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Most older adults hospitalized with COVID-19 survive their acute illness. The impact of COVID-19 hospitalization on patient-centered outcomes, including physical function, cognition, and symptoms, is not well understood. To address this knowledge gap, we collected longitudinal data about these issues from a cohort of older survivors of COVID-19 hospitalization.We undertook a prospective study of community-living persons age ≥ 60 years who were hospitalized with COVID-19 from June 2020-June 2021. A baseline interview was conducted during or up to 2 weeks after hospitalization. Follow-up interviews occurred at one, three, and six months post-discharge. Participants completed comprehensive assessments of physical and cognitive function, symptoms, and psychosocial factors. An abbreviated assessment could be performed with a proxy. Additional information was collected from the electronic health record.Among 341 participants, the mean age was 71.4 (SD 8.4) years, 51% were women, and 37% were of Black race or Hispanic ethnicity. Median length of hospitalization was 8 (IQR 6-12) days. All but 4% of participants required supplemental oxygen, and 20% required care in an intensive care unit or stepdown unit. At enrollment, nearly half (47%) reported at least one preexisting disability in physical function, 45% demonstrated cognitive impairment, and 67% were pre-frail or frail. Participants reported a mean of 9 of 14 (SD 3) COVID-19-related symptoms. At the six-month follow-up interview, more than a third of participants experienced a decline from their pre-hospitalization function, nearly 20% had cognitive impairment, and burdensome symptoms remained highly prevalent.We enrolled a diverse cohort of older adults hospitalized with COVID-19 and followed them after discharge. Functional decline was common, and there were high rates of persistent cognitive impairment and symptoms. Future analyses of these data will advance our understanding of patient-centered outcomes among older COVID-19 survivors.

BackgroundMost older adults hospitalized with COVID-19 survive their acute illness. The impact of COVID-19 hospitalization on patient-centered outcomes, such as physical function, cognitive function, and symptoms, is not well understood. We sought to address this knowledge gap by collecting longitudinal data about these issues from a cohort of older adult survivors of COVID-19 hospitalization.MethodsWe undertook a prospective study of community-living persons age ≥60 years who were hospitalized with COVID-19 from June 2020 to June 2021. A baseline interview was conducted during or up to two weeks after hospitalization. Follow-up interviews occurred at one, three, and six months post-discharge. In interviews, participants completed comprehensive assessments of physical and cognitive function, symptoms, and psychosocial factors. If a participant was too impaired to complete an interview, an abbreviated assessment was performed with a proxy. Additional information was collected from the electronic health record. Baseline characteristics of the cohort are reported here.ResultsAmong 341 participants, the mean age was 71.4 (SD 8.4) years, 51% were women, and 37% were of Black race or Hispanic ethnicity. Median length of hospitalization was 8 (IQR 6-12) days. All but 4% of participants required supplemental oxygen and 21% required a higher level of care in an intensive care unit or stepdown unit. Nearly half (47%) reported at least one disability in physical function, 45% demonstrated cognitive impairment, and 67% were pre-frail or frail. Participants reported a mean of 9 of 14 (SD 3) COVID-19-related symptoms.ConclusionsOlder adults hospitalized with COVID-19 demonstrated high rates of baseline physical and cognitive impairment as well as high symptom burden. Longitudinal findings from this cohort will advance our understanding of outcome trajectories of great importance to older survivors of COVID-19.

OBJECTIVES The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Our aim was to describe procedures that were implemented to optimize participant retention; report retention yields by age, sex, clinical site, and follow-up time; provide reasons for study withdrawals; and highlight the successes and lessons learned from the STRIDE retention efforts. DESIGN Pragmatic cluster randomized trial. SETTING A total of 86 primary care practices within 10 US healthcare systems. PARTICIPANTS A total of 5451 community-living persons, 70 years of age or older, at high risk for serious fall injuries. MEASUREMENTS Study outcomes were collected every 4 months by a central call center. Reconsent was required to extend follow-up beyond the originally planned 36 months. RESULTS Over a median follow-up of 3.2 years (interquartile range = 2.8-3.7 y), 439 (8.1%) participants died and 600 (11.0%) withdrew their consent or did not reconsent to extend follow-up beyond 36 months, yielding rates (per 100 person-years) of deaths and withdrawals of 2.6 and 3.6, respectively. The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site. The most common reasons for withdrawal were illness and unable to contact for reconsent at 36 months. Completion of the follow-up interviews was greater than 93% at each time point. Most participants completed all (71.8%) or all but one (9.2%) of the follow-up interviews. The most common reason for not completing a follow-up interview was unable to contact, with rates ranging from 2.8% at 40 months to 4.6% at 20 months. CONCLUSION Completion of the thrice-yearly follow-up interviews in STRIDE was high, and retention of participants over 44 months exceeded the original projections. The procedures used in STRIDE, together with lessons learned, should assist other investigators who are planning or conducting large pragmatic trials of vulnerable older persons. J Am Geriatr Soc 68:1242-1249, 2020.

Author(s): Jennings, Lee A; Araujo, Katy LB; Meng, Can; Peduzzi, Peter; Charpentier, Peter; Reuben, David B | Abstract: BackgroundBecause 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.MethodsFor 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.ResultsThe 3-item version could be administered by telephone in approximately 6nmin and was highly correlated with the full MoCA (rn=n0.78, p l 0.0001).ConclusionsThis 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.

Background After the passage of the 21st Century Cures Act in the U.S., the Inclusion Across the Lifespan policy eliminates upper-age limits for research participation unless risk justified. Broader inclusion will necessitate the use of reliable instruments in research that characterize the health status and function of older adults with multiple chronic conditions. As there is a plethora of such instruments, the Geriatrics Research Instrument Library (GRIL) was developed as freely available online resource of data collection instruments commonly used in gerontological research. GRIL has been revised and updated by the Advancing Geriatrics Infrastructure and Network Growth (AGING) Initiative, a joint endeavor of the Health Care Systems Research Network (HCSRN) and the Older Americans Independence Centers (OAICs). Methods Extensive PubMed literature searches and domain expert feedback were utilized to inventory and update GRIL through the addition of instruments and compiling of instrument metadata. GRIL is hosted on the National Institute on Aging OAIC Coordinating Center website with a platform utilizing Microsoft Structured Query Language (SQL) and an Adobe ColdFusion application server. Tracking statistics are collected using Google Analytics. Results Presently, GRIL includes 175 instruments across 18 domains, including instrument metadata such as instrument description, copyright information, completion time estimates, keywords, available translations, and a link and reference to the original manuscript describing the instrument. The GRIL website includes user-friendly features such as mobile platforming and resource links. Conclusions GRIL provides a user-friendly public resource that facilitates clinical researchers in efficiently selecting appropriate instruments to measure clinical outcomes relevant to older adults across a full range of domains.

Author(s): Gill, Thomas M; Bhasin, Shalender; Reuben, David B; Latham, Nancy K; Araujo, Katy; Ganz, David A; Boult, Chad; Wu, Albert W; Magaziner, Jay; Alexander, Neil; Wallace, Robert B; Miller, Michael E; Travison, Thomas G; Greenspan, Susan L; Gurwitz, Jerry H; Rich, Jeremy; Volpi, Elena; Waring, Stephen C; Manini, Todd M; Min, Lillian C; Teresi, Jeanne; Dykes, Patricia C; McMahon, Siobhan; McGloin, Joanne M; Skokos, Eleni A; Charpentier, Peter; Basaria, Shehzad; Duncan, Pamela W; Storer, Thomas W; Gazarian, Priscilla; Allore, Heather G; Dziura, James; Esserman, Denise; Carnie, Martha B; Hanson, Catherine; Ko, Fred; Resnick, Neil M; Wiggins, Jocelyn; Lu, Charles; Meng, Can; Goehring, Lori; Fagan, Maureen; Correa-de-Araujo, Rosaly; Casteel, Carri; Peduzzi, Peter; Greene, Erich J | Abstract: Background/objectivesIn the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to first serious fall injury but a significant 10% reduction in time to first self-reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well-being including concern about falling, anxiety, depression, physical function, and disability.DesignPragmatic cluster-randomized trial of 5,451 community-living persons at high risk for serious fall injuries.SettingA total of 86 primary care practices within 10 U.S. healthcare systems.ParticipantsA random subsample of 743 persons aged 75 and older.MeasurementsThe well-being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument.ResultsParticipants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: -1.19 (99% confidence interval, -2.36 to -.02), with 3.5 points representing a minimally important difference.ConclusionsSTRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.

Author(s): Reuben, David B; Gill, Thomas M; Stevens, Alan; Williamson, Jeff; Volpi, Elena; Lichtenstein, Maya; Jennings, Lee A; Tan, Zaldy; Evertson, Leslie; Bass, David; Weitzman, Lisa; Carnie, Martie; Wilson, Nancy; Araujo, Katy; Charpentier, Peter; Meng, Can; Greene, Erich J; Dziura, James; Liu, Jodi; Unger, Erin; Yang, Mia; Currie, Katherine; Lenoir, Kristin M; Green, Aval-NaʼRee S; Abraham, Sitara; Vernon, Ashley; Samper-Ternent, Rafael; Raji, Mukaila; Hirst, Roxana M; Galloway, Rebecca; Finney, Glen R; Ladd, Ilene; Rahm, Alanna Kulchak; Borek, Pamela; Peduzzi, Peter | Abstract: Background/objectivesAlthough 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.DesignPragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad.SettingFour clinical trial sites (CTSs) based in academic and clinical health systems.ParticipantsA total of 2,150 English- or Spanish-speaking PWD who are not receiving hospice or residing in a nursing home and their caregivers.InterventionsEighteen 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.MeasurementsPrimary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales.Secondary outcomesNPI-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.ResultsThe results will be reported in the spring of 2024.ConclusionD-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.

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.).

In response to the epidemic of falls and serious falls-related injuries in older persons, in 2014, the Patient Centered Outcomes Research Institute (PCORI) and the National Institute on Aging funded a pragmatic trial, Strategies to Reduce Injuries and Develop confidence in Elders (STRIDE) to compare the effects of a multifactorial intervention with those of an enhanced usual care intervention. The STRIDE multifactorial intervention consists of five major components that registered nurses deliver in the role of falls care managers, co-managing fall risk in partnership with patients and their primary care providers (PCPs). The components include a standardized assessment of eight modifiable risk factors (medications; postural hypotension; feet and footwear; vision; vitamin D; osteoporosis; home safety; strength, gait, and balance impairment) and the use of protocols and algorithms to generate recommended management of risk factors; explanation of assessment results to the patient (and caregiver when appropriate) using basic motivational interviewing techniques to elicit patient priorities, preferences, and readiness to participate in treatments; co-creation of individualized falls care plans that patients' PCPs review, modify, and approve; implementation of the falls care plan; and ongoing monitoring of response, regularly scheduled re-assessments of fall risk, and revisions of the falls care plan. Custom-designed falls care management software facilitates risk factor assessment, the identification of recommended interventions, clinic note generation, and longitudinal care management. The trial testing the effectiveness of the STRIDE intervention is in progress, with results expected in late 2019.

Author(s): Bhasin, Shalender; Gill, Thomas M; Reuben, David B; Latham, Nancy K; Gurwitz, Jerry H; Dykes, Patricia; McMahon, Siobhan; Storer, Thomas W; Duncan, Pamela W; Ganz, David A; Basaria, Shehzad; Miller, Michael E; Travison, Thomas G; Greene, Erich J; Dziura, James; Esserman, Denise; Allore, Heather; Carnie, Martha B; Fagan, Maureen; Hanson, Catherine; Baker, Dorothy; Greenspan, Susan L; Alexander, Neil; Ko, Fred; Siu, Albert L; Volpi, Elena; Wu, Albert W; Rich, Jeremy; Waring, Stephen C; Wallace, Robert; Casteel, Carri; Magaziner, Jay; Charpentier, Peter; Lu, Charles; Araujo, Katy; Rajeevan, Haseena; Margolis, Scott; Eder, Richard; McGloin, Joanne M; Skokos, Eleni; Wiggins, Jocelyn; Garber, Lawrence; Clauser, Steven B; Correa-De-Araujo, Rosaly; Peduzzi, Peter | Abstract: Background:Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care. Methods:Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 health care systems across United States. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by health care system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a comanagement model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (nonvertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control. Results:Trial enrolled 5,451 subjects in 20 months. Intervention and follow-up are ongoing. Conclusions:The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults.

Background This 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. Methods STRIDE 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. Discussion Adjudication 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 registration ClinicalTrials.gov (NCT02475850). Electronic supplementary material The online version of this article (10.1186/s40621-019-0190-2) contains supplementary material, which is available to authorized users.

Author(s): Gill, Thomas M; McGloin, Joanne M; Latham, Nancy K; Charpentier, Peter A; Araujo, Katy L; Skokos, Eleni A; Lu, Charles; Shelton, Amy; Bhasin, Shalender; Bianco, Luanne M; Carnie, Martha B; Covinsky, Kenneth E; Dykes, Patricia; Esserman, Denise A; Ganz, David A; Gurwitz, Jerry H; Hanson, Catherine; Nyquist, Linda V; Reuben, David B; Wallace, Robert B; Greene, Erich J | Abstract: BackgroundWe describe the recruitment of participants for Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE), a large pragmatic cluster randomized trial that is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Eligible persons were 70 years or older, community-living, and at increased risk for serious fall injuries. The modified goal was to recruit 5,322 participants over 20 months from 86 primary care practices within 10 diverse health care systems across the United States.MethodsThe at-risk population was identified using two distinct but complementary screening strategies that included three questions administered centrally via the mail (nine sites) or in the clinic (one site), while recruitment was completed centrally by staff at Yale.ResultsFor central screening, 226,603 letters mailed to 135,118 patients yielded 28,719 positive screens (12.7% of those mailed and 46.5% of the 61,729 returned). In the clinic, 22,537 screens were completed, leading to 5,732 positive screens (25.4%). Of the 34,451 patients who screened positive for high risk of serious fall injuries, 31,872 were sent a recruitment packet and, of these, 5,451 (17.1%) were enrolled over 20 months (mean age: 80 years; 62% female). The participation rate was 34.0% among eligible patients. The enrollment yields were 3.6% (vs 5% projected) for each patient screened centrally, despite multiple screens, and 10.5% (vs 33.9% projected) for each positive clinic screen.ConclusionsDespite lower-than-expected yields, the STRIDE Study exceeded its modified recruitment goal. If the STRIDE intervention is found to be effective, the two distinct strategies for identifying a high-risk population of older persons could be implemented by most health care systems.

Objective To examine the potential value of a theory-based, interactive decision support tool in clinical practice for patients with rheumatoid arthritis who are candidates for biologic agents. Methods We conducted an 8-week, 2-arm, parallel, single-blind pilot trial in which candidates for treatment escalation with a biologic agent were randomized to receive either a link to a web-based tool or usual care. Outcomes included changes in objective knowledge, subjective knowledge, values clarification, and satisfaction with risk communication as well as the proportion of subjects defined as making an informed choice to escalate care at 2 weeks. Results A total of 125 subjects were randomized. Significant between-group differences at 2 weeks favoring the intervention group were seen for changes in objective knowledge, subjective knowledge, and values clarification. No significant between-group differences were found in subjects’ satisfaction with risk communication. Among those deciding to escalate care, a greater percentage met the criteria for an informed choice at 2 weeks in the intervention group compared to the control group (32% versus 13%; P = 0.02). Improvements in subjective knowledge and values clarification persisted at 8 weeks. There were no between-group differences in objective knowledge at 8 weeks. Conclusion In this study, use of a decision support tool at the time of decision-making resulted in improved objective and subjective knowledge, as well as values clarity, compared to usual care. Not all improvements were sustained, emphasizing the need to offer educational support should additional escalation of care be required over the course of the illness.

Objectives To examine the effect of the Tool to Reduce Inappropriate Medications (TRIM), a web tool linking an electronic health record (EHR) to a clinical decision support system, on medication communication and prescribing. Design Randomized clinical trial. Setting Primary care clinics at a Veterans Affairs Medical Center. Participants Veterans aged 65 and older prescribed seven or more medications randomized to receipt of TRIM or usual care (N = 128). Intervention TRIM extracts information on medications and chronic conditions from the EHR and contains data entry screens for information obtained from brief chart review and telephonic patient assessment. These data serve as input for automated algorithms identifying medication reconciliation discrepancies, potentially inappropriate medications (PIMs), and potentially inappropriate regimens. Clinician feedback reports summarize discrepancies and provide recommendations for deprescribing. Patient feedback reports summarize discrepancies and self-reported medication problems. Measurements Primary: subscales of the Patient Assessment of Care for Chronic Conditions (PACIC) related to shared decision-making; clinician and patient communication. Secondary: changes in medications. Results 29.7% of TRIM participants and 15.6% of control participants provided the highest PACIC ratings; this difference was not significant. Adjusting for covariates and clustering of patients within clinicians, TRIM was associated with significantly more-active patient communication and facilitative clinician communication and with more medication-related communication among patients and clinicians. TRIM was significantly associated with correction of medication discrepancies but had no effect on number of medications or reduction in PIMs. Conclusion TRIM improved communication about medications and accuracy of documentation. Although there was no association with prescribing, the small sample size provided limited power to examine medication-related outcomes.

Importance Bacteriuria plus pyuria is highly prevalent among older women living in nursing homes. Cranberry capsules are an understudied, nonantimicrobial prevention strategy used in this population. Objective To test the effect of 2 oral cranberry capsules once a day on presence of bacteriuria plus pyuria among women residing in nursing homes. Design, Setting, and Participants Double-blind, randomized, placebo-controlled efficacy trial with stratification by nursing home and involving 185 English-speaking women aged 65 years or older, with or without bacteriuria plus pyuria at baseline, residing in 21 nursing homes located within 50 miles (80 km) of New Haven, Connecticut (August 24, 2012-October 26, 2015). Interventions Two oral cranberry capsules, each capsule containing 36 mg of the active ingredient proanthocyanidin (ie, 72 mg total, equivalent to 20 ounces of cranberry juice) vs placebo administered once a day in 92 treatment and 93 control group participants. Main Outcomes and Measures Presence of bacteriuria (ie, at least 10 5 colony-forming units [CFUs] per milliliter of 1 or 2 microorganisms in urine culture) plus pyuria (ie, any number of white blood cells on urinalysis) assessed every 2 months over the 1-year study surveillance; any positive finding was considered to meet the primary outcome. Secondary outcomes were symptomatic urinary tract infection (UTI), all-cause death, all-cause hospitalization, all multidrug antibiotic–resistant organisms, antibiotics administered for suspected UTI, and total antimicrobial administration. Results Of the 185 randomized study participants (mean age, 86.4 years [SD, 8.2], 90.3% white, 31.4% with bacteriuria plus pyuria at baseline), 147 completed the study. Overall adherence was 80.1%. Unadjusted results showed the presence of bacteriuria plus pyuria in 25.5% (95% CI, 18.6%-33.9%) of the treatment group and in 29.5% (95% CI, 22.2%-37.9%) of the control group. The adjusted generalized estimating equations model that accounted for missing data and covariates showed no significant difference in the presence of bacteriuria plus pyuria between the treatment group vs the control group (29.1% vs 29.0%; OR, 1.01; 95% CI, 0.61-1.66; P = .98). There were no significant differences in number of symptomatic UTIs (10 episodes in the treatment group vs 12 in the control group), rates of death (17 vs 16 deaths; 20.4 vs 19.1 deaths/100 person-years; rate ratio [RR], 1.07; 95% CI, 0.54-2.12), hospitalization (33 vs 50 admissions; 39.7 vs 59.6 hospitalizations/100 person-years; RR, 0.67; 95% CI, 0.32-1.40), bacteriuria associated with multidrug-resistant gram-negative bacilli (9 vs 24 episodes; 10.8 vs 28.6 episodes/100 person-years; RR, 0.38; 95% CI, 0.10-1.46), antibiotics administered for suspected UTIs (692 vs 909 antibiotic days; 8.3 vs 10.8 antibiotic days/person-year; RR, 0.77; 95% CI, 0.44-1.33), or total antimicrobial utilization (1415 vs 1883 antimicrobial days; 17.0 vs 22.4 antimicrobial days/person-year; RR, 0.76; 95% CI, 0.46-1.25). Conclusions and Relevance Among older women residing in nursing homes, administration of cranberry capsules vs placebo resulted in no significant difference in presence of bacteriuria plus pyuria over 1 year. Trial Registration clinicaltrials.gov Identifier:NCT01691430

tudy Objective To create a clinical decision support system (CDSS) for evaluating problems with medications among older outpatients based on a broad set of criteria. Design Web-based CDSS development. Setting Primary care clinics at a Veterans Affairs medical center. Participants Forty veterans 65 years and older who were prescribed seven or more medications that included those for treatment of diabetes mellitus and hypertension. Measurements and Main Results The Tool to Reduce Inappropriate Medications (TRIM) uses a program to extract age, medications, and chronic conditions from the electronic health record to identify high-risk patients and as input for evaluating the medication regimen. Additional health variables obtained through chart review and direct patient assessment are entered into a Web-based program. Based on a series of algorithms, TRIM generates feedback reports for clinicians. TRIM identified medication reconciliation discrepancies in 98% (39/40) of veterans, potentially inappropriate medications in 58% (23/40), potential problems with feasibility (based on poor adherence and/or cognitive impairment) in 25% (10/40), potential overtreatment of hypertension in 50% (20/40), potential overtreatment of diabetes in 43% (17/40), inappropriate dosing of renally excreted medications in 5% (2/40), and patient-reported adverse reactions in 5% (2/40). Conclusion This evaluation of TRIM demonstrated that data elements can be extracted from the electronic health record to identify older primary care patients at risk for potentially problematic medication regimens. Supplemented with chart review and direct patient assessment, these data can be processed through clinical algorithms that identify potential problems and generate patient-specific feedback reports. Additional work is necessary to assess the effects of TRIM on medication deprescribing.

The medical and personal circumstances of older persons present challenges for designing and analyzing clinical research studies in which they participate. These challenges that elderly study samples present are not unique, but they are sufficiently distinctive to warrant deliberate and systematic attention. Their distinctiveness originates in the multifactorial etiologies of geriatric health syndromes and the multiple morbidities accruing with aging at the end of life. The objective of this article is to identify a set of statistical challenges arising in research with older persons that should be considered conjointly in the practice of clinical research and addressed systematically in the training of biostatisticians intending to work with gerontologists, geriatricians, and older study participants. The statistical challenges include design and analytical strategies for multicomponent interventions, multiple outcomes, state transition models, floor and ceiling effects, missing data, and mixed methods. The methodological and pedagogical themes of this article will be integrated by a description of a proposed subdiscipline of "gerontologic biostatistics" and supported by the introduction of new set of statistical resources for researchers working in this area. These conceptual and methodological resources have been developed in the context of several collaborating Claude D. Pepper Older Americans Independence Centers.

This study was designed to determine whether an education program consisting of classroom and on-road training could enhance driving performance.This randomized controlled trial with blinded endpoint assessment enrolled 126 community-living drivers 70 years old or older who were recruited from clinic and community sources. Treatment assignment was concealed until eligibility was established. Participants randomized to intervention underwent two 4-hour classroom and two 1-hour on-road sessions focused on common problem areas of older drivers. Controls received modules directed at vehicle, home, and environmental safety. A knowledge test and driving performance were assessed at baseline and 8 weeks. On-road driving performance was assessed by an experienced evaluator in a dual-brake-equipped vehicle in urban, residential, and highway traffic. Driving performance was rated on a 36-item scale with potential scores from 0 to 72 (higher score better). The knowledge test included 20 road knowledge and eight road sign questions, scored from 0 to 28 correct.The least squares mean change in road test score relative to baseline was 2.87 points higher in the intervention than in the control group (p =.001). The least squares mean change in knowledge test scores relative to baseline was 3.45 points higher in the intervention than in the control group (p.001).An education program consisting of classroom and on-road training targeted to common errors of older drivers enhanced performance on knowledge and on-road tests. Such interventions offer older drivers the potential to continue driving safely longer and to maintain their out-of-home mobility.

Risk factors for suicidal ideation and attempts have been shown to differ between African Americans and Whites across the lifespan. In the present study, risk factors for suicidality were examined separately by race/ethnicity in a population of 131 older adult patients considered vulnerable to suicide due to substance abuse and/or medical frailty. In adjusted analyses, social support was significantly associated with suicidality in African American patients, while younger age and the presence of an anxiety disorder were significantly associated with suicidality in White patients. The results suggest that race/ethnicity-specific risk profiles may improve the detection of suicidality in vulnerable populations.

Background As the number of older drivers increases, concern has been raised about the potential safety implications. Flexibility, coordination, and speed of movement have been associated with older drivers’ on road performance. Objective To determine whether a multicomponent physical conditioning program targeted to axial and extremity flexibility, coordination, and speed of movement could improve driving performance among older drivers. Design Randomized controlled trial with blinded assignment and end point assessment. Participants randomized to intervention underwent graduated exercises; controls received home, environment safety modules. Participants Drivers, 178, age ≥ 70 years with physical, but without substantial visual (acuity 20/40 or better) or cognitive (Mini Mental State Examination score ≥24) impairments were recruited from clinics and community sources. Measurements On-road driving performance assessed by experienced evaluators in dual-brake equipped vehicle in urban, residential, and highway traffic. Performance rated three ways: (1) 36-item scale evaluating driving maneuvers and traffic situations; (2) evaluator’s overall rating; and (3) critical errors committed. Driving performance reassessed at 3 months by evaluator blinded to treatment group. Results Least squares mean change in road test scores at 3 months compared to baseline was 2.43 points higher in intervention than control participants (P = .03). Intervention drivers committed 37% fewer critical errors (P = .08); there were no significant differences in evaluator’s overall ratings (P = .29). No injuries were reported, and complaints of pain were rare. Conclusions This safe, well-tolerated intervention maintained driving performance, while controls declined during the study period. Having interventions that can maintain or enhance driving performance may allow clinician–patient discussions about driving to adopt a more positive tone, rather than focusing on driving limitation or cessation.

Background. Pneumonia remains an important public health problem among elderly nursing home residents. This clinical trial sought to determine if a multicomponent intervention protocol, including manual tooth/gum brushing plus 0.12% chlorhexidine oral rinse, twice per day, plus upright positioning during feeding, could reduce the incidence of radiographically documented pneumonia among nursing home residents, compared with usual care. Methods. This cluster-randomized clinical trial was conducted in 36 nursing homes in Connecticut. Eligible residents >65 years with at least 1 of 2 modifiable risk factors for pneumonia (ie, impaired oral hygiene, swallowing difficulty) were enrolled. Nursing homes were randomized to the multicomponent intervention protocol or usual care. Participants were followed for up to 2.5 years for development of the primary outcome, a radiographically documented pneumonia, and secondary outcome, a lower respiratory tract infection (LRTI) without radiographic documentation. Results. A total of 834 participants were enrolled: 434 to intervention and 400 to usual care. The trial was terminated for futility. The number of participants in the intervention vs control arms with first pneumonia was 119 (27.4%) vs 94 (23.5%), respectively, and with first LRTI, 125 (28.8%) vs 100 (25.0%), respectively. In a multivariable Cox regression model, the hazard ratio in the intervention vs control arms, respectively, was 1.12 (95% confidence interval [CI], .84–1.50; P = .44) for first pneumonia and 1.07 (95% CI, .79–1.46, P = .65) for first LRTI. Conclusions. The multicomponent intervention protocol did not significantly reduce the incidence of first radiographically confirmed pneumonia or LRTI compared with usual care in nursing home residents. Clinical Trials Registration. {"type":"clinical-trial","attrs":{"text":"NCT00975780","term_id":"NCT00975780"}}NCT00975780.

Since in hospitalized older patients delirium is associated with poor outcomes, we evaluated the effectiveness of a multicomponent strategy for the prevention of delirium.We studied 852 patients 70 years of age or older who had been admitted to the general-medicine service at a teaching hospital. Patients from one intervention unit and two usual-care units were enrolled by means of a prospective matching strategy. The intervention consisted of standardized protocols for the management of six risk factors for delirium: cognitive impairment, sleep deprivation, immobility, visual impairment, hearing impairment, and dehydration. Delirium, the primary outcome, was assessed daily until discharge.Delirium developed in 9.9 percent of the intervention group as compared with 15.0 percent of the usual-care group, (matched odds ratio, 0.60; 95 percent confidence interval, 0.39 to 0.92). The total number of days with delirium (105 vs. 161, P=0.02) and the total number of episodes (62 vs. 90, P=0.03) were significantly lower in the intervention group. However, the severity of delirium and recurrence rates were not significantly different. The overall rate of adherence to the intervention was 87 percent, and the total number of targeted risk factors per patient was significantly reduced. Intervention was associated with significant improvement in the degree of cognitive impairment among patients with cognitive impairment at admission and a reduction in the rate of use of sleep medications among all patients. Among the other risk factors per patient there were trends toward improvement in immobility, visual impairment, and hearing impairment.The risk-factor intervention strategy that we studied resulted in significant reductions in the number and duration of episodes of delirium in hospitalized older patients. The intervention had no significant effect on the severity of delirium or on recurrence rates; this finding suggests that primary prevention of delirium is probably the most effective treatment strategy.

In phase II to phase IV studies, randomization has gained widespread acceptance as a methodologic tool for the allocation of patients to treatment. However, randomization is not always feasible. At times, the treatment intervention occurs universally throughout one or more units (for example, a hospital unit), while the control therapy is the only intervention provided in other units. Patients may arrive randomly at a unit, based solely on availability of the unit to accept new subjects. Thus, the treatment assignment process is out of the investigator's control and not subject to selection bias. We describe a prospective individual matching procedure through which one can achieve balanced allocation of subjects to treatment groups in this comparative study setting. In this paper, we compare balance of baseline covariates and power for this design, in which the subject is selected at random and assigned to a treatment group, and the traditional randomized block design, in which the treatment is chosen at random and assigned to a subject. We show that the prospective individual matching procedure compares favourably to the traditional randomized blocked design with respect to both baseline covariate comparability and statistical power.

To describe the development, implementation, and results of a home-based rehabilitation protocol for older persons after hip fracture.Demonstration study.Community.One hundred forty-eight community-living, nondemented participants at least 65 years of age who underwent repair of a fractured hip at two local hospitals.A linked assessment-intervention, home-based rehabilitation strategy. The physical therapy (PT) component of the intervention was designed to identify and ameliorate impairments in balance, strength, transfers, gait, and stair climbing; the functional therapy (FT) component was designed to identify and improve unsafe and/or inefficient performance of specific activities of daily living (ADL).The percentage of participants able to complete each component and the extent of progress noted in strength, balance, transfers, gait, and daily functioning.A total of 104 of the 148 participants (70%) completed the 6-month PT and FT program; 4 completed only PT and 6 refused both PT and FT. The remaining 32 participants (22%) received partial PT and FT that was terminated by death, hospitalization, or institutionalization. Seventy-seven percent of participants reported performing at least half of the recommended daily exercise sessions. Ninety-four percent and 96% of participants progressed in upper and lower extremity conditioning respectively; 33% progressed to the highest level in the graduated resisted exercise program. All participants progressed in the competency-based graded balance program, with 55% progressing to the fifth (most difficult) level. Similarly, the majority progressed in transfer maneuvers, stair climbing, and outdoor gait. One repetition maximum (RM) elbow extension increased from a mean of 5.8 (SD 4.6) pounds at baseline to 7.2 (SD 3.8) pounds at 6mo (t 2.22; p.02). One RM knee extension increased from 5.8 (SD 5.8) pounds to 10.8 (SD 5.4) pounds (t = 8.06; p.0001). The number of gait deviations decreased from 2.1 (SD 1.3) to 0.6 (SD 0.9) (p.0001), while the mean modified Berg Balance Scale Score increased from 13.0 (SD 4.8) to 20.5 (SD 6.8) (t = 16.6; p.0001). Finally, the Total ADL Score increased from a mean of 48.2 (SD 15.0) to 77.7 (SD 18.8) (t = 17.03; p = .0001).This systematic assessment and intervention protocol, targeting impairments and ADL, was feasible, safe, and effective. Protocols such as the one presented should enhance the ability to implement rehabilitation programs for the increasing number of multiply impaired older persons receiving home-based therapy and to document the process and outcomes of this care.

PURPOSE: Delirium, defined as an acute, fluctuating disorder of attention and cognition, is a serious and increasingly common problem for hospitalized older persons. Delirium poses unique ethical challenges for the informed consent process, notably the preservation of patient autonomy in the face of potentially fluctuating decision-making capacity. To clarify these issues, we examined the informed consent process in a group of hospitalized older patients who developed delirium. PATIENTS: Eighty-four hospitalized patients aged >70 years who developed delirium during hospitalization at a large urban teaching hospital. METHODS: We conducted a clinical epidemiologic investigation of informed consent in 173 medical and surgical procedures performed in 84 patients. Clinical researchers carried out detailed cognitive evaluation of patients on or near the consent date. A separate blinded researcher extracted medical record information on the procedures and informed consent process variables. RESULTS: Of 173 procedures, 33 (19%) had no documentation of any consent, and 34 (20%) used surrogate consent. There were no documented assessments of competency/decisional capacity; cognitive assessments were done in 7 (4%) cases, and legal consults in 2 (1%) cases. Discussion of potential risks of the procedure with patient or surrogate were documented in 61 (35%) cases. In multivariable analysis, independent predictors for failure to obtain consent were presence of delirium (adjusted odds ratio [OR] = 2.7, 95% confidence interval [CI] 1.3, 5.3) and less invasive procedure (OR = 5.0, CI 2.0, 12.8). Although cognitive impairment predicted surrogate use, we found that 47% of cases with substantial impairment did not involve use of a surrogate, whereas surrogates signed for 4% of cases with normal mental status near the time of consent. CONCLUSIONS: Our results highlight the ethical challenges that delirium poses for the informed consent process, including the high rate of no consent, lack of cognitive and decisional capacity assessment, and inconsistent surrogate use.

The role of self-esteem in modulating patterns of neuroendocrine response to challenge at older ages was examined in 16 healthy 70-yr-olds. Responses to two challenges were examined: (1) a driving simulation designed to reflect a 'real life' challenge situation; and (2) a pharmacologic, corticotropin-releasing-hormone (CRH) challenge (1 micrograms/kg). Both challenges evoked significant elevations in cortisol and adrenocorticotropic hormone (ACTH). Levels of self-esteem were significantly and negatively associated with peak elevations in cortisol in response to the driving simulation challenge (r = -0.51, p = 0.04). ACTH responses showed similar trends (r = -0.41, p = 0.12). Self-esteem levels were not correlated with responses to the CRH challenge. These data indicate that psychological characteristics such as self-esteem may play a role in modulating patterns of neuroendocrine response to cognitive/behavioral challenges in everyday life in older individuals.

Objectives: To compare readmissions of Medicare recipients of usual home care and a matched group of recipients of a restorative model of home care. Design: Quasiexperimental; matched and unmatched. Setting: Community, home care. Participants: Seven hundred seventy individuals receiving care from a large home care agency after hospitalization. Intervention: A restorative care model based on principles adapted from geriatric medicine, nursing, rehabilitation, goal attainment, chronic care management, and behavioral change theory. Measurements: Hospital readmission, length of home care episode. Results: Among the matched pairs, 13.2% of participants who received restorative care were readmitted to an acute hospital during the episode of home care, versus 17.6% of those who received usual care. Individuals receiving the restorative model of home care were 32% less likely to be readmitted than those receiving usual care (conditional odds ratio = 0.68, 95% confidence interval = 0.43�1.08). The mean length of home care episodes was 20.3 ± 14.8 days in the restorative care group and 29.1 ± 31.7 days in the usual care group (P < .001). Results were similar in unmatched analyses. Conclusion: Although statistical significance was marginal, results suggest that the restorative care model offers an effective approach to reducing the occurrence of avoidable readmissions. It was previously shown that the restorative model of home care was associated with better functional recovery, fewer emergency department visits, and shorter episodes of home care. This model could be incorporated into usual home care practices and care delivery redesign.

Objective Despite the importance of achieving tight control, many patients with rheumatoid arthritis (RA) are not effectively treated with disease-modifying antirheumatic drugs. The objective of this study was to develop a decision support tool to inform RA patients with ongoing active disease about the risks and benefits related to biologic therapy. Methods We developed a balanced, web-based, decision support tool. Options, values, and probabilistic information were described using theoretically supported formulations. We conducted a pre-/posttest study to assess preliminary evidence of the tool's efficacy in improving knowledge related to biologics, clarity of values, willingness to take a biologic, and informed choice. Results We interviewed 104 subjects (mean age 62 years, 84% women, 87% white, and median duration of RA 8 years). Knowledge (coded on a 0–20 scale) and willingness to take a biologic (coded on a 0–10 scale) significantly increased after viewing the tool (mean differences 2.3 and 1.4, respectively; P < 0.0001 for both). Perceived knowledge and values clarity (coded on 0–100 scales) also significantly improved (mean differences 20.4 and 20.8, respectively; P < 0.0001 for both). The proportion of subjects making an informed value-concordant choice increased substantially from 35% to 64%. Conclusion A tool designed to effectively communicate the risks and benefits associated with biologic therapy increased knowledge, patient willingness to escalate care, and the likelihood of making an informed choice. The results of this study support the need for a clinical trial to examine the impact of the tool in clinical practice.

Gill TM, Baker DI, Gottschalk M, Gahbauer EA, Charpentier PA, de Regt PT, Wallace SJ. A prehabilitation program for physically frail community-living older persons. Arch Phys Med Rehabil 2003;84:394-404. Objectives: To describe the development and implementation of a preventive, home-based physical therapy program (PREHAB) and to provide evidence for the safety and interrater reliability of the PREHAB protocol. Design: Demonstration study. Setting: General community. Participants: Ninety-four physically frail, community-living persons, aged 75 years or older, who were randomized to the PREHAB program in a clinical trial. Interventions: The PREHAB program built on the physical therapy component of 2 previous home-based protocols. A total of 223 assessment items were linked to 28 possible interventions, including progressive balance and conditioning exercises, by using detailed algorithms and decisions rules that were automated on notebook computers. Main Outcome Measures: The percentages of participants who were eligible for and who completed each intervention, the extent of progress noted in the balance and conditioning exercises, adherence to the training program, and adverse events. Results: Participants who completed the PREHAB program and those who ended it prematurely received an average of 9.7 and 7.2 interventions during an average of 14.9 and 9.5 home visits, respectively. With few exceptions, the completion rate and interrater reliability for the specific interventions were high. Despite high self-reported adherence to the training program, the majority of participants did not advance beyond the initial Thera-Band[reg ] level for the upper- and lower-extremity conditioning exercises, and only about a third advanced to the highest 2 levels of the balance exercises. Adverse events were no more common in the PREHAB group than in the educational control group. Conclusion: Our results support the feasibility and safety of the PREHAB program, but also show the special challenges and pitfalls of such a strategy when it is implemented among persons of advanced age and physical frailty. [copy ] 2003 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation

A method is described to achieve balance across prognostic factors in intervention trials for which randomized allocation to treatment group is not possible. The method involves prospective individual matching of patients that have already been assigned to treatment groups. Data can be analyzed using methods appropriate for prospective matched cohort studies. Successful implementation depends on the number and complexity of factors to be matched, and on the number of available control patients. Simulation studies suggest that, in order to yield satisfactory match rates and to reduce costs associated with screening unmatched controls, no more than three prognostic factors should generally be considered. Baseline prognostic indices, incorporating information from multiple variables, provide effective matching factors. The implementation of the method in a successful clinical trial, the Delirium Prevention Trial, is discussed. In that study, treatment group was determined by hospital admission to either an intervention floor or to one of two usual care hospital floors. The ratio of available control to intervention patients was 1.3, and 95% of the eligible intervention floor patients were successfully matched to control floor patients. Excellent balance was demonstrated for non-matching factors, due in part to the use of a composite baseline risk score as a matching factor. In addition, external validity is enhanced because most eligible intervention patients are enrolled as they present. The methods outlined in this report provide a methodologically rigorous alternative for achieving balance across treatment groups, with respect to important prognostic factors, in non-randomized clinical trials, and will have broad applicability in the numerous situations in which randomization is not possible.

Background Performance-based measures of physical performance are examined for an older cohort of relatively high-functioning men and women. The influences of baseline behavioral, social, and psychological characteristics on patterns of change in performance over 2.5 years are examined. Methods A cohort of relatively high-functioning men and women, aged 70-79, identified in 1988 by subsampling from three community-based studies on the basis of physical and cognitive function. Baseline assessments included physical performance, sociodemographic characteristics, health status, and behavioral, social, and psychological characteristics. A summary measure of physical performance was developed from tests of balance, gait, lower body strength and coordination, and manual dexterity. In-home assessments were repeated at follow-up in 1991. Results Linear regression models were used to identify significant behavioral, social, and psychological predictors of better performance at follow-up, controlling for known sociodemographic and health status predictors. Significant, independent associations with better performance were found for participation in moderate and/or strenuous exercise activity and greater frequency of emotional support from social networks, particularly among those reporting low frequency of instrumental support. These effects remained significant independent of incident health conditions during follow-up. None of the psychological characteristics was a significant predictor. Conclusions Maintenance of better physical performance within a high-functioning cohort is influenced by prior exercise behavior and social network emotional support. Observed patterns of both decline and improvement in performance suggest that older age is not uniformly associated with declines. Predictors of better performance identified here may offer potential for effective interventions to promote more successful aging.

Previous research has suggested that women may have greater and more prolonged hypothalamic-pituitary-adrenal response to challenge at older ages. Data on patterns of ACTH and cortisol responses to a "naturalistic" driving simulation challenge were examined to test the hypothesis that older women (aged 70-79 years) would show greater response than a comparable group of older men. Analyses of mean ACTH or cortisol responses in terms of maximal increase, area under the curve and repeated measures ANOVA did not reveal significant gender differences. By contrast, analyses of the joint occurrence of ACTH and cortisol responses above the respective sample medians indicated that women were significantly more likely to respond to the challenge with elevated ACTH and cortisol responses. The lack of significant gender difference in the analyses of mean scores resulted from the sensitivity of this measure of typically (or average response) to outliers in the data, thereby substantially distorting the report of typical (or average) responses for the male population. Analyses of the temporal patterns of ACTH and cortisol response in terms of the stability of the subject's relative rank at each sampling time indicated that: (1) there was considerable stability of rankings based on the initial cortisol response (though not ACTH) through the recovery period; and (2) women exhibited greater instability than men, being more likely to exhibit shifts in rank from high to low over time. These findings suggest that: (1) as a group, older women are more likely to show larger responses than comparably healthy older men to a "naturalistic" driving simulation challenge; (2) there is considerable stability in patterns of cortisol response from initial response at 20 min through the recovery period, indicating that those showing greater initial response continue to experience higher levels of cortisol during the post-challenge recovery period; and (3) instability is more common among women than men.

BACKGROUND: Performance-based measures of physical performance were examined for an older cohort of relatively high-functioning men and women. Relationships between baseline physical performance and sociodemographic and health status characteristics were also examined. Three-year pattern changes in performance are described, and sociodemographic and health status predictors of change are investigated. METHODS: A cohort of relatively high-functioning men and women, aged 70-79, was identified in 1988 by subsampling from three community-based studies on the basis of physical and cognitive function. Baseline in-home assessments included tests of physical performance and measurement of sociodemographic characteristics and health status. A summary measure of physical performance was developed from tests of balance, gait, lower body strength and coordination, and manual dexterity. In-home assessments were repeated at follow-up in 1991. RESULTS: Better physical performance at baseline was more common among males, Whites, those reporting higher income and education, and those with fewer chronic conditions. In linear regression models, declines in performance were predicted by older age, lower income, higher education, relative weight and blood pressure, lower peak expiratory flow, prevalent diabetes and incident health conditions and hospitalizations during follow-up. Improvements in performance were also observed; the only significant association was with race (i.e., being Black). CONCLUSIONS: Declines in physical performance within a high-functioning cohort are predictable from sociodemographic and health status characteristics. The patterns of both decline and improvement in performance observed in this cohort suggest that older age is not uniformly associated with declines, indicating the potential for effective interventions to promote more successful aging. Language: en

ContextIllness and hospitalization often trigger functional decline among older persons. Home care services implemented for functional decline provide an opportunity to intervene to improve outcomes.ObjectiveTo compare functional status and the likelihood of remaining at home for persons receiving restorative care vs usual home care.Design and SettingIntervention using prospective individual matching conducted between November 1, 1998, and April 30, 2000. Six offices of a home care agency in Connecticut were used. One branch office served as the restorative care unit and the other 5 served as usual care offices.ParticipantsPatients receiving home care through the restorative care office who were 65 years or older; in receipt of Medicare-covered home care lasting at least 7 days; with absence of severe cognitive impairment; and not terminal, bedridden, or requiring total care were matched with patients from 1 of the usual care offices. The matching factors included age, sex, race, baseline self-care function, cognitive status, whether hospitalization preceded the home care episode, and date of the home care episode. Of the 712 eligible restorative care patients, 691 (97%) were matched with a usual care patient.InterventionRestorative care, provided by the home care agency nursing, therapy, and home health aide staff, was based on principles from geriatric medicine, nursing, rehabilitation, and goal attainment.Main Outcome MeasuresRemaining at home, functional status at completion of the home care episode, and duration and intensity of home care episode.ResultsCompared with usual care, and after adjusting for baseline characteristics and other factors, restorative care was associated with a greater likelihood of remaining at home (82% vs 71%; odds ratio [OR], 1.99; 95% confidence interval [CI], 1.47-2.69) and a reduced likelihood of visiting an emergency department (10% vs 20%; OR, 0.44; 95% CI, 0.32-0.61). Home care episodes were shorter (mean [SD], 24.8 [26.8] days vs 34.3 [44.2] days; S = −17 821; P

Objective. —To prospectively develop and validate a predictive model for delirium based on precipitating factors during hospitalization, and to examine the interrelationship of precipitating factors and baseline vulnerability. Design. —Two prospective cohort studies, in tandem. Setting. —General medical wards, university teaching hospital. Patients. —For the development cohort, 196 patients aged 70 years and older with no delirium at baseline, and for the validation cohort, 312 comparable patients. Main Outcome Measure. —New-onset delirium by hospital day 9, defined by the Confusion Assessment Method diagnostic criteria. Results. —Delirium developed in 35 patients (18%) in the development cohort. Five independent precipitating factors for delirium were identified: use of physical restraints (adjusted relative risk [RR], 4.4; 95% confidence interval [CI], 2.5 to 7.9), malnutrition (RR, 4.0; 95% CI, 2.2 to 7.4), more than three medications added (RR, 2.9; 95% CI, 1.6 to 5.4), use of bladder catheter (RR, 2.4; 95% CI, 1.2 to 4.7), and any iatrogenic event (RR, 1.9; 95% CI, 1.1 to 3.2). Each precipitating factor preceded the onset of delirium by more than 24 hours. A risk stratification system was developed by adding 1 point for each factor present. Rates of delirium for low-risk (0 points), intermediate-risk (1 to 2 points), and high-risk groups (≥3 points) were 3%, 20%, and 59%, respectively (P Conclusions. —A simple predictive model based on the presence of five precipitating factors can be used to identify elderly medical patients at high risk for delirium. Precipitating and baseline vulnerability factors are highly interrelated and contribute to delirium in independent, substantive, and cumulative ways. (JAMA. 1996;275:852-857)

Acutely bereaved widows and widowers (N = 150) and a comparison group of non-bereaved married persons (N = 68) whose spouse was hospitalized with life-threatening illness were studied to te...

Background While older adults (age 75 and over) represent a large and growing proportion of patients with acute myocardial infarction (AMI), they have traditionally been under-represented in cardiovascular studies. Although chronological age confers an increased risk for adverse outcomes, our current understanding of the heterogeneity of this risk is limited. The Comprehensive Evaluation of Risk Factors in Older Patients with AMI (SILVER-AMI) study was designed to address this gap in knowledge by evaluating risk factors (including geriatric impairments, such as muscle weakness and cognitive impairments) for hospital readmission, mortality, and health status decline among older adults hospitalized for AMI. Methods/Design SILVER-AMI is a prospective cohort study that is enrolling 3000 older adults hospitalized for AMI from a recruitment network of approximately 70 community and academic hospitals across the United States. Participants undergo a comprehensive in-hospital assessment that includes clinical characteristics, geriatric impairments, and health status measures. Detailed medical record abstraction complements the assessment with diagnostic study results, in-hospital procedures, and medications. Participants are subsequently followed for six months to determine hospital readmission, mortality, and health status decline. Multivariable regression will be used to develop risk models for these three outcomes. Discussion SILVER-AMI will fill critical gaps in our understanding of AMI in older patients. By incorporating geriatric impairments into our understanding of post-AMI outcomes, we aim to create a more personalized assessment of risk and identify potential targets for interventions. Trial registration Trial registration number: NCT01755052.