2019-10838. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled “An Evaluation of CDC's STEADI Older Adult Fall Prevention Initiative in a 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.

DATES:

CDC must receive written comments on or before July 23, 2019.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2019-0037 by any of the following methods:

• Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

Please note:

Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffery M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. 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 submissions of responses.

5. Assess information collection costs.

Proposed Project

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 or not 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 hours is 3,836.

Estimated Annualized Burden Hours

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (hours)	Total burden (hours)
Patient	Stay Independent Fall Risk Screener	5,093	1	10/60	849
	Patient Consent Form	* 1,333	1	12/60	267
	Patient Baseline Survey	1,000	1	15/60	250
	Patient Follow-up Survey	896	3	15/60	672
	Patient Falls Diary	896	12	10/60	1,792
Nurse	Nurse Interview Guide/Consent	1	1	1	1
Physician/Physician Assistants/Nurse Practitioners	Provider Interview Guide/Consent	3	1	1	3
Clinic operations Manager	Operations Manager Guide/Consent	2	1	1	2
Total					3,836

Jeffrey M. Zirger,

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