The competency index for clinical research professionals: a potential tool for competency-based clinical research academic program evaluation.

Background: Accreditation of graduate academic programs in clinical research requires demonstration of program achievement of Joint Task Force for Clinical Trial Competence-based standards. Evaluation of graduate programs include enrollment, student grades, skills-based outcomes, and completion rates, in addition to other measures. Standardized measures of competence would be useful. Methods: We used the Competency Index for Clinical Research Professionals (CICRP), in a separate-sample pretest-posttest study to measure self-confidence or self-efficacy in clinical research competency comparing cohorts of students entering and completing a master's degree program in clinical research across three semesters (summer 2021 - spring 2022). CICRP is a 20-item Likert scale questionnaire (0 = Not at all confident; 10 = extremely confident). Results: The study sample of 110 students (54 in the entry course, 56 in the exit course) showed overall 80.9% entered the program with only a baccalaureate degree and 55.5% had no prior experience in managing clinical trial research. Cronbach alpha for the instrument showed a high level of content validity (range 0.93-0.98). Median CICRP item rating range at entry was [1, 6] and at exit [7, 10]. Mean CICRP total score (sum of 20 items) at entry was 72.7 (SD 41.9) vs. 167.0 (SD 21.1) at exit (p < 0.001). Mean total score at program entry increased with increasing years of clinical trial management experience but attenuated at program exit. Conclusion: This is the first use of the CICRP for academic program evaluation. The CICRP may be a useful tool for competency-based academic program evaluation, in addition to other measures of program excellence.

Which hematology/oncology patients are high priority for ambulatory clinical pharmacist review? A three-round Delphi survey by the National Comprehensive Cancer Network.

INTRODUCTION: Prioritization and acuity tools have been leveraged to facilitate targeted and efficient clinical pharmacist interventions. However, there is a lack of established pharmacy-specific acuity factors in the ambulatory hematology/oncology setting. Therefore, National Comprehensive Cancer Network's Pharmacy Directors Forum conducted a survey to establish consensus on acuity factors associated with hematology/oncology patients that are high priority for ambulatory clinical pharmacist review. METHODS: A three-round electronic Delphi survey was conducted. During the first round, respondents were asked an open-ended question to suggest acuity factors based on their expert opinion. Respondents were then asked in the second round to agree or disagree with the compiled acuity factors, in which those with ≥75% agreement were included in the third round. The final consensus was defined as a mean score ≥3.33 on a modified 4-point Likert scale (4 = strongly agree, 1 = strongly disagree) during the third round. RESULTS: A total of 124 hematology/oncology clinical pharmacists completed the first round of the Delphi survey (invitation response rate, 36.7%), of which 103 completed the second round (response rate, 83.1%) and 84 the third round (response rate, 67.7%). A final consensus was achieved for 18 acuity factors. Acuity factors were identified in the following themes: antineoplastic regimen characteristics, drug interactions, organ dysfunction, pharmacogenomics, recent discharge, laboratory parameters, and treatment-related toxicities. CONCLUSIONS: This Delphi panel of 124 clinical pharmacists achieved consensus on 18 acuity factors that would identify a hematology/oncology patient as a high priority for ambulatory clinical pharmacist review. The research team envisions incorporating these acuity factors into a pharmacy-specific electronic scoring tool.

Key ePortfolio features and strategies for student success in a competency-based clinical research program.

BACKGROUND: Student ePortfolios provide an interactive space for faculty, student peers, and potential employers to view skillsets and reflective expressions of students. EDUCATIONAL ACTIVITY: The adoption of ePortfolios in an interdisciplinary, competency-based, master's degree program in clinical research at a university in the Midwestern United States is described. Students submitted their ePortfolios as their culminating assessment. A survey was used to collect objective and open-ended responses from 104 students between 2015 and 2019 followed by a voluntary post-survey interview. Two ePortfolio platforms and instructional methods were compared. CRITICAL ANALYSIS OF THE EDUCATIONAL ACTIVITY: A user-friendly platform enhanced student engagement and reduced student and faculty frustration with the ePortfolio requirement. Thirty-seven students and alumni responded to an ePortfolio survey, and five students shared their experiences in a post-survey interview. Students described positive experiences related to their academic program and job search as a result of completing the ePortfolio. However, alumni were not strongly motivated to maintain their ePortfolio post-graduation. ePortfolios provide evidence of student acquisition of core competencies in a professional graduate degree. Facilitating the process of ePortfolio creation with instruction guides, exemplar ePortfolios, and an evaluation rubric support student success. A user-friendly ePortfolio platform with social media linking features will enhance exposure of the student's work to key stakeholders during and after their academic program. If the ePortfolio is to have an impact on a student's professional trajectory after graduation, it should contain meaningful examples of academic work that can be shared publicly and allow updating of ePortfolio content.

Evaluation of medication safety resources in pediatric hospitals.

PURPOSE: As health systems continue to expand pharmacy and clinical services, the ability to evaluate potential medication safety risks and mitigate errors remains a high priority. Workload and productivity monitoring tools for the assessment of operational and clinical pharmacy services exist. However, such tools are not currently available to justify medication safety pharmacy services. The purpose of this study is to determine methods used to assess, allocate, and justify medication safety resources in pediatric hospitals. METHODS: A 32-question survey was designed and distributed utilizing the Research Electronic Data Capture (REDCap) tool. The survey was disseminated to 46 pediatric hospitals affiliated with the Children's Hospital Association (CHA). The survey was distributed in October 2018, and the respondents were given 3 weeks to submit responses. Data analysis includes the use of descriptive statistics. Categorical variables were summarized by frequencies and percentages to distinguish the differences between pediatric health systems. RESULTS: Of 26 respondents, 15.4% utilized metrics to justify medication safety resources. Metrics utilized were based on medication dispenses, projects, and error coding. Twenty-three percent of respondents were dissatisfied with current pharmacy-based medication safety resources within the organization. There was variability of medication safety resources within pediatric hospitals, including the number of dedicated full-time equivalents, time spent on tasks, and task prioritization. CONCLUSION: Assessing medication safety resources at various pediatric hospitals highlights several potential barriers and opportunities. This information will serve as the foundation for the creation of a standardized workload assessment tool to assist pharmacy leaders with additional resource justification.

Effect of a Pharmacist-Driven Monitoring Program and Electronic Health Record on Bleeding Log Completeness and Documentation.

BACKGROUND: Pharmacists have the ability to enhance comprehensive care for bleeding disorders patients by bridging the gap between hemophilia treatment centers (HTC) and specialty pharmacies, specifically by monitoring bleeding logs. In September 2015, a pharmacist-driven monitoring program was implemented through the specialty pharmacy associated with a medical center to improve bleeding log completeness and electronic documentation for HTC patients. OBJECTIVE: To measure the effect of a pharmacist-driven bleeding disorder monitoring program on bleeding log completeness, successful bleeding log documentation in the electronic health record (EHR), and pharmacist-driven clinical interventions using an EHR tool. METHODS: A single-group pre-post intervention study was conducted of a pharmacist-driven monitoring program. Pre-implementation (January 1, 2014-December 31, 2014), all patients who received and returned a bleeding log following an appointment at the HTC were included; post-implementation (September 1, 2015-December 30, 2015) included patients seen at the HTC who chose to participate in the program for at least 3 months. Before implementation, patient-completed bleeding logs were scanned into the EHR by clinic staff. After implementation, bleeding logs were completed by a pharmacist and documented using a case management tool in the integrated EHR. Bleeding log records successfully documented in the EHR were collected. Completeness was calculated based on 10 clinical data elements for each bleeding log record. Pharmacist-driven interventions resulting from the program in the post-implementation period were recorded. RESULTS: In the pre-implementation period, 19 of 117 bleeding log records (16.2%) were documented in the EHR; all 15 (100%) records were documented post-implementation (P < 0.001). Among all clinical data elements across all records, 706 of 1,170 data elements were recorded pre-implementation (60.3%), and 120 of 150 (80.0%) were recorded post-implementation (P < 0.001). Pre-implementation, no logs were 100% complete; post-implementation, only 6.7% of logs were fully complete (P = 0.114). For the 15 bleeding log records documented in the EHR during the post-implementation period, 14 documented pharmacist-driven clinical interventions occurred. The majority of interventions fell under coordination of care (8 [57.1%]). CONCLUSIONS: Improvement in bleeding log completeness and documentation in the EHR was associated with the use of an EHR tool and pharmacist-driven monitoring program. DISCLOSURES: Not outside funding supported this study. The authors have nothing to disclose.

Economic Evaluation of a Patient-Directed Music Intervention for ICU Patients Receiving Mechanical Ventilatory Support.

OBJECTIVES: Music intervention has been shown to reduce anxiety and sedative exposure among mechanically ventilated patients. Whether music intervention reduces ICU costs is not known. The aim of this study was to examine ICU costs for patients receiving a patient-directed music intervention compared with patients who received usual ICU care. DESIGN: A cost-effectiveness analysis from the hospital perspective was conducted to determine if patient-directed music intervention was cost-effective in improving patient-reported anxiety. Cost savings were also evaluated. One-way and probabilistic sensitivity analyses determined the influence of input variation on the cost-effectiveness. SETTING: Midwestern ICUs. PATIENTS: Adult ICU patients from a parent clinical trial receiving mechanical ventilatory support. INTERVENTIONS: Patients receiving the experimental patient-directed music intervention received a MP3 player, noise-canceling headphones, and music tailored to individual preferences by a music therapist. MEASUREMENTS AND MAIN RESULTS: The base case cost-effectiveness analysis estimated patient-directed music intervention reduced anxiety by 19 points on the Visual Analogue Scale-Anxiety with a reduction in cost of $2,322/patient compared with usual ICU care, resulting in patient-directed music dominance. The probabilistic cost-effectiveness analysis found that average patient-directed music intervention costs were $2,155 less than usual ICU care and projected that cost saving is achieved in 70% of 1,000 iterations. Based on break-even analyses, cost saving is achieved if the per-patient cost of patient-directed music intervention remains below $2,651, a value eight times the base case of $329. CONCLUSIONS: Patient-directed music intervention is cost-effective for reducing anxiety in mechanically ventilated ICU patients.

Establishing a clinical pharmacology fellowship program for physicians, pharmacists, and pharmacologists: a newly accredited interdisciplinary training program at the Ohio State University.

Studying the effect of drugs on humans, clinical pharmacologists play an essential role in many academic medical and research teams, within the pharmaceutical industry and as members of government regulatory entities. Clinical pharmacology fellowship training programs should be multidisciplinary and adaptable, and should combine didactics, applied learning, independent study, and one-on-one instruction. This article describes a recently developed 2 year clinical pharmacology fellowship program - one of only nine accredited by the American Board of Clinical Pharmacology - that is an integrative, multi faceted, adaptable method for training physicians, pharmacists, and scientists for leadership roles in the pharmaceutical industry, in academia, or with regulatory or accreditation agencies. The purpose of this article is to provide information for academic clinicians and researchers interested in designing a similar program, for professionals in the field of clinical pharmacology who are already affiliated with a fellowship program and may benefit from supplemental information, and for clinical researchers interested in clinical pharmacology who may not be aware that such training opportunities exist. This article provides the details of a recently accredited program, including design, implementation, accreditation, trainee success, and future directions.

Persistence of warfarin therapy for residents in long-term care who have atrial fibrillation.

BACKGROUND: Among long-term care (LTC) residents with atrial fibrillation (AF), the use of warfarin to prevent stroke has been shown to be suboptimal. For those who begin warfarin prophylaxis in LTC, persistence on this therapy has not been reported. OBJECTIVE: This study was conducted to estimate persistence on warfarin among LTC residents with AF. METHODS: A retrospective analysis was conducted by using data from an LTC database. Pharmacy dispensing data were used to track warfarin use in residents with a diagnosis of AF who were newly started on warfarin therapy. The main outcome measure was persistence of warfarin over the first year of therapy. Survival analysis included Kaplan-Meier plots and a multivariate Cox proportional hazards model to test the association of resident characteristics and conditions with warfarin discontinuation. RESULTS: A total of 148 residents new to warfarin therapy met all study inclusion criteria. Median age was 84 years; 69% were female. Median time to therapy discontinuation was 197 days (95% CI, 137-249) across all study residents. By 90 days after the initiation of therapy, 37% (95% CI, 28-47) of study residents had discontinued warfarin; by 1 year, 65% (54%-76%) had discontinued warfarin therapy. The multivariate Cox regression analysis found that the following factors were independently associated with discontinuation of warfarin therapy: age 65 to 74 years (hazard ratio [HR] = 3.01 [95% CI, 1.04-8.73]), female sex (HR = 0.45 [95% CI, 0.24-0.87]), Hispanic race/ethnicity (HR = 2.86 [95% CI, 1.30-6.26]), Midwest region (HR = 2.13 [95% CI, 1.02-4.48]), and Alzheimer disease or dementia (HR = 1.97 [95% CI, 1.05-3.68]). CONCLUSIONS: Although clinical practice guidelines exist for the prevention of stroke in AF patients, persistence on warfarin therapy seems suboptimal in many LTC residents with AF.

Warfarin for prevention of thrombosis among long-term care residents with atrial fibrillation: evidence of continuing low use despite consideration of stroke and bleeding risk.

OBJECTIVES: The aims of the study were to evaluate usage rates of warfarin in stroke prophylaxis and the association with assessed stages of stroke and bleeding risk in long-term care (LTC) residents with atrial fibrillation (AFib). METHODS: A cross-sectional analysis of two LTC databases (the National Nursing Home Survey [NNHS] 2004 and an integrated LTC database: AnalytiCare) was conducted. The study involved LTC facilities across the USA (NNHS) and within 19 states (AnalytiCare). It included LTC residents diagnosed with AFib (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] diagnostic code 427.3X). Consensus guideline algorithms were used to classify residents by stroke risk categories: low (none or 1+ weak stroke risk factors), moderate (1 moderate), high (2+ moderate or 1+ high). Residents were also classified by number of risk factors for bleeding (0-1, 2, 3, 4+). Current use of warfarin was assessed. A logistic regression model predicted odds of warfarin use associated with the stroke and bleeding risk categories. RESULTS: The NNHS and AnalytiCare databases had 1,454 and 3,757 residents with AFib, respectively. In all, 34 % and 45 % of residents with AFib in each respective database were receiving warfarin. Only 36 % and 45 % of high-stroke-risk residents were receiving warfarin, respectively. In the logistic regression model for the NNHS data, when compared with those residents having none or 1+ weak stroke risk and 0-1 bleeding risk factors, the odds of receiving warfarin increased with stroke risk (odds ratio [OR] = 1.93, p = 0.118 [1 moderate risk factor]; OR = 3.19, p = 0.005 [2+ moderate risk factors]; and OR = 8.18, p ≤ 0.001 [1+ high risk factors]) and decreased with bleeding risk (OR = 0.83, p = 0.366 [2 risk factors]; OR = 0.47, p ≤ 0.001 [3 risk factors]; OR = 0.17, p ≤ 0.001 [4+ risk factors]). A similar directional but more constrained trend was noted for the AnalytiCare data: only 3 and 4+ bleeding risk factors were significant. CONCLUSIONS: The results from two LTC databases suggest that residents with AFib have a high risk of stroke. Warfarin use increased with greater stroke risk and declined with greater bleeding risk; however, only half of those classified as appropriate warfarin candidates were receiving guideline-recommended anticoagulant prophylaxis.

Usage of medications with high potential to interact with warfarin among atrial fibrillation residents in long-term care facilities.

OBJECTIVES: The rate of potential warfarin drug-drug interactions among long-term care (LTC) residents with atrial fibrillation (AFib) is evaluated. RESEARCH DESIGN AND METHODS: LTC residents from two databases, the National Nursing Home Survey (NNHS) 2004 and the AnalytiCare™ multistate database, with an AFib diagnosis (ICD9 = 427.3x) were studied. Concurrent usage was tabulated for 10 agents/pharmacotherapeutic classes (simple-class screen) and for 96 individual agents (single-agent screen) with strong evidence for warfarin-interaction. RESULTS: Warfarin use was recorded in 502 NNHS and 1,674 AnalytiCare residents with AFib. Using the simple-class screen, ≥ 1 of the 10 classes/agents were prescribed concurrently in 59% (CI: 54.0 - 63.6%) of warfarin users in NNHS and 85% (CI: 82.9 - 86.3%) in AnalytiCare. Using the more comprehensive single-agent screen, usage of any interacting agent was higher in both databases: 87% (CI: 83.9 - 90.3%) in NNHS and 94% (CI: 93.0 - 95.3%) in AnalytiCare. Among 873 interacting agents dispensed to residents while continuously using warfarin (AnalytiCare database), 360 (41%) were changed (added or withdrawn), while 513 (59%) were maintained over two consecutive 45-day periods. CONCLUSIONS: Concurrent use of agents with a high potential for interaction occurs among most LTC residents who are receiving warfarin. Large proportions of interacting agents appear to be added or withdrawn during continuous warfarin therapy and thus have implications for anticoagulation control.

Prevalence of atrial fibrillation in US nursing homes: results from the National Nursing Home Survey, 1985-2004.

OBJECTIVES: To evaluate the prevalence of atrial fibrillation (AFib) in US nursing homes from 1985 to 2004 and to project the prevalence of AFib to 2030. DESIGN: This study is an analysis of cross-sectional data from the US National Nursing Home Survey, years 1985, 1995, 1997, 1999, and 2004. SETTING: Randomly selected long term care facilities in the United States licensed by the state or certified for Medicaid/Medicare reimbursement. PARTICIPANTS: Randomly selected residents within study facilities. MEASUREMENTS: National Nursing Home Survey demographics and current medical conditions data were analyzed. Population estimates were calculated using National Nursing Home Survey sample weights. Absolute observed annual linear growth of the AFib prevalence rate was calculated using linear regression. Predictive margins were estimated using logistic regression models to evaluate effect of changes in resident case-mix over the survey years. Three estimation methods predicted the number residents having AFib in 2030. RESULTS: The sample sizes of surveyed resident groups were as follows: n = 5238 (1985); n = 8056 (1995); n = 8138 (1997); n = 8215 (1999); and n = 13,507 (2004). Prevalence rates of AFib by year were 2.8% (95% confidence interval [CI]: 2.3-3.4%; 1985), 5.1% (95% CI: 4.6-5.6%; 1995), 5.8% (95% CI: 5.3-6.3%; 1997), 6.9% (95% CI: 6.3-7.4%; 1999), and 10.9% (95% CI: 10.2-11.5%; 2004). Population estimates of nursing home residents with AFib (in thousands) were 42.2 (95% CI: 34.1-50.3; 1985), 78.7 (95% CI: 70.8-86.7; 1995), 93.6 (95% CI: 84.9-102.3; 1997), 111.8 (95% CI: 102.1-121.5; 1999), and 162.1 (95% CI: 152.4-171.7; 2004). Absolute annual linear growth in the prevalence rate of AFib was +0.38% observed (P = .022), +0.39% using unadjusted predictive margins (P = .007), and +0.37% using adjusted predictive margins (P = .007). Projected estimates showed that 272,000 (95% CI: 197,000-347,000), 300,000, or 325,000 residents would have AFib in the year 2030. CONCLUSION: The prevalence of AFib in US nursing home residents increased from 1985 to 2004 and is projected to grow substantially over the next 20 years, potentially resulting in an increased nursing home staff burden owing to increased stroke risk evaluations.

Use of warfarin in long-term care: a systematic review.

BACKGROUND: The use of warfarin in older patients requires special consideration because of concerns with comorbidities, interacting medications, and the risk of bleeding. Several studies have suggested that warfarin may be underused or inconsistently prescribed in long-term care (LTC); no published systematic review has evaluated warfarin use for stroke prevention in this setting. This review was conducted to summarize the body of published original research regarding the use of warfarin in the LTC population. METHODS: A systematic literature search of the PubMed, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library was conducted from January 1985 to August 2010 to identify studies that reported warfarin use in LTC. Studies were grouped by (1) rates of warfarin use and prescribing patterns, (2) association of resident and institutional characteristics with warfarin prescribing, (3) prescriber attitudes and concerns about warfarin use, (4) warfarin management and monitoring, and (5) warfarin-related adverse events. Summaries of study findings and quality assessments of each study were developed. RESULTS: Twenty-two studies met the inclusion criteria for this review. Atrial fibrillation (AF) was the most common indication for warfarin use in LTC and use of warfarin for stroke survivors was common. Rates of warfarin use in AF were low in 5 studies, ranging from 17% to 57%. These usage rates were low even among residents with high stroke risk and low bleeding risk. Scored bleeding risk had no apparent association with warfarin use in AF. In physician surveys, factors associated with not prescribing warfarin included risk of falls, dementia, short life expectancy, and history of bleeding. International normalized ratio was in the target range approximately half of the time. The combined overall rate of warfarin-related adverse events and potential events was 25.5 per 100 resident months on warfarin therapy. CONCLUSIONS: Among residents with AF, use of warfarin and maintenance of INR levels to prevent stroke appear to be suboptimal. Among prescribers, perceived challenges associated with warfarin therapy often outweigh its benefits. Further research is needed to explicitly consider the appropriate balancing of risks and benefits in this frail patient population.

Pharmacoeconomic considerations in treating actinic keratosis.

Actinic keratosis is among the most commonly treated skin conditions in the outpatient setting. Its prevalence spans the globe, with greater distribution in fair skinned individuals and the immunocompromised. With high prevalence, increasing incidence and the risk of transformation to a cancerous lesion, prevention and timely treatment present opportunities to rein in costs. The purpose of this article is to review published economic studies relating to the treatment of actinic keratosis, to summarize results discussing the cost drivers of current treatment modalities and to identify parameters most likely to influence the cost effectiveness of treatment. We systematically conducted a published literature search for pharmacoeconomic research of actinic keratosis using title, abstract or full-text searches with the following search terms ([actinic OR solar] AND [keratosis OR keratoses]) AND (economic OR cost OR pharmacoeconomics OR decision). We included published articles referencing actinic keratosis in a standalone study or in a broader study referencing non-melanoma skin cancer and articles evaluating cost-of-illness, cost-of-treatment, cost minimization, cost effectiveness, cost utility, cost-benefit analysis and cost consequence. Our review of the literature found nine studies devoted to pharmacoeconomic considerations of actinic keratosis treatments, with one article investigating both cost-of-illness and cost-of-treatment, two measuring cost-of-illness, two evaluating cost-of-treatment, one focusing on cost minimization, and three focusing on cost effectiveness. The literature compared a broad range of actinic keratosis treatments including topical medications, cryotherapy, photodynamic therapy, excision and a combination of treatment modalities. The direct cost of actinic keratosis management in the US was estimated at $US1.2 billion per year, with indirect costs totalling $US295 million (year 2004 values). The primary drivers of cost were physician office visits and associated procedures. Pharmacoeconomic research defining standards, outcomes and areas of efficiencies in the treatment of actinic keratosis is in its infancy. To move towards more comprehensive analysis, research needs to focus on updating epidemiological data, evolving evidence-based standards, delineating cost drivers in immunocompetent and immunocompromised populations, and on health outcomes.