Working to Increase Stability through Exercise (WISE): Study protocol for a pragmatic randomized controlled trial of a coached exercise program to reduce serious fall-related injuries.
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SUBMITTER: Sciamanna C
PROVIDER: S-EPMC6333097 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
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Working to Increase Stability through Exercise (WISE): Study protocol for a pragmatic randomized controlled trial of a coached exercise program to reduce serious fall-related injuries.
Sciamanna Christopher C Ballentine Noel H NH Bopp Melissa M Brach Jennifer S JS Chinchilli Vernon M VM Ciccolo Joseph T JT Conroy Molly B MB Fisher Abigail A Fox Edward J EJ Greenspan Susan L SL Jan De Beur Suzanne M M Kearcher Kalen K Kraschnewski Jennifer L JL McTigue Kathleen M KM McAuley Edward E Morone Natalia E NE Paranjape Anuradha A Rodriguez-Colon Sol S Rosenzweig Andrew A Smyth Joshua M JM Stewart Kerry J KJ Stuckey Heather L HL
Contemporary clinical trials 20180924
Approximately one-third of older adults fall each year and fall-related injuries are a leading cause of death and disability among this rapidly expanding age group. Despite the availability of bisphosphonates to reduce fractures, concerns over side effects have dramatically reduced use, suggesting that other treatment options are needed. Though many smaller studies have shown that physical activity programs can reduce falls, no study has been adequately powered to detect a reduction in fall-rela ...[more]
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Project description:BackgroundThis paper describes a protocol for determining the incidence of serious fall injuries for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large, multicenter pragmatic clinical trial with limited resources for event adjudication. We describe how administrative data (from participating health systems and Medicare claims) can be used to confirm participant-reported events, with more time- and resource-intensive full-text medical record data used only on an "as-needed" basis.MethodsSTRIDE is a pragmatic cluster-randomized controlled trial involving 5451 participants age ≥ 70 and at increased risk for falls, served by 86 primary care practices in 10 US health systems. The STRIDE intervention involves a nurse falls care manager who assesses a participant's underlying risks for falls, suggests interventions using motivational interviewing, and then creates, implements and longitudinally follows up on an individualized care plan with the participant (and caregiver when appropriate), in partnership with the participant's primary care provider. STRIDE's primary outcome is serious fall injuries, defined as a fall resulting in: (1) medical attention billable according to Medicare guidelines with a) fracture (excluding isolated thoracic vertebral and/or lumbar vertebral fracture), b) joint dislocation, or c) cut requiring closure; OR (2) overnight hospitalization with a) head injury, b) sprain or strain, c) bruising or swelling, or d) other injury determined to be "serious" (i.e., burn, rhabdomyolysis, or internal injury). Two sources of data are required to confirm a serious fall injury. The primary data source is the participant's self-report of a fall leading to medical attention, identified during telephone interview every 4 months, with the confirmatory source being (1) administrative data capturing encounters at the participating health systems or Medicare claims and/or (2) the full text of medical records requested only as needed.DiscussionAdjudication is ongoing, with over 1000 potentially qualifying events adjudicated to date. Administrative data can be successfully used for adjudication, as part of a hybrid approach that retrieves full-text medical records only when needed. With the continued refinement and availability of administrative data sources, future studies may be able to use administrative data completely in lieu of medical record review to maximize the quality of adjudication with finite resources.Trial registrationClinicalTrials.gov (NCT02475850).
| S-EPMC6582694 | biostudies-literature
Project description:BackgroundDespite increasing numbers of older adults undergoing surgery and the known risks of opioids, little is known about the potential association between opioid prescribing and serious falls and fall-related injuries after surgery.ObjectiveTo determine the incidence and risk factors of serious falls and fall-related injuries after elective, outpatient surgery.DesignRetrospective cohort study of 20% national sample of Medicare claims among beneficiaries ≥ 65 years of age with Medicare Part D claims and who underwent elective outpatient surgery from January 1, 2009, through December 31, 2014.ParticipantsOpioid-naïve patients ≥ 65 years undergoing elective, minor, outpatient surgical procedures. The exposure was opioid prescription fills in the perioperative period (i.e., 30 days before up until 3 days after surgery) converted to total oral morphine equivalents (OME) over a period 30 days prior to and 30 days after surgery.Main measuresSerious falls and fall-related injuries within 30 days after surgery, examined through Poisson regression analysis with reported fall and fall-related injury rates adjusted for potential confounders.Key resultsAmong 44,247 opioid-naïve surgical patients, 76.3% filled an opioid prescription in the perioperative period. Overall, 0.62% of patients suffered a serious fall or fall-related injury within 30 days after surgery. Risk factors for serious falls or fall-related injuries after surgery included older age (80-84 years: RR 1.64, 95% CI 1.12-2.40; 85 years and older: RR 1.81, 95% CI 1.25-2.86), female sex (RR 3.04, 95% CI 2.29-4.05), Medicaid eligibility (RR 1.63, 95% CI 1.17-2.26), and higher amounts of opioids filled following surgery (≥ 225 OME: RR 2.29, 95% CI 1.72-3.07).ConclusionsSerious falls after elective, outpatient surgery are uncommon, but correlated with age, sex, Medicaid eligibility, and the amount of opioids filled in the perioperative period. Judicious prescribing of opioids after surgery is paramount and is an opportunity to improve the safety of surgical care among older individuals.
| S-EPMC7572978 | biostudies-literature
Project description:BackgroundInjuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined.MethodsWe conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group.ResultsThe demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups.ConclusionsA multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).
| S-EPMC7421468 | biostudies-literature
Project description:Falls are common and associated with adverse outcomes in patients on dialysis. Limited data are available in earlier stages of CKD.We analyzed data from 8744 Reasons for Geographic and Racial Differences in Stroke Study participants ?65 years old with Medicare fee for service coverage. Serious fall injuries were defined as a fall-related fracture, brain injury, or joint dislocation using Medicare claims. Hazard ratios (HRs) for serious fall injuries were calculated by eGFR and albumin-to-creatinine ratio (ACR). Among 2590 participants with CKD (eGFR<60 ml/min per 1.73 m(2) or ACR?30 mg/g), cumulative mortality after a serious fall injury compared with age-matched controls without a fall injury was calculated.Overall, 1103 (12.6%) participants had a serious fall injury over 9.9 years of follow-up. The incidence rates per 1000 person-years of serious fall injuries were 21.7 (95% confidence interval [95% CI], 20.3 to 23.2), 26.6 (95% CI, 22.6 to 31.3), and 38.3 (95% CI, 31.2 to 47.0) at eGFR levels ?60, 45-59, and <45 ml/min per 1.73 m(2), respectively, and 21.3 (95% CI, 20.0 to 22.8), 31.7 (95% CI, 27.5 to 36.5), and 42.2 (95% CI, 31.3 to 56.9) at ACR levels <30, 30-299, and ?300 mg/g, respectively. Multivariable adjusted HRs for serious fall injuries were 0.91 (95% CI, 0.76 to 1.09) and 1.09 (95% CI, 0.86 to 1.37) for eGFR=45-59 and <45 ml/min per 1.73 m(2), respectively, versus eGFR?60 ml/min per 1.73 m(2) and 1.31 (95% CI, 1.11 to 1.54) and 1.81 (95% CI, 1.30 to 2.50) for ACR=30-299 and ?300 mg/g, respectively, versus ACR<30 mg/g. Among participants with CKD, cumulative 1-year mortality rates among patients with a serious fall and age-matched controls were 21.0% and 5.5%, respectively.Elevated ACR but not lower eGFR was associated with serious fall injuries. Evaluation for fall risk factors and fall prevention strategies should be considered for older adults with elevated ACR.
| S-EPMC4934847 | biostudies-other
Project description:Obesity increases risk of falling, but the effect of bariatric surgery on fall-related injuries is unknown. The aim of this study was therefore to study the association between bariatric surgery and long-term incidence of fall-related injuries in the prospective, controlled Swedish Obese Subjects study. At inclusion, body mass index was ≥ 34 kg/m2 in men and ≥38 kg/m2 in women. The surgery per-protocol group (n = 2007) underwent gastric bypass (n = 266), banding (n = 376), or vertical banded gastroplasty (n = 1365), and controls (n = 2040) received usual care. At the time of analysis (31 December 2013), median follow-up was 19 years (maximal 26 years). Fall-related injuries requiring hospital treatment were captured using data from the Swedish National Patient Register. During follow-up, there were 617 first-time fall-related injuries in the surgery group and 513 in the control group (adjusted hazard ratio 1.21, 95% CI, 1.07-1.36; P = 0.002). The incidence differed between treatment groups (P < 0.001, log-rank test) and was higher after gastric bypass than after usual care, banding and vertical banded gastroplasty (adjusted hazard ratio 0.50-0.52, P < 0.001 for all three comparisons). In conclusion, gastric bypass surgery was associated with increased risk of serious fall-related injury requiring hospital treatment.
| S-EPMC6252168 | biostudies-literature
Project description:Antihypertensive medication and low systolic blood pressure (BP) and diastolic BP have been associated with an increased falls risk in some studies. Many older adults have indicators of frailty, which may increase their risk for falls. We contrasted the association of systolic BP, diastolic BP, number of antihypertensive medication classes taken, and indicators of frailty with risk for serious fall injuries among 5236 REGARDS study (Reasons for Geographic and Racial Difference in Stroke) participants ?65 years taking antihypertensive medication at baseline with Medicare fee-for-service coverage. Systolic BP and diastolic BP were measured, and antihypertensive medication classes being taken assessed through a pill bottle review during a study visit. Indicators of frailty included low body mass index, cognitive impairment, depressive symptoms, exhaustion, impaired mobility, and history of falls. Serious fall injuries were defined as fall-related fractures, brain injuries, or joint dislocations using Medicare claims through December 31, 2014. Over a median of 6.4 years, 802 (15.3%) participants had a serious fall injury. The multivariable-adjusted hazard ratio for a serious fall injury among participants with 1, 2, or ?3 indicators of frailty versus no frailty indicators was 1.18 (95% confidence interval, 0.99-1.40), 1.49 (95% confidence interval, 1.19-1.87), and 2.04 (95% confidence interval, 1.56-2.67), respectively. Systolic BP, diastolic BP, and number of antihypertensive medication classes being taken at baseline were not associated with risk for serious fall injuries after multivariable adjustment. In conclusion, indicators of frailty, but not BP or number of antihypertensive medication classes, were associated with increased risk for serious fall injuries among older adults taking antihypertensive medication.
| S-EPMC5667360 | biostudies-literature
Project description:BackgroundAntihypertensive medication use has been associated with an increased risk of falls in some but not all studies. Few data are available on the short-term risk of falls after antihypertensive medication initiation and intensification.Methods and resultsWe examined the association between initiating and intensifying antihypertensive medication and serious fall injuries in a case-crossover study of 90 127 Medicare beneficiaries who were ≥65 years old and had a serious fall injury between July 1, 2007, and December 31, 2012, based on emergency department and inpatient claims. Antihypertensive medication initiation was defined by a prescription fill with no fills in the previous year. Intensification was defined by the addition of a new antihypertensive class, and separately, titration by the addition of a new class or increase in dosage of a current class. Exposures were ascertained for the 15 days before the fall (case period) and six 15-day earlier periods (control periods). Overall, 272, 1508, and 3113 Medicare beneficiaries initiated, added a new class of antihypertensive medication or titrated therapy within 15 days of their serious fall injury. The odds for a serious fall injury was increased during the 15 days after antihypertensive medication initiation (odds ratio, 1.36 [95% confidence interval, 1.19-1.55]), adding a new class (odds ratio, 1.16 [95% confidence interval, 1.10-1.23]), and titration [odds ratio, 1.13 [95% confidence interval, 1.08-1.18]). These associations were attenuated beyond 15 days.ConclusionsAntihypertensive medication initiation and intensification was associated with a short-term, but not long-term, increased risk of serious fall injuries among older adults.
| S-EPMC4871744 | biostudies-literature
Project description:BackgroundCardiovascular (CV) disease is the leading cause of death for people with serious mental illness (SMI), but clinicians are often slow to address this risk.Methods/design78 Midwestern primary care clinics were randomized to receive or not receive access to a clinical decision support (CDS) tool. Between March 2016 and September 2018, primary care clinicians (PCPs) received CDS alerts during visits with adult patients with SMI who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Psychiatrists received CDS alerts during their next visit with an eligible patient with SMI that alerted them to an elevated body mass index or recent weight gain and the presence of an obesogenic SMI medication. Study outcomes include total modifiable CV risk, six modifiable CV risk factors, and use of obesogenic SMI medications.DiscussionThis cluster-randomized pragmatic trial allowed PCPs and psychiatrists the opportunity to improve CV risk in a timely manner for patients with SMI. Effectiveness will be assessed using an intent-to-treat analysis, and outcomes will be assessed largely through electronic health record data harvested by the CDS tool itself. In total, 10,347 patients with SMI had an index primary care visit in a randomized clinic, and 8937 patients had at least one follow-up visit. Analyses are ongoing, and trial results are expected in mid-2020.Trial registrationClinicalTrials.gov Identifier: NCT02451670.
| S-EPMC7263956 | biostudies-literature
Project description:ObjectiveTo test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations.DesignMulticenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study).SettingEight centers across the United States, February 2010 to December 2011.Participants1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤ 9, but who were able to walk 400 m.InterventionsA permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises.Main outcome measuresSerious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis.ResultsOver a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction).ConclusionsIn this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men.Trial registration ClinicalsTrials.gov NCT01072500.
| S-EPMC4772786 | biostudies-literature
Project description:ImportanceFalls represent a leading cause of preventable injury in hospitals and a frequently reported serious adverse event. Hospitalization is associated with an increased risk for falls and serious injuries including hip fractures, subdural hematomas, or even death. Multifactorial strategies have been shown to reduce falls in acute care hospitals, but evidence for fall-related injury prevention in hospitals is lacking.ObjectiveTo assess whether a fall-prevention tool kit that engages patients and families in the fall-prevention process throughout hospitalization is associated with reduced falls and injurious falls.Design, setting, and participantsThis nonrandomized controlled trial using stepped wedge design was conducted between November 1, 2015, and October 31, 2018, in 14 medical units within 3 academic medical centers in Boston and New York City. All adult inpatients hospitalized in participating units were included in the analysis.InterventionsA nurse-led fall-prevention tool kit linking evidence-based preventive interventions to patient-specific fall risk factors and designed to integrate continuous patient and family engagement in the fall-prevention process.Main outcomes and measuresThe primary outcome was the rate of patient falls per 1000 patient-days in targeted units during the study period. The secondary outcome was the rate of falls with injury per 1000 patient-days.ResultsDuring the interrupted time series, 37 231 patients were evaluated, including 17 948 before the intervention (mean [SD] age, 60.56 [18.30] years; 9723 [54.17%] women) and 19 283 after the intervention (mean [SD] age, 60.92 [18.10] years; 10 325 [53.54%] women). There was an overall adjusted 15% reduction in falls after implementation of the fall-prevention tool kit compared with before implementation (2.92 vs 2.49 falls per 1000 patient-days [95% CI, 2.06-3.00 falls per 1000 patient-days]; adjusted rate ratio 0.85; 95% CI, 0.75-0.96; P = .01) and an adjusted 34% reduction in injurious falls (0.73 vs 0.48 injurious falls per 1000 patient-days [95% CI, 0.34-0.70 injurious falls per 1000 patient-days]; adjusted rate ratio, 0.66; 95% CI, 0.53-0.88; P = .003).Conclusions and relevanceIn this nonrandomized controlled trial, implementation of a fall-prevention tool kit was associated with a significant reduction in falls and related injuries. A patient-care team partnership appears to be beneficial for prevention of falls and fall-related injuries.Trial registrationClinicalTrials.gov Identifier: NCT02969343.
| S-EPMC7672520 | biostudies-literature