Shotgun Metagenomics Reveals Impacts of Copper and Water Heater Anodes on Pathogens and Microbiomes in Hot Water Plumbing Systems.

Hot water building plumbing systems are vulnerable to the proliferation of opportunistic pathogens (OPs), including Legionella pneumophila and Mycobacterium avium. Implementation of copper as a disinfectant could help reduce OPs, but a mechanistic understanding of the effects on the microbial community under real-world plumbing conditions is lacking. Here, we carried out a controlled pilot-scale study of hot water systems and applied shotgun metagenomic sequencing to examine the effects of copper dose (0-2 mg/L), orthophosphate corrosion control agent, and water heater anode materials (aluminum vs magnesium vs powered anode) on the bulk water and biofilm microbiome composition. Metagenomic analysis revealed that, even though a copper dose of 1.2 mg/L was required to reduce Legionella and Mycobacterium numbers, lower doses (e.g., ≤0.6 mg/L) measurably impacted the broader microbial community, indicating that the OP strains colonizing these systems were highly copper tolerant. Orthophosphate addition reduced bioavailability of copper, both to OPs and to the broader microbiome. Functional gene analysis indicated that both membrane damage and interruption of nucleic acid replication are likely at play in copper inactivation mechanisms. This study identifies key factors (e.g., orthophosphate, copper resistance, and anode materials) that can confound the efficacy of copper for controlling OPs in hot water plumbing.

Development of a centralized, remote clinical pharmacy service to enhance primary care.

More than 50% of Americans possess at least one chronic condition and another 25% suffer from two or more, leaving primary care teams tasked to care for the chronic, acute, and preventive care needs of their large patient panels. Pharmacists can reduce the burden on busy providers by effectively managing chronic diseases as members of health care teams. Many private physician practices lack the resources to include pharmacists on their teams. A centralized, remote clinical pharmacy services model allows pharmacists to remotely manage chronic disease in patients in collaboration with primary care providers. The purpose of this report is to describe how a centralized, remote clinical pharmacy team was developed, trained, and effectively integrated into multiple, diverse primary care settings across the U.S.

Development of a centralized, remote clinical pharmacy service to enhance primary care

More than 50% of Americans possess at least one chronic condition and another 25% suffer from two or more, leaving primary care teams tasked to care for the chronic, acute, and preventive care needs of their large patient panels. Pharmacists can reduce the burden on busy providers by effectively managing chronic diseases as members of health care teams. Many private physician practices lack the resources to include pharmacists on their teams. A centralized, remote clinical pharmacy services model allows pharmacists to remotely manage chronic disease in patients in collaboration with primary care providers. The purpose of this report is to describe how a centralized, remote clinical pharmacy team was developed, trained, and effectively integrated into multiple, diverse primary care settings across the U.S

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Dissemination of a telehealth cardiovascular risk service: The CVRS live protocol.

BACKGROUND: Medical clinics are increasingly hiring clinical pharmacists to improve management of cardiovascular disease (CVD). However, the limited number of clinical pharmacists employed in a clinic may not impact the large number of complex patients needing the services. We have developed a remote telehealth service provided by clinical pharmacists to complement CVD services provided by on-site clinical pharmacists and aid sites without a clinical pharmacist. This cardiovascular risk service (CVRS) has been studied in two NIH-funded trials, however, we identified barriers to optimal intervention implementation. The purpose of this study is to examine how to implement the CVRS into medical offices and see if the intervention will be sustained. METHODS: This is a 5-year, pragmatic, cluster-randomized clinical trial in 13 primary care clinics across the US. We randomized clinics to receive CVRS or usual care and will enroll 325 patient subjects and 288 key stakeholder subjects. We have obtained access to the electronic medical records (EMRs) of all study clinics to recruit subjects and provide the pharmacist intervention. The intervention is staggered so that after 12 months, the usual care sites will receive the intervention for 12 months. Follow-up will be accomplished though medical record abstraction at baseline, 12 months, 24 months, and 36 months. CONCLUSIONS: This study will enroll subjects through 2021 and results will be available in 2024. This study will provide unique information on how the CVRS provided by remote clinical pharmacists can be effectively implemented in medical offices, many of which already employ on-site clinical pharmacists. CLINICAL TRIAL REGISTRATION INFORMATION: NCT03660631: http://clinicaltrials.gov/ct2/show/NCT03660631.

A pharmacist intervention for monitoring and treating hypertension using bidirectional texting: PharmText BP.

BACKGROUND: New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists located remotely. The purpose of this study is to evaluate whether the BP texting approach combined with a pharmacist-based intervention improves BP management and to determine if the approach is cost effective. METHODS: This study is a randomized, prospective trial in four primary care offices that serve patients in rural areas. Subjects will receive standardized research BP measurements at baseline, 6 and 12 months. The primary outcome will be differences between the intervention and control group in mean systolic BP at 12 months. Secondary outcomes will include systolic BP at 6 months; diastolic BP at 6 and 12 months, number of medication changes and costs. CONCLUSIONS: This study plans to enroll subjects through 2022, follow-up will be completed in 2023 and results will be available in 2024. This study will provide information on whether a combined approach using texting of home BP values and a pharmacist-based telehealth services can improve BP control.

Evaluation of a clinical pharmacist team-based telehealth intervention in a rural clinic setting: a pilot study of feasibility, organizational perceptions, and return on investment.

BACKGROUND: Remote, centralized clinical pharmacist services provided by board-certified clinical pharmacists have been shown to effectively assist in chronic disease management. We assess the feasibility of implementing a pharmacist-led, remote, centralized pharmacy service to improve A1c levels in patient with diabetes in a rural clinic setting. METHODS: This was a non-randomized pilot and feasibility study. Participants were enrolled in a pharmacist-led telehealth intervention service, with data prior to enrollment used as baseline data for control. To be included, patients needed to have A1c readings of greater than 7% to be considered uncontrolled. A1c changes were reported for two groups based on A1c ranges: between 7 and 10% and ≥ 10%. Clinical pharmacists and clinical pharmacy interns initiated contact with patients via telephone communication and managed the patients remotely. The following outcomes were evaluated: organization perceptions (patients, providers, and clinic staff), changes in A1c, medication discrepancies, impact of an internally operated Patient Assistance Program, and potential return on investment (ROI). RESULTS: Fifty-two patients were initially identified and referred to the service with 43 patients consenting to participate in the intervention. Patient and provider survey responses were recorded. In the initial analysis occurring during the first 3 to 5 months of the program, there was considerable improvement in diabetes control as measured by A1c. For patients with uncontrolled diabetes with a baseline A1c > 7% but less than < 10% and ≥ 10%, the intervention resulted in an A1c decrease of 0.57% and 2.55%, respectively. Clinical pharmacists and clinical pharmacy interns identified at least one medication discrepancy in 44% of patients, with number of discrepancies ranging from 1 to 5 per patient. At the conclusion of the study window, 42 potentially billable encounters were documented, which would have generated a net profit of $1140 USD, had they been submitted for reimbursement. Given the potential revenue generation, the service theoretically yields a ROI of 1.4 to 1. CONCLUSIONS: Initial results suggest that a pharmacist-led telehealth intervention has potential to decrease A1c levels in patients with diabetes, assist in identification of medication discrepancies, provide a positive return on investment for rural clinics, and potentially increase reimbursement for providers and clinics tasked with managing patients with uncontrolled diabetes.

A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence.

BACKGROUND: Numerous studies have demonstrated the value of including pharmacists in team-based care to improve adherence to cardiovascular (CV) guidelines, medication adherence, and risk factor control. However, there is limited information on whether these models can be successfully implemented more widely in diverse settings and populations. The purpose of this study is to evaluate whether a centralized, web-based cardiovascular risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics. METHODS: This study is a prospective trial in 20 primary care offices stratified by the percent of under-represented minorities and then randomized to either the CVRS intervention or usual care. The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months. The primary outcome is the difference in guideline adherence between groups. Data will also be abstracted from the medical record at 24 months to determine if the intervention effect is sustained after it is discontinued. CONCLUSIONS: Patient enrollment will continue through 2016, with results expected in 2019. This study will provide information on whether a distant, centralized CVRS can be implemented in large numbers of medical offices, if it is effective in diverse populations, and if there is a long-term sustained effect.

A centralized cardiovascular risk service to improve guideline adherence in private primary care offices.

BACKGROUND: Many large health systems now employ clinical pharmacists in team-based care to assist patients and physicians with management of cardiovascular (CV) diseases. However, small private offices often lack the resources to hire a clinical pharmacist for their office. The purpose of this study is to evaluate whether a centralized, web-based CV risk service (CVRS) managed by clinical pharmacists will improve guideline adherence in primary care medical offices in rural and small communities. METHODS: This study is a cluster randomized prospective trial in 12 primary care offices. Medical offices were randomized to either the CVRS intervention or usual care. The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months. Primary outcomes will include adherence to treatment guidelines and control of key CV risk factors. Data will also be abstracted from the medical record at 30 months to determine if the intervention effect is sustained after it is discontinued. CONCLUSIONS: This study will enroll subjects through 2015 and results will be available in 2018. This study will provide information on whether a distant, centralized CV risk service can improve guideline adherence in medical offices that lack the resources to employ clinical pharmacists.