Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Kennelty K

PROVIDER: S-EPMC10234512 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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

Kennelty Korey K Coffey Christopher S CS Ardery Gail G Uribe Liz L Yankey Jon J Ecklund Dixie D James Paul A PA Vander Weg Mark W MW Chrischilles Elizabeth A EA Christensen Alan J AJ Polgreen Linnea A LA Gryzlak Brian B Carter Barry L BL

Journal of the American College of Clinical Pharmacy : JACCP 20210702 10

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 37265855

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Project description:BackgroundThe 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 resultsThis 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).ConclusionsThe 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 registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT 01983813.

Project description:Rationale & objectiveThe study aimed to develop, implement, and evaluate a clinical decision support (CDS) system for chronic kidney disease (CKD) in a primary care setting, with the goal of improving CKD care in adults.Study designThis was a cluster randomized trial.Setting & participantsA total of 32 Midwestern primary care clinics were randomly assigned to either receive usual care or CKD-CDS intervention. Between April 2019 and March 2020, we enrolled 6,420 patients aged 18-75 years with laboratory-defined glomerular filtration rate categories of CKD Stage G3 and G4, and 1 or more of 6 CKD care gaps: absence of a CKD diagnosis, suboptimal blood pressure or glycated hemoglobin levels, indication for angiotensin-converting enzyme inhibitor or angiotensin receptor blocker but not prescribed, a nonsteroidal anti-inflammatory agent on the active medication list, or indication for a nephrology referral.InterventionThe CKD-CDS provided personalized suggestions for CKD care improvement opportunities directed to both patients and clinicians at primary care encounters.OutcomesWe assessed the proportion of patients meeting each of 6 CKD-CDS quality metrics representing care gap resolution after 18 months.ResultsThe adjusted proportions of patients meeting quality metrics in CKD-CDS versus usual care were as follows: CKD diagnosis documented (26.6% vs 21.8%; risk ratio [RR], 1.17; 95% CI, 0.91-1.51); angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescribed (15.9% vs 16.1%; RR, 0.95; 95% CI, 0.76-1.18); blood pressure control (20.4% vs 20.2%; RR, 0.98; 95% CI, 0.84-1.15); glycated hemoglobin level control (21.4% vs 22.1%; RR, 1.00; 95% CI, 0.80-1.24); nonsteroidal anti-inflammatory agent not on the active medication list (51.5% vs 50.4%; RR, 1.03; 95% CI, 0.90-1.17); and referral or visit to a nephrologist (38.7% vs 36.1%; RR, 1.02; 95% CI, 0.79-1.32).LimitationsWe encountered an overall reduction in expected primary care encounters and obstacles to point-of-care CKD-CDS utilization because of the coronavirus disease 2019 pandemic.ConclusionsThe CKD-CDS intervention did not lead to a significant improvement in CKD quality metrics. The challenges to CDS use during the coronavirus disease 2019 pandemic likely influenced these results.FundingNational Institute of Diabetes and Digestive and Kidney Diseases (R18DK118463).Trial registrationclinicaltrials.gov Identifier: NCT03890588.

Project description:BackgroundTo evaluate the effectiveness of a structured prescription review and prescriber feedback program in reducing prescribing errors in government primary care clinics within an administrative region in Malaysia.MethodsThis was a three group, pragmatic, cluster randomised trial. In phase 1, we randomised 51 clinics to a full intervention group (prescription review and league tables plus authorised feedback letter), a partial intervention group (prescription review and league tables), and a control group (prescription review only). Prescribers in these clinics were the target of our intervention. Prescription reviews were performed by pharmacists; 20 handwritten prescriptions per prescriber were consecutively screened on a random day each month, and errors identified were recorded in a standardised data collection form. Prescribing performance feedback was conducted at the completion of each prescription review cycle. League tables benchmark prescribing errors across clinics and individual prescribers, while the authorised feedback letter detailed prescribing performance based on a rating scale. In phase 2, all clinics received the full intervention. Pharmacists were trained on data collection, and all data were audited by researchers as an implementation fidelity strategy. The primary outcome, percentage of prescriptions with at least one error, was displayed in p-charts to enable group comparison.ResultsA total of 32,200 prescriptions were reviewed. In the full intervention group, error reduction occurred gradually and was sustained throughout the 8-month study period. The process mean error rate of 40.7% (95% CI 27.4, 29.5%) in phase 1 reduced to 28.4% (95% CI 27.4, 29.5%) in phase 2. In the partial intervention group, error reduction was not well sustained and showed a seasonal pattern with larger process variability. The phase 1 error rate averaging 57.9% (95% CI 56.5, 59.3%) reduced to 44.8% (95% CI 43.3, 46.4%) in phase 2. There was no evidence of improvement in the control group, with phase 1 and phase 2 error rates averaging 41.1% (95% CI 39.6, 42.6%) and 39.3% (95% CI 37.8, 40.9%) respectively.ConclusionsThe rate of prescribing errors in primary care settings is high, and routine prescriber feedback comprising league tables and a feedback letter can effectively reduce prescribing errors.Trial registrationNational Medical Research Register: NMRR-12-108-11,289 (5th March 2012).

Project description:BackgroundThe number and complexity of patients being admitted to hospitals is rising and some patients may not receive a full clinical pharmacy review or be reviewed as regularly as needed during their inpatient stay. This is a risk factor for medication errors. Clinical prioritisation identifies patients who are high-risk and most in need of a pharmacist review, targeting finite pharmacy resources to patients who will benefit the most.ObjectivesAssess and enhance clinical prioritisation within a hospital pharmacy department.MethodsThe study was conducted in a large urban academic teaching hospital. A cross-sectional survey of clinical pharmacists in the hospital was conducted to establish the patient clinical criteria they prioritise in their work. A clinical prioritisation tool was developed based on survey findings and was integrated into an existing electronic pharmacy care interface. A pre- and post-intervention study was conducted, consisting of data collection for five days pre- and five days post-implementation of the tool. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed by thematic analysis.ResultsOf 39 eligible pharmacists, 37 (95%) responded to the survey. The top-rated prioritisation criteria, including medicines reconciliation tasks and high-risk medicines, helped to inform the content of the clinical prioritisation tool. Post-intervention, there were more Level 1 complex patients reviewed by pharmacists and fewer Level 3 stable patients compared to pre-intervention. Tool sensitivity ranged from 51 to 88%, depending on the experience of the pharmacist using the tool. High levels of satisfaction with clinical prioritisation were reported by those using the tool.ConclusionThis newly developed clinical prioritisation tool has the potential to support pharmacists in identifying and reviewing patients in a more targeted manner than practice prior to tool development. Continued development and validation of the tool is essential, with a focus on developing a fully automated tool.

Project description:BackgroundThe COVID-19 outbreak has increased challenges associated with health management, especially cancer management. In an effort to provide continuous pharmaceutical care to cancer patients, Sun Yat-sen University Cancer Center (SYSUCC) implemented a remote pharmacy service platform based on its already existing web-based hospital app known as Cloud SYSUCC.ObjectiveThe aim of this study was to investigate the characteristics, acceptance, and initial impact of the Cloud SYSUCC app during a COVID-19 outbreak in a tertiary cancer hospital in China.MethodsThe total number of online prescriptions and detailed information on the service were obtained during the first 6 months after the remote service platform was successfully set up. The patients' gender, age, residence, primary diagnosis, drug classification, weekly number of prescriptions, and prescribed drugs were analyzed. In addition, a follow-up telephonic survey was conducted to evaluate patients' satisfaction in using the remote prescription service.ResultsA total of 1718 prescriptions, including 2022 drugs for 1212 patients, were delivered to 24 provinces and municipalities directly under the Central Government of China between February 12, 2020, and August 11, 2020. The majority of patients were female (841/1212, 69.39%), and 90.18% (1093/1212) of them were aged 31-70 years old. The top 3 primary diagnoses for which remote medical prescriptions were made included breast cancer (599/1212, 49.42%), liver cancer (249/1212, 20.54%), and thyroid cancer (125/1212, 10.31%). Of the 1718 prescriptions delivered, 1435 (83.5%) were sent to Guangdong Province and 283 (16.5%) were sent to other provinces in China. Of the 2022 drugs delivered, 1012 (50.05%) were hormonal drugs. The general trend in the use of the remote prescription service declined since the 10th week. A follow-up telephonic survey found that 88% (88/100) of the patients were very satisfied, and 12% (12/100) of the patients were somewhat satisfied with the remote pharmacy service platform.ConclusionsThe remote pharmacy platform Cloud SYSUCC is efficient and convenient for providing continuous pharmaceutical care to patients with cancer during the COVID-19 crisis. The widespread use of this platform can help to reduce person-to-person transmission as well as infection risk for these patients. Further efforts are needed to improve the quality and acceptance of the Cloud SYSUCC platform, as well as to regulate and standardize the management of this novel service.

Project description:Lightweight, high stability, and high-temperature adaptability are the primary considerations when designing the primary mirror of a micro/nano satellite remote sensing camera. In this paper, the optimized design and experimental verification of the large-aperture primary mirror of the space camera with a diameter of Φ610 mm is carried out. First, the design performance index of the primary mirror was determined according to the coaxial tri-reflective optical imaging system. Then, SiC, with excellent comprehensive performance, was selected as the primary mirror material. The initial structural parameters of the primary mirror were obtained using the traditional empirical design method. Due to the improvement of SiC material casting complex structure reflector technology level, the initial structure of the primary mirror was improved by integrating the flange with the primary mirror body design. The support force acts directly on the flange, changing the transmission path of the traditional back plate support force, and has the advantage that the primary mirror surface shape accuracy can be maintained for a long time when subjected to shock, vibration, and temperature changes. Then, a parametric optimization algorithm based on the mathematical method of compromise programming was used to optimize the design of the initial structural parameters of the improved primary mirror and the flexible hinge, and finite element simulation was conducted on the optimally designed primary mirror assembly. Simulation results show that the root mean square (RMS) surface error is less than λ/50 (λ = 632.8 nm) under gravity, 4 °C temperature rise, and 0.01 mm assembly error. The mass of the primary mirror is 8.66 kg. The maximum displacement of the primary mirror assembly is less than 10 μm, and the maximum inclination angle is less than 5″. The fundamental frequency is 203.74 Hz. Finally, after the primary mirror assembly was precision manufactured and assembled, the surface shape accuracy of the primary mirror was tested by ZYGO interferometer, and the test value was 0.02 λ. The vibration test of the primary mirror assembly was conducted at a fundamental frequency of 208.25 Hz. This simulation and experimental results show that the optimized design of the primary mirror assembly meets the design requirements of the space camera.

Project description:ImportanceBest practices for improving access to assessment of hereditary cancer risk in primary care are lacking.ObjectiveTo compare 2 population-based engagement strategies for identifying primary care patients with a family or personal history of cancer and offering eligible individuals genetic testing for cancer susceptibility.Design, setting, and participantsThe EDGE (Early Detection of Genetic Risk) clinical trial cluster-randomized 12 clinics from 2 health care systems in Montana, Wyoming, and Washington state to 1 of 2 engagement approaches for assessment of hereditary cancer risk in primary care. The study population included 95 623 English-speaking patients at least 25 years old with a primary care visit during the recruitment window between April 1, 2021, and March 31, 2022.InterventionThe intervention comprised 2 risk assessment engagement approaches: (1) point of care (POC), conducted by staff immediately preceding clinical appointments, and (2) direct patient engagement (DPE), where letter and email outreach facilitated at-home completion. Patients who completed risk assessment and met prespecified criteria were offered genetic testing via a home-delivered saliva testing kit at no cost.Main outcomes and measuresPrimary outcomes were the proportion of patients with a visit who (1) completed the risk assessment and (2) completed genetic testing. Logistic regression models were used to compare the POC and DPE approaches, allowing for overdispersion and including clinic as a design factor. An intention-to-treat analysis was used to evaluate primary outcomes.ResultsOver a 12-month window, 95 623 patients had a primary care visit across the 12 clinics. Those who completed the risk assessment (n = 13 705) were predominately female (64.7%) and aged between 65 and 84 years (39.6%). The POC approach resulted in a higher proportion of patients completing risk assessment than the DPE approach (19.1% vs 8.7%; adjusted odds ratio [AOR], 2.68; 95% CI, 1.72-4.17; P < .001) but a similar proportion completing testing (1.5% vs 1.6%; AOR, 0.96; 95% CI, 0.64-1.46; P = .86). Among those eligible for testing, POC test completion was approximately half of that for the DPE approach (24.7% vs 44.7%; AOR, 0.49; 95% CI, 0.37-0.64; P < .001). The proportion of tested patients identified with an actionable pathogenic variant was significantly lower for the POC approach than the DPE approach (3.8% vs 6.6%; AOR, 0.61; 95% CI, 0.44-0.85; P = .003).Conclusions and relevanceIn this cluster randomized clinical trial of risk assessment delivery, POC engagement resulted in a higher rate of assessment of hereditary cancer risk than the DPE approach but a similar rate of genetic testing completion. Using a combination of engagement strategies may be the optimal approach for greater reach and impact.Trial registrationClinicalTrials.gov Identifier: NCT04746794.

Dataset Information

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

Background

Methods

Results

Conclusions

Clinical trial registration

Publications

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

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