Results Summary
What was the research about?
Nearly one in four older adults falls each year, which can cause serious injury and disability. In this study, the research team compared two approaches to prevent falls among older adults living at home:
- Tailored fall prevention plan. A nurse assessed fall risk and worked with the patient to tailor a plan based on their risks and preferences. The plan included actions for the patient, nurse, and doctor. It also included referrals to other health professionals or community programs. The nurse reassessed the patient's fall risk once a year for up to two and a half years.
- Enhanced usual care. The research team notified clinics about patients who were at high risk for falls. Patients received usual care and a fall prevention brochure in the mail that encouraged patients to talk with their doctors. Doctors and staff had access to a fall prevention webinar.
What were the results?
The rate of serious injuries from falls verified by doctors didn’t differ between the two approaches. But compared with patients who received enhanced usual care, patients who received a fall prevention plan reported lower rates of fall injuries. They also had lower symptoms of depression, but the difference wasn’t meaningful.
After two years, patients who received the two approaches didn’t differ in:
- Ability to do daily activities
- Symptoms of anxiety
- Confidence about avoiding falls
Who was in the study?
The study included 5,451 adults at least 70 years old. Patients were at high risk for falls based on fall injuries in the last year, falling two or more times in the last year, or fear of a fall from balance or walking problems. Patients received care at one of 86 primary care practices from 10 health systems across the United States. Of these patients, 91 percent were White, 5 percent were Black, and 4 percent reported other race or did not report a race; 7 percent were Latino or Hispanic. The average age was 80, and 62 percent were women.
What did the research team do?
The research team assigned clinics by chance to one of the two approaches. Patients received the approach assigned to their clinic.
Every four months, the research team called patients to ask about falls and fall injuries. The team looked at electronic health records and insurance claims to verify these injuries. The team also chose 743 patients by chance to ask about their well-being at the start of the study and again one year and two years later.
Patients, caregivers, and staff from clinics and the National Institute on Aging gave input on the study.
What were the limits of the study?
Most patients in the study were White. Results may differ for patients of other racial backgrounds. The research team couldn’t track if patients fully followed the care plan.
Future research could look at whether patients and doctors follow the fall prevention plan and any barriers to doing so.
How can people use the results?
Researchers can use these results when considering ways to prevent falls in older adults.
| PCORI® partnered with the National Institute on Aging of the National Institutes of Health in 2013 to fund this large-scale research study. |
Professional Abstract
Objective
To compare the effectiveness of a multifactorial intervention using evidence-based practices versus enhanced usual care on reducing serious injuries from falls and improving well-being among older adults at risk for falls
Study Design
| Design Element | Description |
|---|---|
| Design | Cluster randomized controlled trial |
| Population | 5,451 adult patients at least 70 years old at high risk for falls based on at least one of the following criteria: (1) had fallen and hurt themselves in the past year, (2) had fallen 2 or more times in the past year, or (3) were afraid that they might fall because of balance or walking problems. Patients received care at 1 of 86 primary care practices within 10 health systems. |
| Interventions/ Comparators |
|
| Outcomes |
Primary: rate of first verified serious fall injury Secondary: self-reported fall injuries, concern about falling, physical function and disability, anxiety, depression |
| Timeframe | Up to 44-month follow-up for primary outcome |
This cluster randomized pragmatic trial compared a fall prevention intervention versus enhanced usual care on decreasing serious fall injuries and increasing patient well-being among older, community-dwelling adults at risk for falls.
Researchers randomly assigned primary care practices to one of the two fall prevention methods. Patients received the method assigned to their practice.
- Multifactorial fall prevention intervention. Nurses, acting as falls care managers (FCMs), conducted in-person fall risk assessments. Based on assessments and patient priorities elicited through motivational interviewing, the patient and FCM developed a personalized, evidence-based fall care plan. The plan included fall risk reduction interventions initiated by the FCM; healthcare recommendations by other professionals, such as medication changes or physical therapy referrals; and referrals to community programs. The FCM reassessed patients' fall risk annually.
- Enhanced usual care. Primary care practices received notification of patients identified with a high fall risk. Patients received usual care plus a fall prevention brochure in the mail. The brochure described fall risk factors and encouraged patients to talk with their doctors. Doctors and practice staff had access to a fall prevention webinar.
The study included 5,451 patients receiving primary care at one of 86 practices across 10 health systems in the United States. Among patients, 91% were White, 5% were Black, 4% reported other race or did not report a race; 7% were Latino or Hispanic. The average age was 80, and 62% were female.
Every four months, researchers called patients and asked about falls and fall injuries. Researchers reviewed electronic health records and claims data to verify reported injuries. For 743 randomly selected patients, researchers asked about well-being at baseline and again one year and two years later.
Patients, caregivers, and representatives from health systems and the National Institute on Aging gave input on the study.
Results
Rates of verified serious fall injuries did not differ significantly between the two groups. Compared with patients receiving enhanced usual care, those receiving the intervention had lower rates of first self-reported injuries from a fall (hazard ratio: 0.90; 99% confidence interval [CI]: 0.83, 0.99).
After two years, patients in the two groups did not differ significantly in concerns about falling, physical function and disability, or anxiety. Patients receiving the intervention reported lower symptoms of depression (99% CI: -2.36, -0.02) than patients receiving usual care; however, the difference was not clinically meaningful.
Limitations
Most patients were White. Results may differ for people of other racial backgrounds. The pragmatic study design limited researchers’ ability to monitor adherence to care plan recommendations.
Conclusions and Relevance
In this study, a multifactorial intervention did not reduce serious fall injuries more than enhanced usual care.
Future Research Needs
Future research could include measures to track adherence and evaluate methods to remove barriers to adherence to fall care plans.
| PCORI® partnered with the National Institute on Aging of the National Institutes of Health in 2013 to fund this large-scale research study. |
Final Research Report
View this project's final research report.
Journal Citations
Article Highlight: In a paper in the New England Journal of Medicine, this study reported that having nurses tailor and administer fall-prevention plans for older adults at high risk resulted in about an 8 percent to 10 percent reduction in serious fall injuries, but this effect was not statistically significant. The paper discusses potential barriers to care and other factors that could account for why a more significant reduction in serious fall injuries was not seen when risk-reduction strategies shown to be effective in previous studies were deployed this way in real-world circumstances and settings.
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked the researchers to add information about the falls case managers used in this study, including their background and training. They also asked the researchers why nurses were chosen for this role. The researchers added information to the text on the training provided for falls case manager. Regarding the use of nurses, the researchers explained that nurses have the professional background and patient access that put them in the best place to conduct standardized assessments and follow treatment protocols.
- The reviewers suggested that the researchers add to their discussion about the lower-than-expected rate of falls among their study sample and how that affected their power to identify treatment effects. The researchers acknowledged that there were fewer falls than expected but assured the reviewers that the study sample was sufficient to run the proposed statistical tests. In addition, the researchers ran simulation studies throughout the study to monitor the study power.
- The reviewers noted that the researchers provided some potential reasons for not reaching the 20% expected reduction in falls that was based on efficacy trials of the same treatments but did not consider whether the patient population in this study was different from the population usually seen in smaller efficacy trials. The researchers explained since this study was a pragmatic trial, they did not collect some of the data that might be important to comparing study samples, such as gait, balance, and other fall risk factors. For the factors they did examine, including age and falls risk, the present study sample was comparable to prior efficacy studies.