Validation of a Rule-Based ICD-10-CM Algorithm to Detect Fall Injuries in Medicare Data.

BACKGROUND: Diagnosis-code-based algorithms to identify fall injuries in Medicare data are useful for ascertaining outcomes in interventional and observational studies. However, these algorithms have not been validated against a fully external reference standard, in ICD-10-CM, or in Medicare Advantage (MA) data. METHODS: We linked self-reported fall injuries leading to medical attention (FIMA) from the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial (reference standard) to Medicare fee-for-service (FFS) and MA data from 2015-19. We measured the area under the receiver operating characteristic curve (AUC) based on sensitivity and specificity of a diagnosis-code-based algorithm against the reference standard for presence or absence of ≥1 FIMA within a specified window of dates, varying the window size to obtain points on the curve. We stratified results by source (FFS vs MA), trial arm (intervention vs control), and STRIDE's 10 participating health care systems. RESULTS: Both reference standard data and Medicare data were available for 4 941 (of 5 451) participants. The reference standard and algorithm identified 2 054 and 2 067 FIMA, respectively. The algorithm had 45% sensitivity (95% confidence interval [CI]: 43%-47%) and 99% specificity (95% CI: 99%-99%) to identify reference standard FIMA within the same calendar month. The AUC was 0.79 (95% CI: 0.78-0.81) and was similar by FFS or MA data source and by trial arm but showed variation among STRIDE health care systems (AUC range by health care system, 0.71 to 0.84). CONCLUSIONS: An ICD-10-CM algorithm to identify fall injuries demonstrated acceptable performance against an external reference standard, in both MA and FFS data.

Changes in Older Adult Trauma Quality When Evaluated Using Longer-Term Outcomes vs In-Hospital Mortality.

Importance: Lack of knowledge about longer-term outcomes remains a critical blind spot for trauma systems. Recent efforts have expanded trauma quality evaluation to include a broader array of postdischarge quality metrics. It remains unknown how such quality metrics should be used. Objective: To examine the utility of implementing recommended postdischarge quality metrics as a composite score and ascertain how composite score performance compares with that of in-hospital mortality for evaluating associations with hospital-level factors. Design, Setting, and Participants: This national hospital-level quality assessment evaluated hospital-level care quality using 100% Medicare fee-for-service claims of older adults (aged ≥65 years) hospitalized with primary diagnoses of trauma, hip fracture, and severe traumatic brain injury (TBI) between January 1, 2014, and December 31, 2015. Hospitals with annual volumes encompassing 10 or more of each diagnosis were included. The data analysis was performed between January 1, 2021, and December 31, 2022. Exposures: Reliability-adjusted quality metrics used to calculate composite scores included hospital-specific performance on mortality, readmission, and patients' average number of healthy days at home (HDAH) within 30, 90, and 365 days among older adults hospitalized with all forms of trauma, hip fracture, and severe TBI. Main Outcomes and Measures: Associations with hospital-level factors were compared using volume-weighted multivariable logistic regression. Results: A total of 573 554 older adults (mean [SD] age, 83.1 [8.3] years; 64.8% female; 35.2% male) from 1234 hospitals were included. All 27 reliability-adjusted postdischarge quality metrics significantly contributed to the composite score. The most important drivers were 30- and 90-day readmission, patients' average number of HDAH within 365 days, and 365-day mortality among all trauma patients. Associations with hospital-level factors revealed predominantly anticipated trends when older adult trauma quality was evaluated using composite scores (eg, worst performance was associated with decreased older adult trauma volume [odds ratio, 0.89; 95% CI, 0.88-0.90]). Results for in-hospital mortality showed inverted associations for each considered hospital-level factor and suggested that compared with nontrauma centers, level 1 trauma centers had a 17 times higher risk-adjusted odds of worst (highest quantile) vs best (lowest quintile) performance (odds ratio, 17.08; 95% CI, 16.17-18.05). Conclusions and Relevance: The study results challenge historical notions about the adequacy of in-hospital mortality as the single measure of older adult trauma quality and suggest that, when it comes to older adults, decisions about how quality is evaluated can profoundly alter understandings of what constitutes best practices for care. Composite scores appear to offer a promising means by which postdischarge quality metrics could be used.

Costs of fall injuries in the STRIDE study: an economic evaluation of healthcare system heterogeneity and heterogeneity of treatment effect.

OBJECTIVES: The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Study cluster-randomized 86 primary care practices in 10 healthcare systems to a patient-centered multifactorial fall injury prevention intervention or enhanced usual care, enrolling 5451 participants. We estimated total healthcare costs from participant-reported fall injuries receiving medical attention (FIMA) that were averted by the STRIDE intervention and tested for healthcare-system-level heterogeneity and heterogeneity of treatment effect (HTE). METHODS: Participants were community-dwelling adults age ≥ 70 at increased fall injury risk. We estimated practice-level total costs per person-year of follow-up (PYF), assigning unit costs to FIMA with and without an overnight hospital stay. Using independent variables for treatment arm, healthcare system, and their interaction, we fit a generalized linear model with log link, log follow-up time offset, and Tweedie error distribution. RESULTS: Unadjusted total costs per PYF were $2,034 (intervention) and $2,289 (control). The adjusted (intervention minus control) cost difference per PYF was -$167 (95% confidence interval (CI), -$491, $216). Cost heterogeneity by healthcare system was present (p = 0.035), as well as HTE (p = 0.090). Adjusted total costs per PYF in control practices varied from $1,529 to $3,684 for individual healthcare systems; one system with mean intervention minus control costs of -$2092 (95% CI, -$3,686 to -$944) per PYF accounted for HTE, but not healthcare system cost heterogeneity. CONCLUSIONS: We observed substantial heterogeneity of healthcare system costs in the STRIDE study, with small reductions in healthcare costs for FIMA in the STRIDE intervention accounted for by a single healthcare system. TRIAL REGISTRATION: Clinicaltrials.gov (NCT02475850).

Beyond In-hospital Mortality: Use of Postdischarge Quality-Metrics Provides a More Complete Picture of Older Adult Trauma Care.

OBJECTIVE: To identify the distributions of and extent of variability among 3 new sets of postdischarge quality-metrics measured within 30/90/365 days designed to better account for the unique health needs of older trauma patients: mortality (expansion of the current in-hospital standard), readmission (marker of health-system performance and care coordination), and patients' average number of healthy days at home (marker of patient functional status). BACKGROUND: Traumatic injuries are a leading cause of death and loss of independence for the increasing number of older adults living in the United States. Ongoing efforts seek to expand quality evaluation for this population. METHODS: Using 100% Medicare claims, we calculated hospital-specific reliability-adjusted postdischarge quality-metrics for older adults aged 65 years or older admitted with a primary diagnosis of trauma, older adults with hip fracture, and older adults with severe traumatic brain injury. Distributions for each quality-metric within each population were assessed and compared with results for in-hospital mortality, the current benchmarking standard. RESULTS: A total of 785,867 index admissions (305,186 hip fracture and 92,331 severe traumatic brain injury) from 3692 hospitals were included. Within each population, use of postdischarge quality-metrics yielded a broader range of outcomes compared with reliance on in-hospital mortality alone. None of the postdischarge quality-metrics consistently correlated with in-hospital mortality, including death within 1 year [ r =0.581 (95% CI, 0.554-0.608)]. Differences in quintile-rank revealed that when accounting for readmissions (8.4%, κ=0.029) and patients' average number of healthy days at home (7.1%, κ=0.020), as many as 1 in 14 hospitals changed from the best/worst performance under in-hospital mortality to the completely opposite quintile rank. CONCLUSIONS: The use of new postdischarge quality-metrics provides a more complete picture of older adult trauma care: 1 with greater room for improvement and better reflection of multiple aspects of quality important to the health and recovery of older trauma patients when compared with reliance on quality benchmarking based on in-hospital mortality alone.

Utility of a short, telephone-administered version of the Montreal Cognitive Assessment.

BACKGROUND: Because of the COVID-19 pandemic, the ongoing D-CARE pragmatic trial of two models of dementia care management needed to transition to all data collection by telephone. METHODS: For the first 1069 D-CARE participants, we determined the feasibility of administering a short 3-item version of the Montreal Cognitive Assessment (MoCA) to persons with dementia by telephone and examined the correlation with the full 12-item version. RESULTS: The 3-item version could be administered by telephone in approximately 6 min and was highly correlated with the full MoCA (r = 0.78, p < 0.0001). CONCLUSIONS: This brief version of the MoCA was feasible to collect by telephone and could be used as an alternative to the full MoCA, particularly if the purpose of cognitive assessment is characterization of study participants.

Strategy for addressing research-site overlap in pragmatic clinical trials: lessons learned from the NIH-DOD-VA Pain Management Collaboratory (PMC).

BACKGROUND: The Pain Management Collaboratory (PMC) is a multi-site network of pragmatic clinical trials (PCTs) focused on nonpharmacological approaches to pain management, conducted in health care systems of the US Department of Defense (DoD) and Department of Veterans Affairs (VA) and co-funded by the National Institutes of Health (NIH). Concerns about potential research-site overlap prompted the PMC investigator community to consider strategies to avert this problem that could negatively affect recruitment and contaminate interventions and thus pose a threat to trial integrity. METHODS: We developed a two-step strategy to identify and remediate research-site overlap by obtaining detailed recruitment plans across all PMC PCTs that addressed eligibility criteria, recruitment methods, trial settings, and timeframes. The first, information-gathering phase consisted of a 2-month period for data collection from PIs, stakeholders, and ClinicalTrials.gov . The second, remediation phase consisted of a series of moderated conference calls over a 1-month time period to develop plans to address overlap. Remediation efforts focused on exclusion criteria and recruitment strategies, and they involved collaboration with sponsors and stakeholder groups such as the Military Treatment Facility Engagement Committee (MTFEC). The MTFEC is comprised of collaborating DoD and university-affiliated PIs, clinicians, and educators devoted to facilitating successful pragmatic trials in DoD settings. RESULTS: Of 61 recruitment sites for the 11 PMC PCTs, 17 (28%) overlapped. Four PCTs had five overlapping Military Treatment Facilities (MTFs), and eight PCTs had 12 overlapping VA Medical Centers (VAMCs). We developed three general strategies to avoid research-site overlap: (i) modify exclusion criteria, (ii) coordinate recruitment efforts, and/or (iii) replace or avoid any overlapping sites. Potential overlap from competing studies outside of the PMC was apparent at 26 sites, but we were not able to confirm them as true conflicts. CONCLUSION: Proactive strategies can be used to resolve the issue of overlapping research sites in the PMC. These strategies, combined with open and impartial mediation approaches that include researchers, sponsors, and stakeholders, provide lessons learned from this large and complex pragmatic research effort.

D-CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System-Based Versus Community-Based Dementia Care Versus Usual Dementia Care.

BACKGROUND/OBJECTIVES: Although several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost effectiveness of community-based dementia care (CBDC) versus health system-based dementia care (CBDC) and the effectiveness of both approaches compared with usual care (UC) are unknown. DESIGN: Pragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad. SETTING: Four clinical trial sites (CTSs) based in academic and clinical health systems. PARTICIPANTS: A total of 2,150 English- or Spanish-speaking PWD who are not receiving hospice or residing in a nursing home and their caregivers. INTERVENTIONS: Eighteen months of (1) HSDC provided by a nurse practitioner or physician's assistant dementia care specialist who works within the health system, or (2) CBDC provided by a social worker or nurse care consultant who works at a community-based organization, or (3) UC with as needed referral to the Alzheimer's Association Helpline. MEASUREMENTS: Primary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales. SECONDARY OUTCOMES: NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, "time spent at home," Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost effectiveness using intervention costs and Medicare claims. RESULTS: The results will be reported in the spring of 2024. CONCLUSION: D-CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared with UC and will evaluate the cost effectiveness of each intervention.

Effect of ß-blockers on cardiac and pulmonary events and death in older adults with cardiovascular disease and chronic obstructive pulmonary disease.

CONTEXT: In older adults with multiple conditions, medications may not impart the same benefits seen in patients who are younger or without multimorbidity. Furthermore, medications given for one condition may adversely affect other outcomes. ß-Blocker use with coexisting cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD) is such a situation. OBJECTIVE: To determine the effect of ß-blocker use on cardiac and pulmonary outcomes and mortality in older adults with coexisting COPD and CVD. DESIGN, SETTING, PARTICIPANTS: The study included 1062 participants who were members of the 2004-2007 Medicare Current Beneficiary Survey cohorts, a nationally representative sample of Medicare beneficiaries. Study criteria included age over 65 years plus coexisting CVD and COPD/asthma. Follow-up occurred through 2009. We determined the association between ß-blocker use and the outcomes with propensity score-adjusted and covariate-adjusted Cox proportional hazards. MAIN OUTCOME MEASURES: The 3 outcomes were major cardiac events, pulmonary events, and all-cause mortality. RESULTS: Half of the participants used ß-blockers. During follow-up, 179 participants experienced a major cardiac event; 389 participants experienced a major pulmonary event; and 255 participants died. Each participant could have experienced any ≥1 of these events. The hazard ratio for ß-blocker use was 1.18 [95% confidence interval (CI), 0.85-1.62] for cardiac events, 0.91 (95% CI, 0.73-1.12) for pulmonary events, and 0.87 (95% CI, 0.67-1.13) for death. CONCLUSION: In this population of older adults, ß-blockers did not seem to affect occurrence of cardiac or pulmonary events or death in those with CVD and COPD.

Efficacy and effectiveness as aspects of cluster randomized trials with nursing home residents: methodological insights from a pneumonia prevention trial.

This report discusses how methodological aspects of study efficacy and effectiveness combine in cluster randomized trials in nursing homes. Discussion focuses on the relationships between these study aspects in the Pneumonia Reduction in Institutionalized Disabled Elders (PRIDE) trial, an ongoing cluster randomized clinical trial of pneumonia prevention among nursing home residents launched in October 2009 in Greater New Haven, Connecticut. This clinical trial has enrolled long-term care nursing home residents, over 65years in age, who have either inadequate oral care or swallowing difficulty, previously identified risk factors for pneumonia. It has used a multicomponent intervention consisting of manual tooth/gum brushing, 0.12% chlorhexidine oral rinse administered twice daily by nurses, and upright feeding positioning at meals to reduce rates of radiographically documented pneumonia. Cluster randomization is attractive for nursing home intervention studies because physical proximity and administrative arrangements make it difficult to deliver different interventions to residents of the same nursing home. Implementing an intervention in an entire home requires integration into the daily life of residents and into the administrative procedures of the nursing home. This characteristic of nursing home cluster randomized trials makes them approximate "real-world" research contexts, but implementation can be challenging. The PRIDE trial of pneumonia prevention utilized specific methodological choices that include both efficacy and effectiveness elements. Cluster randomized trials in nursing homes having elements of both efficacy and effectiveness (i.e., hybrid designs) can address some of the methodological challenges of conducting clinical research in nursing homes; they have distinctive advantages and some limitations.

An economic analysis of robot-assisted therapy for long-term upper-limb impairment after stroke.

BACKGROUND AND PURPOSE: Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested its cost-effectiveness. METHODS: We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization. RESULTS: A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively (P<0.001), and both were significantly more expensive than usual care alone (no additional intervention costs). At 36 weeks postrandomization, the total costs were comparable for the 3 groups ($17 831 for robot therapy, $19 746 for intensive comparison therapy, and $19 098 for usual care). Changes in quality of life were modest and not statistically different. CONCLUSIONS: The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00372411.

Robot-assisted therapy for long-term upper-limb impairment after stroke.

BACKGROUND: Effective rehabilitative therapies are needed for patients with long-term deficits after stroke. METHODS: In this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks. RESULTS: At 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported. CONCLUSIONS: In patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.)

Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding.

BACKGROUND: Despite widespread agreement on the importance of informed consent in clinical research, uncertainty remains about the adequacy of current consent procedures and documentation. METHODS: The objective of the study was to compare an informed consent document developed by a consumer group of potential study participants to one developed by the study investigators. The study was a cluster randomized, controlled study embedded in a 'parent' randomized controlled trial of 1092 participants with Gulf War veterans' illnesses recruited in 1999-2000 at 20 US medical centers. Centers were randomized to the investigator-developed or participant-developed consent document. The primary outcome measure was an Informed Consent Questionnaire-4 (ICQ-4), a validated four-item scale measuring self-reported participant understanding scored from 0 to 1. Secondary outcomes included the Client Satisfaction Questionnaire-8 and measures of study refusal and adherence to the parent trial protocol. RESULTS: There were no significant differences between consent documents on the ICQ-4 score overall or at any of the time points. Mean (95% CI) treatment differences ranged from +0.020 (-0.015, 0.055) (better understanding) at entry to -0.021 (-0.054, 0.012) (worse understanding) at three-months for the participant versus the investigator document group. There were also no significant differences in satisfaction, adherence to the protocol, or in the proportion of patients who refused to participate in the trial. LIMITATIONS: The consumer group may not have been representative of the study participants and they did not suggest dramatic changes to the consent document. The outcome assessment questionnaire was not validated prior to the trial's initiation. CONCLUSIONS: Consumer modification of the consent document did not lead to either benefit or harm in understanding, satisfaction, or study refusal and adherence rates. This study did demonstrate, however, that embedding consent studies in a clinical trial is feasible and can address important questions about informed consent without disrupting the primary study.

A case study found that a regression tree outperformed multiple linear regression in predicting the relationship between impairments and Social and Productive Activities scores.

OBJECTIVE: Many important physiologic and clinical predictors are continuous. Clinical investigators and epidemiologists' interest in these predictors lies, in part, in the risk they pose for adverse outcomes, which may be continuous as well. The relationship between continuous predictors and a continuous outcome may be complex and difficult to interpret. Therefore, methods to detect levels of a predictor variable that predict the outcome and determine the threshold for clinical intervention would provide a beneficial tool for clinical investigators and epidemiologists. STUDY DESIGN AND SETTING: We present a case study using regression tree methodology to predict Social and Productive Activities score at 3 years using five modifiable impairments. The predictive ability of regression tree methodology was compared with multiple linear regression using two independent data sets, one for development and one for validation. RESULTS: The regression tree approach and the multiple linear regression model provided similar fit (model deviances) on the development cohort. In the validation cohort, the deviance of the multiple linear regression model was 31% greater than the regression tree approach. CONCLUSION: Regression tree analysis developed a better model of impairments predicting Social and Productive Activities score that may be more easily applied in research settings than multiple linear regression alone.