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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): 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.

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.).

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.

Objective The purpose of this study was to examine the relationship between dynapenia and metabolic risk factors in obese and nonobese older adults. Methods A total of 1453 men and women (age ≥70 years) from the Lifestyle Interventions and Independence for Elders (LIFE) Study were categorized as (1) nondynapenic/nonobese (NDYN-NO), (2) dynapenic/nonobese (DYN-NO), (3) nondynapenic/obese (NDYN-O), or (4) dynapenic/obese (DYN-O), based on muscle strength (Foundation for the National Institute of Health criteria) and body mass index. Dependent variables were blood lipids, fasting glucose, blood pressure, presence of at least 3 metabolic syndrome (MetS) criteria, and other chronic conditions. Results A significantly higher likelihood of having abdominal obesity criteria in NDYN-NO compared with DYN-NO groups (55.6 vs 45.1%, P ≤ .01) was observed. Waist circumference also was significantly higher in obese groups (DYN-O = 114.0 ± 12.9 and NDYN-O = 111.2 ± 13.1) than in nonobese (NDYN-NO = 93.1 ± 10.7 and DYN-NO = 92.2 ± 11.2, P ≤ .01); and higher in NDYN-O compared with DYN-O ( P = .008). Additionally, NDYN-O demonstrated higher diastolic blood pressure compared with DYN-O (70.9 ± 10.1 vs 67.7 ± 9.7, P ≤ .001). No significant differences were found across dynapenia and obesity status for all other metabolic components ( P > .05). The odds of having MetS or its individual components were similar in obese and nonobese, combined or not with dynapenia (nonsignificant odds ratio [95% confidence interval]). Conclusion Nonobese dynapenic older adults had fewer metabolic disease risk factors than nonobese and nondynapenic older adults. Moreover, among obese older adults, dynapenia was associated with lower risk of meeting MetS criteria for waist circumference and diastolic blood pressure. Additionally, the presence of dynapenia did not increase cardiometabolic disease risk in either obese or nonobese 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.

Background Data are sparse regarding the value of physical activity ( PA ) surveillance among older adults—particularly among those with mobility limitations. The objective of this study was to examine longitudinal associations between objectively measured daily PA and the incidence of cardiovascular events among older adults in the LIFE (Lifestyle Interventions and Independence for Elders) study. Methods and Results Cardiovascular events were adjudicated based on medical records review, and cardiovascular risk factors were controlled for in the analysis. Home‐based activity data were collected by hip‐worn accelerometers at baseline and at 6, 12, and 24 months postrandomization to either a physical activity or health education intervention. LIFE study participants (n=1590; age 78.9±5.2 [ SD ] years; 67.2% women) at baseline had an 11% lower incidence of experiencing a subsequent cardiovascular event per 500 steps taken per day based on activity data (hazard ratio, 0.89; 95% confidence interval, 0.84–0.96; P =0.001). At baseline, every 30 minutes spent performing activities ≥500 counts per minute (hazard ratio, 0.75; confidence interval, 0.65–0.89 [ P =0.001]) were also associated with a lower incidence of cardiovascular events. Throughout follow‐up (6, 12, and 24 months), both the number of steps per day (per 500 steps; hazard ratio, 0.90, confidence interval, 0.85–0.96 [ P =0.001]) and duration of activity ≥500 counts per minute (per 30 minutes; hazard ratio, 0.76; confidence interval, 0.63–0.90 [ P =0.002]) were significantly associated with lower cardiovascular event rates. Conclusions Objective measurements of physical activity via accelerometry were associated with cardiovascular events among older adults with limited mobility (summary score >10 on the Short Physical Performance Battery) both using baseline and longitudinal data. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 01072500.

Objective: The objective of this study was to describe the rates of residential relocations over the course of 10.5 years and evaluate differences in these relocation rates according to gender and decedent status. Design: Prospective, longitudinal study with monthly telephone follow-up for up to 126 months. Setting: Greater New Haven, CT. Participants: There were 754 participants, aged 70 years or older, who were initially community-living and nondisabled in their basic activities of daily living. Measurements: Residential location was assessed during monthly interviews and included community, assisted living facility, and nursing home. A residential relocation was defined as a change of residential location for at least 1 week and included relocations within (eg, community-community) or between (community- assisted living) locations. We calculated the rates of relocations per 1000 patient-months and evaluated differences by gender and decedent status. Results: Sixty-six percent of participants had at least one residential relocation (range 0e12). Women had lower rates of relocations from nursing home to community (rate ratio [RR] 0.59, P ¼ .02); otherwise, there were no gender differences. Decedents had higher rates of relocation from community to assisted living (RR 1.71, P ¼ .002), from community to nursing home (RR 3.64, P < .001), between assisted living facilities (RR 3.65, P < .001), and from assisted living to nursing home (RR 2.5, P < .001). In decedents, relocations from community to nursing home (RR 3.58, P < .001) and from assisted living to nursing home (RR 3.3, P < .001) were most often observed in the last year of life. Conclusions: Most older people relocated at least once during 10.5 years of follow-up. Women had lower rates of relocation from nursing home to community. Decedents were more likely to relocate to a residential location providing a higher level of assistance, compared with nondecedents. Residential relocations were most common in the last year of life. 2014 AMDA e The Society for Post-Acute and Long-Term Care Medicine.

OBJECTIVES: To describe several recruitment parametersderived from the Lifestyle Interventions and Independencefor Elders pilot (LIFE-P) study for use in a full-scale trial ofmobility disability prevention.DESIGN: A description of the recruiting methods andbaseline characteristics of a four-site randomized, con-trolled trial testing the effectiveness of a physical activityintervention at preventing mobility disability.SETTING: The Cooper Institute, Dallas, Texas; StanfordUniversity, Stanford, California; University of Pittsburgh,Pittsburgh,Pennsylvania;andWakeForestUniversity,Win-ston-Salem, North Carolina.PARTICIPANTS: Community-livingpersonsaged70to89whowereabletowalk400mwithin15minutesandwereathigh risk for disability (scoringo10 on the Short PhysicalPerformance Battery (SPPB)) but without comorbidity se-vere enough to preclude full study participation.MEASUREMENTS: Measures of efficiency includednum-ber of randomized participants per recruitment techniqueand costsper randomized participantacross randomizationtechniques.RESULTS: The 9-month recruiting period resulted in3,141 telephone screens, of which 424 (13.5%) partici-pants were randomized (68.9% women, 25.7% minorities,41.5% with SPPB scoreso8). Forty percent of telephone-screened participants were excluded primarily because ofregular participation in physical activity, health exclusions,or self-reported mobility disability. Of the 1,252 personsattempting the physical performance assessments, 41%scored above the SPPB cutoff. Of the 566 remaining eligi-ble, 9.9% could not complete the 400-m walk, and another18.9% had various medical exclusions. Direct mailing wasthe most productive recruitment strategy (61.6% of allrandomized participants). Recruitment cost approximately$439 per randomized participant.CONCLUSION: The LIFE study achieved all recruitmentgoals and demonstrated the feasibility of recruiting high-risk community-dwelling older persons for trials of disabi-lity prevention in diverse geographic areas. J Am GeriatrSoc 55:674–683, 2007.Key words: recruitment; clinical trials; prevention ofmobility disability; physical activity

To evaluate the extent of variability in functional responses in participants in the Lifestyle Interventions and Independence for Elders (LIFE) study and to identify the relative contributions of intervention adherence, physical activity, and demographic and health characteristics to this variability.Secondary analysis.Multicenter institutions.A volunteer sample (N=1635) of sedentary men and women aged 70 to 89 years who were able to walk 400m but had physical limitations, defined as a Short Physical Performance Battery (SPPB) score of ≤9.Moderate-intensity physical activity (n=818) consisting of aerobic, resistance, and flexibility exercises performed both center-based (2times/wk) and home-based (3-4times/wk) sessions or health education program (n=817) consisting of weekly to monthly workshops covering relevant health information.Physical function (gait speed over 400m) and lower extremity function (SPPB score) assessed at baseline and 6, 12, and 24 months.Greater baseline physical function (gait speed, SPPB score) was negatively associated with change in gait speed (regression coefficient β=-.185; P.001) and change in SPPB score (β=-.365; P.001), whereas higher number of steps per day measured by accelerometry was positively associated with change in gait speed (β=.035; P.001) and change in SPPB score (β=.525; P.001). Other baseline factors associated with positive change in gait speed and/or SPPB score include younger age (P.001), lower body mass index (P.001), and higher self-reported physical activity (P=.002).Several demographic and physical activity-related factors were associated with the extent of change in functional outcomes in participants in the LIFE study. These factors should be considered when designing interventions for improving physical function in older adults with limited mobility.

Older adults continue to be underrepresented in clinical research despite their burgeoning population in the United States and worldwide. Physicians often propose treatment plans for older adults based on data from studies involving primarily younger, more-functional, healthier participants. Major barriers to recruitment of older adults in aging research relate to their substantial health problems, social and cultural barriers, and potentially impaired capacity to provide informed consent. Institutionalized older adults offer another layer of complexity that requires cooperation from the institutions to participate in research activities. This paper provides study recruitment and retention techniques and strategies to address concerns and overcome barriers to older adult participation in clinical research. Key approaches include early in-depth planning; minimizing exclusion criteria; securing cooperation from all interested parties; using advisory boards, timely screening, identification, and approach of eligible patients; carefully reviewing the benefit:risk ratio to be sure it is appropriate; and employing strategies to ensure successful retention across the continuum of care. Targeting specific strategies to the condition, site, and population of interest and anticipating potential problems and promptly employing predeveloped contingency plans are keys to effective recruitment and retention.

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.

Beginning in 1982, the 3-year incidence of nursing home admission was determined for community-dwelling residents aged 65 and over in East Boston, Massachusetts (4%); New Haven, Connecticut (9%); and Iowa and Washington Counties, Iowa (12%). A common methodology was used to collect baseline risk factor and follow-up data on nursing home admissions among persons in each community as part of the National Institute on Aging's Established Populations for Epidemiologic Studies of the Elderly. A multivariate logistic regression model of baseline risk factors that included the participant's age, race, sex, history of prior admission, ADL limitations, cognitive function, living arrangements, and level of income predicted 80% of the users in each community.

OBJECTIVES: To compare the efficiency and cost of two distinct but complementary recruitment strategies for a clinical trial of physically frail, community-living persons, age 75 and older. DESIGN: In the first recruitment strategy, potential participants were identified and screened for physical frailty during office visits to their primary care physicians; in the second, potential participants were identified from the patient rosters of primary care physicians and were screened for physical frailty in their home. Physical frailty was defined on the basis of slow gait speed and inability to stand from a chair with one's arms folded. SETTING: General community in greater Bridgeport, Connecticut. PARTICIPANTS: Community-living persons, age 75 and older, who met criteria for physical frailty. MEASUREMENTS: Measures of efficiency included the number of persons screened for each participant randomized, the number of persons eligible for each participant randomized, and the refusal rate. Costs were calculated per randomized participant. RESULTS: One hundred eighty-eight participants, with a mean age of 83.2 years, were enrolled over 22 months. One hundred and one participants were enrolled via the office-based strategy; 87 were enrolled via the roster-based strategy. Participants in each group had considerable quadriceps weakness and performed poorly on objective measures of gait and upper- and lower-extremity function. For each participant randomized, the number of persons screened, number of persons eligible, and cost were 15.2, 1.2, and $868, respectively, for the office-based strategy and 11.6, 1.1, and $764, respectively, for the roster-based strategy. The corresponding refusal rates for the two strategies were 14.9% and 10.1%, respectively (P