Change Request Justification

Change Request

Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System

(OMB no. 0920-0612, exp. date 03/31/2025)

August 18, 2023

Background and Justification

The Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program is a direct service program that provides clinical screening and healthy behavior support services to uninsured and underinsured women aged 40 to 64. The goal of the WISEWOMAN program is to reduce risk factors for cardiovascular disease (CVD) in a vulnerable and under-served population. Women in lower income brackets, or without health insurance, have an increased risk of CVD morbidity and mortality because they have limited access to health services such as screenings, medications, and healthy behavior support services. Through CDC’s WISEWOMAN Program, CDC currently funds a maximum of 35 state governments and tribal organizations who receive funding to provide these services, and report information to CDC through the funding recipient’s annual progress report and an electronic dataset on clients enrolled in the program. With anticipated funding, up to 5 more programs are expected to be selected in the very near future bringing the maximum number to 40. Thus, the estimated burden per response and the total estimated annualized burden hours are being updated through this change request.

The current dataset consists of 70 minimum data elements (MDE) that address CVD risk factors such as elevated blood cholesterol, high blood pressure, obesity, diabetes, smoking, sedentary lifestyle, client demographics and behaviors, and social services and support, which are incorporated into the client’s health department electronic health record. Information is collected by providers at the time of enrollment and at rescreening (a minimum of 11 months post-enrollment). The information reported to CDC is used to evaluate the effectiveness and outcomes of WISEWOMAN services and programs.

CDC requests OMB approval for one additional minimum data element that aligns with the current purpose and scope of existing WISEWOMAN data elements. CDC also requests the refinement of the wording of a question for one existing MDE question. The additional MDE and refinement of an existing MDE question will strengthen:

• Program fidelity: Proposed additional element will involve ascertaining social needs and will help decipher ways to mitigate barriers that are preventing active participation in the WISEWOMAN program. These proposed changes will improve CDC’s ability to improve CVD risk analysis and program efficacy.

• Data Quality: The proposed an additional MDE will provide companion data to existing data elements to provide a more complete picture for underserved women in the WISEWOMAN Program.

This request is a refinement of our current data approach of continuously serving underserved populations and also in line with HHS’s current health equity goals. The additional data element and refinement of an existing data element emanate from the upcoming cooperative agreement (CDC-RFA-DP-23-0003) that was published in late March and application process is ongoing. This additional MDE and refinement of an existing MDE will help improve analytical utility, program fidelity, and data quality and will have negligible impact on burden hours. Overall, if approved the total number of MDEs will be 71. There are no other changes to the currently approved Minimum Data Elements (MDEs) or response options or the WISEWOMAN program’s data collection and reporting system that is used to screen, monitor, provide services to participants, and to evaluate and improve program efficacy. No changes are being proposed to the Annual Progress Report.

An overview of the proposed change to the MDEs is provided in Exhibit 1. Details of how the updated MDE will appear and their locations in the manual are provided in Exhibit. The exhibit is attached.

Attachments

• Exhibits

  1. Overview of Change Request

  2. Additional Proposed Minimum Data Element

  3. Revision of response option for existing Minimum Data Element

• WISEWOMAN MDE Manual

Implementation Schedule

CDC is submitting this change request to OMB to provide Minimum Data Elements implementation guidance to programs for the new program year, which begins at the end of September 2023.

Effect on Burden Estimate

The change in burden with the addition of one MDE and minor revision of an existing MDE question in non-substantive. Only the total estimated annualized burden hours are being updated to reflect 40 programs as noted in Table 2.

Table 1: Number of Respondents and Current Estimated Burden

                                                                                                                                      

Type of Respondents	Type of Collection	No. of Respondents	Annual Frequency per Response	Hours per Response	Total Hours
WISEWOMAN Awardees	Screening and Assessment and Lifestyle Program MDEs	35	2	25	1750
	Annual Progress Report	35	1	16	560
	Total		3	41	2,310

Table 2: Increase in Number of Respondents and change in Estimated Burden

Type of Respondents	Type of Collection	No. of Respondents	Annual Frequency per Response	Hours per Response	Total Hours
WISEWOMAN Awardees	Screening and Assessment and Lifestyle Program MDEs	40	2	25	2000
	Annual Progress Report	40	1	16	640
	Total		3	41	2,640

Exhibit 1. Overview of Change Request

Type	Minimum Data Elements	Number of Elements
Additions to Minimum Data Elements Question or Response Options	Date of Referral to Social Needs	1
Revision of response options for current MDE	Computer Use	1

Exhibit 2. Proposed Addition to Minimum Data Elements Question or Response Options

We propose to add 1 new MDE question.  Capturing this will enhance program enhance the analysis of social services data elements.

No.	MDE Field Name and File Position Location	Reference Document Current Information Collection	Changes Document Proposed Changes	Rationale Brief description of intent of change
1	Item Current Location: No current Location Proposed Location: Starting at 623	NO CURRENT QUESTION	Date of Social Services and Support Utilization MM/DD/YYYY	Participants have utilized social services and support.

Exhibit 3. Proposed Revision to Minimum Data Elements Question or Response Options

We propose a revision to an existing MDE question.  Clarifying this question will enhance program enhance the analysis of social services data elements.

No.	MDE Field Name and File Position Location	Reference Document Current Information Collection	Changes Document Proposed Changes	Rationale Brief description of intent of change
1	Item Current Location: Existing question 21a Existing Location: 541	Do you own or use any of the following types of computer? Desktop/Laptop Smartphone Tablet/Other portable wireless Computer 1. Yes 2. No 7. Don’t know 8. Don’t want to answer 9. No answer recorded	Do you use any of the following types of computer? Desktop/Laptop Smartphone Tablet/Other portable wireless Computer 1. Yes 2. No 7. Don’t know 8. Don’t want to answer 9. No answer recorded	To clarify question to ascertain use of computer by participant.

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