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Rationale and design of the Study To Understand Fall Reduction and Vitamin D in You (STURDY): A randomized clinical trial of Vitamin D supplement doses for the prevention of falls in older adults.

ABSTRACT: Prior evidence suggests that vitamin D supplementation may reduce fall risk, but existing data are inconsistent and insufficient to guide policy. We designed a two-stage Bayesian response-adaptive dose-finding and seamless confirmatory randomized trial of vitamin D supplementation to prevent falls. Up to 1200 community-dwelling persons, aged ?70?years, of predominantly white and African-American race, with serum 25(OH)D concentrations of 10-29?ng/mL and at elevated fall risk, will be randomized to one of four vitamin D3 (cholecalciferol) supplement doses: 200 (control), 1000, 2000, or 4000?IU/day and treated for up to 2?years. Stage 1 is designed to identify the best of the non-control doses for fall prevention. If a best dose is selected, Stage 2 will start seamlessly, with enrollees assigned to control or the best dose in Stage 1 continuing on that dose unchanged, enrollees assigned to the two non-control, non-best doses in Stage 1 switched to the best dose, and new enrollees randomly assigned 1:1 to control or the best dose. In Stage 2, we will compare the control dose group to the best dose group to potentially confirm the efficacy of that dose for fall prevention. The primary outcome measure in both stages is time to first fall or death, whichever comes first. Falls are ascertained from calendars, scheduled interviews, or interim self-reports. Secondary outcome measures include time to each component of the composite primary outcome and gait speed. Additional outcomes include the Short Physical Performance Battery score, physical activity level (assessed by accelerometry), and frailty score. CLINICAL TRIAL REGISTRATION:NCT02166333.

SUBMITTER: Michos ED

PROVIDER: S-EPMC6251709 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Rationale and design of the Study To Understand Fall Reduction and Vitamin D in You (STURDY): A randomized clinical trial of Vitamin D supplement doses for the prevention of falls in older adults.

Michos Erin D ED Mitchell Christine M CM Miller Edgar R ER Sternberg Alice L AL Juraschek Stephen P SP Schrack Jennifer A JA Szanton Sarah L SL Walston Jeremy D JD Kalyani Rita R RR Plante Timothy B TB Christenson Robert H RH Shade Dave D Tonascia James J Roth David L DL Appel Lawrence J LJ

Contemporary clinical trials 20180820

Prior evidence suggests that vitamin D supplementation may reduce fall risk, but existing data are inconsistent and insufficient to guide policy. We designed a two-stage Bayesian response-adaptive dose-finding and seamless confirmatory randomized trial of vitamin D supplementation to prevent falls. Up to 1200 community-dwelling persons, aged ≥70 years, of predominantly white and African-American race, with serum 25(OH)D concentrations of 10-29 ng/mL and at elevated fall risk, will be randomized ...[more]

PMID: 30138718

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Project description:BackgroundFalls are common in older adults and can lead to severe injuries. The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial cluster-randomized 86 primary care practices across 10 health systems to a multifactorial intervention to prevent fall injuries, delivered by registered nurses trained as falls care managers, or enhanced usual care. STRIDE enrolled 5451 community-dwelling older adults age ≥70 at increased fall injury risk.MethodsWe assessed fall-related outcomes via telephone interviews of participants (or proxies) every 4 months. At baseline, 12 and 24 months, we assessed health-related quality of life (HRQOL) using the EQ-5D-5L and EQ-VAS. We used Poisson models to assess intervention effects on falls, fall-related fractures, fall injuries leading to hospital admission, and fall injuries leading to medical attention. We used hierarchical longitudinal linear models to assess HRQOL.ResultsFor recurrent event models, intervention versus control incidence rate ratios were 0.97 (95% confidence interval [CI], 0.93-1.00; p = 0.048) for falls, 0.93 (95% CI, 0.80-1.08; p = 0.337) for self-reported fractures, 0.89 (95% CI, 0.73-1.07; p = 0.205) for adjudicated fractures, 0.91 (95% CI, 0.77-1.07; p = 0.263) for falls leading to hospital admission, and 0.97 (95% CI, 0.89-1.06; p = 0.477) for falls leading to medical attention. Similar effect sizes (non-significant) were obtained for dichotomous outcomes (e.g., participants with ≥1 events). The difference in least square mean change over time in EQ-5D-5L (intervention minus control) was 0.009 (95% CI, -0.002 to 0.019; p = 0.106) at 12 months and 0.005 (95% CI, -0.006 to 0.015; p = 0.384) at 24 months.ConclusionsAcross a standard set of outcomes typically reported in fall prevention studies, we observed modest improvements, one of which was statistically significant. Future work should focus on patient-, practice-, and organization-level operational strategies to increase the real-world effectiveness of interventions, and improving the ability to detect small but potentially meaningful clinical effects.Clinicaltrialsgov identifier: NCT02475850.

Project description:ObjectivesPrevention of falls and fall-related injuries is a priority due to the substantial health and financial burden of falls on patients and healthcare systems. Deprescribing medications known as 'fall-risk increasing drugs' (FRIDs) is a common strategy to prevent falls. We conducted a systematic review to determine its efficacy for the prevention of falls and fall-related complications.DesignSystematic review and meta-analysis.Data sourcesMEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL and grey literature from inception to 1 August 2020.Eligibility criteria for selecting studiesRandomised controlled trials of FRID withdrawal compared with usual care evaluating the rate of falls, incidence of falls, fall-related injuries, fall-related fractures, fall-related hospitalisations or adverse effects related to the intervention in adults aged ≥65 years.Data extraction and synthesisTwo reviewers independently performed citation screening, data abstraction, risk of bias assessment and certainty of evidence grading. Random-effects models were used for meta-analyses.ResultsFive trials involving 1305 participants met eligibility criteria. Deprescribing FRIDs did not change the rate of falls (rate ratio (RaR) 0.98, 95% CI 0.63 to 1.51), the incidence of falls (risk difference 0.01, 95% CI -0.06 to 0.09; relative risk 1.04, 95% CI 0.86 to 1.26) or rate of fall-related injuries (RaR 0.89, 95% CI 0.57 to 1.39) over a follow-up period of 6-12 months. No trials evaluated the impact of deprescribing FRIDs on fall-related fractures or hospitalisations.ConclusionThere is a paucity of robust high-quality evidence to support or refute that a FRID deprescribing strategy alone is effective at preventing falls or fall-related injury in older adults. Although there may be other reasons to deprescribe FRIDs, our systematic review found that it may result in little to no difference in the rate or risk of falls as a sole falls reduction strategy.Prospero registration numberCRD42016040203.

Project description:ObjectiveTo evaluate whether a service to prevent falls in the community would help reduce the rate of falls in older people who call an emergency ambulance when they fall but are not taken to hospital.DesignRandomised controlled trial.SettingCommunity covered by four primary care trusts, England.Participants204 adults aged more than 60 living at home or in residential care who had fallen and called an emergency ambulance but were not taken to hospital.InterventionsReferral to community fall prevention services or standard medical and social care.Main outcome measuresThe primary outcome was the rate of falls over 12 months, ascertained from monthly diaries. Secondary outcomes were scores on the Barthel index, Nottingham extended activities of daily living scale, and falls efficacy scale at baseline and by postal questionnaire at 12 months. Analysis was by intention to treat.Results102 people were allocated to each group. 99 (97%) participants in the intervention group received the intervention. Falls diaries were analysed for 88.6 person years in the intervention group and 84.5 person years in the control group. The incidence rates of falls per year were 3.46 in the intervention group and 7.68 in the control group (incidence rate ratio 0.45, 95% confidence interval 0.35 to 0.58, P<0.001). The intervention group achieved higher scores on the Barthel index and Nottingham extended activities of daily living and lower scores on the falls efficacy scale (all P<0.05) at the 12 month follow-up. The number of times an emergency ambulance was called because of a fall was significantly different during follow-up (incidence rate ratio 0.60, 95% confidence interval 0.40 to 0.92, P=0.018).ConclusionA service to prevent falls in the community reduced the fall rate and improved clinical outcome in the high risk group of older people who call an emergency ambulance after a fall but are not taken to hospital.Trial registrationCurrent Controlled Trials ISRCTN67535605.

Project description:ImportanceThere is insufficient research on the costs of patient falls in health care systems, a leading source of nonreimbursable adverse events.ObjectiveTo report the costs of inpatient falls and the cost savings associated with implementation of an evidence-based fall prevention program.Design, setting, and participantsIn this economic evaluation, a matched case-control study used the findings from an interrupted time series analysis that assessed changes in fall rates following implementation of an evidence-based fall prevention program to understand the cost of inpatient falls. An economic analysis was then performed to assess the cost benefits associated with program implementation across 2 US health care systems from June 1, 2013, to August 31, 2019, in New York, New York, and Boston, Massachusetts. All adults hospitalized in participating units were included in the analysis. Data analysis was performed from October 2021 to November 2022.InterventionsEvidence-based fall prevention program implemented in 33 medical and surgical units in 8 hospitals.Main outcomes and measuresPrimary outcome was cost of inpatient falls. Secondary outcome was the costs and cost savings associated with the evidence-based fall prevention program.ResultsA total of 10 176 patients who had a fall event (injurious or noninjurious) with 29 161 matched controls (no fall event) were included in the case-control study and the economic analysis (51.9% were 65-74 years of age, 67.1% were White, and 53.6% were male). Before the intervention, there were 2503 falls and 900 injuries; after the intervention, there were 2078 falls and 758 injuries. Based on a 19% reduction in falls and 20% reduction in injurious falls from the beginning to the end of the postintervention period, the economic analysis demonstrated that noninjurious and injurious falls were associated with cost increases of $35 365 and $36 776, respectively. The implementation of the evidence-based fall prevention program was associated with $14 600 in net avoided costs per 1000 patient-days.Conclusions and relevanceThis economic evaluation found that fall-related adverse events represented a clinical and financial burden to health care systems and that the current Medicare policy limits reimbursement. In this study, costs of falls only differed marginally by injury level. Policies that incentivize organizations to implement evidence-based strategies that reduce the incidence of all falls may be effective in reducing both harm and costs.

Dataset Information

Rationale and design of the Study To Understand Fall Reduction and Vitamin D in You (STURDY): A randomized clinical trial of Vitamin D supplement doses for the prevention of falls in older adults.

Publications

Rationale and design of the Study To Understand Fall Reduction and Vitamin D in You (STURDY): A randomized clinical trial of Vitamin D supplement doses for the prevention of falls in older adults.

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