Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in the Elderly with Alzheimer's Disease (D-PRESCRIBE-AD): Trial protocol and rationale of an open-label pragmatic, prospective randomized controlled trial.

CONTEXT: Potentially inappropriate prescribing of medications in older adults, particular those with dementia, can lead to adverse drug events including falls and fractures, worsening cognitive impairment, emergency department visits, and hospitalizations. Educational mailings from health plans to patients and their providers to encourage deprescribing conversations may represent an effective, low-cost, "light touch", approach to reducing the burden of potentially inappropriate prescription use in older adults with dementia. OBJECTIVES: The objective of the Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease (D-PRESCRIBE-AD) trial is to evaluate the effect of a health plan based multi-faceted educational outreach intervention to community dwelling patients with dementia who are currently prescribed sedative/hypnotics, antipsychotics, or strong anticholinergics. METHODS: The D-PRESCRIBE-AD is an open-label pragmatic, prospective randomized controlled trial (RCT) comparing three arms: 1) educational mailing to both the health plan patient and their prescribing physician (patient plus physician arm, n = 4814); 2) educational mailing to prescribing physician only (physician only arm, n = 4814); and 3) usual care (n = 4814) among patients with dementia enrolled in two large United States based health plans. The primary outcome is the absence of any dispensing of the targeted potentially inappropriate prescription during the 6-month study observation period after a 3-month black out period following the mailing. Secondary outcomes include dose-reduction, polypharmacy, healthcare utilization, mortality and therapeutic switching within targeted drug classes. CONCLUSION: This large pragmatic RCT will contribute to the evidence base on promoting deprescribing of potentially inappropriate medications among older adults with dementia. If successful, such light touch, inexpensive and highly scalable interventions have the potential to reduce the burden of potentially inappropriate prescribing for patients with dementia. ClinicalTrials.gov Identifier: NCT05147428.

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.

Weight Loss in Newly Admitted Nursing Home Residents With Obesity.

BACKGROUND: The prevalence of obesity (body mass index ≥ 30) among nursing home residents has been increasing, but there has been little research on weight change in this population. We examined resident characteristics associated with substantial weight loss among nursing home residents with obesity. METHODS: Using data from the Minimum Data Set 3.0, this retrospective study included long-stay nursing home residents with obesity newly admitted to a facility in 2014 who had annual assessments in 2015. Substantial weight loss was defined as a loss of ≥10% body weight within a year. Multivariate regression analyses were conducted to identify factors associated with weight loss, including demographic characteristics, medical conditions, and functional limitations in activities of daily living (ADL). RESULTS: Among 59782 newly admitted nursing home residents with obesity, 23% experienced substantial weight loss during their first year in the nursing home. Moderate ADL dependency (odds ratio [OR] = 1.42, 95% confidence interval [CI]: 1.31-1.53), severe ADL dependency (OR = 1.83; 95% CI: 1.67-1.99), severe mobility impairment (OR = 1.15; 95% CI: 1.04-1.23), and severe cognitive impairment (OR = 1.13; 95% CI: 1.07-1.19), as well as cancer (OR = 1.10; 95% CI: 1.01-1.20), heart failure (OR = 1.06; 95% CI: 1.01-1.11), end-stage renal disease (OR = 1.17; 95% CI: 1.11-1.23), and bowel incontinence (OR = 1.19; 95% CI: 1.14-1.25) were associated with weight loss. CONCLUSION: Substantial weight loss is common among nursing home residents with obesity over a 1-year period following admission, and these residents have a greater burden of functional and cognitive impairment and specific medical conditions. These findings suggest the need to further elucidate the clinical implications of weight loss among this population.

Association of neighborhood-level social determinants of health with psychosocial distress in patients newly diagnosed with lung cancer.

BACKGROUND AND AIM: Patients with lung cancer experience high rates of psychosocial distress. They are also more likely to have unresolved, unmet social needs which may contribute to psychosocial distress. Despite this, neighborhood-level social determinants of health (SDOH) in relation to psychosocial distress have not been adequately investigated in patients with lung cancer. The goal of this study is to examine the association between neighborhood-level SDOH and psychosocial distress among a sample of newly diagnosed patients with lung cancer. METHODS: This cross-sectional study included newly diagnosed, adult lung cancer patients from an accredited cancer center. Psychosocial distress was measured with the Distress Thermometer. Neighborhood-level SDOH indicators for income and education were used to create a composite SDOH variable categorized into low, medium, and high deprivation levels. Covariates were age, gender, race/ethnicity, comorbidity index, cancer stage, and insurance status. Using multivariate logistic regression modeling, the association of psychosocial distress with the neighborhood-level SDOH was examined. RESULTS: The prevalence of psychosocial distress in the sample was 58.4%. Neighborhood-level SDOH indicators were not significantly associated with psychosocial distress. Higher odds of psychosocial distress were significantly associated with being female and having distant or regional cancer versus localized cancer. The age group 66-75 years was significantly associated with lower distress compared with those aged <65 years. CONCLUSIONS: Psychosocial distress was consistently high across all the SDOH deprivation categories; but these neighborhood-level SDOH indicators do not appear to be predictive of psychosocial distress at the time of diagnosis of lung cancer.

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.

Video-Based Communication Assessment of Physician Error Disclosure Skills by Crowdsourced Laypeople and Patient Advocates Who Experienced Medical Harm: Reliability Assessment With Generalizability Theory.

BACKGROUND: Residents may benefit from simulated practice with personalized feedback to prepare for high-stakes disclosure conversations with patients after harmful errors and to meet American Council on Graduate Medical Education mandates. Ideally, feedback would come from patients who have experienced communication after medical harm, but medical researchers and leaders have found it difficult to reach this community, which has made this approach impractical at scale. The Video-Based Communication Assessment app is designed to engage crowdsourced laypeople to rate physician communication skills but has not been evaluated for use with medical harm scenarios. OBJECTIVE: We aimed to compare the reliability of 2 assessment groups (crowdsourced laypeople and patient advocates) in rating physician error disclosure communication skills using the Video-Based Communication Assessment app. METHODS: Internal medicine residents used the Video-Based Communication Assessment app; the case, which consisted of 3 sequential vignettes, depicted a delayed diagnosis of breast cancer. Panels of patient advocates who have experienced harmful medical error, either personally or through a family member, and crowdsourced laypeople used a 5-point scale to rate the residents' error disclosure communication skills (6 items) based on audiorecorded responses. Ratings were aggregated across items and vignettes to create a numerical communication score for each physician. We used analysis of variance, to compare stringency, and Pearson correlation between patient advocates and laypeople, to identify whether rank order would be preserved between groups. We used generalizability theory to examine the difference in assessment reliability between patient advocates and laypeople. RESULTS: Internal medicine residents (n=20) used the Video-Based Communication Assessment app. All patient advocates (n=8) and 42 of 59 crowdsourced laypeople who had been recruited provided complete, high-quality ratings. Patient advocates rated communication more stringently than crowdsourced laypeople (patient advocates: mean 3.19, SD 0.55; laypeople: mean 3.55, SD 0.40; P<.001), but patient advocates' and crowdsourced laypeople's ratings of physicians were highly correlated (r=0.82, P<.001). Reliability for 8 raters and 6 vignettes was acceptable (patient advocates: G coefficient 0.82; crowdsourced laypeople: G coefficient 0.65). Decision studies estimated that 12 crowdsourced layperson raters and 9 vignettes would yield an acceptable G coefficient of 0.75. CONCLUSIONS: Crowdsourced laypeople may represent a sustainable source of reliable assessments of physician error disclosure skills. For a simulated case involving delayed diagnosis of breast cancer, laypeople correctly identified high and low performers. However, at least 12 raters and 9 vignettes are required to ensure adequate reliability and future studies are warranted. Crowdsourced laypeople rate less stringently than raters who have experienced harm. Future research should examine the value of the Video-Based Communication Assessment app for formative assessment, summative assessment, and just-in-time coaching of error disclosure communication skills.

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.

Antidopaminergic-Antiparkinsonian Medication Prescribing Cascade in Persons with Alzheimer's Disease.

OBJECTIVES: Persons living with Alzheimer's disease (AD) may be at increased risk for prescribing cascades due to greater multimorbidity, polypharmacy, and the need for more complex care. Our objective was to assess the proportion of the antidopaminergic-antiparkinsonian medication prescribing cascades among persons living with Alzheimer's disease. SETTING: Two large administrative claims databases in the United States. PARTICIPANTS: We identified patients aged ≥50 on January 1, 2017, who were dispensed a drug used to treat Alzheimer's disease for at least 1 day in the 365 days prior to or on cohort entry date and who had medical and pharmacy coverage in the 365 days prior to the cohort entry date. We excluded individuals with a recent institutional stay. We identified incident antidopaminergic (antipsychotic/metoclopramide) use in the 183 days following cohort entry and identified subsequent incident antiparkinsonian drug use within 8 to 365 days. RESULTS: There were 121,538 patients with Alzheimer's disease eligible for inclusion. Approximately 62% were women with a mean age of 79.5 (SD ± 8.6). The mean number of drugs dispensed was 9.2 (SD ± 4.9). There were 36 incident antiparkinsonian users among 4,534 incident antipsychotic/metoclopramide users (0.8%). CONCLUSION: We determined that the proportion of antidopaminergic-antiparkinsonian medication prescribing cascades, widely considered as high-priority, was low. Our approach can be used to assess the proportion of prescribing cascades in populations considered to be at high risk and to prioritize system-level interventional efforts to improve medication safety in these patients.

Encouraging Patients to Speak up About Problems in Cancer Care.

OBJECTIVES: Many patients with cancer believe that something has gone wrong in their care but are reluctant to speak up. This pilot study sought to evaluate the impact of an intervention of active outreach to patients undergoing cancer treatment, wherein patients were encouraged to speak up if they had concerns about their care and to describe the types of concerns patients reported. METHODS: Patients receiving cancer care at two sites were randomly assigned to an intervention or control group. Intervention patients received a brochure encouraging them to speak up about any concerns and an outreach telephone call during which the interviewer explicitly asked about concerns. Participants in both groups received baseline and follow-up questionnaires assessing their perceptions of their care and whether anything had "gone wrong" and provided ratings of health care providers' communication and responsiveness. Qualitative content coding was used to categorize patient-reported concerns collected through the baseline and follow-up questionnaires (both groups) and during telephone outreach (intervention patients only). The primary outcome was the number of patients reporting a concern about their care. Communication and responsiveness ratings for intervention and control group patients were compared using t tests. RESULTS: Of the 60 patients in the intervention group, 34 (56.7%) reported at least one problem or concern, compared with 16 (29.1%) of the 55 patients in the control group (P = 0.003). The telephone outreach in particular resulted in more than half of those reached reporting a new concern (55.3%). We detected no impact of the intervention on patients' ratings of communication or support for speaking up. CONCLUSIONS: Patients in this study reported a variety of concerns in response to active outreach, demonstrating that active outreach to patients can provide healthcare teams and systems the opportunity to offer a real-time response to the patient, identify where system improvements are needed, and implement policies, procedures, or programs to prevent recurrences.

Prescribing cascades in persons with Alzheimer's disease: engaging patients, caregivers, and providers in a qualitative evaluation of print educational materials.

INTRODUCTION: Prescribing cascades occur when the side effect of a drug is misinterpreted as a new medical condition, and a second drug is prescribed to address the side effect. Persons with Alzheimer's disease (AD) are at increased risk of prescribing cascades due to greater multimorbidity, polypharmacy, and complexity of care. The objective of this study was to evaluate educational materials about prescribing cascades in persons with AD, and elicit input on their use in a future trial. METHODS: We interviewed community-dwelling adults with either an AD diagnosis or a prescription drug used to treat AD (n = 12), caregivers of patients meeting the same criteria (n = 14), and providers (n = 15). We coded interview transcripts and organized themes according to the communication-human information processing model. We revised the materials based on the interviews, and surveyed participating caregivers and providers for their reactions to the revised materials. RESULTS: Analysis of patients', caregivers', and providers' comments suggest: (a) Providers had conflicting views about the messaging of materials; (b) Caregivers were likely to read letters addressed to patients; (c) Providers were likely to ignore letters, but were receptive to patient/caregiver-initiated conversations; (d) Patients and caregivers had difficulty understanding prescribing cascades; (e) Providers worried that mailed materials would undermine trust; (f) Participants had mixed views on how materials might affect the clinical encounter; (g) Participants felt that materials would improve patient/caregiver engagement. When surveyed, most providers found the revised materials informative and actionable, and most caregivers found them understandable and useful. CONCLUSIONS: This evaluation of educational materials about prescribing cascades in patients with AD provides strong support for engaging caregivers to communicate with providers about prescribing cascades. By giving patients and caregivers a basic description of the prescribing cascade concept, our educational materials may help them prepare for a conversation with the provider, who can then tailor the discussion of the possible cascade to the specific needs of the individual patient and caregiver. However, evidence on whether materials can stimulate such conversations awaits testing in a future trial. LAY SUMMARY: Patient, caregiver and provider thoughts on educational materials about prescribing and medication safety Prescribing cascades occur when the side effect of a medication is misinterpreted as a new medical condition, and a second medication is prescribed to treat the side effect. Persons with Alzheimer's disease (AD) are at increased risk of prescribing cascades because they often have more medical conditions, more medications, and more complex care. The goal of this study was to evaluate mailed educational materials about prescribing cascades in persons with AD, and get input on their use in a future study. We interviewed 12 adults with AD, or prescribed a medication to treat AD, 14 caregivers of persons with AD, and 15 providers. We reviewed the interview transcripts to identify important findings about our educational materials. We edited the materials based on the interviews, and sent participating caregivers and providers a questionnaire to get their reactions to the new materials. Important findings from the interviews suggest: (a) Providers had conflicting views about the recommendations given; (b) Caregivers were likely to read letters addressed to patients; (c) Providers were likely to ignore letters, but were receptive to patients/caregivers introducing the topic; (d) Patients and caregivers had difficulty understanding prescribing cascades; (e) Providers worried mailed materials would undermine trust; (f) Participants had mixed views on how materials might affect a doctor's appointment; (g) Participants felt strongly that materials would improve patient/caregiver engagement. When surveyed, almost all providers found the revised materials informative and actionable; and most caregivers found them understandable and useful. These findings provide strong support for engaging caregivers to communicate with providers about prescribing cascades. The educational materials may help patients and caregivers prepare for a conversation with the provider, who can then tailor the discussion of the possible cascade to the specific needs of the individual patient and caregiver. However, evidence on whether materials can stimulate such conversations awaits testing in a future study.

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.

Enhancing Success of Medicare's Shared Decision Making Mandates Using Implementation Science: Examples Applying the Pragmatic Robust Implementation and Sustainability Model (PRISM).

The Centers for Medicare and Medicaid Services (CMS) has mandated shared decision making (SDM) using patient decision aids for three conditions (lung cancer screening, atrial fibrillation, and implantable defibrillators). These forward-thinking approaches are in response to a wealth of efficacy data demonstrating that decision aids can improve patient decision making. However, there has been little focus on how to implement these approaches in real-world practice. This article demonstrates how using an implementation science framework may help programs understand multilevel challenges and opportunities to improve adherence to the CMS mandates. Using the PRISM (Pragmatic Robust Implementation and Sustainability Model) framework, we discuss general challenges to implementation of SDM, issues specific to each mandate, and how to plan for, enhance, and assess SDM implementation outcomes. Notably, a theme of this discussion is that successful implementation is context-specific and to truly have successful and sustainable changes in practice, context variability, and adaptation to context must be considered and addressed.

Tools to Promote Shared Decision-Making in Lung Cancer Screening Using Low-Dose CT Scanning: A Systematic Review.

BACKGROUND: Decisions about lung cancer screening are inherently complex and create a need for methods to convey the risks and benefits of screening to patients. RESEARCH QUESTION: What kind of decision aids or tools are available to support shared decision-making for lung cancer screening? What is the current evidence for the effectiveness, acceptability, and feasibility of those tools? STUDY DESIGN AND METHODS: We conducted a systematic review of studies and searched PubMed, MEDLINE, EMBASE, Cochrane Clinical Trials Register, and ClinicalTrials.gov from inception to December 2019 for studies that evaluated the effectiveness and acceptability of tools to promote shared decision-making for patients who are considering lung cancer screening. RESULTS: After screening 2,427 records, we included one randomized control trial, two observational studies, 11 before/after studies of a decision aid or an educational tool. Fifteen distinct tools in various formats were evaluated in 14 studies. Most studies were of fair quality. Studies reported improvement in patients' knowledge of lung cancer screening (n = 9 studies), but improvements in specific areas of knowledge were inconsistent. Decisional conflict was low or reduced after the administration of the tools (n = 7 studies). The acceptability of tools was rated as "high" by patients (n = 7 studies) and physicians (n = 1 study). Low dose CT scan completion rates varied among studies (n = 6 studies). INTERPRETATION: Evidence from 14 studies suggests that some elements of existing tools for lung cancer screening may help to prepare patients for decision-making by improving knowledge and reducing decisional conflict. Such tools generally are acceptable to patients and providers. Further studies that use consistent measures and reporting methods and assess relevant decisional and clinical outcomes are needed to determine the comparative effectiveness and feasibility of implementation of these tools. CLINICAL TRIAL REGISTRATION: PROSPERO 2018 CRD4201874814.

Comparison of a Collective Intelligence Tailored Messaging System on Smoking Cessation Between African American and White People Who Smoke: Quasi-Experimental Design.

BACKGROUND: The Patient Experience Recommender System for Persuasive Communication Tailoring (PERSPeCT) is a machine learning recommender system with a database of messages to motivate smoking cessation. PERSPeCT uses the collective intelligence of users (ie, preferences and feedback) and demographic and smoking profiles to select motivating messages. PERSPeCT may be more beneficial for tailoring content to minority groups influenced by complex, personally relevant factors. OBJECTIVE: The objective of this study was to describe and evaluate the use of PERSPeCT in African American people who smoke compared with white people who smoke. METHODS: Using a quasi-experimental design, we compared African American people who smoke with a historical cohort of white people who smoke, who both received up to 30 emailed tailored messages over 65 days. People who smoke rated the daily message in terms of perceived influence on quitting smoking for 30 days. Our primary analysis compared daily message ratings between the two groups using a t test. We used a logistic model to compare 30-day cessation between the two groups and adjusted for covariates. RESULTS: The study included 119 people who smoke (African Americans, 55/119; whites, 64/119). At baseline, African American people who smoke were significantly more likely to report allowing smoking in the home (P=.002); all other characteristics were not significantly different between groups. Daily mean ratings were higher for African American than white people who smoke on 26 of the 30 days (P<.001). Odds of quitting as measured by 30-day cessation were significantly higher for African Americans (odds ratio 2.3, 95% CI 1.04-5.53; P=.03) and did not change after adjusting for allowing smoking at home. CONCLUSIONS: Our study highlighted the potential of using a recommender system to personalize for African American people who smoke. TRIAL REGISTRATION: ClinicalTrials.gov NCT02200432; https://clinicaltrials.gov/ct2/show/NCT02200432. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/jmir.6465.

Shared Decision Making in Patients With Suspected Uncomplicated Ureterolithiasis: A Decision Aid Development Study.

OBJECTIVE: The objective was to develop a decision aid (DA) to facilitate shared decision making (SDM) around whether to obtain computed tomography (CT) imaging in patients presenting to the emergency department (ED) with suspected uncomplicated ureterolithiasis. METHODS: We used evidence-based DA development methods, including qualitative methods and iterative stakeholder engagement, to develop and refine a DA. Guided by the Ottawa Decision Support Framework, International Patient Decision Aid Standards (IPDAS), and a steering committee made up of stakeholders, we conducted interviews and focus groups with a purposive sample of patients, community members, emergency clinicians, and other stakeholders. We used an iterative process to code the transcripts and identify themes. We beta-tested the DA with patient-clinician dyads facing the decision in real time. RESULTS: From August 2018 to August 2019, we engaged 102 participants in the design and iterative refinement of a DA focused on diagnostic options for patients with suspected ureterolithiasis. Forty-six were ED patients, community members, or patients with ureterolithiasis, and the remaining were emergency clinicians (doctors, residents, advanced practitioners), researchers, urologists, nurses, or other physicians. Patients and clinicians identified several key decisional needs including an understanding of accuracy, uncertainty, radiation exposure/cancer risk, and clear return precautions. Patients and community members identified facilitators to SDM, such as a checklist of signs and symptoms. Many stakeholders, including both patients and ED clinicians, expressed a strong pro-CT bias. A six-page DA was developed, iteratively refined, and beta-tested. CONCLUSIONS: Using stakeholder engagement and qualitative inquiry, we developed an evidence-based DA to facilitate SDM around the question of CT scan utilization in patients with suspected uncomplicated ureterolithiasis. Future research will test the efficacy of the DA in facilitating SDM.

Nurses' Perspectives on Family Caregiver Medication Management Support and Deprescribing.

Nurses who care for patients with life-limiting illness operate at the interface of family caregivers (FCGs), patients, and prescribers and are uniquely positioned to guide late-life medication management, including challenging discussions about deprescribing. The study objective was to describe nurses' perspectives about their role in hospice FCG medication management. Content analysis was used to analyze qualitative interviews with nurses from a parent study exploring views on medication management and deprescribing for advanced cancer patients. Ten home and inpatient hospice nurses, drawn from 3 hospice agencies and their referring hospital systems in New England, were asked to describe current practices of medication management and deprescribing and to evaluate a pilot tool to standardize hospice medication review. Analysis of the 10 interviews revealed that hospice nurses are receptive to a standardized approach for comprehensive medication review upon hospice transition and responded favorably to opportunities to discuss medication discontinuation with FCGs and prescribers. Effective framing for discussions included focus on reducing harmful and nonessential medications and reducing caregiver burden. Results indicate that nurses who care for hospice-eligible and enrolled patients are willing to discuss deprescribing with FCGs and prescribers when conversations are framed around medication harms and their impact on quality of life.

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 Implementation Process for Pharmacogenomic Testing for Cancer-Targeted Therapies.

Recent advances in genomic medicine have led to the availability of genomic tests that have the potential to improve population health, yet the process for obtaining these tests and getting them reimbursed by insurers has not been described. The objective of this study was to describe the process of ordering pharmacogenomic tests by interviewing providers, patients, and laboratories about cancer-related pharmacogenomic tests. We interviewed patients who were prescribed, providers who prescribed medications that should be guided by pharmacogenomic testing, and individuals from diagnostic laboratories. A total of 10 providers, 16 patients, and eight diagnostic laboratories described logistical and insurance issues relating to ordering and receiving pharmacogenomic tests and medications. We found that the process of ordering pharmacogenomic tests is time-consuming, expensive, and complex. Ordering pharmacogenomic tests is quite different across institutions. Even in the same institution, multiple providers can order the test. Once the provider places the order for the pharmacogenomic test, the laboratory receives the request and usually begins testing without knowing how the test will be paid for. Next, the laboratory completes the pharmacogenomic testing and the results of the tests are reported to providers, patients, or placed directly in the medical record. In conclusion, processes related to ordering and obtaining insurance coverage for pharmacogenomic tests varies greatly across institutions and is time-consuming.

Insurance Coverage Policies for Pharmacogenomic and Multi-Gene Testing for Cancer.

Insurance coverage policies are a major determinant of patient access to genomic tests. The objective of this study was to examine differences in coverage policies for guideline-recommended pharmacogenomic tests that inform cancer treatment. We analyzed coverage policies from eight Medicare contractors and 10 private payers for 23 biomarkers (e.g., HER2 and EGFR) and multi-gene tests. We extracted policy coverage and criteria, prior authorization requirements, and an evidence basis for coverage. We reviewed professional society guidelines and their recommendations for use of pharmacogenomic tests. Coverage for KRAS, EGFR, and BRAF tests were common across Medicare contractors and private payers, but few policies covered PML/RARA, CD25, or G6PD. Thirteen payers cover multi-gene tests for nonsmall lung cancer, citing emerging clinical recommendations. Coverage policies for single and multi-gene tests for cancer treatments are consistent among Medicare contractors despite the lack of national coverage determinations. In contrast, coverage for these tests varied across private payers. Patient access to tests is governed by prior authorization among eight private payers. Substantial variations in how payers address guideline-recommended pharmacogenomic tests and the common use of prior authorization underscore the need for additional studies of the effects of coverage variation on cancer care and patient outcomes.

ComprehENotes, an Instrument to Assess Patient Reading Comprehension of Electronic Health Record Notes: Development and Validation.

BACKGROUND: Patient portals are widely adopted in the United States and allow millions of patients access to their electronic health records (EHRs), including their EHR clinical notes. A patient's ability to understand the information in the EHR is dependent on their overall health literacy. Although many tests of health literacy exist, none specifically focuses on EHR note comprehension. OBJECTIVE: The aim of this paper was to develop an instrument to assess patients' EHR note comprehension. METHODS: We identified 6 common diseases or conditions (heart failure, diabetes, cancer, hypertension, chronic obstructive pulmonary disease, and liver failure) and selected 5 representative EHR notes for each disease or condition. One note that did not contain natural language text was removed. Questions were generated from these notes using Sentence Verification Technique and were analyzed using item response theory (IRT) to identify a set of questions that represent a good test of ability for EHR note comprehension. RESULTS: Using Sentence Verification Technique, 154 questions were generated from the 29 EHR notes initially obtained. Of these, 83 were manually selected for inclusion in the Amazon Mechanical Turk crowdsourcing tasks and 55 were ultimately retained following IRT analysis. A follow-up validation with a second Amazon Mechanical Turk task and IRT analysis confirmed that the 55 questions test a latent ability dimension for EHR note comprehension. A short test of 14 items was created along with the 55-item test. CONCLUSIONS: We developed ComprehENotes, an instrument for assessing EHR note comprehension from existing EHR notes, gathered responses using crowdsourcing, and used IRT to analyze those responses, thus resulting in a set of questions to measure EHR note comprehension. Crowdsourced responses from Amazon Mechanical Turk can be used to estimate item parameters and select a subset of items for inclusion in the test set using IRT. The final set of questions is the first test of EHR note comprehension.