Designing implementation strategies to improve identification, cascade testing, and management of families with familial hypercholesterolemia: An intervention mapping approach.

Introduction: Familial hypercholesterolemia (FH) is a common inherited cholesterol disorder that, without early intervention, leads to premature cardiovascular disease. Multilevel strategies that target all components of FH care including identification, cascade testing, and management are needed to address gaps that exist in FH care. We utilized intervention mapping, a systematic implementation science approach, to identify and match strategies to existing barriers and develop programs to improve FH care. Methods: Data were collected utilizing two methods: a scoping review of published literature, related to any component of FH care, and a parallel mixed method study using interviews and surveys. The scientific literature was searched using key words including "barriers" or "facilitators" and "familial hypercholesterolemia" from inception to December 1, 2021. The parallel mixed method study recruited individuals and families with FH to participate in either dyadic interviews (N = 11 dyads/22 individuals) or online surveys (N = 98 respondents). Data generated from the scoping review, dyadic interviews, and online surveys were used in the 6-step intervention mapping process. Steps 1-3 included a needs assessment, development of program outcomes and creation of evidence-based implementation strategies. Steps 4-6 included program development, implementation, and evaluation of implementation strategies. Results: In steps 1-3, a needs assessment found barriers to FH care included underdiagnosis of the condition which led to suboptimal management due to a myriad of determinants including knowledge gaps, negative attitudes, and risk misperceptions by individuals with FH and clinicians. Literature review highlighted barriers to FH care at the health system level, notably the relative lack of genetic testing resources and infrastructure needed to support FH diagnosis and treatment. Examples of strategies to overcome identified barriers included development of multidisciplinary care teams and educational programs. In steps 4-6, an NHLBI-funded study, the Collaborative Approach to Reach Everyone with FH (CARE-FH), deployed strategies that focused on improving identification of FH in primary care settings. The CARE-FH study is used as an example to describe program development, implementation, and evaluation techniques of implementation strategies. Conclusion: The development and deployment of evidence-based implementation strategies that address barriers to FH care are important next steps to improve identification, cascade testing, and management.

Implementation strategies to improve statin utilization in individuals with hypercholesterolemia: a systematic review and meta-analysis.

BACKGROUND: Numerous implementation strategies to improve utilization of statins in patients with hypercholesterolemia have been utilized, with varying degrees of success. The aim of this systematic review is to determine the state of evidence of implementation strategies on the uptake of statins. METHODS AND RESULTS: This systematic review identified and categorized implementation strategies, according to the Expert Recommendations for Implementing Change (ERIC) compilation, used in studies to improve statin use. We searched Ovid MEDLINE, Embase, Scopus, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov from inception to October 2018. All included studies were reported in English and had at least one strategy to promote statin uptake that could be categorized using the ERIC compilation. Data extraction was completed independently, in duplicate, and disagreements were resolved by consensus. We extracted LDL-C (concentration and target achievement), statin prescribing, and statin adherence (percentage and target achievement). A total of 258 strategies were used across 86 trials. The median number of strategies used was 3 (SD 2.2, range 1-13). Implementation strategy descriptions often did not include key defining characteristics: temporality was reported in 59%, dose in 52%, affected outcome in 9%, and justification in 6%. Thirty-one trials reported at least 1 of the 3 outcomes of interest: significantly reduced LDL-C (standardized mean difference [SMD] - 0.17, 95% CI - 0.27 to - 0.07, p = 0.0006; odds ratio [OR] 1.33, 95% CI 1.13 to 1.58, p = 0.0008), increased rates of statin prescribing (OR 2.21, 95% CI 1.60 to 3.06, p < 0.0001), and improved statin adherence (SMD 0.13, 95% CI 0.06 to 0.19; p = 0.0002; OR 1.30, 95% CI 1.04 to 1.63, p = 0.023). The number of implementation strategies used per study positively influenced the efficacy outcomes. CONCLUSION: Although studies demonstrated improved statin prescribing, statin adherence, and reduced LDL-C, no single strategy or group of strategies consistently improved outcomes. TRIAL REGISTRATION: PROSPERO CRD42018114952 .

Barriers, facilitators, and solutions to familial hypercholesterolemia treatment.

BACKGROUND: Familial hypercholesterolemia (FH) is an inherited lipid disorder that confers high risk for premature cardiovascular disease but remains undertreated. Causes are multifactorial and multilevel, ranging from underprescribing (at the clinician-level) to medication nonadherence (at the patient-level). We evaluated patient and clinician stakeholder barriers and facilitators for treatment of FH to explore possible solutions to the problem. METHODS AND RESULTS: Semi-structured interviews and focus groups guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), were conducted with 33 patients and 17 clinician stakeholders across three healthcare systems. A total of14 patients and 9 clinician stakeholders participated in on-site focus groups and the remainder were individual interviews. Transcripts were coded using an iterative process to create a static codebook. We characterized patient and clinician stakeholder barriers into three categories: medical care-, medication-, and life-related. Feasibility of brainstormed solutions varied and was not always representative of the needs of all stakeholders. Patients suggested a need for childhood screening for FH and doctors being persistent about the importance of treating FH, creation of a patient peer group, data transparency, advocacy, and policy changes that would enable patients to receive better treatment. Clinician stakeholders suggested the need for clinical champions. Both groups of stakeholders discussed the need for education about FH. CONCLUSIONS: Proposed solutions to improve treatment of FH proffered by participants in this study included resources for both patients and clinician stakeholders that clarify cardiovascular disease risks from FH, develop programs to screen for and identify FH at younger ages, and foster open conversations between patients and clinicians about treatment.

Developing implementation strategies to improve uptake of guideline-recommended treatments for individuals with familial hypercholesterolemia: A protocol.

BACKGROUND: Familial hypercholesterolemia (FH) affects more than one million Americans, and most individuals have not been formally diagnosed with the condition. Individuals with FH have markedly elevated serum low-density lipoprotein cholesterol (LDL-C) levels from birth that substantially increase their risk for early-onset cardiovascular (CV) events. Guideline-recommended treatments exist to lower LDL-C and reduce the risk of CV events in individuals with FH and hypercholesterolemia. This study seeks to address a significant gap in the care of individuals with FH by systematically developing an effective approach to increase the adoption of guideline-recommended treatments for FH. METHODS: This developmental study will consist of three aims: 1) determine the barriers to and facilitators of treatment of FH; 2) develop a list of potential implementation strategies to promote the adoption of guideline-recommended treatment of individuals with FH, and 3) pilot one implementation strategy from Aim 2 in one health care system to evaluate implementation outcomes of the strategy. The Practical, Robust Implementation and Sustainability Model will guide this project, including the development of interview questions, implementation strategies, and evaluation of the implementation strategy. The implementation outcomes include: of individuals targeted by the implementation strategy, how many are impacted by it (reach), measure the change in knowledge, attitude, and behavior that is impacted by the implementation strategy (effectiveness), in settings targeted by the implementation strategy, how many adopt it (adoption), and fidelity and cost of the implementation strategy (implementation). Data sources will include electronic health records, administrative databases, surveys, and semi-structured interviews. DISCUSSION: The inclusion of patient and organizational stakeholder experiences is a critically important step in developing efficient and effective implementation strategies. Additionally, perspectives from a variety of geographic areas and cultural perspectives should increase feasibility and fidelity of the interventional approach to improve adoption of guideline-recommended practices for FH care.

Assessment of symptom burden and adherence to respiratory medications in individuals self-reporting a diagnosis of COPD within a community pharmacy setting.

OBJECTIVES: Data on symptom burden or medication adherence in patients with chronic obstructive pulmonary disease (COPD) within a community pharmacy setting are limited. This study assessed symptom burden and adherence to respiratory medications in individuals reporting COPD, chronic bronchitis, or emphysema diagnoses visiting community pharmacies. DESIGN: This cross-sectional study enrolled participants visiting 35 community pharmacies in Missouri (October 2016 to April 2017). PARTICIPANTS: Eligible participants (aged 40 years or more with a self-reported history of COPD, prescription for at least 1 COPD maintenance medication during the previous 12 months, and able to complete an English questionnaire) were identified from pharmacy dispensing records. MAIN OUTCOME MEASURES: Participants completed a questionnaire assessing demographics, clinical characteristics, health literacy, COPD Assessment Test (CAT) modified Medical Research Council (mMRC) dyspnea scale scores, and exacerbation history. Recent spirometry data were obtained, if available, from participants' physicians. COPD was classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016 criteria. Medication adherence was assessed as proportion of days covered (PDC) from dispensing records. RESULTS: Of 682 participants (mean age 63.0 years; 57% female) with available pharmacy data, 251 (36.8%) had available spirometry data. Most participants had mMRC scores ≥ 2 (60.9%) and CAT scores ≥ 10 (90.2%); 57.2% reported at least 2 moderate or 1 or more severe exacerbations within the previous 12 months. GOLD classifications varied depending on the scale used (mMRC vs. CAT); more participants were classified as group C/D than group A/B, with the highest proportion classified as group D (higher symptom burden and exacerbation risk). Mean PDC was 0.46 ± 0.37; only 28.7% of participants were adherent (PDC ≥ 80%) to at least 1 COPD maintenance medication. CONCLUSION: Individuals self-reporting a COPD diagnosis receiving respiratory medications from community pharmacies in Missouri have a high symptom burden and low medication adherence. Further research should determine reasons for low adherence and ways to reduce COPD symptoms.

Implementation Science to Advance Care Delivery: A Primer for Pharmacists and Other Health Professionals.

Health care is experiencing increasing pressure to implement evidence-based interventions that improve quality, control costs, and maximize value. Unfortunately, many clinical services and interventions to optimize medication use do not consistently produce the intended humanistic, clinical, and economic outcomes. The lack of conclusive results is believed to stem from the widely recognized research-to-practice gap. The field of implementation science seeks to discover and apply strategies designed to accelerate successful integration of interventions into routine practice. This primer provides an overview of implementation science principles for pharmacists and other health care providers interested in accelerating practice transformation to improve health care delivery and, ultimately, patient care.

Dissemination and implementation sciences in pharmacy: A call to action for professional organizations.

There is a substantial gap between the generation of new knowledge and its widespread incorporation into routine clinical practice, including the medication use process. Principles of dissemination and implementation sciences, if fully embraced by clinicians and researchers, have the potential of improving healthcare effectiveness, efficiency, quality, and safety. This commentary is a call to action for member-driven professional organizations in pharmacy to serve their members and the profession by proactively and strategically leading efforts to develop pharmacist's abilities to incorporate principles of dissemination and implementation sciences into their practice. Additionally, these organizations should provide meaningful support for dissemination and implementation research that hastens the adoption, promotes intervention fidelity, and demonstrates the scaling and sustaining of evidence-based practices to optimize patient care delivery and medication therapy outcomes.

An Approach for All in Pharmacy Informatics Education.

Computerization is transforming health care. All clinicians are users of health information technology (HIT). Understanding fundamental principles of informatics, the field focused on information needs and uses, is essential if HIT is going to support improved patient outcomes. Informatics education for clinicians is a national priority. Additionally, some informatics experts are needed to bring about innovations in HIT. A common approach to pharmacy informatics education has been slow to develop. Meanwhile, accreditation standards for informatics in pharmacy education continue to evolve. A gap remains in the implementation of informatics education for all pharmacy students and it is unclear what expert informatics training should cover. In this article, we propose the first of two complementary approaches to informatics education in pharmacy: to incorporate fundamental informatics education into pharmacy curricula for all students. The second approach, to train those students interested in becoming informatics experts to design, develop, implement, and evaluate HIT, will be presented in a subsequent issue of the Journal.

An Approach for Some in Advanced Pharmacy Informatics Education.

Computerization is transforming health care while the quantity and complexity of biomedical knowledge rapidly grows. Today, all clinicians use health information technology (HIT), but only some pharmacists need to be cross-trained in "all" that advanced informatics entails so they can devise new and better information systems to support the pharmacy practice of the future. We propose a dual approach to informatics education in pharmacy: incorporate fundamental informatics education into pharmacy curricula for all students; and train some students interested in becoming informatics experts to design, develop, implement, and evaluate novel HIT for pharmacy. This commentary focuses specifically on the latter. It discusses the advanced pharmacy informatics training needed by some pharmacists to support innovation of HIT and to enable a shift to a more fully system-supported pharmacy practice.

Defining the opportunity for pharmacogenetic intervention in primary care.

UNLABELLED: Pharmacogenetics (PG), the study of human genome function and its effects on drug response, represents an exciting approach for reducing adverse drug events and increasing therapeutic efficacy. However, there is no clear information of the potential impact of PG in the primary care setting. Therefore, a study was conducted to determine the frequency of use of medications under PG influence, including 16 PG adverse drug reaction (ADR)-associated medications, in the primary care setting. PATIENTS AND METHODS: A cohort of 607 consecutive patients was accrued over a 3-month period from three primary care practices. Patients were asked to answer a verbal survey of demographics and medication use during the past 12 months. The survey specifically evaluated 16 drugs known to commonly cause ADRs and undergo metabolism by polymorphic enzymes. Patients also disclosed information on all other medication use in the last year. Medication use was verified by chart review. The primary outcome was the frequency of medication use. RESULTS: Among the 16 ADR-associated medications, patients used analgesics (88.5%), antihypertensives (14.3%) and antidepressants (9.6%) most commonly. Overall, 28.6% of patients took more than one of the PG ADR-associated medications. Neither gender nor race appeared to influence the frequency of use of these medications (p=0.5 and p=0.08, respectively). Patients taking one or more of the drugs were older (p<0.001). More patients seen for a chronic visit took one or more of the ADR-associated drugs than patients seen for an acute visit (35.8 versus 18.5%, p<0.001). DISCUSSION: This is the first attempt to describe the potential role of pharmacogenetics in the primary care setting. The findings indicate that at least one in four primary care patients take at least one medication that commonly causes adverse drug reactions due to genetic variability in drug metabolism, indicating that there is a potential role of pharmacogenomics in primary care. Nearly every patient was on a medication with putative PG association. CONCLUSIONS: Studies of the ability of PG should not be limited to medical subspecialties, as there is a great potential impact of PG on the primary care setting.

Implementing a commercial rule base as a medication order safety net.

A commercial rule base (Cerner Multum) was used to identify medication orders exceeding recommended dosage limits at five hospitals within BJC HealthCare, an integrated health care system. During initial testing, clinical pharmacists determined that there was an excessive number of nuisance and clinically insignificant alerts, with an overall alert rate of 9.2%. A method for customizing the commercial rule base was implemented to increase rule specificity for problematic rules. The system was subsequently deployed at two facilities and achieved alert rates of less than 1%. Pharmacists screened these alerts and contacted ordering physicians in 21% of cases. Physicians made therapeutic changes in response to 38% of alerts presented to them. By applying simple techniques to customize rules, commercial rule bases can be used to rapidly deploy a safety net to screen drug orders for excessive dosages, while preserving the rule architecture for later implementations of more finely tuned clinical decision support.

Concordance between medication histories and outpatient electronic prescription claims in patients hospitalized with heart failure.

Using an electronic prescription claims database and electronic hospital records, we retrospectively compared outpatient heart failure (HF) prescriptions dispensed with reported use obtained during medication histories taken at hospital admission. We found significant disagreement between each source for all but one HF medication class.