Cost Conversations About Anticoagulation Between Patients With Atrial Fibrillation and Their Clinicians: A Secondary Analysis of a Randomized Clinical Trial.

Importance: How patients with atrial fibrillation (AF) and their clinicians consider cost in forming care plans remains unknown. Objective: To identify factors that inform conversations regarding costs of anticoagulants for treatment of AF between patients and clinicians and outcomes associated with these conversations. Design, Setting, and Participants: This cohort study of recorded encounters and participant surveys at 5 US medical centers (including academic, community, and safety-net centers) from the SDM4AFib randomized trial compared standard AF care with and without use of a shared decision-making (SDM) tool. Included patients were considering anticoagulation treatment and were recruited by their clinicians between January 30, 2017, and June 27, 2019. Data were analyzed between August and November 2019. Main Outcomes and Measures: The incidence of and factors associated with cost conversations, and the association of cost conversations with patients' consideration of treatment cost burden and their choice of anticoagulation. Results: A total of 830 encounters (out of 922 enrolled participants) were recorded. Patients' mean (SD) age was 71.0 (10.4) years; 511 patients (61.6%) were men, 704 (86.0%) were White, 303 (40.9%) earned between $40 000 and $99 999 in annual income, and 657 (79.2%) were receiving anticoagulants. Clinicians' mean (SD) age was 44.8 (13.2) years; 75 clinicians (53.2%) were men, and 111 (76%) practiced as physicians, with approximately half (69 [48.9%]) specializing in either internal medicine or cardiology. Cost conversations occurred in 639 encounters (77.0%) and were more likely in the SDM arm (378 [90%] vs 261 [64%]; OR, 9.69; 95% CI, 5.77-16.29). In multivariable analysis, cost conversations were more likely to occur with female clinicians (66 [47%]; OR, 2.85; 95% CI, 1.21-6.71); consultants vs in-training clinicians (113 [75%]; OR, 4.0; 95% CI, 1.4-11.1); clinicians practicing family medicine (24 [16%]; OR, 12.12; 95% CI, 2.75-53.38]), internal medicine (35 [23%]; OR, 3.82; 95% CI, 1.25-11.70), or other clinicians (21 [14%]; OR, 4.90; 95% CI, 1.32-18.16) when compared with cardiologists; and for patients with an annual household income between $40 000 and $99 999 (249 [82.2%]; OR, 1.86; 95% CI, 1.05-3.29) compared with income below $40 000 or above $99 999. More patients who had cost conversations reported cost as a factor in their decision (244 [89.1%] vs 327 [69.0%]; OR 3.66; 95% CI, 2.43-5.50), but cost conversations were not associated with the choice of anticoagulation agent. Conclusions and Relevance: Cost conversations were common, particularly for middle-income patients and with female and consultant-level primary care clinicians, as well as in encounters using an SDM tool; they were associated with patients' consideration of treatment cost burden but not final treatment choice. With increasing costs of care passed on to patients, these findings can inform efforts to promote cost conversations in practice. Trial Registration: ClinicalTrials.gov Identifier: NCT02905032.

Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial.

Importance: Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear. Objective: To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF. Design, Setting, and Participants: This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019. Interventions: Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter. Main Outcomes and Measures: Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process. Results: The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, -0.3 to 2.5 minutes). Conclusion and Relevance: The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration. These results help to calibrate expectations about the value of implementing SDM tools in the care of patients with AF. Trial Registration: ClinicalTrials.gov Identifier: NCT02905032.

Incidence and Management of Late Adverse Radiation Effects After Arteriovenous Malformation Radiosurgery.

BACKGROUND: Late adverse radiation effects (ARE) typically occur many years after stereotactic radiosurgery (SRS) of intracranial arteriovenous malformations (AVM). They are characterized by perilesional edema or cyst formation and are distinct from radiation-induced changes (RIC) noted in the first 1 to 2 years after AVM SRS and radiation necrosis. OBJECTIVE: To determine the incidence of late ARE after AVM SRS. METHODS: Retrospective review of 233 AVM patients having SRS from 1990 to 2009. Patients had sporadic AVM, no prior radiation, and a minimum of 5 years of magnetic resonance imaging (MRI) follow-up. The median MRI follow-up after SRS was 9.8 years (range, 5-24.2). RESULTS: Late ARE were observed in 16 patients (6.9%) at a median of 8.7 years after SRS (range, 2.0-16.1). The 5-, 10-, and 15-year incidence of late ARE was 0.4%, 7.7%, and 12.5%, respectively. Eight patients (3.4%) were symptomatic at the time of ARE detection. Three of 8 patients who were initially asymptomatic had documented cyst progression (at 11, 40, and 42 months), for an overall symptomatic rate of 4.7%. Five patients with asymptomatic ARE have been observed for a median of 9.3 years (range, 2.0-14.1) without progression. Patients having early RIC (hazard ratio [HR] = 2.11, P < .001), patients having obliteration (HR = 1.24, P = .02), and patients having SRS before April 1997 (HR = 1.12, P = .02) were more likely to develop late ARE. CONCLUSION: Late ARE are common in AVM patients who develop early RIC after SRS. Resection of the thrombosed AVM and the adjacent damaged tissue is effective at eliminating the mass effect and improving patients' neurological condition.

Comparative safety and costs of stepping down asthma medications in patients with controlled asthma.

BACKGROUND: Limited data exist regarding outcomes after stepping down asthma medication. OBJECTIVE: We sought to compare the safety and costs of stepping down asthma controller medications with maintaining current treatment levels in patients with controlled asthma. METHODS: Patients with persistent asthma were identified from the US Medical Expenditure Panel Survey years 2000-2010. Each patient had Medical Expenditure Panel Survey data for 2 years, and measurement was divided into 5 periods of 4 to 5 months each. Eligibility for stepping down asthma controller medications included no hospitalizations or emergency department visits for asthma in periods 1 to 3 and no systemic corticosteroid and 3 or less rescue inhalers dispensed in periods 2 and 3. Steps were defined by type and dose of chronic asthma medication based on current guidelines when comparing period 4 with period 3. The primary outcome of complete asthma control in period 5 was defined as no asthma hospitalizations, emergency department visits, and dispensed systemic corticosteroids and 2 or fewer dispensed rescue inhalers. Multivariable analyses were conducted to assess safety and costs after step down compared with those who maintained the treatment level. RESULTS: Overall, 29.9% of patients meeting the inclusion criteria (n = 4235) were eligible for step down; 89.4% (95% CI, 86.4% to 92.4%) of those who stepped down had preserved asthma control compared with 83.5% (95% CI, 79.9% to 87.0%) of those who were similarly eligible for step down but maintained their treatment level. The average monthly asthma-related cost savings was $34.02/mo (95% CI, $5.42/mo to $61.24/mo) with step down compared with maintenance of the treatment level. CONCLUSION: Stepping down asthma medications in those whose symptoms were controlled led to similar clinical outcomes at reduced cost compared with those who maintained their current treatment level.

Asthma expenditures in the United States comparing 2004 to 2006 and 1996 to 1998.

OBJECTIVES: To describe how the types of healthcare expenditures for patients with asthma have changed over the past decade. STUDY DESIGN: Cross-sectional comparison between individuals from 1996 to 1998 and 2004 to 2006. METHODS: Expenditures among US individuals (aged 5 to 56 years) with asthma were compared using the 1996 to 1998 and the 2004 to 2006 Medical Expenditure Panel Surveys. Direct expenditures (medications, inpatient, outpatient, and emergency services) and changes in productivity (missed school and work days) were compared over this time frame. The adjusted analyses controlled for age, education level, race/ethnicity, gender, poverty, region, metropolitan statistical area, self-reported health, and Charlson Comorbidity Index. RESULTS: Mean annual per capita healthcare expenditures increased between 1996 to 1998 and 2004 to 2006 ($3802 vs $5322 inflated to 2010 US dollars, P <.0001). Annual medication expenditures doubled from $974 to $2010 per person (P <.0001) and outpatient visit expenditures increased from $861 to $1174 (P <.0001) while hospitalization and emergency department (ED) visit expenditures were similar over the same time period. Missed school and work days decreased between the 2 periods (9.23 days in 1996-1998 vs 6.39 days in 2004-2006, P = .001). CONCLUSIONS: An increase in total direct expenditures in individuals with asthma was largely driven by an increase in spending on medications comparing 2004 to 2006 and 1996 to 1998 data. However, this increase was not offset by lower spending on hospitalization and ED visits.

The effects of incremental costs of smoking and obesity on health care costs among adults: a 7-year longitudinal study.

OBJECTIVE: To provide the simultaneous 7-year estimates of incremental costs of smoking and obesity among employees and dependents in a large health care system. METHODS: We used a retrospective cohort aged 18 years or older with continuous enrollment during the study period. Longitudinal multivariate cost analyses were performed using generalized estimating equations with demographic adjustments. RESULTS: The annual incremental mean costs of smoking by age group ranged from $1274 to $1401. The incremental costs of morbid obesity II by age group ranged from $5467 to $5530. These incremental costs drop substantially when comorbidities are included. CONCLUSIONS: Obesity and smoking have large long-term impacts on health care costs of working-age adults. Controlling comorbidities impacted incremental costs of obesity but may lead to underestimation of the true incremental costs because obesity is a risk factor for developing chronic conditions.

Direct medical costs of constipation from childhood to early adulthood: a population-based birth cohort study.

BACKGROUND: Although direct medical costs for constipation-related medical visits are thought to be high, to date there have been no studies examining whether longitudinal resource use is persistently elevated in children with constipation. Our aim was to estimate the incremental direct medical costs and types of health care use associated with constipation from childhood to early adulthood. METHODS: A nested case-control study was conducted to evaluate the incremental costs associated with constipation. The original sample consisted of 5718 children in a population-based birth cohort who were born during 1976 to 1982 in Rochester, MN. The cases included individuals who presented to medical facilities with constipation. The controls were matched and randomly selected among all noncases in the sample. Direct medical costs for cases and controls were collected from the time subjects were between 5 and 18 years of age or until the subject emigrated from the community. RESULTS: We identified 250 cases with a diagnosis of constipation in the birth cohort. Although the mean inpatient costs for cases were $9994 (95% Confidence interval [CI] 2538-37,201) compared with $2391 (95% CI 923-7452) for controls (P = 0.22) during the time period, the mean outpatient costs for cases were $13,927 (95% CI 11,325-16,525) compared with $3448 (95% CI 3771-4621) for controls (P < 0.001) during the same time period. The mean annual number of emergency department visits for cases was 0.66 (95% CI 0.62-0.70) compared with 0.34 (95% CI 0.32-0.35) for controls (P < 0.0001). CONCLUSIONS: Individuals with constipation have higher medical care use. Outpatient costs and emergency department use were significantly greater for individuals with constipation from childhood to early adulthood.

How well does patient self-report predict asthma medication possession? Implications for medication reconciliation and adherence assessment.

BACKGROUND: Self-report is the most commonly used method for collecting information regarding asthma medication possession and adherence in clinical practice. OBJECTIVE: To determine the agreement between self-report and pharmacy claims data for asthma medication possession. METHODS: This is a retrospective study that examined pharmacy claims data 12 months before and after participants completed a structured asthma survey. This study was performed in a sample of health care workers and dependents >17 years old in a large, self-insured Midwestern United States health care center. The main outcome measure was agreement (kappa calculation) between self-report and pharmacy claims data of asthma medication possession. RESULTS: Self-report of asthma medication use agreed moderately with pharmacy claims data for short-acting albuterol (κ=0.47 ± 0.03), salmeterol (κ=0.79 ± 0.04), and montelukast (κ=0.69 ± 0.03) but only slightly for inhaled corticosteroids (κ=0.18 ± 0.03) and prednisone (κ=0.10 ± 0.03) (n=1050 respondents). Both under self-reporting and over self-reporting were common with inhaled corticosteroids (14.4% and 23.1%, respectively) and varied significantly by specific drug type. CONCLUSIONS: Self-report moderately agrees with asthma medication possession for most adult asthma patients, though the agreement differs considerably between and within asthma medication classes.

The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department.

BACKGROUND: Chest pain is a common presenting complaint in the emergency department (ED). Despite the frequency with which clinicians evaluate patients with chest pain, accurately determining the risk of acute coronary syndrome (ACS) and sharing risk information with patients is challenging. The aims of this study are (1) to develop a decision aid (CHEST PAIN CHOICE) that communicates the short-term risk of ACS and (2) to evaluate the impact of the decision aid on patient participation in decision-making and resource use. METHODS/DESIGN: This is a protocol for a parallel, 2-arm randomized trial to compare an intervention group receiving CHEST PAIN CHOICE to a control group receiving usual ED care. Adults presenting to the Saint Mary's Hospital ED in Rochester, MN USA with a primary complaint of chest pain who are being considered for admission for prolonged ED observation in a specialized unit and urgent cardiac stress testing will be eligible for enrollment. We will measure the effect of CHEST PAIN CHOICE on six outcomes: (1) patient knowledge regarding their short-term risk for ACS and the risks of radiation exposure; (2) quality of the decision making process; (3) patient and clinician acceptability and satisfaction with the decision aid; (4) the proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing; (5) economic costs and healthcare utilization; and (6) the rate of delayed or missed ACS. To capture these outcomes, we will administer patient and clinician surveys after each visit, obtain video recordings of the clinical encounters, and conduct 30-day phone follow-up. DISCUSSION: This pilot randomized trial will develop and evaluate a decision aid for use in ED chest pain patients at low risk for ACS and provide a preliminary estimate of its effect on patient participation in decision-making and resource use. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01077037.