Development of REDCap-based architecture for a clinical decision support tool linked to the electronic health record for assessment of medication appropriateness.

Objective: To develop the architecture for a clinical decision support system (CDSS) linked to the electronic health record (EHR) using the tools provided by Research Electronic Data Capture (REDCap) to assess medication appropriateness in older adults with polypharmacy. Materials and Methods: The tools available in REDCap were used to create the architecture for replicating a previously developed stand-alone system while overcoming its limitations. Results: The architecture consists of data input forms, drug- and disease-mapper, rules engine, and report generator. The input forms integrate medication and health condition data from the EHR with patient assessment data. The rules engine evaluates medication appropriateness through rules built through a series of drop-down menus. The rules generate output, which are a set of recommendations to the clinician. Discussion and conclusion: This architecture successfully replicates the stand-alone CDSS while addressing its limitations. It is compatible with several EHRs, easily shared among the large community using REDCap, and readily modifiable.

Optimizing Retention in a Pragmatic Trial of Community-Living Older Persons: The STRIDE Study.

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.

Screening, Recruitment, and Baseline Characteristics for the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) Study.

Background: We 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. Methods: The 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. Results: For 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. Conclusions: Despite 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.

Effect of the Tool to Reduce Inappropriate Medications on Medication Communication and Deprescribing.

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.

Development of the Tool to Reduce Inappropriate Medications (TRIM): A Clinical Decision Support System to Improve Medication Prescribing for Older Adults.

STUDY 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.

Gerontologic biostatistics: the statistical challenges of clinical research with older study participants.

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.

A prehabilitation program for physically frail community-living older persons.

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 OUTCOMES 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 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.

Differences between African Americans and whites in the outcome of heart failure: Evidence for a greater functional decline in African Americans.

BACKGROUND: National statistics indicate that African Americans are disproportionately affected by mortality and hospitalizations resulting from heart failure when compared with other racial/ethnic groups. This might, in part, reflect a poorer course of heart failure among African Americans. METHODS: We conducted a prospective cohort study of 316 white and 82 African American consecutive patients aged > or =50 years with decompensated heart failure on hospital admission. The outcome of the study was death or decline in activities of daily living function at 6 months relative to baseline. RESULTS: African American patients were on average 8 years younger and had less favorable socioeconomic and access-to-care indicators. African Americans more often had a history of hypertension, renal insufficiency, and diabetes, but there were no differences in functional status, self-reported health status, signs of decompensation, or left ventricular ejection fraction. Quality-of-care indicators did not differ by race. Mortality rates at 6 months were similar in African Americans and whites (19.5% vs 17.2%, age adjusted), but African Americans had a greater functional decline (37.6% vs 24.7%). After adjusting for baseline characteristics, African Americans had an almost 50% higher risk of either death or decline in activities of daily living functioning (relative risk 1.45, 95% CI, 1.06-1.81). Adjustment for socioeconomic, access-to-care and quality-of-care indicators did not substantially change this estimate. CONCLUSIONS: African Americans have similar mortality but greater functional decline than whites after hospitalization for heart failure. This outcome is not explained by clinical, socioeconomic, access-to-care or quality-of-care differences.