Change Request Justification Memo

Change Request

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

(OMB no. 0920-0612, exp. date 08/31/2022)

October 5, 2020

Summary

CDC requests OMB approval for non-substantive changes to the approved WISEWOMAN information collection, OMB approval number 0920-0612, exp. 08/31/2022. The request is to make minor modifications to the WISEWOMAN program’s reporting system, used to both screen and monitor participants, as well as to evaluate and improve program efficacy. The current WISEWOMAN information collection consists of two parts, a Progress Report and Minimum Data Elements (MDE).

The proposed change to the MDEs is to improve data accuracy and analytical utility. This change request is minor and will only affect three MDEs by adding one additional response option to each, as reflected in the MDE Manual 18.2. No other changes will be made to the MDE manual and the number of MDEs remains constant at 59. No changes are proposed to the Annual Progress Report.

An overview of the proposed added response options to the three MDEs is provided in Exhibit 1. Details of which MDEs are impacted and how the updated MDEs will appear in the MDE Manual are provided in Exhibit 2. The exhibits are attached.

Attachments

• Exhibits

  1. Overview of proposed improvements

  2. Modifications to element questions or response options

• WISEWOMAN MDE Manual 18.2

Background

CDC collects information from funded WISEWOMAN programs (currently 27 state health departments and 3 tribal organizations). Programs submit this information via a CDC web portal. The information is used to monitor, evaluate, and report on funded programs. WISEWOMAN is a direct service program with clinical screening and healthy behavior support services. It is authorized by the U.S. Congress to extend the preventive services to participants of the NBCCEDP ( National Breast and Cervical Cancer Early Detection Program) by expanding services to address heart disease and stroke risk factors among at-risk, low-income, uninsured, and underinsured women aged 40 to 64.

WISEWOMAN recipients gather responses to the MDEs from clinical providers, who administer and/or record responses in their electronic health record or another format the state approves. The MDEs address heart disease risk factors such as high blood pressure, elevated blood cholesterol, obesity, diabetes, smoking, and sedentary lifestyle. Clinical providers collect the MDEs at the time of the participants screening visit. The WISEWOMAN program encourages recipients to use electronic health records and to auto-fill fields in their files.

Justification

The proposed change to add a response to three MDEs is to improve WISEWOMAN data quality and analytical utility.

Data quality: Adding an additional response option to selected MDEs that would improve reliability and limit analytical variability. Improved data quality will lead to more accurate responses by conveying existing concepts more clearly, which will increase efficiency.

Analytical utility: Proposed changes involve including a “participant refused referral” option to selected MDEs. These proposed changes will improve CDC’s ability to decipher program fidelity and provide technical assistance.

Implementation Schedule

CDC is submitting this non-substantive change request to OMB to provide implementation guidance to programs for the new program year, which began September 30, 2020.

Effect on Burden Estimate

No change in burden is projected. Adding three additional response options to MDEs is

non-substantive and therefore the burden is unchanged.

Terms of Clearance:

	Previously Approved	Requested
Expiration Date	08/31/2022	08/31/2022
Responses	70	70
Time Burden (Hours)	2,240	2,240
Cost Burden (Dollars)	0	0

Exhibit 1. Overview of Proposed Improvements

Type	Elements Affected	Number of Elements Impacted
Adding a Response Option to Minimum Data Elements	1) Lifestyle Program (LSP) / Health Coaching (HC) Referral Date	3
	2) Date of Referral to Tobacco Cessation Resource
	3) Type of Tobacco Cessation Resource

Exhibit 2. Adding a Response Option

MDE Field Number	Current Information Collection Phrasing	Proposed Changes (added response option in bold)	Rationale
Item 18a.	18a. Lifestyle Program (LSP) / Health Coaching (HC) Referral Date MM/DD/CCYY Date	18a Lifestyle Program (LSP) / Health Coaching (HC) Referral Date MM/DD/CCYY Date 88888888-Refused to answer	We propose to add “refused to answer” to decipher between program fidelity and participant refusal when assessing missing data.
Item 20a.	20a. Date of Referral to Tobacco Cessation Resource MM/DD/CCYY Date	20a Date of Referral to Tobacco Cessation Resource MM/DD/CCYY Date 88888888-Refused to answer	We propose to add “refused to answer” to decipher between program fidelity and participant refusal when assessing missing data.
Item 20b.	20b. Type of Tobacco Cessation Resource Quit line Community-based tobacco program Other tobacco cessation resources No answer recorded	20b. Type of Tobacco Cessation Resource Quit line Community-based tobacco program Other tobacco cessation resources Internet-based tobacco program No answer recorded	We propose to add Internet-based tobacco program to improve analytical utility around tobacco cessation resources.

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