Request for Information (RFI): Interests and Perspectives of Care Organizations and Patients Regarding an Effectiveness Trial of a Multifactorial Fall Injuries Prevention Strategy for Non-Institutionalized Older PersonsNotice Number: NOT-AG-13-015
Date: June 12, 2013
Response Date: July 9, 2013
National Institute on Aging (NIA)
Fall injuries among older persons constitute a substantial public health and economic burden. Risk factors spanning a wide range of health conditions, functional impairments, and environmental conditions, contribute to injurious falls. A variety of multifactorial risk reduction strategies to prevent falls have been developed. Clinical trials have found substantial efficacy for some, and lack of efficacy for others. An evidence-based falls prevention protocol, developed jointly by the American Geriatrics Society and the British Geriatrics Society (J Am Geriatr Soc 2012), calls for screening older populations to identify persons at high risk for falling, comprehensive assessment of high-risk persons' specific risks, and tailored, multifactorial treatment and ongoing monitoring of high-risk persons.
Although many individual components of multifactorial fall risk reduction strategies, which are delivered by physicians and other health care providers, are covered by third-party payers, the lack of financial and organizational support for the communication, planning, and coordination among such care providers, which is needed to implement multifactorial strategies, has frequently been noted as one obstacle to their effective implementation. Other potential barriers to implementing such strategies with fidelity and stability include: burdensome travel between people's homes and sites of care, gaps in fall-specific provider expertise, competing demands on clinicians and their reluctance to implement new practices for small segments of their patient caseloads, and organizations' unwillingness to commit the managerial resources and expertise needed to facilitate and sustain changes in practice.
Attention to new strategies to support and provide patient-centered care coordination has been increasing in a variety of types of care organizational settings, e.g., Accountable Care Organizations (ACOs), Patient-Centered Medical Homes (PCMHs) and other primary care organizations, HMOs, and assisted-living facilities (ALFs). To the extent that provider organizations can overcome the obstacles and barriers noted above, such settings could provide venues for a clinical trial of a coordinated fall injuries prevention strategy designed both to be effective in reducing injuries from falls and (if effective) to be organizationally and financially sustainable and diffusible after the conclusion of the trial.
The National Institute on Aging (NIA), in collaboration with the Patient-Centered Outcomes Research Institute (PCORI), is exploring possible options for such a trial in non-institutionalized older persons. As part of this process, NIA seeks information from individual stakeholders and organizations involved in the care and well-being of older persons. Types of information of interest from differing groups of stakeholders include, but are not limited to, the following:
1. Organizations (or individual members of organizations) that provide health care and housing for older persons, e.g., ACOs, HMOs, ALFs, PCMH's, and other primary care organizations.
a) Availability of information about its service population that is needed to design a fall-injury prevention trial and estimate its sample size (e.g., fall-injury rates, prevalence of risk factors for falls and fall injuries, and currently-used fall-prevention strategies); opportunities to obtain this information, if it is not currently available.
b) Organizations' specific methods and incentives for coordinating primary care with the care provided by other health professionals (e.g., specialists, podiatrists, rehabilitation therapists).
c) Opportunities and challenges perceived to be associated with organizations' participation in a clinical trial of a multifactorial fall injuries prevention program.
d) Organizations' willingness and capacity to participate in a multi-site clinical trial of fall injuries prevention.
e) Clinical, logistical, managerial, financial, and other considerations that would influence organizations' post-trial decisions about adopting and sustaining a proven and effective multifactorial fall injury prevention strategy.
2. Health care professionals who would assess and treat the high-risk participants in multifactorial falls prevention programs, e.g., primary care physicians, nurses, physical therapists, and occupational therapists.
a) If they were to integrate falls prevention services into the routine care of their high-risk patients - their willingness to complete supplemental training on the prevention of falls and fall injuries; willingness to adhere to the study protocol for assessing, treating, and monitoring high-risk patients; willingness to collaborate and communicate with the other professionals on the fall-injuries prevention team; willingness to provide documentation of adherence to a fall injuries prevention protocol; willingness to travel and perform environmental assessments in patients' homes; and willingness to complete research surveys.
b) If they were to provide falls prevention services to clinical trial participants 12-14 hours per week at an assisted living facility – their willingness to complete supplemental training on the prevention of falls; willingness to adhere to a study protocol for assessing, treating and monitoring high-risk patients; willingness to collaborate and communicate with the other professionals on the fall-injuries prevention team; willingness to provide documentation of adherence to a fall injuries prevention protocol; willingness to perform environmental assessments in patients' apartments; and willingness to complete research surveys.
3. Older persons living in their homes or ALFs who have fallen, as well as their family caregivers and representatives of relevant patient-advocacy organizations.
a) Concerns about falling and about being injured.
b) Interest and potential willingness to participate in a study of a comprehensive fall injuries- prevention program.
c) Beliefs about potential beneficial and/or undesirable effects of participating in a multifactorial fall injury prevention program that included modifications in health care, e.g., medications, and in living environment, including
d) Beliefs about self-management strategies that would be effective in preventing fall injuries.
All responses must be submitted to firstname.lastname@example.org by July 9, 2013. Please include the Notice number NOT-AG-13-015 in the subject line.
Response to this Request for Information (RFI) is voluntary. Responders are free to address any or all of the elements listed above. The submitted information will be reviewed by the NIH staff. Submitted information will be considered confidential.
This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the U.S. Government or the National Institutes of Health (NIH). The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.
The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future solicitation(s). The information provided will be analyzed and may appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Please direct all inquiries to:
Sergei V. Romashkan, M.D.
National Institute on Aging (NIA)
7201 Wisconsin Avenue, Suite 525A
Bethesda, MD 20892-9205
(Fed Ex Packages use ZIP 20814)