnered The edit to Q27 allows the interviewer to better plan their data collection time and approach as the question helps determine which additional forms respondents must complete
Background Form	G5, 9, 11, 17, 24, 28, 35	These questions have revised response options.	The edits improve the question response options while retaining the content of the original questions.
Background Form	G4, 1a, 5, 6, 7, 16, 20, 22, 26, 33	These questions were removed.	The questions were removed because they collect redundant information or no longer coincide with performance measures in the FY24-FY29 Healthy Start Notice of Funding Opportunity.
Background Form	New Numbering - 8, 9, 10, 11, 15, 17	These questions were added.	Questions 8-11 were added to address the social determinants of health for all respondents, including food security, housing, transportation, and safety. Question 15 and 17 were added to collect information on referrals to services to align with new performance measures added in the FY24-FY29 Healthy Start Notice of Funding Opportunity.
Demographic Form	General Instructions, G1, G3, 3, 7, 8	These items were added: General Instructions G1 and G3 (standard questions on all forms) Question 3, 7, and 8	General instructions, G1, and G3 were added because they are standard items across all the forms that communicate information for administering the form, instructions for updating forms, identify participants via their unique identification number, and indicate the version of the form. Question 3 was added to align with other MCHB programs and federal recommendations for collecting gender and sex data. Question 7 and 8 were added to collect respondent primary language in alignment with Census American Community Survey approach for data collection of primary language.
Prenatal Form	G4, G5	These questions were combined into new Prenatal Form G2.	These questions were combined to improve the underlying data structure.
Prenatal Form	2, 4, 7, Post-Pregnancy Q7	These questions have revised response options.	The edits to Question 2 and 4 improve the accuracy of response options by converting them to weeks instead of trimesters while maintaining the original question content. Question 7 includes additional health conditions respondents may select to better track pre-existing health conditions that may affect pregnancy and birth outcomes. Post-Pregnancy Section Q7 includes the new response option “participant self-report” to better identify the sources of data used to complete the questions in the section.
Prenatal Form	4, 5, 6a, Post-Pregnancy Section Q4	These questions have revised question text but maintain their original content/meaning.	Edits to Q4 still collect the reproductive phase when a participant enrolled in Healthy Start but is now directed to the form respondent instead of the interviewer. Edits to Q5 now refer to “weeks” pregnancy instead of “months”. Edits to Q6a now refer to “more than one baby” instead of “multiple fetuses”. Edits to Post-Pregnancy Section Q4 now use a more accurate and precise definition of maternal mortality.
Prenatal Form	G2, G3, 3, 6*, 8, 10, 11, 12, 13 *Note former Q6 appears as deleted Q5 in the red-lined version	These questions were removed.	Question G2 and G3 were removed because they contain redundant information with the Background Form. Question 3, and 6 were removed because they contained redundant information with other questions in the Prenatal Form. Question 8, 10, 11, 12, and 13 were removed because they no longer coincide with performance measures in the FY24-FY29 Healthy Start Notice of Funding Opportunity.
Prenatal Form	New Numbering – 7, Post-pregnancy Section 2 & 3	These questions were added.	Question 7 in the updated Prenatal Form was added to track health conditions diagnosed during pregnancy, as these may influence pregnancy and birth outcomes. New Prenatal Form Post-Pregnancy Section Question 2 and 3 were added to track the method of child delivery, and to document any short- or long-term health consequences of pregnancy. These two questions allow for tracking of morbidity in the program population.
Parent/Child Form	G6, G7, G8	These questions were combined into new G5.	These questions were combined to improve the underlying data structure.
Parent/Child Form	G9, G10, G11	These questions were moved: G9 was moved to Question 2 G10 was moved to Question 9 and response type was changed from single-select to free text G11 was moved to Question 22	Question G9 was moved to Question 2 to align with the rest of the demographic data collection. Question G10 was moved to Question 9 to allow interviewers to easily update the information at regular intervals, and response type was updated to collect information more accurately. Question G11 was moved to Question 22 to create a single section for follow-up after a child loss.
Parent/Child Form	G5, 2, 3, 13, 14, 24	These questions have revised response options.	Edits to Question G5 remove the “primary participant” response because it is redundant with information collected on the Background Form. Question 2 and 3 responses were revised to align with HHS standards collecting race/ethnicity data. Question 13, 14, and 24 received updated response options to increase the accuracy of collected data while retaining the original content of the question.
Parent/Child Form	G1, 4, 6, 8, 10, 11, 21, 22, 25	These questions were removed.	Question G1 was removed as the information is redundant with the Background Form. Question 4, 6, and 8 were removed because they collected redundant information with other questions in the form. Question 10, 11, 21, 22, and 25 were removed because they no longer coincide with performance measures in the FY24-FY29 Healthy Start Notice of Funding Opportunity.
Parent/Child Form	New Numbering - 8	This question was added.	Question 8 in the updated form was added to track the number of children with an intensive care unit stay (NICU), as they may be at higher risk of infant mortality.

Attachments:

1. Demographic Form (new)

2. Background Form (All changes and additions are tracked in the attached document)

3. Prenatal Form (All changes and additions are tracked in the attached document)

4. Parent/Child Form (All changes and additions are tracked in the attached document)