Skip to Content

Notice

Proposed Data Collection Submitted for Public Comment and Recommendations

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 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.

Start Further Info

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: omb@cdc.gov.

End Further Info End Preamble Start Supplemental Information

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 Start Printed Page 2521implemented. 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

Type of respondentForm nameNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total burden hours (in hours)
Older adult PatientsSurvey correspondence to patients and consent form for patients2,29912/6077
Pre-discharge Patient800110/60133
Post-discharge Patient800310/60400
Clinical staff (Pharmacists, nurses, physicians)Survey correspondence to clinical staff10011/602
Clinical staff evaluation Questionnaire5015/604
Primary care providers (PCP)Survey correspondence to primary care providers10011/602
PCP post discharge survey5015/604
Total622
Start Signature

Jeffrey M. Zirger,

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

End Signature End Supplemental Information

[FR Doc. 2019-01331 Filed 2-6-19; 8:45 am]

BILLING CODE 4163-19-P