2019-23365. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Evaluation of CDC's STEADI Older Adult Fall Prevention Initiative in a Primary Care Setting” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on May 24, 2019, to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone] or send an email to [e-mail]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

An Evaluation of CDC's STEADI Older Adult Fall Prevention Initiative in a Primary Care Setting—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Falls are the leading cause of both fatal and non-fatal injuries among older adults, defined as age 65 and older. From 2007 to 2016, fall death age-adjusted rates increased by 31% with almost 30,000 older adults dying as the result of a fall in 2016. The economic consequences of falls are significant and growing as the population ages, with medical costs of older adult falls estimated at $50 billion. CDC created the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative to guide health care providers' fall prevention activities in the primary care setting.

This new data collection effort is an essential component to determine the impact of CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative on falls, emergency department visits, and hospitalizations due to falls. It will help CDC determine the impact of less resource intense versions of STEADI and evaluate the process of implementing STEADI fall prevention initiative in a primary care setting to provide context for the impact evaluations. The study population will be limited to adults 65 and older who have an outpatient visit during the study period and screen as high risk for falls at the selected primary care clinics implementing the STEADI fall prevention initiative. The study population for the process evaluation will include the clinical implementation staff at the selected clinics where the intervention will take place (physicians, physician assistants/nurse practitioners, study research nurses, and practice or operations manager).

Two data collection methods will be used; the CDC's Stay Independent Fall Risk Screener will be administered to older adult patients at selected primary care clinics to determine which older adults are at high risk for a fall. Those who screen at high risk will be assigned, based on clinic attended and week of attendance, to one of three study arms. Patient surveys will be used to determine whether these patients experience a fall during the study period, are treated for a fall, and/or use any fall prevention strategies throughout the study period. Four surveys will be administered to each patient during a 12-month period: One baseline survey and three follow-up surveys. Older adults will also be asked to keep track of their falls in a monthly falls diary, so they can accurately recall and report the information during the 12-month period for the patient surveys. The process evaluation interviews will be used to understand the attitudes of clinical staff towards the implementation process, barriers and facilitators to implementation, and the implementation fidelity to core components of the STEADI initiative. Descriptive statistics and cross tabulations will be used to describe quantitative data from the patient survey and process evaluation data. Risk ratios of the effect of the intervention on post-intervention falls will be calculated comparing intervention and control groups while controlling for demographic, health, attitude, and behavior variables.

The data collected from this study will be used to demonstrate the impact of STEADI and different components of STEADI on falls and fall injuries in a primary care setting, and improve the implementation of STEADI in a primary care setting. There are no costs to the respondents other than their time. The total estimated annualized burden is 1,578 hours.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (hours)
Patient	Stay Independent Fall Risk Screener (Att. D)	4,035	1	6/60
	Consent Form (Att. C)	1,235	1	12/60
	Patient Baseline Survey (Att. B1)	1,000	1	15/60
	Patient Follow-up Survey (Att. B2)	896	3	15/60
Physician/Physician Assistants/Nurse Practitioners	Provider Interview Guide/Consent (Att. E1)	3	1	50/60
Clinic Operations Manager	Operations Manager Interview Guide/Consent (Att. E2)	2	1	50/60

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.