[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57434-57435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23365]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-19ARD]


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 
(404) 639-7570 or send an email to [email protected]. 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 (202) 395-5806. 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.

[[Page 57435]]

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


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-23365 Filed 10-24-19; 8:45 am]
 BILLING CODE 4163-18-P