Effect of a Physician/Pharmacist Collaborative Care Model on Time in Target Range for Systolic Blood Pressure: Post Hoc Analysis of the CAPTION Trial.

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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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Targeting of uncontrolled hypertension in the emergency department (TOUCHED): Design of a randomized controlled trial.

BACKGROUND: Uncontrolled or undiagnosed hypertension (HTN) is estimated to be as high as 46% in emergency departments (EDs). Uncontrolled HTN contributes significantly to cardiovascular morbidity and disproportionately affects communities of color. EDs serve high risk populations with uncontrolled conditions that are often missed by other clinical settings and effective interventions for uncontrolled HTN in the ED are critically needed. The ED is well situated to decrease the disparities in HTN control by providing a streamlined intervention to high risk populations that may use the ED as their primary care. METHODS: Targeting of UnControlled Hypertension in the Emergency Department (TOUCHED), is a two-arm single site randomized controlled trial of 770 adults aged 18-75 presenting to the ED with uncontrolled HTN comparing (1) usual care, versus (2) an Educational and Empowerment (E2) intervention that integrates a Post-Acute Care Hypertension Consultation (PACHT-c) with a mobile health BP self-monitoring kit. The primary outcome is differences in mean systolic blood pressure (SBP) at 6-months post enrollment. Secondary outcomes include differences in mean SBP and mean diastolic BP (DBP) at 3-months and mean DBP at 6-months. Additionally, improvement in cardiovascular risk score, medication adherence, primary care engagement, and HTN knowledge will also be assessed as part of this study. CONCLUSIONS: The TOUCHED trial will be instrumental in determining the effectiveness of a brief ED-based intervention that is portable to other urban EDs with high-risk populations. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03749499.

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 cluster randomized trial to evaluate a centralized remote clinical pharmacy service in large, health system primary care clinics.

Background: We developed a remote cardiovascular risk service (CVRS) managed by clinical pharmacists to support primary care teams. The purpose of this study was to examine whether the CVRS could improve guideline adherence in primary care clinics with diverse geographic and patient characteristics. Methods: This study was a cluster-randomized trial initiated in 20 primary care clinics across the US. Clinics were stratified as high or low minority and then randomized to receive the intervention or maintain usual care for 12 months. The primary outcome was adherence to relevant The Guideline Advantage (TGA) criteria met. TGA is a compilation of criteria from practice guidelines intended to improve the quality of primary care. Post-hoc outcomes included changes in individual TGA measures. Results: A total of 401 study subjects were included in the analysis. Mean TGA scores remained the same in the intervention group (n=193, 0.72) and slightly decreased in the usual care group (n=208, 0.67 to 0.66) over the 12-month study period. There was no significant difference between the mean TGA scores in intervention and usual care groups for the overall population at 12 months (0.72 versus 0.66 respectively, p=0.10). For under-represented minority subjects, there was no significant difference between TGA scores at 12 months (n=186; 0.70 versus 0.67, respectively, p=0.50). In a post-hoc analysis of subjects uncontrolled at baseline, there was a significant improvement in systolic BP at 12 months in the intervention group versus usual care (model-based difference of -8.03mmHg, p=0.03). Conclusions: Improvements in individual TGA measures were limited, in part, due to higher than expected baseline TGA scores. Future studies of this model should focus on patients with uncontrolled conditions at high risk for cardiovascular events. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02215408; https://clinicaltrials.gov/ct2/show/NCT02215408?id=NCT02215408.

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.

The Cardiovascular Effects of Treatment with Hydroxychloroquine and Azithromycin.

Hydroxychloroquine combined with azithromycin has been investigated for activity against coronavirus disease 2019 (COVID-19), but concerns about adverse cardiovascular (CV) effects have been raised. This study evaluated claims data to determine if risks for CV events were increased with hydroxychloroquine alone or combined with azithromycin. We identified data from 43,752 enrollees that qualified for analysis. The number of CV events increased by 25 (95% confidence interval [CI]: 8, 42, p=0.005) per 1000 people per year of treatment with hydroxychloroquine alone compared with pretreatment levels and by 201 (95% CI: 145, 256, p<0.001) events per 1000 people per year when individuals took hydroxychloroquine and azithromycin. These rates translate to an additional 0.34 (95% CI: 0.11, 0.58) CV events per 1000 patients placed on a 5-day treatment with hydroxychloroquine monotherapy and 2.75 (95% CI: 1.99, 3.51) per 1000 patients on a 5-day treatment with both hydroxychloroquine and azithromycin. The rate of adverse events increased with age following exposure to hydroxychloroquine alone and combined with azithromycin. For females aged 60 to 79 years prescribed hydroxychloroquine, the rate of adverse CV events was 0.92 per 1000 patients on 5 days of therapy, but it increased to 4.78 per 1000 patients when azithromycin was added. The rate of adverse CV events did not differ significantly from zero for patients 60 years of age or younger. These data suggest that hydroxychloroquine with or without azithromycin is likely safe in individuals under 60 years of age if they do not have additional CV risks. However, the combination of hydroxychloroquine and azithromycin should be used with extreme caution in older patients.

Self-identified barriers to rural mental health services in Iowa by older adults with multiple comorbidities: qualitative interview study.

OBJECTIVES: Individuals in rural areas face critical health disparities, including limited access to mental healthcare services and elevated burden of chronic illnesses. While disease outcomes are often worse in individuals who have both physical and mental comorbidities, few studies have examined rural, chronically-ill older adults' experiences accessing mental health services. The aim of the study was to determine barriers to finding, receiving and adhering to mental health treatments in this population to inform future interventions delivering services. DESIGN: We conducted a qualitative study of barriers and facilitators to mental healthcare access. 19 interviews were analysed deductively for barriers using a modified version of Penchansky and Thomas's theory of access as an analytical framework. SETTING: This study was conducted remotely using telephonic interviews. Patients were located in various rural Iowa towns and cities. PARTICIPANTS: 15 rural Iowan older adults with multiple physical comorbidities as well as anxiety and/or depression. RESULTS: We found that while patients in this study often felt that their mental health was important to address, they experienced multiple, but overlapping, barriers to services that delayed care or broke their continuity of receiving care, including limited knowledge of extant services and how to find them, difficulties obtaining referrals and unsatisfactory relationships with mental health service providers. CONCLUSIONS: Our findings indicate that intervention across multiple domains of access is necessary for successful long-term management of mental health disorders for patients with multiple chronic comorbidities in Iowa.

A texting-based blood pressure surveillance intervention.

The authors examined whether using home BP measurements collected via a custom-built bi-directional-texting platform incorporated into patients' electronic medical records would lead to treatment calibration and improved BP management. Patients were randomized to either the intervention group and collected home measurements based on reminders and reported via bi-directional texting, or to the control group, with home BP measurement reporting via standard practice (eg, phone, electronic medical record portal) and instructed to return 7 morning and 7 evening BP measurements. Outcomes included number of BP measurements submitted, the number of medication changes, reduction in BP, and BP control. 72% of the intervention group submitted at least 14 readings, compared with 45% of the control group. BP control improved in both groups. However, the authors found no statistically significant difference in BP or the number of BP-medication changes at 1, 3, or 6 months compared with the control group.

Cluster-Randomized Trial to Evaluate a Centralized Clinical Pharmacy Service in Private Family Medicine Offices.

BACKGROUND: The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities. METHODS AND RESULTS: This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects. There was no improvement in the Guideline Advantage score from baseline to 12 months in the control group (64.7% versus 63.1%, respectively; P=0.21). There was a statistically significant improvement in the intervention group from 63.3% at baseline to 67.8% at 12 months (P=0.02). The estimated benefit of the intervention was 5.0%±2.4% (95% confidence interval=-0.5% to 10.4%; P=0.07). Several criteria were significantly better for intervention subjects, including appropriate statin therapy (P<0.001), body mass index, screening (P<0.001), and alcohol screening (P<0.001). Only 13.7% of subjects with diabetes mellitus had hemoglobin A1c at goal at baseline, and this increased to 30.8% and 21.0% in the intervention and control group, respectively, at 12 months (P=0.10). CONCLUSIONS: The centralized, remote pharmacist intervention was successfully implemented. The improvements in outcomes were modest, in part because of higher than expected baseline guideline adherence. Future studies of this model should focus on patients with uncontrolled conditions at high risk for cardiovascular events. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT 01983813.

Pharmacist Intervention for Blood Pressure Control in Patients with Diabetes and/or Chronic Kidney Disease.

OBJECTIVES: The objectives of this study were to determine if hypertensive patients with comorbid diabetes mellitus (DM) and/or chronic kidney disease (CKD) receiving a pharmacist intervention had a greater reduction in mean blood pressure (BP) and improved BP control at 9 months compared with those receiving usual care; and compare Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guideline and 2014 guideline (JNC 8) BP control rates in patients with DM and/or CKD. METHODS: This cluster randomized trial included 32 medical offices in 15 states. Clinical pharmacists made treatment recommendations to physicians at intervention sites. This post hoc analysis evaluated mean BP and BP control rates in the intervention and control groups. MAIN RESULTS: The study included 335 patients (227 intervention, 108 control) when mean BP and control rates were evaluated by JNC 7 inclusion and control criteria. When JNC 8 inclusion and control criteria were applied, 241 patients (165 intervention, 76 control) remained and were included in the analysis. The pharmacist-intervention group had significantly greater mean systolic blood pressure reduction compared with usual care at 9 months (8.64 mm Hg; 95% confidence interval [CI] -12.8 to -4.49, p<0.001). The pharmacist-intervention group had significantly higher BP control at 9 months than usual care by either the JNC 7 or JNC 8 inclusion and control groups (adjusted odds ratio [OR] 1.97, 95% CI 1.01-3.86, p=0.0470 and OR 2.16, 95% CI 1.21-3.85, p=0.0102, respectively). PRINCIPAL CONCLUSIONS: This study demonstrated that a physician-pharmacist collaborative intervention was effective in reducing mean systolic BP and improving BP control in patients with uncontrolled hypertension with DM and/or CKD, regardless of which BP guidelines were used.

Team-Based Care with Pharmacists to Improve Blood Pressure: a Review of Recent Literature.

PURPOSE OF REVIEW: We review studies published since 2014 that examined team-based care strategies and involved pharmacists to improve blood pressure (BP). We then discuss opportunities and challenges to sustainment of team-based care models in primary care clinics. RECENT FINDINGS: Multiple studies presented in this review have demonstrated that team-based care including pharmacists can improve BP management. Studies highlighted the cost-effectiveness of a team-based pharmacy intervention for BP control in primary care clinics. Little information was found on factors influencing sustainability of team-based care interventions to improve BP control. Future work is needed to determine the best populations to target with team-based BP programs and how to implement team-based approaches utilizing pharmacists in diverse clinical settings. Future studies need to not only identify unmet clinical needs but also address reimbursement issues and stakeholder engagement that may impact sustainment of team-based care interventions.

Selection bias and subject refusal in a cluster-randomized controlled trial.

BACKGROUND: Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. METHODS: The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE) study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site's allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. RESULTS: There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1.92). CONCLUSIONS: Though there appeared to be a higher consent rate for females than for males, the overall impact of potential selection bias and refusal to participate was minimal. Without rigorous methodology, selection bias may be a threat to external validity in cluster-randomized trials. TRIAL REGISTRATION: NCT01983813 . Date of registration: Oct. 28, 2013.

Cost-utility analysis of physician-pharmacist collaborative intervention for treating hypertension compared with usual care.

OBJECTIVE: To estimate long-term costs and outcomes attributable to a physician-pharmacist collaborative intervention compared with physician management alone for treating essential hypertension. METHODS: A Markov model cohort simulation with a 6-month cycle length to predict acute coronary syndrome, stroke, and heart failure throughout lifetime was performed. A cohort of 399 patients was obtained from two prospective, cluster randomized controlled clinical trials implementing physician-pharmacist collaborative interventions in community-based medical offices in the Midwest, USA. Framingham risk equations and other algorithms were used to predict the vascular diseases. SBP reduction due to the interventions deteriorated until 5 years. Direct medical costs using a payer perspective were adjusted to 2015 dollar value, and the main outcome was quality-adjusted life years (QALYs); both were discounted at 3%. The intervention costs were estimated from the trials, whereas the remaining parameters were from published studies. A series of sensitivity analyses including changing patient risks of vascular diseases, probabilistic sensitivity analysis, and a cost-effectiveness acceptability curve were performed. RESULTS: The lifetime incremental costs were $26 807.83 per QALY (QALYs gained = 0.14). The intervention provided the greatest benefit for the high-risk patients, moderate benefit for the trial patients, and the lowest benefit for the low-risk patients. If a payer is willing to pay $50 000 per QALY gained, in 48.6% of the time the intervention would be cost-effective. CONCLUSION: Team-based care such as a physician-pharmacist collaboration appears to be a cost-effective strategy for treating hypertension. The intervention is most cost-effective for high-risk patients.

Physician-Pharmacist Collaborative Management: Narrowing the Socioeconomic Blood Pressure Gap.

Physician-pharmacist collaboration improves blood pressure, but there is little information on whether this model can reduce the gap in healthcare disparities. This trial involved 32 medical offices in 15 states. A clinical pharmacist was embedded within each office and made recommendations to physicians and patients in intervention offices. The purpose of the present analysis was to evaluate whether the pharmacist intervention could reduce healthcare disparities by improving blood pressure in high-risk racial and socioeconomic subjects compared with the control group. The analyses in minority subjects were prespecified secondary analyses, but all other comparisons were secondary, post hoc analyses. The 9-month visit was completed by 539 patients: 345 received the intervention, and 194 were in the control group. Following the intervention, mean systolic blood pressure was found to be 7.3 mm Hg (95% confidence interval 2.4, 12.3) lower in subjects from racial minority groups who received the intervention compared with the control group (P=0.0042). Subjects with ≤12 years of education in the intervention group had a systolic blood pressure 8.1 mm Hg (95% confidence interval 3.2, 13.1) lower than the control group with lower education (P=0.0001). Similar reductions in blood pressure occurred in patients with low incomes, those receiving Medicaid, or those without insurance. This study demonstrated that a pharmacist intervention reduced racial and socioeconomic disparities in the treatment of blood pressure. Although disparities in blood pressure were reduced by the intervention, there were still nonsignificant gaps in mean systolic blood pressure when compared with intervention subjects not at risk. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00935077.