July 13, 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 modify the baseline and follow-up patient surveys and the provider interview guide (attachments 1, 2, and 3 respectively)
We are in desperate need to star collecting August 1, 2020. OMB# 0920-1281 was approved in January 2020. We were planning to start data collection in mid-March when the COVID19 epidemic started in the U.S. and we were not able to start the study. Once regular practice resumed, it was conducted via tele-medicine, so we had to redesign our data collection instruments to account for that. We are ready to start the study and have a target of August 1, 2020 to start.
Our study design is to recruit patients for a year and then collect data from each patient for a year. If we start August 1, 2020 then we will recruit our last patient on July 31, 2021. Data collection for that patient would end July 31,2022. The mechanism for the contract expires November 2022. If we start August 1, 2020, we will have just 3 months to analyze data – if we start any later we may not have sufficient time on the contract to collect one year of data for each patient and will not have time for the contractor to conduct the required analysis. We are also concerned that once flu season starts, annual and non-urgent visits may be put on hold again which would keep us from being able to recruit patients. It is important that we start now to recruit a large part of our sample prior to flu season.
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 collect data from patients using the baseline and follow-up patient surveys (attachments 1 and 2) and to collect data from providers using the provider interview guide (attachment 3)
Since NCIPC’s submission and approval of this ICR, due to the COVID-19 pandemic, the majority of non-acute visits will be taking place via telemedicine in the selected healthcare system
The baseline, follow-up patient surveys and the provider interview guide data collection instruments for the “Evaluation of CDC’s STEADI Older Adult Fall Prevention Initiative in a Primary Care Setting” study need to be modified to appropriately capture information in a telemedicine environment
One question needs to be added to the baseline survey to determine who was available to help the patients with their telemedicine STEADI assessment. The wording of additional questions needs to be modified to accurately describe the visit patients had with their healthcare provider
Additional options need to be added to questions in the follow-up survey to capture whether visits with providers were via telemedicine or in person and whether fall interventions were provided via telemedicine or in person. This will help us control for any differences between setting of care in our analysis
In the telemedicine environment there have been changes as to which staff roles are responsible for patient intake. The provider interview guide needs to be modified to include the correct job titles.
Two additional questions need to be added to the provider interview guide to assess providers attitudes towards STEADI in a telemedicine environment
Change to Burden and/or Cost
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 | 2022-02-12 |