Association of spatial proximity to fixed-site syringe services programs with HCV serostatus and injection equipment sharing practices among people who inject drugs in rural New England, United States.

BACKGROUND: Hepatitis C virus (HCV) disproportionately affects rural communities, where health services are geographically dispersed. It remains unknown whether proximity to a syringe services program (SSP) is associated with HCV infection among rural people who inject drugs (PWID). METHODS: Data are from a cross-sectional sample of adults who reported injecting drugs in the past 30 days recruited from rural counties in New Hampshire, Vermont, and Massachusetts (2018-2019). We calculated the road network distance between each participant's address and the nearest fixed-site SSP, categorized as ≤ 1 mile, 1-3 miles, 3-10 miles, and > 10 miles. Staff performed HCV antibody tests and a survey assessed past 30-day injection equipment sharing practices: borrowing used syringes, borrowing other used injection equipment, and backloading. Mixed effects modified Poisson regression estimated prevalence ratios (aPR) and 95% confidence intervals (95% CI). Analyses were also stratified by means of transportation. RESULTS: Among 330 PWID, 25% lived ≤ 1 mile of the nearest SSP, 17% lived 1-3 miles of an SSP, 12% lived 3-10 miles of an SSP, and 46% lived > 10 miles from an SSP. In multivariable models, compared to PWID who lived within 1 mile of an SSP, those who lived 3 to 10 miles away had a higher prevalence of HCV seropositivity (aPR: 1.25, 95% CI 1.06-1.46), borrowing other used injection equipment (aPR: 1.23, 95% CI 1.04-1.46), and backloading (aPR: 1.48, 95% CI 1.17-1.88). Similar results were observed for PWID living > 10 miles from an SSP: aPR [HCV]: 1.19, 95% CI 1.01-1.40; aPR [borrowing other used equipment]:1.45, 95% CI 1.29-1.63; and aPR [backloading]: 1.59, 95% CI 1.13-2.24. Associations between living 1 to 3 miles of an SSP and each outcome did not reach statistical significance. When stratified by means of transportation, associations between distance to SSP and each outcome (except borrowing other used injection equipment) were only observed among PWID who traveled by other means (versus traveled by automobile). CONCLUSIONS: Among PWID in rural New England, living farther from a fixed-site SSP was associated with a higher prevalence of HCV seropositivity, borrowing other used injection equipment, and backloading, reinforcing the need to increase SSP accessibility in rural areas. Means of transportation may modify this relationship.

Patient and provider-level drivers of healthcare utilization related to a diagnosis of a precancerous condition: monoclonal gammopathy of undetermined significance (MGUS).

PURPOSE: Monoclonal gammopathy of undetermined significance (MGUS) is the precursor of multiple myeloma. This qualitative study described patient (n = 14) experiences and healthcare providers' (n = 8) opinions and practices concerning care for patients with MGUS in the US. METHODS: Semi-structured, in-depth interviews were analyzed using thematic analysis. RESULTS: We identified six overarching themes related to the care pathway for patients with MGUS: (1) Process of MGUS diagnosis, (2) Providers' explanations, (3) Patients' understanding, (4) Impact of the diagnosis, (5) Follow-up/management, and (6) Factors influencing healthcare utilization. Patients demonstrated a basic understanding of MGUS. However, some patients felt anxiety around the diagnosis, which may affect other aspects of their lives. Non-hematologist providers report having less MGUS-specific knowledge. Older age, high-risk MGUS, and insurance coverage/healthcare costs influenced healthcare utilization. CONCLUSION: Patients with MGUS may have difficulty processing this premalignant diagnosis. Non-hematologist providers may have gaps in knowledge around specific care for patients with MGUS.

Multicomponent Pharmacist Intervention Did Not Reduce Clinically Important Medication Errors for Ambulatory Patients Initiating Direct Oral Anticoagulants.

BACKGROUND: Anticoagulants including direct oral anticoagulants (DOACs) are among the highest-risk medications in the United States. We postulated that routine consultation and follow-up from a clinical pharmacist would reduce clinically important medication errors (CIMEs) among patients beginning or resuming a DOAC in the ambulatory care setting. OBJECTIVE: To evaluate the effectiveness of a multicomponent intervention for reducing CIMEs. DESIGN: Randomized controlled trial. PARTICIPANTS: Ambulatory patients initiating a DOAC or resuming one after a complication. INTERVENTION: Pharmacist evaluation and monitoring based on the implementation of a recently published checklist. Key elements included evaluation of the appropriateness of DOAC, need for DOAC affordability assistance, three pharmacist-initiated telephone consultations, access to a DOAC hotline, documented hand-off to the patient's continuity provider, and monitoring of follow-up laboratory tests. CONTROL: Coupons and assistance to increase the affordability of DOACs. MAIN MEASURE: Anticoagulant-related CIMEs (Anticoagulant-CIMEs) and non-anticoagulant-related CIMEs over 90 days from DOAC initiation; CIMEs identified through masked assessment process including two physician adjudication of events presented by a pharmacist distinct from intervention pharmacist who reviewed participant electronic medical records and interview data. ANALYSIS: Incidence and incidence rate ratio (IRR) of CIMEs (intervention vs. control) using multivariable Poisson regression modeling. KEY RESULTS: A total of 561 patients (281 intervention and 280 control patients) contributed 479 anticoagulant-CIMEs including 31 preventable and ameliorable ADEs and 448 significant anticoagulant medication errors without subsequent documented ADEs (0.95 per 100 person-days). Failure to perform required blood tests and concurrent, inappropriate usage of a DOAC with aspirin or NSAIDs were the most common anticoagulant-related CIMEs despite pharmacist documentation systematically identifying these issues when present. There was no reduction in anticoagulant-related CIMEs among intervention patients (IRR 1.17; 95% CI 0.98-1.42) or non-anticoagulant-related CIMEs (IRR 1.05; 95% CI 0.80-1.37). CONCLUSION: A multi-component intervention in which clinical pharmacists implemented an evidence-based DOAC Checklist did not reduce CIMEs. NIH TRIAL NUMBER: NCT04068727.

Impact of a pharmacist intervention on DOAC knowledge and satisfaction in ambulatory patients.

Patient education of high-risk medications such as direct oral anticoagulants (DOACs) is limited in ambulatory care settings. Clinical pharmacists are uniquely equipped to educate patients about DOACS but seldom interact with patients in those settings where patient education and satisfaction are often overlooked. Recently, the Anticoagulation Forum endorsed a checklist (DOAC Checklist) to guide and educate patients initiating or resuming DOACs. We assessed the impact on knowledge and satisfaction of an intervention framed around the checklist. Randomized clinical trial. Ambulatory patients starting a DOAC or resuming one after setback (bleeding, stroke, or transient ischemic attack) in an ambulatory setting (office, emergency department, or short stay hospitalization). Three educational clinical pharmacist tele-visits, hotline access to the pharmacist, and coordination with continuity providers in 3 months. Patient knowledge scores from a 15-item DOAC-related questionnaire and satisfaction scores from an abbreviated version of the Duke Anticoagulation Satisfaction Survey (DASS). Of 561 randomized patients, 436 completed our follow-up surveys. Knowledge scores were similar for the 233 intervention patients vs. 203 control patients (63.7% vs 62.2% correct). Satisfaction scores on the 7-point Likert scale were virtually identical (6.24 and 6.22). Our pharmacist-led intervention framed around the DOAC checklist had little impact on knowledge and satisfaction. Delays between intervention end and completion of the follow-up questionnaires may have obscured benefits experienced earlier. More intensive education or strategies other than telephone-based consultation may be required to produce sustained knowledge.TRN: NCT04068727 retrospectively registered on August 22, 2019.

Multi-trajectory models of serum biomarkers among patients with monoclonal gammopathy of undetermined significance.

Understanding the progression of monoclonal gammopathy of undetermined significance (MGUS) to multiple myeloma (MM) is needed to identify patients who would benefit from closer clinical surveillance. Given that two of the defining criteria of MM are renal failure and anemia, we described the trajectories of creatinine (Cr) and hemoglobin (Hgb) over time in patients with a diagnosis of MGUS. Patients diagnosed with MGUS (n = 424) were identified by a previously validated case-finding algorithm using health claims and electronic health record data (2007-2015) and followed through 2018. Group-based trajectory modeling identified patients with distinct laboratory value trajectories of Cr (mg/dl) and Hgb (g/dl). Most patients were non-Hispanic White (97.6%) with a mean age of 75 years at MGUS diagnosis. Three multi-trajectory groups were identified: (1) Normal Cr/Hgb (n = 225; 53.1%)-stable serum Cr levels and decreasing, normal Hgb levels; (2) Normal Cr/lower-normal Hgb group (n = 188; 44.3%)-stable, slightly elevated levels of Cr and decreasing levels of Hgb; and (3) High Cr/borderline Hgb group (n = 11; 2.6%)-increased Cr levels and stable low levels of Hgb. Patients with MGUS in Group 2 were older than patients in other groups, and patients in group 3 had more comorbidities than participants in all other groups. Few patients developed MM during the study period. We were able to identify distinct biomarker trajectories in patients with MGUS over time. Future research should investigate how these trajectories may be related to the risk of progression to MM, including M-protein levels.

Differences in Hospital, Emergency Room and Outpatient Visits Among Adults With and Without Monoclonal Gammopathy of Undetermined Significance.

INTRODUCTION: This study evaluated the impact of receiving a monoclonal gammopathy of undetermined significance (MGUS) diagnosis on healthcare utilization from patients at a community-based multispecialty provider organization. METHODS: A cohort of patients with MGUS (n = 429) were matched on sex, age, and length of enrollment to a cohort of patients without MGUS (n = 1286). Healthcare utilization was assessed: 1-12 months before, 1 month before and after, and 1-12 months after diagnosis/index date. Multivariable conditional Poisson models compared change in utilization of each service in patients with and without MGUS. RESULTS: During the 2 months around diagnosis/index date, the rates of emergency room, hospital and outpatient visits were higher for patients with MGUS than patients without MGUS. In the year before MGUS diagnosis, the association was still elevated, although attenuated. CONCLUSION: Understanding the care of MGUS patients is important given that multiple myeloma patients with a pre-existing MGUS diagnosis may have a better prognosis.

Association between Initiation of Pulmonary Rehabilitation and Rehospitalizations in Patients Hospitalized with Chronic Obstructive Pulmonary Disease.

Rationale: Although clinical trials have found that pulmonary rehabilitation (PR) can reduce the risk of readmissions after hospitalization for a chronic obstructive pulmonary disease (COPD) exacerbation, less is known about PR's impact in routine clinical practice. Objectives: To evaluate the association between initiation of PR within 90 days of discharge and rehospitalization(s). Methods: We analyzed a retrospective cohort of Medicare beneficiaries (66 years of age or older) hospitalized for COPD in 2014 who survived at least 30 days after discharge. Measurements and Main Results: We used propensity score matching and estimated the risk of recurrent all-cause rehospitalizations at 1 year using a multistate model to account for the competing risk of death. Of 197,376 total patients hospitalized in 4,446 hospitals, 2,721 patients (1.5%) initiated PR within 90 days of discharge. Overall, 1,534 (56.4%) patients who initiated PR and 125,720 (64.6%) who did not were rehospitalized one or more times within 1 year of discharge. In the propensity-score-matched analysis, PR initiation was associated with a lower risk of readmission in the year after PR initiation (hazard ratio, 0.83; 95% confidence interval, 0.77-0.90). The mean cumulative number of rehospitalizations at 1 year was 0.95 for those who initiated PR within 90 days and 1.15 for those who did not (P < 0.001). Conclusions: After hospitalization for COPD, Medicare beneficiaries who initiated PR within 90 days of discharge experienced fewer rehospitalizations over 1 year. These results support findings from randomized controlled clinical trials and highlight the need to identify effective strategies to increase PR participation.

Video-based communication assessment for weight management counseling training in medical residents: a mixed methods study.

BACKGROUND: Physician delivered weight management counseling (WMC) occurs infrequently and physicians report lack of training and poor self-efficacy. The purpose of this study was to develop and test the Video-based Communication Assessment (VCA) for weight management counseling (WMC) training in medical residents. METHODS: This study was a mixed methods pilot conducted in 3 phases. First, we created five vignettes based on our prior data and expert feedback, then administered the vignettes via the VCA to Internal Medicine categorical residents (n = 16) from a University Medical School. Analog patients rated responses and also provided comments. We created individualized feedback reports which residents were able to view on the VCA. Lastly, we conducted debriefing interviews with the residents (n = 11) to obtain their feedback on the vignettes and personalized feedback. Interviews were transcribed, and we used thematic analysis to generate and apply codes, followed by identifying themes. RESULTS: Descriptive statistics were calculated and learning points were created for the individualized feedback reports. In VCA debriefing interviews with residents, five themes emerged: 1) Overall the VCA was easy to use, helpful and more engaging than traditional learning and assessment modes, 2) Patient scenarios were similar to those encountered in the clinic, including diversity, health literacy and different stages of change, 3) The knowledge, skills, and reminders from the VCA can be transferred to practice, 4) Feedback reports were helpful, to the point and informative, including the exemplar response of how to best respond to the scenario, and 5) The VCA provide alternatives and practice scenarios to real-life patient situations when they aren't always accessible. CONCLUSIONS: We demonstrated the feasibility and acceptability of the VCA, a technology delivered platform, for delivering WMC to residents. The VCA exposed residents to diverse patient experiences and provided potential opportunities to tailor providers responses to sociological and cultural factors in WMC scenarios. Future work will examine the effect of the VCA on WMC in actual clinical practice.

Advancing clinical trials in nursing homes: A proposed roadmap to success.

An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.

Identifying prescribing cascades in Alzheimer's disease and related dementias: The calcium channel blocker-diuretic prescribing cascade.

PURPOSE: Prescribing cascades occur when a physician prescribes a new drug to address the side-effect of another drug. Persons with Alzheimer's disease and related dementias (ADRD) are at increased risk for prescribing cascades. Our objective was to develop an approach to estimating the proportion of calcium channel blocker-diuretic (CCB-diuretic) prescribing cascades among persons with ADRD in two U.S. health plans. METHODS: We identified patients aged ≥50 on January 1, 2017, dispensed a drug to treat ADRD in the 365-days prior to/on cohort entry date. Patients had medical/pharmacy coverage for 1 year before and through cohort entry. We excluded individuals with an institutional stay encounter in the 45 days prior to cohort entry and censored patients based on: disenrollment from coverage, death, or end of data. We identified incident and prevalent CCB use in the 183-days following cohort entry, and identified subsequent incident diuretic use among incident and prevalent CCB-users within 365-days from cohort entry. RESULTS: There were 121 538 eligible patients. Approximately 62% were female, with a mean age of 79.5 (SD ±8.6). Overall 2.1% of the cohort experienced a prevalent CCB-diuretic prescribing cascade with 1586 incident diuretic-users among 36 462 prevalent CCB-users (4.3%, 95% CI 4.1-4.6%]); and there were161 incident diuretic-users among 3304 incident CCB-users (4.9%, 95% CI 4.2-5.7%) (incident CCB-diuretic cascade). CONCLUSIONS: We describe an approach to identify prescribing cascades in persons with ADRD, which can be used to assess the proportion of prescribing cascades in large cohorts. We determined the proportion of CCB-diuretic prescribing cascades was low.

Attitudes Toward a Potential SARS-CoV-2 Vaccine : A Survey of U.S. Adults.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has rapidly instigated a global pandemic. Vaccine development is proceeding at an unprecedented pace. Once available, it will be important to maximize vaccine uptake and coverage. OBJECTIVE: To assess intent to be vaccinated against COVID-19 among a representative sample of adults in the United States and identify predictors of and reasons for vaccine hesitancy. DESIGN: Cross-sectional survey, fielded from 16 through 20 April 2020. SETTING: Representative sample of adults residing in the United States. PARTICIPANTS: Approximately 1000 adults drawn from the AmeriSpeak probability-based research panel, covering approximately 97% of the U.S. household population. MEASUREMENTS: Intent to be vaccinated against COVID-19 was measured with the question, "When a vaccine for the coronavirus becomes available, will you get vaccinated?" Response options were "yes," "no," and "not sure." Participants who responded "no" or "not sure" were asked to provide a reason. RESULTS: A total of 991 AmeriSpeak panel members responded. Overall, 57.6% of participants (n = 571) intended to be vaccinated, 31.6% (n = 313) were not sure, and 10.8% (n = 107) did not intend to be vaccinated. Factors independently associated with vaccine hesitancy (a response of "no" or "not sure") included younger age, Black race, lower educational attainment, and not having received the influenza vaccine in the prior year. Reasons for vaccine hesitancy included vaccine-specific concerns, a need for more information, antivaccine attitudes or beliefs, and a lack of trust. LIMITATIONS: Participants' intent to be vaccinated was explored before a vaccine was available and when the pandemic was affecting a narrower swath of the United States. Questions about specific information or factors that might increase vaccination acceptance were not included. The survey response rate was 16.1%. CONCLUSION: This national survey, conducted during the coronavirus pandemic, revealed that approximately 3 in 10 adults were not sure they would accept vaccination and 1 in 10 did not intend to be vaccinated against COVID-19. Targeted and multipronged efforts will be needed to increase acceptance of a COVID-19 vaccine when one becomes available. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Evaluating the Effectiveness of NoteAid in a Community Hospital Setting: Randomized Trial of Electronic Health Record Note Comprehension Interventions With Patients.

BACKGROUND: Interventions to define medical jargon have been shown to improve electronic health record (EHR) note comprehension among crowdsourced participants on Amazon Mechanical Turk (AMT). However, AMT participants may not be representative of the general population or patients who are most at-risk for low health literacy. OBJECTIVE: In this work, we assessed the efficacy of an intervention (NoteAid) for EHR note comprehension among participants in a community hospital setting. METHODS: Participants were recruited from Lowell General Hospital (LGH), a community hospital in Massachusetts, to take the ComprehENotes test, a web-based test of EHR note comprehension. Participants were randomly assigned to control (n=85) or intervention (n=89) groups to take the test without or with NoteAid, respectively. For comparison, we used a sample of 200 participants recruited from AMT to take the ComprehENotes test (100 in the control group and 100 in the intervention group). RESULTS: A total of 174 participants were recruited from LGH, and 200 participants were recruited from AMT. Participants in both intervention groups (community hospital and AMT) scored significantly higher than participants in the control groups (P<.001). The average score for the community hospital participants was significantly lower than the average score for the AMT participants (P<.001), consistent with the lower education levels in the community hospital sample. Education level had a significant effect on scores for the community hospital participants (P<.001). CONCLUSIONS: Use of NoteAid was associated with significantly improved EHR note comprehension in both community hospital and AMT samples. Our results demonstrate the generalizability of ComprehENotes as a test of EHR note comprehension and the effectiveness of NoteAid for improving EHR note comprehension.

Prognostic Uncertainty in Critically Ill Patients with Traumatic Brain Injury: A Multicenter Qualitative Study.

BACKGROUND: Prognostic uncertainty is frequently cited as a barrier to communication between physicians and patients and is particularly burdensome for surrogate decision-makers, who must make choices on behalf of their incapacitated family members. The Conceptual Taxonomy of Uncertainty is one model through which physician and surrogate communication can be analyzed to identify strategies for reducing uncertainty in surrogate decision-making. Our objective was to examine themes of uncertainty in physician communication of prognosis and surrogate goals-of-care decision-making for critically ill patients with traumatic brain injury (TBI). METHODS: We performed a secondary analysis of a previous qualitative study that involved semistructured interviews of 16 surrogates of critically ill patients with TBI from two level 1 trauma centers and 20 TBI expert physicians from seven trauma centers. Open-ended questions about prognostic uncertainty were asked. We identified major themes with an inductive approach. The Conceptual Taxonomy of Uncertainty was applied to further characterize these themes as data-centered, system-centered, and patient-centered issues of uncertainty. RESULTS: Nearly all surrogates (15 of 16) and physicians (19 of 20) recognized the emotional burden of uncertainty in the decision-making process for surrogates. More than three quarters of surrogates (13 of 16) described instances in which a lack of information regarding their loved one's disease or prognosis created uncertainty in their decision-making process, identifying both positive and negative instances of prognostic communication by physicians. We found that physicians used one of three strategies to communicate prognostic uncertainty to surrogates: leaving no room for uncertainty, honesty about uncertainty, and range of possibilities. These strategies did not meet the communication preferences of the majority of surrogates, with more than a third of decision-makers (6 of 15) being frustrated by too much ambiguity about prognosis as well as the failure to acknowledge the existence of uncertainty. CONCLUSIONS: We found that physician communication strategies rarely addressed surrogate needs regarding uncertainty adequately, suggesting an urgent need for future research into improved communication of prognostic uncertainty.

Organizational characteristics associated with high performance on quality measures in pediatric primary care: A positive deviance study.

BACKGROUND: Pediatric health care quality in the United States varies, but the reasons for variation are not fully understood. Differences in pediatric practices' organizational characteristics, such as organizational structures, strategies employed to improve quality, and other contextual factors, may contribute to the variation observed. PURPOSE: To assess the relationship between organizational characteristics and performance on clinical quality (CQ) and patient experience (PE) measures in primary care pediatric practices in Massachusetts. METHODOLOGY: A 60-item questionnaire that assessed the presence of selected organizational characteristics was sent to 172 pediatric practice managers in Massachusetts between December 2017 and February 2018. The associations between select organizational characteristics and publicly available CQ and PE scores were analyzed using analysis of variance; open-ended survey questions were analyzed using qualitative content analysis. RESULTS: Eighty-six practices (50.0%) responded; 80 (46.5%) were included in the primary analysis. Having a quality champion ( p = .03), offering co-located specialty services (e.g., behavioral health; p = .04), being a privately owned practice ( p = .04), believing that patients and families feel respected ( p = .03), and having a lower percentage of patients (10%-25%) covered by public health insurance ( p = .04) were associated with higher CQ scores. Higher PE scores were associated with private practice ownership ( p = .0006). Qualitative analysis suggested organizational culture and external factors, such as health care finance, may affect quality. CONCLUSIONS: Both modifiable organizational practices and factors external to a practice may affect quality of care. Addressing differences in practice performance may not be reducible to implementation of changes in single organizational characteristics. PRACTICE IMPLICATIONS: Pediatric practices seeking to improve quality of care may wish to adopt the strategies that were associated with higher performance on quality measures, but additional studies are needed to better understand the mechanisms behind these associations and how they relate to each other.

Improving stamina and mobility with preop walking in surgical patients with frailty traits -OASIS IV: randomized clinical trial study protocol.

BACKGROUND: Frail older surgical patients face more than a two-fold increase in postoperative complications, including myocardial infarction, deep vein thrombosis, pulmonary embolism, pneumonia, ileus, and others. Many of these complications occur because of postoperative loss of stamina and poor mobility. Preoperative exercise may better prepare these vulnerable patients for surgery. We present the protocol for our ongoing randomized trial to assess the impact of a preoperative walking intervention with remote coaching and pedometer on outcomes of stamina (six-minute walk distance- 6MWD) and mobility (postoperative steps) in older adults with frailty traits. METHODS: We will be conducting a randomized clinical trial with a total of 120 patients permitting up to a 33% rate of attrition, to reach a final sample size of 80 (with 40 patients for each study arm). We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial. Using block randomization stratified on baseline 6MWD, we will assign patients to wear a pedometer. At the end of three baseline days, an athletic trainer (AT) will provide a daily step count goal reflecting a 10-20% increase from baseline. Subsequently, the AT will call weekly to further titrate the goal or calls more frequently if the patient is not meeting the prescribed goal. Controls will receive general walking advice. Our main outcome is change in 6MWD on postoperative day (POD) 2/3 vs. baseline. We will also collect 6MWD approximately 4 weeks after surgery and daily in-hospital steps. CONCLUSION: If changes in a 6MWD and step counts are significantly higher for the intervention group, we believe this will confirm our hypothesis that the intervention leads to decreased loss of stamina and mobility. Once confirmed, we anticipate expanding to multiple centers to assess the interventional impact on clinical endpoints. TRIAL REGISTRATION: The randomized clinical trial was registered on clinicaltrials.gov under the identifier NCT03892187 on March 27, 2019.

Electronic Health Record Portal Messages and Interactive Voice Response Calls to Improve Rates of Early Season Influenza Vaccination: Randomized Controlled Trial.

BACKGROUND: Patient reminders for influenza vaccination, delivered via an electronic health record patient portal and interactive voice response calls, offer an innovative approach to engaging patients and improving patient care. OBJECTIVE: The goal of this study was to test the effectiveness of portal and interactive voice response outreach in improving rates of influenza vaccination by targeting patients in early September, shortly after vaccinations became available. METHODS: Using electronic health record portal messages and interactive voice response calls promoting influenza vaccination, outreach was conducted in September 2015. Participants included adult patients within a large multispecialty group practice in central Massachusetts. Our main outcome was electronic health record-documented early influenza vaccination during the 2015-2016 influenza season, measured in November 2015. We randomly assigned all active portal users to 1 of 2 groups: (1) receiving a portal message promoting influenza vaccinations, listing upcoming clinics, and offering online scheduling of vaccination appointments (n=19,506) or (2) receiving usual care (n=19,505). We randomly assigned all portal nonusers to 1 of 2 groups: (1) receiving interactive voice response call (n=15,000) or (2) receiving usual care (n=43,596). The intervention also solicited patient self-reports on influenza vaccinations completed outside the clinic. Self-reported influenza vaccination data were uploaded into the electronic health records to increase the accuracy of existing provider-directed electronic health record clinical decision support (vaccination alerts) but were excluded from main analyses. RESULTS: Among portal users, 28.4% (5549/19,506) of those randomized to receive messages and 27.1% (5294/19,505) of the usual care group had influenza vaccinations documented by November 2015 (P=.004). In multivariate analysis of portal users, message recipients were slightly more likely to have documented vaccinations when compared to the usual care group (OR 1.07, 95% CI 1.02-1.12). Among portal nonusers, 8.4% (1262/15,000) of those randomized to receive calls and 8.2% (3586/43,596) of usual care had documented vaccinations (P=.47), and multivariate analysis showed nonsignificant differences. Over half of portal messages sent were opened (10,112/19,479; 51.9%), and over half of interactive voice response calls placed (7599/14,984; 50.7%) reached their intended target, thus we attained similar levels of exposure to the messaging for both interventions. Among portal message recipients, 25.4% of message openers (2570/10,112) responded to a subsequent question on receipt of influenza vaccination; among interactive voice response recipients, 72.5% of those reached (5513/7599) responded to a similar question. CONCLUSIONS: Portal message outreach to a general primary care population achieved a small but statistically significant improvement in rates of influenza vaccination (OR 1.07, 95% CI 1.02-1.12). Interactive voice response calls did not significantly improve vaccination rates among portal nonusers (OR 1.03, 95% CI 0.96-1.10). Rates of patient engagement with both modalities were favorable. TRIAL REGISTRATION: ClinicalTrials.gov NCT02266277; https://clinicaltrials.gov/ct2/show/NCT02266277.

Association Between Initiation of Pulmonary Rehabilitation After Hospitalization for COPD and 1-Year Survival Among Medicare Beneficiaries.

Importance: Meta-analyses have suggested that initiating pulmonary rehabilitation after an exacerbation of chronic obstructive pulmonary disease (COPD) was associated with improved survival, although the number of patients studied was small and heterogeneity was high. Current guidelines recommend that patients enroll in pulmonary rehabilitation after hospital discharge. Objective: To determine the association between the initiation of pulmonary rehabilitation within 90 days of hospital discharge and 1-year survival. Design, Setting, and Patients: This retrospective, inception cohort study used claims data from fee-for-service Medicare beneficiaries hospitalized for COPD in 2014, at 4446 acute care hospitals in the US. The final date of follow-up was December 31, 2015. Exposures: Initiation of pulmonary rehabilitation within 90 days of hospital discharge. Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. Time from discharge to death was modeled using Cox regression with time-varying exposure to pulmonary rehabilitation, adjusting for mortality and for unbalanced characteristics and propensity to initiate pulmonary rehabilitation. Additional analyses evaluated the association between timing of pulmonary rehabilitation and mortality and between number of sessions completed and mortality. Results: Of 197 376 patients (mean age, 76.9 years; 115 690 [58.6%] women), 2721 (1.5%) initiated pulmonary rehabilitation within 90 days of discharge. A total of 38 302 (19.4%) died within 1 year of discharge, including 7.3% of patients who initiated pulmonary rehabilitation within 90 days and 19.6% of patients who initiated pulmonary rehabilitation after 90 days or not at all. Initiation within 90 days was significantly associated with lower risk of death over 1 year (absolute risk difference [ARD], -6.7% [95% CI, -7.9% to -5.6%]; hazard ratio [HR], 0.63 [95% CI, 0.57 to 0.69]; P < .001). Initiation of pulmonary rehabilitation was significantly associated with lower mortality across start dates ranging from 30 days or less (ARD, -4.6% [95% CI, -5.9% to -3.2%]; HR, 0.74 [95% CI, 0.67 to 0.82]; P < .001) to 61 to 90 days after discharge (ARD, -11.1% [95% CI, -13.2% to -8.4%]; HR, 0.40 [95% CI, 0.30 to 0.54]; P < .001). Every 3 additional sessions was significantly associated with lower risk of death (HR, 0.91 [95% CI, 0.85 to 0.98]; P = .01). Conclusions and Relevance: Among fee-for-service Medicare beneficiaries hospitalized for COPD, initiation of pulmonary rehabilitation within 3 months of discharge was significantly associated with lower risk of mortality at 1 year. These findings support current guideline recommendations for pulmonary rehabilitation after hospitalization for COPD, although the potential for residual confounding exists and further research is needed.

Development of the Initial Surveys for the All of Us Research Program.

BACKGROUND: The All of Us Research Program is building a national longitudinal cohort and collecting data from multiple information sources (e.g., biospecimens, electronic health records, and mobile/wearable technologies) to advance precision medicine. Participant-provided information, collected via surveys, will complement and augment these information sources. We report the process used to develop and refine the initial three surveys for this program. METHODS: The All of Us survey development process included: (1) prioritization of domains for scientific needs, (2) examination of existing validated instruments, (3) content creation, (4) evaluation and refinement via cognitive interviews and online testing, (5) content review by key stakeholders, and (6) launch in the All of Us electronic participant portal. All content was translated into Spanish. RESULTS: We conducted cognitive interviews in English and Spanish with 169 participants, and 573 individuals completed online testing. Feedback led to over 40 item content changes. Lessons learned included: (1) validated survey instruments performed well in diverse populations reflective of All of Us; (2) parallel evaluation of multiple languages can ensure optimal survey deployment; (3) recruitment challenges in diverse populations required multiple strategies; and (4) key stakeholders improved integration of surveys into larger Program context. CONCLUSIONS: This efficient, iterative process led to successful testing, refinement, and launch of three All of Us surveys. Reuse of All of Us surveys, available at http://researchallofus.org, may facilitate large consortia targeting diverse populations in English and Spanish to capture participant-provided information to supplement other data, such as genetic, physical measurements, or data from electronic health records.

Cancer survivors' experiences with breakdowns in patient-centered communication.

OBJECTIVE: This study analyzed cancer survivors' communication experiences that fell short of being patient-centered. Patients' descriptions of communication "breakdowns" were analyzed according to domain (eg, information exchange, fostering relationships, and managing emotions), whether it was a breakdown of commission (what was communicated) or omission (what should have been communicated) and whether it involved a clinician or the health care organization. METHODS: Cancer survivors (from an online panel of patients) completed the Patients Assessment of Communication Experience measure. Ratings less than "excellent" elicited a prompt asking where communication fell short. Communication breakdowns were categorized as one of commission/omission, if it involved a clinician/health care system, and within which communication domain. Thematic analysis explored how communication breakdowns affected respondents' cancer care experiences. RESULTS: Overall communication was rated as less than excellent by 153 respondents, of which 79 identified a specific communication breakdown. Over half (n = 43, 54%) were problems of omission, mostly attributed to interaction with health care organizations (n = 25). Breakdowns of commission (n = 36, 46%) occurred primarily within clinical encounters (n = 32). Most breakdowns were problems of information exchange (49%) or fostering relationships (27%). Three overarching themes emerged-emotional fallout from unmet information needs, inattention to patient perspective, and uncertainty about navigation and team communication. CONCLUSIONS: Patient-centered communication breakdowns create distress that worsens patients' cancer care experiences. Communication skills training for clinicians should address listening, perspective taking, and assessing/satisfying patients' information and emotional needs. Health care organizations should enhance processes to provide timely, useful information to patients.

The Effect of Shared Decisionmaking on Patients' Likelihood of Filing a Complaint or Lawsuit: A Simulation Study.

STUDY OBJECTIVE: Shared decisionmaking has been promoted as a method to increase the patient-centeredness of medical decisionmaking and decrease low-yield testing, but little is known about its medicolegal ramifications in the setting of an adverse outcome. We seek to determine whether the use of shared decisionmaking changes perceptions of fault and liability in the case of an adverse outcome. METHODS: This was a randomized controlled simulation experiment conducted by survey, using clinical vignettes featuring no shared decisionmaking, brief shared decisionmaking, or thorough shared decisionmaking. Participants were adult US citizens recruited through an online crowd-sourcing platform. Participants were randomized to vignettes portraying 1 of 3 levels of shared decisionmaking. All other information given was identical, including the final clinical decision and the adverse outcome. The primary outcome was reported likelihood of pursuing legal action. Secondary outcomes included perceptions of fault, quality of care, and trust in physician. RESULTS: We recruited 804 participants. Participants exposed to shared decisionmaking (brief and thorough) were 80% less likely to report a plan to contact a lawyer than those not exposed to shared decisionmaking (12% and 11% versus 41%; odds ratio 0.2; 95% confidence interval 0.12 to 0.31). Participants exposed to either level of shared decisionmaking reported higher trust, rated their physicians more highly, and were less likely to fault their physicians for the adverse outcome compared with those exposed to the no shared decisionmaking vignette. CONCLUSION: In the setting of an adverse outcome from a missed diagnosis, use of shared decisionmaking may affect patients' perceptions of fault and liability.