scholarly journals Multicomponent intervention to improve blood pressure management in chronic kidney disease: a protocol for a pragmatic clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e054065
Author(s):  
John L Kilgallon ◽  
Michael Gannon ◽  
Zoe Burns ◽  
Gearoid McMahon ◽  
Patricia Dykes ◽  
...  

IntroductionThe purpose of this study is to incorporate behavioural economic principles and user-centred design principles into a multicomponent intervention for the management of uncontrolled hypertension (HTN) in chronic kidney disease (CKD) in primary care.Methods and analysisThis is a multicentre, pragmatic, controlled trial cluster-randomised at the clinician level at The Brigham and Women’s Practice -Based Research Network of 15 practices. Of 220 total clinicians, 184 were eligible to be enrolled, and the remainder were excluded (residents and clinicians who see urgent care or walk-in patients); no clinicians opted out. The intervention consists of a clinical decision support system based in behavioural economic and user-centred design principles that will: (1) synthesise existing laboratory tests, medication orders and vital sign data; (2) increase recognition of CKD, (3) increase recognition of uncontrolled HTN in CKD patients and (4) deliver evidence-based CKD and HTN management recommendations. The primary endpoint is the change in mean systolic blood pressure between baseline and 6 months compared across arms. We will use the Reach Effectiveness Adoption Implementation Maintenance framework. At the conclusion of this study, we will have: (1) validated an intervention that combines laboratory tests, medication records and clinical information collected by electronic health records to recognise uncontrolled HTN in CKD patients and recommend a course of care, (2) tested the effectiveness of said intervention and (3) collected information about the implementation of the intervention that will aid in dissemination of the intervention to other practice settings.Ethics and disseminationThe Human Subjects Institutional Review Board at Brigham and Women’s Hospital provided an expedited review and approval for this study protocol, and a Data Safety Monitoring Board will ensure the ongoing safety of the trial.Trial registration numberNCT03679247.

2021 ◽  
Author(s):  
John L. Kilgallon ◽  
Michael Gannon ◽  
Zoe Burns ◽  
Gearoid McMahon ◽  
Patricia Dykes ◽  
...  

Abstract BackgroundChronic kidney disease is common, leads to end stage renal disease, and is a major risk factor for cardiovascular disease. Although both chronic kidney disease and hypertension, the main risk factor for disease progression, are not difficult to diagnose, both often go unrecognized by primary care providers. It has yet to be determined whether a multicomponent intervention that leverages electronic health records and behavioral economic principles can improve diagnosis, treatment, and control of hypertension in chronic kidney disease. MethodsThe aim of this pragmatic, cluster-randomized controlled trial is to evaluate a clinical decision support system based in behavioral economic and user-centered design principles that will: 1) synthesize existing laboratory tests, medication orders, and vital sign data; 2) increase recognition of chronic kidney disease, 3) increase recognition of uncontrolled hypertension in chronic kidney disease patients, and 4) deliver evidence-based chronic kidney disease and hypertension management recommendations. The intervention has been designed and piloted. The primary endpoint is the change in mean systolic blood pressure between baseline and 6 months compared across arms. We will use an effectiveness-implementation hybrid trial type 2 design and the RE-AIM framework to guide evaluation of process and outcome measures. Patients with two prior eGFR 16-59 mL/min/1.73m2 separated by 90 days or two prior UACR >30mg/g, one SBP >140 mmHg within the 2 years preceding the enrollment visit, and SBP >140 mmHg at enrollment will be included; patients with a most recent eGFR ≤ 20 or 2 previous eGFRs within 2 years separated by at least 90 days ≤ 15 will be excluded. Rao-Scott chi-square tests and GEE z-tests will be used. We calculated that 497 evaluable patients per arm and an average of 6 patients per provider would provide over 80% power to detect an average 3 mmHg SBP decrease in the intervention arm. Discussionhe proposed study, if successful, would be the first to improve hypertension in chronic kidney disease patients through a multicomponent intervention that incorporates clinical decision support and behavioral methods. Trial RegistrationClinicalTrials.gov identifier: NCT03679247. Registered September 20, 2018, https://clinicaltrials.gov/ct2/show/NCT03679247?term=Samal&draw=2&rank=1.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
N Landler ◽  
S Bro ◽  
B Feldt-Rasmussen ◽  
D Hansen ◽  
A.L Kamper ◽  
...  

Abstract Background The cardiovascular mortality of patients with chronic kidney disease (CKD) is 2–10 times higher than in the average population. Purpose To estimate the prevalence of abnormal cardiac function or structure across the stages CKD 1 to 5nonD. Method Prospective cohort study. Patients with CKD stage 1 to 5 not on dialysis, aged 30 to 75 (n=875) and age-/sex-matched controls (n=173) were enrolled consecutively. All participants underwent a health questionnaire, ECG, morphometric and blood pressure measurements. Blood and urine were analyzed. Echocardiography was performed. Left ventricle (LV) hypertrophy, dilatation, diastolic and systolic dysfunction were defined according to current ESC guidelines. Results 63% of participants were men. Mean age was 58 years (SD 12.6 years). Mean eGFR was 46.7 mL/min/1,73 m (SD 25.8) for patients and 82.3 mL/min/1,73 m (SD 13.4) for controls. The prevalence of elevated blood pressure at physical exam was 89% in patients vs. 53% in controls. Patients were more often smokers and obese. Left ventricular mass index (LVMI) was slightly, albeit insignificantly elevated at CKD stages 1 & 2 vs. in kontrols: 3.1 g/m2, CI: −0.4 to 6.75, p-value 0.08. There was no significant difference in LV-dilatation between patients and controls. Decreasing diastolic and systolic function was observed at CKD stage 3a and later: LVEF decreased 0.95% (CI: −1.5 to −0.2), GLS increased 0.5 (CI: 0.3 to 0.8), and OR for diastolic dysfunction increased 3.2 (CI 1.4 to 7.3) pr. increment CKD stage group. Conclusion In accordance to previous studies, we observe in the CPHCKD cohort study signs of early increase of LVMI in patients with CKD stage 1 & 2. Significant decline in systolic and diastolic cardiac function is apparent already at stage 3 CKD. Figure 1. Estimated GFR vs. GLS & histogram of GLS Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): The Capital Region of Denmark


2016 ◽  
pp. 160-166 ◽  
Author(s):  
César Augusto Restrepo Valencia ◽  
Jose Vicente Aguirre Arango

Objective: To determine whether patients with chronic kidney disease (CKD) without dialysis their stage impacts the native vitamin D levels. Methods: Patients over 18 years with chronic kidney disease stage 2-5 without dialysis treatment. They demographic, anthropometric variables, degree of sun exposure, disease etiology and laboratory variables related to bone and mineral disorders were evaluated. Study analytical cross-sectional prospective. Descriptive statistical methods for quantitative and qualitative are characterized, and analytical correlation between levels of vitamin D statistical laboratory tests related to bone and mineral disorders, sun exposure and ethnicity variables for each stage were characterized. By descriptive statistical methods, quantitative and qualitative variables were characterized, and analytical statistical correlation between levels of vitamin D with laboratory tests related to bone and mineral disorders, sun exposure and ethnicity for each stage were practiced. Results: 331 patients were evaluated, with a mean age of 71 years, the mestizo majority (71%), 173 women, main etiology of CKD hypertensive nephropathy (33.2%). 21.1% of patients had normal levels of vitamin D, 70.1% insufficient, and 8.8% in deficit. Negative correlation was detected between the levels of vitamin 25(OH)D and serum creatinine, phosphorus, calcium x phosphorus product, PTH, proteins in urine 24 hours and BMI. Positive correlation for calcium and albumin. Positive statistical significance between the levels of vitamin 25(OH)D and sun exposure for 3b and 4 stages was found. Conclusions: In patients with CKD is common to detect low levels of vitamin 25(OH)D, which can contribute to the generation of secondary hyperparathyroidism.


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