Evaluation of a multidisciplinary lipid clinic to improve the care of individuals with severe lipid conditions: A RE-AIM framework analysis

BACKGROUND: Individuals with complex dyslipidemia, or those with medication intolerance, are often difficult to manage in primary care. They require the additional attention, expertise, and adherence counseling that occurs in multidisciplinary lipid clinics (MDLCs). We conducted a program evaluation of the first year of a newly implemented MDLC utilizing the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework to provide empirical data not only on program effectiveness, but also on components important to local sustainability and future generalizability. METHODS: The purpose of the MDLC is to increase the uptake of guideline-based care for lipid conditions. Established in 2019, the MDLC provides care via a centralized clinic location within the healthcare system. Primary care providers and cardiologists were invited to refer individuals with lipid conditions. Using a pre/post-study design, we evaluated the implementation outcomes from the MDLC using the RE-AIM framework. RESULTS: In 2019, 420 referrals were made to the MDLC (reach). Referrals were made by 19% (148) of the 796 active cardiology and primary care providers, with an average of 35 patient referrals per month in 2019 (SD 12) (adoption). The MDLC saw 83 patients in 2019 (reach). Additionally, 50% (41/82) had at least one follow-up MDLC visit, and 12% (10/82) had two or more follow-up visits in 2019 (implementation). In patients seen by the MDLC, we found an improved diagnosis of specific lipid conditions (FH (familial hypercholesterolemia), hypertriglyceridemia, and dyslipidemia), increased prescribing of evidence-based therapies, high rates of medication prior authorization approvals, and significant reductions in lipid levels by lipid condition subgroup (effectiveness). Over time, the operations team decided to transition from in-person follow-up to telehealth appointments to increase capacity and sustain the clinic (maintenance). CONCLUSIONS: Despite limited reach and adoption of the MDLC, we found a large intervention effect that included improved diagnosis, increased prescribing of guideline-recommended treatments, and clinically significant reduction of lipid levels. Attention to factors including solutions to decrease the large burden of unseen referrals, discussion of the appropriate number and duration of visits, and sustainability of the clinic model could aid in enhancing the success of the MDLC and improving outcomes for more patients throughout the system

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 \u3c 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

Returning Results in the Genomic Era: Initial Experiences of the eMERGE Network

A goal of the 3rd phase of the Electronic Medical Records and Genomics (eMERGE3) Network was to examine the return of results (RoR) of actionable variants in more than 100 genes to consenting participants and their healthcare providers. Each of the 10 eMERGE sites developed plans for three essential elements of the RoR process: Disclosure to the participant, notification of the health care provider, and integration of results into the electronic health record (EHR). Procedures and protocols around these three elements were adapted as appropriate to individual site requirements and limitations. Detailed information about the RoR procedures at each site was obtained through structured telephone interviews and follow-up surveys with the clinical investigator leading or participating in the RoR process at each eMERGE3 institution. Because RoR processes at each of the 10 sites allowed for taking into account differences in population, disease focus and institutional requirements, significant heterogeneity of process was identified, including variability in the order in which patients and clinicians were notified and results were placed in the EHR. This heterogeneity in the process flow for eMERGE3 RoR reflects the “real world” of genomic medicine in which RoR procedures must be shaped by the needs of the patients and institutional environments

High-Risk Breast Cancer Clinic –– A New Risk-Stratified, Evidence-Based, and Efficient Patient Care Model

Background/Aims: There is considerable variation in adherence to available evidence-based recommendations for risk assessment, screening, genetic counseling and testing, surveillance and preventive care for women at risk for breast cancer. To improve adherence and patient outcomes and to facilitate appropriate referral to genetic testing, Geisinger implemented a new care model in February 2015 to systematically and efficiently deliver appropriate risk assessment and management services using midlevel providers. This “high-risk breast cancer clinic” provides any interested woman with a personal risk assessment and care plan. Validated risk assessment approaches are used to stratify women into differing risk levels. This new approach focuses on the large moderate-risk (5-year risk ≥ 1.7% and/or lifetime risk ≥ 20%) and average-risk (5-year risk ≤ 1.7%) populations, who comprise the majority of women and who are typically underserved with usual care. It provides them with evidence-based counseling, surveillance and chemoprevention care services. This clinic also serves women with dense breasts (density \u3e 50%, which includes about half of all women) who also are known to be at increased risk for breast cancer. Methods: For women at moderate risk of developing breast cancer, a decision-analysis model compares care, outcomes and costs for the high-risk breast cancer clinic’s approach to usual care. Assumptions for the model are based on Geisinger patient data, literature and expert opinion to develop estimates for clinical and economic outcomes. Results: A decision-analysis model comparing Geisinger’s high-risk breast cancer clinic to usual care is used for a budget impact analysis to show the estimated effects of differences in patient care on outcomes and costs, including benefits of delivering risk-based prevention and treatment at earlier stages to moderate-risk patients. This analysis is used to make a business case for this new care model in an integrated health system. Conclusion: A new targeted care model providing evidence-based evaluation and services to women at moderate and average risk for developing breast cancer offers the potential to improve delivery of appropriate care, patient experience and health outcomes with a favorable impact on cost

Parental Expectations and Attitudes Towards Receiving Genomic Information About Children Participating in a Population-Based Biorepository

Background/Aims: Guidelines published by the American College of Genetics and Genomics recommend, when clinical sequencing studies are performed, returning genetic results in 56 genes, regardless of patient age. The American Academy of Pediatrics and standard clinical genetic testing practice recommend neither testing nor providing results to children for adult-onset conditions with no childhood manifestations or screening guidelines, such as hereditary breast and ovarian cancer (HBOC) and Lynch syndrome. Geisinger’s MyCode® biorepository aims to collect samples and whole exome sequence data on 250,000 adult and pediatric participants. Consent to participate in MyCode includes consent to receive genomic results. Some genomic results have medical implications and management guidelines for children; however, the six genes related to HBOC and Lynch syndrome have no immediate health implications or recommended medical management for children. Prior studies have indicated that our adult participants are interested in genomic results regardless of medical actionability; however, few studies have reported on parental attitudes towards receiving results for their children that are medically actionable in childhood versus those that do not have implications until adulthood. Methods: Multiple focus groups are being conducted with adult MyCode participants who have at least one child enrolled in the biorepository. Participants are selected on the basis of child age (0–8 or 9–17) and geographic location. A semi-structured guide was developed to elicit expectations regarding their children’s participation in the biorepository and opinions and reactions to different return of results scenarios. Parents are first introduced to the issues through a scenario in which they learn that a child has a genetic condition that can be medically managed in childhood (Marfan syndrome), and then they are challenged to think about receiving genetic information about adult-onset conditions in their children, specifically HBOC and Lynch syndrome. Results: Results from in-depth thematic analysis of focus group transcripts will be presented. Conclusion: In developing pediatric biorepository consent processes and return of results protocols, it is crucial to elicit and understand both parental and, to the extent possible, pediatric participant attitudes and responses to different types of genomic information — specifically information that has childhood implications versus information that is medically actionable only during adulthood

Barriers, facilitators, and solutions to familial hypercholesterolemia treatment.

BackgroundFamilial 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 resultsSemi-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.ConclusionsProposed 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