Prescription Claims for Immunomodulator and Antiinflammatory Drugs Among Persons With Ehlers-Danlos Syndromes.

OBJECTIVE: Joint hypermobility in Ehlers-Danlos Syndromes (EDS) predisposes persons with EDS to frequent subluxations and dislocations, chronic arthralgia, and soft-tissue rheumatism. Epidemiologic trends of rheumatologic conditions among persons with EDS are lacking. Prescription claims databases can reflect underlying disease burdens by using medication claims as disease proxies. We examined the prevalence of prescription claims for commonly prescribed immunomodulator and antiinflammatory (IMD) drugs among persons with EDS compared with their matched control person, and hypothesized peripubertal increases among female persons with EDS. METHODS: We compared the percentages of IMD drug prescription claims among 3,484 persons with EDS (ages 5-62 years) against their age-, sex-, state of residence-, and earliest claim date-matched control persons using 10 years (2005-2014) of private prescription claims data and a minimum 2-year enrollment inclusion criterion. RESULTS: Our cohort comprised 70% adults and 74% female persons. At least 1 IMD medication was prescribed to 65.4% of persons with EDS compared with 47.4% of control persons. We observed 1.3 to 4.2 times higher odds (P < 0.0001) for 5 out of 6 IMD drug classes among persons with EDS compared with matched control persons, except for biologic agents (conditional odds ratio 1.3, 95% confidence interval 0.8-2.0). Peripubertal increases were observed for nonsteroidal antiinflammatory drugs, oral, and injectable steroids. CONCLUSIONS: To our knowledge, our study is the first to examine the full range of IMD drug prescription claim trends among persons with EDS. We believe our research findings can have notable diagnostic and management implications for EDS patients who present with multiple comorbidities and generally require a more granular assessment of their medical conditions.

Gastrointestinal medication burden among persons with the Ehlers-Danlos syndromes.

BACKGROUND: The Ehlers-Danlos syndromes (EDSs) are a group of heritable disorders of connective tissue associated with an increased prevalence of both structural and functional GI conditions. METHODS: We used 10 years (2005-2014) of administrative claims data comprised of 4294 people with clinician-diagnosed EDS, aged 5-62 years, and compared their frequency of GI drug prescription claims to their age-, sex-, state of residence-, and earliest claim date-matched controls. We categorized the GI medications into the following groups: acid suppressants, anti-emetics, irritable bowel syndrome drugs, and visceral hypersensitivity (VHS) medications. KEY RESULTS: Compared to controls, a significantly higher proportion of persons with EDS had prescription claims for at least one GI drug group, as well as for drugs in each of the four GI drug groups included in our study. By age-group, 25.7% children and 45.1% adults with EDS had prescription claims for at least one GI drug group compared with only 7.4% and 21.0% of controls, respectively (p < 0.0001). By gender, 44.0% of women and 25.3% of men with EDS had prescription claims for at least one class of GI drugs compared with 19.2% and 9.6% of controls, respectively (p < 0.0001). CONCLUSIONS AND KEY INFERENCES: Predominant medication burden occurs among women with EDS, beginning peri-pubertally for anti-emetics and VHS drugs. High GI medication burden underscores previous evidence that GI dysmotility is common among persons with EDS.

An Analysis of Recruitment Efficiency for an End-of-Life Advance Care Planning Randomized Controlled Trial.

BACKGROUND:: Optimizing recruitment efficiency is an important strategy to address the resource limitations that typically constrain clinical research. Surprisingly, little empiric data exist to guide research teams attempting to recruit a difficult population into similar studies. Our objective was to investigate factors associated with enrollment into an advance care planning interventional trial. METHODS:: This study used secondary data of patients with advanced cancer receiving treatment at an academic medical center in central Pennsylvania who were referred to a randomized controlled trial of an advance care planning intervention. Enrolled participants were compared to nonparticipants with regard to age, gender, race, season of recruitment, elapsed time between recruitment stage, distance to study site, and number of recruitment calls. RESULTS:: Of the 1988 patients referred, 200 participants were enrolled yielding a recruitment efficiency of 10%. Two-thirds of all enrolled participants were recruited with 1 or less phone calls, whereas only 5% were enrolled after 3 calls. There were no statistically significant differences in enrollment based on gender ( P = .88) or elapsed time between recruitment contacts ( P = .22). However, nonparticipants were slightly older ( P = .02). CONCLUSIONS:: Our finding that individuals were more likely to enroll within the first 3 phone calls suggests that recruitment efforts should be focused on making initial contacts with potential participants, rather than continuing attempts to those who are unable to be contacted easily. Researchers could optimize their recruitment strategy by periodically performing similar analyses, comparing differences between participants and nonparticipants.

A Randomized Controlled Trial of Strategies to Improve Family Members' Preparedness for Surrogate Decision-Making.

OBJECTIVE: To evaluate 2 strategies for preparing family members for surrogate decision-making. DESIGN: A 2 × 2 factorial, randomized controlled trial testing whether: (1) comprehensive online advance care planning (ACP) is superior to basic ACP, and (2) having patients engage in ACP together with family members is superior to ACP done by patients alone. SETTING: Tertiary care centers in Hershey, Pennsylvania, and Boston, Massachusetts. PARTICIPANTS: Dyads of patients with advanced, severe illness (mean age 64; 46% female; 72% white) and family members who would be their surrogate decision-makers (mean age 56; 75% female; 75% white). INTERVENTIONS: Basic ACP: state-approved online advance directive plus brochure. Making Your Wishes Known (MYWK): Comprehensive ACP decision aid including education and values clarification. MEASUREMENTS: Pre-post changes in family member self-efficacy (100-point scale) and postintervention concordance between patients and family members using clinical vignettes. RESULTS: A total 285 dyads enrolled; 267 patients and 267 family members completed measures. Baseline self-efficacy in both MYWK and basic ACP groups was high (90.2 and 90.1, respectively), and increased postintervention to 92.1 for MYWK ( P = .13) and 93.3 for basic ACP ( P = .004), with no between-group difference. Baseline self-efficacy in alone and together groups was also high (90.2 and 90.1, respectively), and increased to 92.6 for alone ( P = .03) and 92.8 for together ( P = .03), with no between-group difference. Overall adjusted concordance was higher in MYWK compared to basic ACP (85.2% vs 79.7%; P = .032), with no between-group difference. CONCLUSION: The disconnect between confidence and performance raises questions about how to prepare family members to be surrogate decision-makers.

Costs of hepato-pancreato-biliary surgery and readmissions in privately insured US patients.

BACKGROUND: Surgical costs are influenced by perioperative care, readmissions, and further therapies. We aimed to characterize costs in hepato-pancreato-biliary surgery in the United States. METHODS: The MarketScan database (2008-2010) was used to identify privately insured patients undergoing pancreatectomy (n = 2254) or hepatectomy (n = 1702). Costs associated with the index surgery, readmissions, and total short-term costs were assessed from a third party payer perspective using generalized linear regression models. RESULTS: Mean total costs of pancreatectomy and hepatectomy were $107,600 (95% confidence interval [CI], 101,200-114,000) and $81,300 (95% CI, 77,600-85,000), respectively, with corresponding surgical costs of 69.2% and 60.9%. Ninety-day readmission costs were $36,200 (95% CI, 32,000-40,400) and $34,100 (95% CI, 28,100-40,100), respectively. In multivariate analysis, readmissions were associated with an almost two-fold increase in total costs in both pancreatectomy (cost ratio = 1.98; P < 0.001) and hepatectomy (cost ratio = 1.92; P < 0.001). CONCLUSIONS: Hepato-pancreato-biliary surgery is associated with significant economic burden in the privately insured population. Substantial costs are incurred beyond the index surgical admission, with readmissions representing a major source of potentially preventable health care spending. Sustained efforts in defining high-risk populations and decreasing the burden of postoperative complications through a combination of prevention and improved outpatient management offer promising strategies to reduce readmissions and control costs.

Screening for psychological distress in surgical breast cancer patients.

BACKGROUND: This pilot study assessed the levels of patient emotional distress and impact on clinic throughput time. METHODS: From April through August 2012, 149 breast cancer patients at the Penn State Hershey Breast Center were screened with the emotions thermometer (ET), a patient-rated visual 0-10 scale that measures distress, anxiety, depression, anger, burden, and need for help. Also, patients indicated their most pressing cancer-related concerns. Clinic visit time was computed and compared with a control group. RESULTS: Using a previously validated cut point ≥4 for any thermometer, we found emotional difficulty in the following proportions: distress 22 %, anxiety 28 %, depression 18 %, anger 14 %, burden 16 %, and need for help 10 %; 35 % scored above the cut point on at least 1 thermometer. We found higher levels of distress in all domains associated with younger age at diagnosis. More extensive surgery (bilateral mastectomy vs unilateral mastectomy vs. lumpectomy) was correlated with higher levels of psychosocial distress. Most often cited concerns, experienced by >20 %, included eating/weight, worry about cancer, sleep problems, fatigue, anxiety, and pain. Mean clinic visit time for evaluable patients screened using the ET (n = 109) was 43.9 min (SD 18.6), compared with 42.6 min (SD 16.2) for the control group (n = 50). CONCLUSIONS: Utilizing the ET, more than one-third of women screened met criteria for psychological distress. Younger age at diagnosis and more extensive surgery were risk factors. The ET is a simple validated screening tool that identifies patients in need of further psychological evaluation without impacting clinic throughput time.

Factors that affect decisions to receive (or not receive) life-sustaining treatment in advance care planning.

This study identifies factors that affect decisions people make regarding whether they want to receive life-sustaining treatment. It is an interpretive-descriptive study based on qualitative data from three focus groups (N = 23), representing a diverse population in central Pennsylvania. Study sites included a suburban senior center serving a primarily White, middle-class population; an urban senior center serving a frail, underserved, African American population; and a breast cancer support group. The most important factors affecting whether participants wished to receive life-sustaining medical treatment were prognosis, expected quality of life, burden to others, burden to oneself in terms of the medical condition and treatment, and effect on mental functioning and independence. Our findings contribute to the knowledge of the complex factors that influence how people make decisions about advance care planning and life-sustaining treatments. This understanding is critical if nurses are to translate the patient's goals, values, and preferences into an actionable medical plan.

Psychotropic medication trends among children and adolescents with autism spectrum disorder in the Medicaid program.

This study characterized psychotropic medication use among Medicaid-enrolled children and adolescents with autism spectrum disorders by examining trends over time, including length of treatment and polypharmacy using 4 years of administrative claims data from 41 state Medicaid programs (2000-2003). The data set included nearly 3 million children and adolescents who were 17 years or younger. Approximately, 65% of children with autism spectrum disorder received a psychotropic medication. The results indicate an increasing overall trend in the use of psychotropic drugs among children and adolescents with autism spectrum disorders. Among the different classes of psychotropic drugs, antipsychotics were the most common. Increasing trends in polypharmacy were observed both within and between medication classes.

Quality of life assessment in postoperative patients with upper GI malignancies.

BACKGROUND: By current estimates there are more than 10.8 million cancer survivors in the United States. Increasingly, oncologists are realizing that despite the "success" of cancer therapies, cancer survivors are facing previously unrecognized psychosocial issues related to cancer survivorship. In GI cancers, the medical and surgical oncologists charged with the care of the patient are not well-equipped to deal with these issues. At our institution's GI Cancer Survivorship Clinic, we utilize a multi-disciplinary model, led by surgical oncologists, that includes psychologic and pastoral support as a priority. The goal of this study was to assess our patients' quality of life (QOL) in order to better understand their survivorship needs and to optimize survivor care. MATERIALS AND METHODS: Patients with upper GI malignancies undergoing post-treatment evaluation completed the Functional Assessment of Chronic Illness Therapy-Spirituality Scale (FACIT-Sp) questionnaire that includes five domains of QOL: physical well being; social/family well being; emotional well being; functional well being; and spiritual well being. RESULTS: The results of our evaluation of health related QOL in a sample of 99 patients revealed higher self-reported QOL than those seen in a normative sample of cancer patients. Social/family well being was strongly associated with total QOL scores, and married patients reported higher social/family well being, as well as higher overall QOL. CONCLUSIONS: Cross-sectional evaluation of health related QOL in our patients revealed higher self-reported QOL than those seen in a normative sample of general cancer patients. Despite aggressive surgical and medical treatment for malignancies with a generally poor prognosis, the results of our pilot study suggest that cancer survivors treated and followed in a multidisciplinary setting can experience acceptable health-related QOL.

Caring for the brain tumor patient: family caregiver burden and unmet needs.

The rapid onset and progression of a brain tumor, cognitive and behavioral changes, and uncertainty surrounding prognosis are issues well known to health practitioners in neuro-oncology. We studied the specific challenges that family caregivers face when caring for patients experiencing the significant neurocognitive and neurobehavioral disorders associated with brain tumors. We selected 25 family caregivers of adult brain tumor patients to represent the brain tumor illness trajectory (crisis, chronic, and terminal phases). Interviews documented caregiving tasks and decision-making and information and support needs. Themes were permitted to emerge from the data in qualitative analysis. We found that the family caregivers in this study provided extraordinary uncompensated care involving significant amounts of time and energy for months or years and requiring the performance of tasks that were often physically, emotionally, socially, or financially demanding. They were constantly challenged to solve problems and make decisions as care needs changed, yet they felt untrained and unprepared as they struggled to adjust to new roles and responsibilities. Because the focus was on the patient, their own needs were neglected. Because caregiver information needs are emergent, they are not always known at the time of a clinic visit. Physicians are frequently unable to address caregiver questions, a situation compounded by time constraints and cultural barriers. We provide specific recommendations for (1) improving the delivery of information; (2) enhancing communication among patients, families, and health care providers; and (3) providing psychosocial support for family caregivers.

Implementation of an institutional program to improve clinical and financial outcomes of mechanically ventilated patients: one-year outcomes and lessons learned.

OBJECTIVE: To determine the effect of an institutional approach to the care of patients requiring mechanical ventilation for longer than three consecutive days in five adult intensive care units (ICU) on clinical and financial outcomes. DESIGN: A multidisciplinary team was selected from five adult ICUs to design the approach. Planning occurred from August 1999 to September 2000. The process was called outcomes management (OM) and included an evidence-based clinical pathway, protocols for weaning and sedation use, and the selection of four advanced practice nurses (called outcomes managers) to manage and monitor the program. SETTING: The project was completed in a 550-bed mid-Atlantic academic medical center. The ICUs included the following: coronary care, medical ICU, neuroscience ICU, surgical trauma ICU, and thoracic cardiovascular ICU. PATIENTS: The sample included 595 pre-OM patients and 510 post-OM patients mechanically ventilated for greater than three consecutive days. INTERVENTIONS: Full implementation of the OM approach occurred in March 2001. Retrospective baseline (18 months pre-OM) and prospective (12 months OM) clinical and financial data were compared. MEASUREMENTS AND MAIN RESULTS: Statistically significant differences in clinical outcomes were demonstrated in the managed patients compared with those managed before the institutional approach. Outcomes include ventilator duration (median days declined from ten to nine; p =.0001), ICU length of stay (median days declined from 15 to 12; p =.0008), hospital length of stay (median days declined from 22 to 20; p =.0001), and mortality rate (declined from 38% to 31%, p =.02). More than 3,000,000 US dollars cost savings were realized in the OM group. CONCLUSIONS: This institutional approach to the care of patients ventilated >3 days improved all clinical and financial outcomes of interest. To date, few similar initiatives have demonstrated similar results. The approach and lessons learned in this process improvement project may be helpful to other institutions attempting to improve outcomes in this vulnerable population.