[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2520-2521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01331]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-19-19GH; Docket No. CDC-2018-0116]


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.

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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 and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``Evaluating the implementation 
and impact of a fall prevention program, including opioid medication 
management, in a hospital discharge setting.'' This study will evaluate 
the implementation and impact of a fall prevention program in a 
hospital discharge setting. Components of the program will target 
opioid medication management in the acute and post-acute settings, and 
referral to clinically effective programs to reduce the risk of falls 
and opioid misuse.

DATES: CDC must receive written comments on or before April 8, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0116 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 Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

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

    Evaluating the implementation and impact of a fall prevention 
program, including opioid medication management, in a hospital 
discharge 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 injury, and injuries leading to 
death in older adults. Medications which affect the central nervous 
system can cause side effects that increase the chances of falling, 
such as dizziness, sedation, confusion, blurred vision, and orthostatic 
hypotension. Opioids are strongly associated with increased fall risk 
in older adults. When opioids are taken with other medications, like 
benzodiazepines, there can be a synergistic effect on cognition and 
physical function, potentially leading to a more pronounced injury or 
unintentional overdose.
    A key intervention in the Centers for Disease Control and 
Prevention (CDC)'s fall prevention program STEADI (Stopping Elderly 
Accidents, Deaths, and Injuries) initiative is medication management to 
reduce the fall risk. Medication review and management, especially upon 
care transitions, can reduce inappropriate opioid use, the risk of 
injury, and improve patient health. This data collection will evaluate 
the implementation and impact of a fall prevention program, including 
opioid medication management, in a hospital discharge setting. 
Components of the program will target opioid medication management in 
the acute and post-acute settings and referral to clinically effective 
programs to reduce the risk of falls and opioid misuse. This data 
collected will be used to: (1) Examine post-discharge use of opioids or 
alternative therapies for pain management among older adult patients, 
(2) examine post-discharge compliance and follow up by older adults 
with primary care doctors and/or specialist referrals for pain 
management and fall prevention efforts, (3) identify rate of 
readmission for a fall by level of patient compliance and follow-up 
post-discharge, (4) evaluate the uptake of the program by clinical 
staff, and (5) identify opportunities for program and process 
improvement.
    The study population will be limited to older adults (65 years and 
older) considered high risk due to opioid use identified during 
discharge at a specific Medical Center inpatient. The study population 
for the clinical staff evaluation questionnaire will be limited to the 
same Medical Center clinical staff (i.e., nurses, pharmacists, 
physicians) involved in older-adult patient pain management and post-
discharge planning that work in hospital units where this program has 
been

[[Page 2521]]

implemented. The study population for the primary care provider post-
discharge questionnaire will be Primary Care Providers (PCP) associated 
with the same Medical Center who care for older adult study patients 
discharged each month. Four questionnaires will be administered. (1) 
The Pre-discharge patient questionnaire will be used to survey older 
adults in the hospital (before discharge). (2) The Post-discharge 
patient questionnaire will be used to survey the older adults that 
completed the pre-discharge survey three additional times (at 14, 30 
and 60 days) after being discharged from the Medical Center. (3) The 
Clinical staff evaluation questionnaire will be used to survey clinical 
staff at the Medical Center. (4) The Primary Care Provider (PCP) post-
discharge questionnaire will be used to survey primary care providers 
involved in the care of patients discharged. The open-ended questions 
will be analyzed to identify themes, and results will be presented by 
theme. Frequencies, cross-tabs, and regression analysis will be used 
for categorical questions.
    The total estimated annualized burden hours is 622. There are no 
costs to respondents other than their time.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden   Total burden
               Type of respondent                               Form name                    Number of     responses per   per response      hours (in
                                                                                            respondents     respondent      (in hours)        hours)
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Older adult Patients...........................  Survey correspondence to patients and             2,299               1            2/60              77
                                                  consent form for patients.
                                                 Pre-discharge Patient..................             800               1           10/60             133
                                                 Post-discharge Patient.................             800               3           10/60             400
Clinical staff.................................  Survey correspondence to clinical staff             100               1            1/60               2
(Pharmacists, nurses, physicians)..............
                                                 Clinical staff evaluation Questionnaire              50               1            5/60               4
Primary care providers (PCP)...................  Survey correspondence to primary care               100               1            1/60               2
                                                  providers.
                                                 PCP post discharge survey..............              50               1            5/60               4
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             622
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Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-01331 Filed 2-6-19; 8:45 am]
BILLING CODE 4163-19-P