Looking Beyond Mortality Prediction: Primary Care Physician Views of Patients' Palliative Care Needs Predicted by a Machine Learning Tool.

OBJECTIVE: To assess primary care physicians' (PCPs) perception of the need for serious illness conversations (SIC) or other palliative care interventions in patients flagged by a machine learning tool for high one-year mortality risk. MATERIALS AND METHODS: We surveyed PCPs from four Brigham and Women's Hospital primary care practice sites. Multiple mortality prediction algorithms were ensembled to assess adult patients of these PCPs who were either enrolled in the hospital's integrated care management program or had one of several chronic conditions. The patients were classified as high or low-risk of one-year mortality. A blinded survey had PCPs evaluate these patients for palliative care needs. We measured PCP and machine learning tool agreement regarding patients' need for an SIC/elevated risk of mortality. RESULTS: Of 66 PCPs, 20 (30.3%) participated in the survey. Out of 312 patients evaluated, 60.6% were female, with a mean (SD) age of 69.3 (17.5) years, and a mean (SD) Charlson comorbidity index of 2.80 (2.89). The machine learning tool identified 162 (51.9%) patients as high-risk. Excluding deceased or unfamiliar patients, PCPs felt that an SIC was appropriate for 179 patients; the machine learning tool flagged 123 of these patients as high-risk (68.7% concordance). For 105 patients whom PCPs deemed SIC-unnecessary, the tool classified 83 as low-risk (79.1% concordance). There was substantial agreement between PCPs and the tool (Gwet's agreement coefficient of 0.640). CONCLUSIONS AND RELEVANCE: A machine learning mortality prediction tool offers promise as a clinical decision aid, helping clinicians pinpoint patients needing palliative care interventions.

Quantifying and Reducing Errors in Vascular Imaging Examination Orders Through a Multistage Quality Improvement Intervention.

PURPOSE: The aims of this study were to quantify order error rates for vascular imaging examinations and to assess the effects of a multistage quality improvement intervention on those rates. METHODS: In this prospective, institutional review board-exempt project at a large academic quaternary care hospital, the authors aimed to quantify and reduce the order error rate by 50%. The authors analyzed 844 orders for all vascular imaging examinations placed before the intervention (July 19 to August 1, 2021, and September 13 to September 26, 2021), after an intervention in the cardiac surgery department consisting of a new customized order option in the electronic health record for routine preoperative patients (postintervention 1, February 28 to March 27, 2022); and after an educational and feedback campaign (postintervention 2, May 23 to June 5, 2022). Incorrect orders were identified by a radiology trainee during protocoling if the reasons for ordered examination and imaging examination were discordant and subsequently confirmed with the ordering provider. The primary outcome, order error rate, was compared across the project periods using the χ2 test and by ordering department using the χ2 and Fisher exact tests. RESULTS: The preintervention order error rate of 16% (50 of 306) decreased by 83% to 3% (10 of 353) at postintervention 1 (P < .001) and was durable at 3% (6 of 185) by project end. Chest CT with or without contrast constituted the majority of incorrect orders (44%, 22 of 50); "Pre-Op" was the most common examination reason (32% [16 of 50]). Cardiac surgery orderers were responsible for the most incorrect orders (32% [16 of 50]). All four most common ordering departments, including cardiac surgery, reduced their order error rates after the intervention (P < .001). CONCLUSIONS: Incorrect orders for imaging examinations can be reduced through targeted quality improvement interventions combining tailored electronic health record order options with education and feedback on practice habits.

Discriminative Factors of Malignancy of Ipsilateral Nonmass Enhancement in Women With Newly Diagnosed Breast Cancer on Initial Staging Breast MRI.

BACKGROUND: Nonmass enhancement (NME) on breast MRI impacts surgical planning. PURPOSE: To evaluate positive predictive values (PPVs) and identify malignancy discriminators of NME ipsilateral to breast cancer on initial staging MRI. STUDY TYPE: Retrospective. SUBJECTS: Eighty-six women (median age, 48 years; range, 26-75 years) with 101 NME lesions (BI-RADS 4 and 5) ipsilateral to known cancers and confirmed histopathology. FIELD STRENGTH/SEQUENCE: 1.5 T and 3.0 T dynamic contrast-enhanced fat-suppressed T1-weighted fast spoiled gradient-echo. ASSESSMENT: Three radiologists blinded to pathology independently reviewed MRI features (distribution, internal enhancement pattern, and enhancement kinetics) of NME, locations relative to index cancers (contiguous, non-contiguous, and different quadrants), associated mammographic calcifications, lymphovascular invasion (LVI), axillary node metastasis, and radiology-pathology correlations. Clinical factors, NME features, and cancer characteristics were analyzed for associations with NME malignancy. STATISTICAL TESTS: Fisher's exact, Chi-square, Wilcoxon rank sum tests, and mixed-effect multivariable logistic regression were used. Significance threshold was set at P < 0.05. RESULTS: Overall NME malignancy rate was 48.5% (49/101). Contiguous NME had a significantly higher malignancy rate (86.7%) than non-contiguous NME (25.0%) and NME in different quadrants (10.7%), but no significant difference was observed by distance from cancer for non-contiguous NME, P = 0.68. All calcified NME lesions contiguous to the calcified index cancer were malignant. NME was significantly more likely malignant when index cancers were masses compared to NME (52.9% vs. 21.4%), had mammographic calcifications (63.2% vs. 39.7%), LVI (81.8% vs. 44.4%), and axillary node metastasis (70.8% vs. 41.6%). NME features with highest PPVs were segmental distribution (85.7%), clumped enhancement (66.7%), and nonpersistent kinetics (77.1%). On multivariable analysis, contiguous NME, segmental distribution, and nonpersistent kinetics were associated with malignancy. DATA CONCLUSION: Malignancy discriminators of ipsilateral NME on staging MRI included contiguous location to index cancers, segmental distribution, and nonpersistent kinetics. EVIDENCE LEVEL: 3 TECHNICAL EFFICACY: Stage 2.

Number of patients with interstitial cystitis/bladder pain syndrome seen before versus during the COVID-19 pandemic at an academic, urban, multisite urogynecology practice.

OBJECTIVES: Little is known about the impact of the COVID-19 pandemic on interstitial cystitis/bladder pain syndrome (IC/BPS). We aim to compare the number of newly diagnosed IC/BPS cases and number of patients with flares prior to and during the pandemic. METHODS: We conducted a retrospective cohort study of women ≥18 years who were diagnosed with or treated for IC/BPS between March 2019 and March 2021 at an academic, urban, multisite urogynecology practice. The primary outcome was the number of IC/BPS cases from March 1, 2019 to February 29, 2020 (pre-pandemic) compared with March 1, 2020 to February 28, 2021 (during pandemic). The secondary outcome was the number of patients with flares during those same two time periods. Demographic and clinical characteristics were compared using nonparametric tests and interrupted time series (ITS) was used to evaluate our outcomes of interest. p-Value <.05 was considered significant. RESULTS: Fifty-four women (4.87% of new patients) were diagnosed with IC/BPS during the pandemic compared with 40 women pre-pandemic (4.05% of new patients). The median age was 35.0. Seventy-two percent were premenopausal, 75% sexually active, and 31% had anxiety, and there were no significant differences between groups. Although the number of patients newly diagnosed with IC/BPS was higher during the pandemic, the diagnosis rates between time periods were not statistically different. Thirty-five patients experienced flares during the pandemic compared with 49 patients the year prior (p = .43). This difference was also not statistically significant on ITS analysis. CONCLUSIONS: Although more patients were diagnosed with IC/BPS during versus before the pandemic, the difference in diagnosis rates was not different between these periods.

Extraglottic device use is rare during emergency airway management: A National Emergency Airway Registry (NEAR) study.

INTRODUCTION: Airway management is a critical component of the management of emergency department (ED) patients. The ED airway literature primarily focuses upon endotracheal intubation; relatively less is known about the ED use of extraglottic devices (EGDs). The goal of this study was to describe the frequency of use, success, and complications for EGDs among ED patients. METHODS: The National Emergency Airway Registry (NEAR) is a prospective, multi-center, observational registry. It captures data on all ED patients at participating sites requiring airway management. Intubating clinicians entered all data into an online system as soon as practical after each encounter. We conducted a secondary analysis of these data for all ED encounters in which EGD placement occurred. We used descriptive statistics to characterize these encounters. RESULTS: Of 19,071 patients undergoing intubation attempts, 56 (0.3%) underwent EGD placement. Of 25 participating sites, 13 reported no cases undergoing EGD placement; the median number of EGDs placed per site was 2 (interquartile range 1-2.5, range 1-31). Twenty-nine (54%) patients had either hypotension or hypoxia prior to the start of airway management. Clinicians reported anticipation of a difficult airway in 55% and at least one difficult airway characteristic in 93% of these patients. Forty-one encounters entailed placement of a laryngeal mask airway (LMA®) Fastrach™, 33 of whom underwent subsequent successful intubation through the EGD and 7 of whom underwent intubation by alternative methods. An additional 10 encounters utilized a standard LMA® device. Providers placed 34 (61%) EGDs during the first intubation attempt. Seventeen EGD patients (30%) experienced peri-procedure adverse events, including 14 (25%) experiencing hypoxemia. None of these patients expired due to failed airways. CONCLUSIONS: EGD use was rare in this multi-center ED registry. EGD occurred predominantly in patients with difficult airway characteristics with favorable airway management outcomes. Clinicians should consider this emergency airway device for patients with a suspected difficult airway.

Oncology distress screening within predominately Black Veterans: Outcomes on supportive care utilization, hospitalizations, and mortality.

BACKGROUND: We evaluated whether patients' initial screening symptoms were related to subsequent utilization of supportive care services and hospitalizations, and whether patient-level demographics, symptoms, hospitalizations, and supportive care service utilization were associated with mortality in primarily low-income, older, Black Veterans with cancer. METHODS: This quality improvement project created collaborative clinics to conduct cancer distress screenings and refer to supportive care services at an urban, VA medical center. All patients completed a distress screen with follow-up screening every 3 months. Supportive care utilization, hospitalization rates, and mortality were abstracted through medical records. Poisson regression models and cox proportional hazard models were utilized. RESULTS: Five hundred and eighty five screened patients were older (m = 72), mostly Black 70% (n = 412), and had advanced cancer 54%. Fifty-eight percent (n = 340) were screened only once with 81% (n = 470) receiving ≥1 supportive care service and 51.5% (n = 297) being hospitalized ≥1 time 18 months following initial screen. Symptom severity was significantly related to number of hospitalizations. Low mood was significantly related to higher supportive services (p < 0.001), but not hospitalizations (p ≥ 0.52). Pain, fatigue, physical function, nutrition, and physical symptoms were significantly associated with more supportive services and hospitalizations (p < 0.01). Twenty percent (n = 168) died; Veterans who were Black, had lower stage cancers, better physical health, and utilized less supportive care services had lower odds of mortality (p ≤ 0.01). CONCLUSION: Individuals with elevated distress needs and those reporting lower physical function utilized more supportive care services and had higher hospitalization rates. Lower physical function, greater supportive care use, higher stage cancer, and being non-Black were associated with higher odds of death.

Utility of Normalized Body Composition Areas, Derived From Outpatient Abdominal CT Using a Fully Automated Deep Learning Method, for Predicting Subsequent Cardiovascular Events.

BACKGROUND. CT-based body composition (BC) measurements have historically been too resource intensive to analyze for widespread use and have lacked robust comparison with traditional weight metrics for predicting cardiovascular risk. OBJECTIVE. The aim of this study was to determine whether BC measurements obtained from routine CT scans by use of a fully automated deep learning algorithm could predict subsequent cardiovascular events independently from weight, BMI, and additional cardiovascular risk factors. METHODS. This retrospective study included 9752 outpatients (5519 women and 4233 men; mean age, 53.2 years; 890 patients self-reported their race as Black and 8862 self-reported their race as White) who underwent routine abdominal CT at a single health system from January 2012 through December 2012 and who were given no major cardiovascular or oncologic diagnosis within 3 months of undergoing CT. Using publicly available code, fully automated deep learning BC analysis was performed at the L3 vertebral body level to determine three BC areas (skeletal muscle area [SMA], visceral fat area [VFA], and subcutaneous fat area [SFA]). Age-, sex-, and race-normalized reference curves were used to generate z scores for the three BC areas. Subsequent myocardial infarction (MI) or stroke was determined from the electronic medical record. Multivariable-adjusted Cox proportional hazards models were used to determine hazard ratios (HRs) for MI or stroke within 5 years after CT for the three BC area z scores, with adjustment for normalized weight, normalized BMI, and additional cardiovascular risk factors (smoking status, diabetes diagnosis, and systolic blood pressure). RESULTS. In multivariable models, age-, race-, and sex-normalized VFA was associated with subsequent MI risk (HR of highest quartile compared with lowest quartile, 1.31 [95% CI, 1.03-1.67], p = .04 for overall effect) and stroke risk (HR of highest compared with lowest quartile, 1.46 [95% CI, 1.07-2.00], p = .04 for overall effect). In multivariable models, normalized SMA, SFA, weight, and BMI were not associated with subsequent MI or stroke risk. CONCLUSION. VFA derived from fully automated and normalized analysis of abdominal CT examinations predicts subsequent MI or stroke in Black and White patients, independent of traditional weight metrics, and should be considered an adjunct to BMI in risk models. CLINICAL IMPACT. Fully automated and normalized BC analysis of abdominal CT has promise to augment traditional cardiovascular risk prediction models.

Biomarker-Based Phase II Study of Sapanisertib (TAK-228): An mTORC1/2 Inhibitor in Patients With Refractory Metastatic Renal Cell Carcinoma.

PURPOSE: Sapanisertib is a kinase inhibitor that inhibits both mammalian target of rapamycin complex 1 (mTORC1) and mTORC2. In this multicenter, single-arm phase II trial, we evaluated the efficacy of sapanisertib in patients with treatment-refractory metastatic renal cell carcinoma (mRCC; NCT03097328). METHODS: Patients with mRCC of any histology progressing through standard therapy (including prior mTOR inhibitors) had baseline biopsy and received sapanisertib 30 mg by mouth once weekly until unacceptable toxicity or disease progression. The primary end point was objective response rate by RECIST 1.1. Tissue biomarkers of mTOR pathway activation were explored. RESULTS: We enrolled 38 patients with mRCC (clear cell = 28; variant histology = 10) between August 2017 and November 2019. Twenty-four (63%) had received ≥ 3 prior lines of therapy; 17 (45%) had received prior rapalog therapy. The median follow-up was 10.4 (range 1-27.4) months. Objective response rate was two of 38 (5.3%; 90% CI, 1 to 15.6); the median progression-free survival (PFS) was 2.5 months (95% CI, 1.8 to 3.7). Twelve patients (32%) developed treatment-related grade 3 adverse events, with no grade 4 or 5 toxicities. Alterations in the mTOR pathway genes were seen in 5 of 29 evaluable patients (MTOR n = 1, PTEN n = 3, and TSC1 n = 1) with no association with response or PFS. Diminished or loss of PTEN expression by immunohistochemistry was seen in 8 of 21 patients and trended toward shorter PFS compared with intact PTEN (median 1.9 v 3.7 months; hazard ratio 2.5; 95% CI, 0.9 to 6.7; P = .055). CONCLUSION: Sapanisertib had minimal activity in treatment-refractory mRCC independent of mTOR pathway alterations. Additional therapeutic strategies are needed for patients with refractory mRCC.

Biomarkers of Angiogenesis and Clinical Outcomes to Cabozantinib and Everolimus in Patients with Metastatic Renal Cell Carcinoma from the Phase III METEOR Trial.

PURPOSE: Antiangiogenic VEGF receptor (VEGFR) inhibitors are approved for metastatic clear cell renal cell carcinoma (mccRCC) and their efficacy is higher in high angiogenic tumors. As cabozantinib inhibits multiple tyrosine kinase receptors, including VEGFRs, we tested whether markers of angiogenesis, including microvascular density (MVD) and mast cell density (MCD), could predict benefit from cabozantinib versus everolimus, using RCC samples from the METEOR (NCT01865747) trial. EXPERIMENTAL DESIGN: MVD and MCD were studied in 430 patients (cabozantinib = 216, everolimus = 214) by double immunohistochemistry for CD31 (vascular marker) and tryptase (mast cell marker) coupled with automated image analysis. Results from evaluable cases (MVD = 360, MCD = 325) were correlated with progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). RESULTS: MVD was positively correlated with MCD. In the whole cohort, high MVD and high MCD were associated with longer PFS; improved PFS was most evident in patients with high levels of both MCD and MVD. Cabozantinib was associated with improved PFS, OS, and ORR compared with everolimus, irrespective of MVD levels. Cabozantinib was also associated with improved ORR compared with everolimus, irrespective of MCD levels. For PFS and OS, the treatment effect for cabozantinib versus everolimus tended to be greater in tumors with low MCD. CONCLUSIONS: High MVD and high MCD are associated with improved outcome in mccRCC but do not predict efficacy to cabozantinib versus everolimus. The high efficacy of cabozantinib in low angiogenic tumors allows us to speculate that its antitumor activity is not exclusively mediated by VEGFR inhibition.

Clinical Activity and Safety of Cabozantinib for Brain Metastases in Patients With Renal Cell Carcinoma.

IMPORTANCE: Patients with brain metastases from renal cell carcinoma (RCC) have been underrepresented in clinical trials, and effective systemic therapy is lacking. Cabozantinib shows robust clinical activity in metastatic RCC, but its effect on brain metastases remains unclear. OBJECTIVE: To assess the clinical activity and toxic effects of cabozantinib to treat brain metastases in patients with metastatic RCC. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included patients with metastatic RCC and brain metastases treated in 15 international institutions (US, Belgium, France, and Spain) between January 2014 and October 2020. Cohort A comprised patients with progressing brain metastases without concomitant brain-directed local therapy, and cohort B comprised patients with stable or progressing brain metastases concomitantly treated by brain-directed local therapy. EXPOSURES: Receipt of cabozantinib monotherapy at any line of treatment. MAIN OUTCOMES AND MEASURES: Intracranial radiological response rate by modified Response Evaluation Criteria in Solid Tumors, version 1.1, and toxic effects of cabozantinib. RESULTS: Of the 88 patients with brain metastases from RCC included in the study, 33 (38%) were in cohort A and 55 (62%) were in cohort B; the majority of patients were men (n = 69; 78%), and the median age at cabozantinib initiation was 61 years (range, 34-81 years). Median follow-up was 17 months (range, 2-74 months). The intracranial response rate was 55% (95% CI, 36%-73%) and 47% (95% CI, 33%-61%) in cohorts A and B, respectively. In cohort A, the extracranial response rate was 48% (95% CI, 31%-66%), median time to treatment failure was 8.9 months (95% CI, 5.9-12.3 months), and median overall survival was 15 months (95% CI, 9.0-30.0 months). In cohort B, the extracranial response rate was 38% (95% CI, 25%-52%), time to treatment failure was 9.7 months (95% CI, 6.0-13.2 months), and median overall survival was 16 months (95% CI, 12.0-21.9 months). Cabozantinib was well tolerated, with no unexpected toxic effects or neurological adverse events reported. No treatment-related deaths were observed. CONCLUSIONS AND RELEVANCE: In this cohort study, cabozantinib showed considerable intracranial activity and an acceptable safety profile in patients with RCC and brain metastases. Support of prospective studies evaluating the efficacy of cabozantinib for brain metastases in patients with RCC is critical.

Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial.

INTRODUCTION: The emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients' own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions. METHODS AND ANALYSIS: International, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm). ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator's site by the Ethics Committee 'Ethikkommission Nordwest- und Zentralschweiz' (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles. TRIAL REGISTRATION NUMBER: NCT04293146.

Results of a multicenter, phase 2 study of nivolumab and ipilimumab for patients with advanced rare genitourinary malignancies.

BACKGROUND: In this multicenter, single-arm, multicohort, phase 2 trial, the efficacy of nivolumab and ipilimumab was evaluated in patients with advanced rare genitourinary cancers, including bladder and upper tract carcinoma of variant histology (BUTCVH), adrenal tumors, platinum-refractory germ cell tumors, penile carcinoma, and prostate cancer of variant histology (NCT03333616). METHODS: Patients with rare genitourinary malignancies and no prior immune checkpoint inhibitor exposure were enrolled. Patients received nivolumab at 3 mg/kg and ipilimumab at 1 mg/kg intravenously every 3 weeks for 4 doses, and this was followed by 480 mg of nivolumab intravenously every 4 weeks. The primary endpoint was the objective response rate (ORR) by the Response Evaluation Criteria in Solid Tumors (version 1.1). RESULTS: Fifty-five patients were enrolled at 6 institutions between April 2018 and July 2019 in 3 cohorts: BUTCVH (n = 19), adrenal tumors (n = 18), and other tumors (n = 18). The median follow-up was 9.9 months (range, 1 to 21 months). Twenty-eight patients (51%) received 4 doses of nivolumab and ipilimumab; 25 patients received nivolumab maintenance for a median of 4 cycles (range, 1-18 cycles). The ORR for the entire study was 16% (80% confidence interval, 10%-25%); the ORR in the BUTCVH cohort, including 2 complete responses, was 37%, and it was 6% in the other 2 cohorts. Twenty-two patients (40%) developed treatment-related grade 3 or higher toxicities; 24% (n = 13) required high-dose steroids (≥40 mg of prednisone or the equivalent). Grade 5 events occurred in 3 patients; 1 death was treatment related. CONCLUSIONS: Nivolumab and ipilimumab resulted in objective responses in a subset of patients with rare genitourinary malignancies, especially those with BUTCVH. An additional cohort exploring their activity in genitourinary tumors with neuroendocrine differentiation is ongoing. LAY SUMMARY: Patients with rare cancers are often excluded from studies and have limited treatment options. Fifty-five patients with rare tumors of the genitourinary system were enrolled from multiple sites and were treated with nivolumab and ipilimumab, a regimen used for kidney cancer. The regimen showed activity in some patients, particularly those with bladder or upper tract cancers of unusual or variant histology; 37% of those patients responded to therapy. Additional studies are ongoing to better determine who benefits the most from this combination.

Drug- and Alcohol-Associated Deaths in U.S. Jails.

Drugs and alcohol are the third leading cause of death in U.S. jails. We analyzed 2000 to 2013 national jail mortality data by coding text data. We identified 1,442 deaths associated with drugs and alcohol. Drug-associated deaths were more than double alcohol-associated deaths during 2009 to 2013 when drug type was available for drug-associated mortality. Only 18% of deaths within 7 days of arrest for alcohol intoxication were officially coded as involving drugs/alcohol intoxication. Among the 103 deaths associated with substance withdrawal, 66 involved alcohol, 21 involved drugs (primarily opioids), and 16 could not be determined. Drugs and alcohol likely contribute to more deaths in jails than has been recognized due to how deaths are coded. Alcohol and opioid withdrawal represent a small but underappreciated contributor to jail deaths.

"Get Ready and Empowered About Treatment" (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV.

BACKGROUND: Little is known about strategies to improve patient activation, particularly among persons living with HIV (PLWH). OBJECTIVE: To assess the impact of a group intervention and individual coaching on patient activation for PLWH. DESIGN: Pragmatic randomized controlled trial. SITES: Eight practices in New York and two in New Jersey serving PLWH. PARTICIPANTS: Three hundred sixty PLWH who received care at participating practices and had at least limited English proficiency and basic literacy. INTERVENTION: Six 90-min group training sessions covering use of an ePersonal Health Record loaded onto a handheld mobile device and a single 20-30 min individual pre-visit coaching session. MAIN MEASURES: The primary outcome was change in Patient Activation Measure (PAM). Secondary outcomes were changes in eHealth literacy (eHEALS), Decision Self-efficacy (DSES), Perceived Involvement in Care Scale (PICS), health (SF-12), receipt of HIV-related care, and change in HIV viral load (VL). KEY RESULTS: The intervention group showed significantly greater improvement than the control group in the primary outcome, the PAM (difference 2.82: 95% confidence interval [CI] 0.32-5.32). Effects were largest among participants with lowest quartile PAM at baseline (p < 0.05). The intervention doubled the odds of improving one level on the PAM (odds ratio 1.96; 95% CI 1.16-3.31). The intervention group also had significantly greater improvement in eHEALS (difference 2.67: 95% CI 1.38-3.9) and PICS (1.27: 95% CI 0.41-2.13) than the control group. Intervention effects were similar by race/ethnicity and low education with the exception of eHealth literacy where effects were stronger for minority participants. No statistically significant effects were observed for decision self-efficacy, health status, adherence, receipt of HIV relevant care, or HIV viral load. CONCLUSIONS: The patient activation intervention modestly improved several domains related to patient empowerment; effects on patient activation were largest among those with the lowest levels of baseline patient activation. TRIAL REGISTRATION: This study is registered at Clinical Trials.Gov (NCT02165735).

Addressing Medication Costs During Primary Care Visits: A Before-After Study of Team-Based Training.

Background: Medications contribute to patients' out-of-pocket costs, yet most clinicians do not routinely screen for patients' cost-of-medication (COM) concerns. Objective: To assess whether a single training session improves COM conversations. Design: Before-after cross-sectional surveys of patients and qualitative interviews with clinicians and staff. Setting: 7 primary care practices in 3 U.S. states. Participants: In total, 700 patients were surveyed from May 2017 to January 2018: 50 patients per practice before the intervention and another 50 patients per practice after the intervention. Eligibility criteria included age 18 years or older and taking 1 or more long-term medications. Qualitative interviews with 45 staff members were conducted. Intervention: A single 60-minute training session for clinicians and staff from each practice on COM importance, team-based screening, and cost-saving strategies. Measurements: Patient data (demographics, number of long-term medications, total monthly out-of-pocket medication costs, and history of cost-related medication nonadherence) were obtained immediately before and 3 months after the intervention. Practice staff were interviewed 3 months after the intervention. Results: A total of 700 patient surveys were completed. Frequency of COM discussion improved in 6 of the 7 practices and remained unchanged in 1 practice. Overall, COM conversations with patients increased from 17% at baseline to 32% postintervention (P = 0.00). There was substantial heterogeneity among sites in before-after differences in patient-reported out-of-pocket COM. Qualitative analyses from key informant interviews showed wide variation in implementation of screening approaches, workflow, adoption of a team-based approach, and strategies for addressing COM. Limitation: It is not known whether improvements in COM conversations were sustained beyond 3 months. Conclusion: A single team training to screen and address patients' medication cost concerns improved COM discussions over the short term. Further research is needed to assess sustained effects and impact on patient costs and medication adherence and to determine whether more intensive, scalable interventions are needed. Primary Funding Source: Robert Wood Johnson Foundation.

Theoretical and Pragmatic Adaptation of the 5As Model to Patient-Centered Hypertension Counselling.

Patient-centered communication is a means for engaging patients in partnership. However, patient centered communication has not always been grounded in theory or in clinicians' pragmatic needs. The objective of this report is to present a practical approach to hypertension counselling that uses the 5As framework and is grounded in theory and best communication practices.

Promoting MedlinePlus utilization in a federally qualified health center using a multimodal approach.

BACKGROUND: Most patients want more health information than their clinicians provide during office visits. Written information can complement information that is provided verbally, yet most primary care practices, including federally qualified health centers, have not implemented systematic programs to ensure that patients receive understandable, relevant, and accurate health information at the point of care. MedlinePlus in particular is underutilized. CASE PRESENTATION: The authors conducted a multimodal intervention to promote the use of MedlinePlus at a federally qualified health center. We provided MedlinePlus training to clinicians and patients through group and one-on-one trainings and multimedia promotion. We administered pre- and post-intervention surveys to patients, clinicians, and nurses to assess changes in the use and recognition of MedlinePlus at the point of care. We used quantitative and qualitative data to understand the impact of the intervention. A National Library of Medicine grant provided resources that supported equipment and staff. Group training improved use of MedlinePlus by clinicians and staff. One-on-one training was most effective for patients, particularly when it was integrated into the work-flow. CONCLUSIONS: A multimodal approach can promote use of MedlinePlus among community health center patients. However, the process is labor- and resource-intensive and requires careful attention to work flow and leveraging of brief opportunities.

Improving patient-centered communication while using an electronic health record: Report from a curriculum evaluation.

INTRODUCTION: Researchers and clinicians are concerned about the impact of electronic health record use and patient-centered communication. Training about patient-centered clinical communication skills with the electronic health record may help clinicians adapt and remain patient-centered. METHODS: We developed an interactive workshop eliciting challenges and opportunities of working with the electronic health record in clinical practice, introduction of specific patient-centered behaviors and mindful practice techniques, and video demonstrating contrasts in common behavior and "better practices." One hundred thirty-nine resident physicians and faculty supervisors in five residency training programs at the University of Rochester Medical Center participated in the workshops. Participants were asked to complete an 11-item survey of behaviors related to their use of the electronic health record prior to training and after attending training. We used paired t-tests to assess changes in self-reported behavior from pre-intervention to post-intervention. RESULTS: We trained 139 clinicians in the workshops; 110 participants completed the baseline assessment and 39 completed both the baseline and post-intervention assessment. Data from post-curriculum respondents found a statistically significant increase in "I told the patient when turning my attention from the patient to the computer," from 60% of the time prior to the training to 70% of the time after. DISCUSSION: Data from our program evaluation demonstrated improvement in one communication behavior. Sample size limited the detection of other changes; further research should investigate effective training techniques for patient-centered communication while using the electronic health record.