April 7, 2020
Justification
This Non-Substantive change request is related to the ICR entitled, “Evaluation of CDC’s STEADI Older Adult Fall Prevention Initiative in a Primary Care Setting,” OMB control number 0920-1281.
This Non-Substantive change request is to cancel one of the previously OMB approved tools: The Stay Independent screener (Attachment 1). The tool will not be needed for this collection as the healthcare system incorporated the tool among their current clinic procedures for all patients.
Falls are the leading cause of fatal and nonfatal injuries among adults aged 65 and older in the United States and represent a significant burden to the healthcare system. Research demonstrates that clinical interventions can reduce fall risk. The American and British Geriatrics Societies (AGS/BGS) have developed a clinical practice guideline to manage fall risk among their older adult patients1. Based on these guidelines, the Centers for Disease Control and Prevention (CDC) developed a fall prevention initiative called the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) Initiative. The STEADI Initiative includes a suite of materials (available at www.cdc.gov/STEADI) to help health care practitioners to implement these clinical guidelines.
To date, there have been no large-scale studies with patients randomized to intervention and control groups to evaluate the health benefits of STEADI-based fall prevention. This data collection effort is a formative evaluation strategy to assess the impact of STEADI in a primary care system. The goal of this study is to evaluate CDC’s Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative in a primary care setting. The data collected from this study will be used to (1) demonstrate the impact of STEADI and different components of STEADI on falls and fall injuries in a primary care setting and (2) improve the implementation of STEADI in a primary care setting. Data collections include (1) using the STEADI Stay Independent screener to determine which older adult patients are at risk of a fall and are therefore eligible for the study, (2) administering patient surveys used to identify the number of falls patients have after entering the study, and the fall prevention behaviors practiced, and (3) interviewing clinical staff to understand their attitudes toward STEADI implementation. 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.
Proposed Changes
OMB previously approved the ICR “Evaluation of CDC’s STEADI Older Adult Fall Prevention Initiative in a Primary Care Setting” (OMB no. 0920-1281 exp. date 01/31/2023). In this ICR NCIPC was approved to use a paper version of the Stay Independent screener (Attachment 1).
Since NCIPC’s submission and approval of this ICR, the healthcare system, which is the implementation site for the study, has come to appreciate the Stay Independent screening tool for fall risk and decided to incorporate the tool into their usual clinic procedures for all patients, independent of the “Evaluation of CDC’s STEADI Older Adult Fall Prevention Initiative in a Primary Care Setting” study.
The “Evaluation of CDC’s STEADI Older Adult Fall Prevention Initiative in a Primary Care Setting” study thus no longer has a need to collect primary data from patients for recruitment purposes. This change would reduce the burden on the patients while still meeting the goals of the project. Going forward, the study will use the secondary data collected by the healthcare system via the Stay Independent screener, to recruit patients rather than use it as a primary data collection.
Change to Burden and/or Cost
This Non-Substantive change request does not include a crosswalk table as the complete Stay Independent screener (Attachment 1) will be canceled and not used.
1 AGS/BGS Clinical Practice Guideline: Prevention of Falls in Older Persons – Summary of Recommendations. (2016). American Geriatrics Society & British Geriatrics Society. Available at: http://www.americangeriatrics.org/health_care_professionals/clinical_practice/clinical_guidelines_recommendations/prevention_of_falls_summary_of_recommendations
Created: 7 December 2009
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
File Title | Change Request Guidance |
Author | jahlani akil |
File Modified | 0000-00-00 |
File Created | 2021-01-13 |