The Acute Kidney Outreach to Prevent Deterioration and Death trial: a large pilot study for a cluster-randomized trial

Abstract Background and Objectives The Acute Kidney Outreach to Reduce Deterioration and Death trial was a large pilot study for a cluster-randomized trial of acute kidney injury (AKI) outreach. Methods An observational control (before) phase was conducted in two teaching hospitals (9 miles apart) and their respective catchment areas. In the intervention (after) phase, a working-hours AKI outreach service operated for the intervention hospital/area for 20 weeks, with the other site acting as a control. All AKI alerts in both hospital and community patients were screened for inclusion. Major exclusion criteria were patients who were at the end of life, unlikely to benefit from outreach, lacking mental capacity or already referred to the renal team. The intervention arm included a model of escalation of renal care to AKI patients, depending on AKI stage. The 30-day primary outcome was a combination of death, or deterioration, as shown by any need for dialysis or progression in AKI stage. A total of 1762 adult patients were recruited; 744 at the intervention site during the after phase. Results A median of 3.0 non-medication recommendations and 0.5 medication-related recommendations per patient were made by the outreach team a median of 15.7 h after the AKI alert. Relatively low rates of the primary outcomes of death within 30 days (11–15%) or requirement for dialysis (0.4–3.7%) were seen across all four groups. In an exploratory analysis, at the intervention hospital during the after phase, there was an odds ratio for the combined primary outcome of 0.73 (95% confidence interval 0.42–1.26; P = 0.26). Conclusions An AKI outreach service can provide standardized specialist care to those with AKI across a healthcare economy. Trials assessing AKI outreach may benefit from focusing on those patients with ‘mid-range’ prognosis, where nephrological intervention could have the most impact.

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Pilot study for a cluster randomized trial of community engagement interventions to increase immunization coverage among children 12-23 months of age in India

http://isrctn.com/ ◽

10.1186/isrctn16703097 ◽

2015 ◽

Author(s):

Mira Johri

Keyword(s):

Pilot Study ◽

Randomized Trial ◽

Community Engagement ◽

Immunization Coverage ◽

Cluster Randomized Trial ◽

Engagement Interventions ◽

Cluster Randomized

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Cluster Randomized Trial to Facilitate Breast Cancer Early Diagnosis in a Rural District of Rwanda

Journal of Global Oncology ◽

10.1200/jgo.19.00209 ◽

2019 ◽

pp. 1-13

Author(s):

Lydia E. Pace ◽

Jean Marie Vianney Dusengimana ◽

Lawrence N. Shulman ◽

Lauren E. Schleimer ◽

Cyprien Shyirambere ◽

...

Keyword(s):

Breast Cancer ◽

Randomized Trial ◽

Low Income ◽

Early Stage ◽

Cluster Randomized Trial ◽

Early Stage Disease ◽

Catchment Areas ◽

Hospital Visits ◽

Cluster Randomized ◽

The Impact

PURPOSE Feasible and effective strategies are needed to facilitate earlier diagnosis of breast cancer in low-income countries. The goal of this study was to examine the impact of health worker breast health training on health care utilization, patient diagnoses, and cancer stage in a rural Rwandan district. METHODS We conducted a cluster randomized trial of a training intervention at 12 of the 19 health centers (HCs) in Burera District, Rwanda, in 2 phases. We evaluated the trainings’ impact on the volume of patient visits for breast concerns using difference-in-difference models. We used generalized estimating equations to evaluate incidence of HC and hospital visits for breast concerns, biopsies, benign breast diagnoses, breast cancer, and early-stage disease in catchment areas served by intervention versus control HCs. RESULTS From April 2015 to April 2017, 1,484 patients visited intervention HCs, and 308 visited control HCs for breast concerns. The intervention led to an increase of 4.7 visits/month for phase 1 HCs ( P = .001) and 7.9 visits/month for phase 2 HCs ( P = .007) compared with control HCs. The population served by intervention HCs had more hospital visits (115.1 v 20.5/100,000 person-years, P < .001) and biopsies (36.6 v 8.9/100,000 person-years, P < .001) and higher breast cancer incidence (6.9 v 3.3/100,000 person-years; P = .28). The incidence of early-stage breast cancer was 3.3 per 100,000 in intervention areas and 0.7 per 100,000 in control areas ( P = .048). CONCLUSION In this cluster randomized trial in rural Rwanda, the training of health workers and establishment of regular breast clinics were associated with increased numbers of patients who presented with breast concerns at health facilities, more breast biopsies, and a higher incidence of benign breast diagnoses and early-stage breast cancers.

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A Pilot Study to Assess the Feasibility of a Multicenter Cluster Randomized Trial for the Management of Asymptomatic Persons with a Thrombophilia

Journal of Genetic Counseling ◽

10.1007/s10897-009-9239-7 ◽

2009 ◽

Vol 18 (5) ◽

pp. 475-482 ◽

Cited By ~ 4

Author(s):

Philip S. Wells ◽

Martha L. Louzada ◽

Monica Taljaard ◽

David R. Anderson ◽

Susan R. Kahn ◽

...

Keyword(s):

Pilot Study ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Cluster Randomized

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Improving Care of Patients With Diabetes and CKD: A Pilot Study for a Cluster-Randomized Trial

American Journal of Kidney Diseases ◽

10.1053/j.ajkd.2007.12.039 ◽

2008 ◽

Vol 51 (5) ◽

pp. 777-788 ◽

Cited By ~ 37

Author(s):

Laura Cortés-Sanabria ◽

Carlos E. Cabrera-Pivaral ◽

Alfonso M. Cueto-Manzano ◽

Enrique Rojas-Campos ◽

Graciela Barragán ◽

...

Keyword(s):

Pilot Study ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Patients With Diabetes ◽

Cluster Randomized

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Evaluation of a critical care outreach service in a middle-income country: A stepped wedge cluster randomized trial and nested qualitative study

Journal of Critical Care ◽

10.1016/j.jcrc.2016.07.018 ◽

2016 ◽

Vol 36 ◽

pp. 212-217 ◽

Cited By ~ 8

Author(s):

Alireza Jeddian ◽

Karla Hemming ◽

Antje Lindenmeyer ◽

Arash Rashidian ◽

Leila Sayadi ◽

...

Keyword(s):

Critical Care ◽

Qualitative Study ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Middle Income Country ◽

Stepped Wedge ◽

Middle Income ◽

Outreach Service ◽

Cluster Randomized ◽

Critical Care Outreach

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Acquisition of Antibiotic-Resistant Gram-negative Bacteria in the Benefits of Universal Glove and Gown (BUGG) Cluster Randomized Trial

Clinical Infectious Diseases ◽

10.1093/cid/ciaa071 ◽

2020 ◽

Cited By ~ 1

Author(s):

Anthony D Harris ◽

Daniel J Morgan ◽

Lisa Pineles ◽

Larry Magder ◽

Lyndsay M O’Hara ◽

...

Keyword(s):

Intensive Care ◽

Randomized Trial ◽

Primary Outcome ◽

Secondary Analysis ◽

Cluster Randomized Trial ◽

Gram Negative Bacteria ◽

Antibiotic Resistant ◽

Gram Negative ◽

Carbapenem Resistant ◽

Cluster Randomized

Abstract Background The Benefits of Universal Glove and Gown (BUGG) cluster randomized trial found varying effects on methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus and no increase in adverse events. The aim of this study was to assess whether the intervention decreases the acquisition of antibiotic-resistant gram-negative bacteria. Methods This was a secondary analysis of a randomized trial in 20 hospital intensive care units. The intervention consisted of healthcare workers wearing gloves and gowns when entering any patient room compared to standard care. The primary composite outcome was acquisition of any antibiotic-resistant gram-negative bacteria based on surveillance cultures. Results A total of 40 492 admission and discharge perianal swabs from 20 246 individual patient admissions were included in the primary outcome. For the primary outcome of acquisition of any antibiotic-resistant gram-negative bacteria, the intervention had a rate ratio (RR) of 0.90 (95% confidence interval [CI], .71–1.12; P = .34). Effects on the secondary outcomes of individual bacteria acquisition were as follows: carbapenem-resistant Enterobacteriaceae (RR, 0.86 [95% CI, .60–1.24; P = .43), carbapenem-resistant Acinetobacter (RR, 0.81 [95% CI, .52–1.27; P = .36), carbapenem-resistant Pseudomonas (RR, 0.88 [95% CI, .55–1.42]; P = .62), and extended-spectrum β-lactamase–producing bacteria (RR, 0.94 [95% CI, .71–1.24]; P = .67). Conclusions Universal glove and gown use in the intensive care unit was associated with a non–statistically significant decrease in acquisition of antibiotic-resistant gram-negative bacteria. Individual hospitals should consider the intervention based on the importance of these organisms at their hospital, effect sizes, CIs, and cost of instituting the intervention. Clinical Trials Registration NCT01318213.

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Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis (TAKE-HOLD): a Cluster Randomized Trial

Kidney360 ◽

10.34067/kid.0001922021 ◽

2021 ◽

pp. 10.34067/KID.0001922021

Author(s):

Tara I. Chang ◽

Emily Tamar Tatoian ◽

Maria E. Montez-Rath ◽

Glenn M. Chertow

Keyword(s):

Randomized Trial ◽

Primary Outcome ◽

Dry Weight ◽

Cluster Randomized Trial ◽

Uncontrolled Hypertension ◽

Intradialytic Hypotension ◽

Antihypertensive Medications ◽

Dialysis Unit ◽

Once Daily ◽

Cluster Randomized

Background: We conducted this study to examine the effect of taking versus holding blood pressure (BP) medications prior to hemodialysis on intradialytic hypotension (IDH). Methods: In this cluster randomized trial, each dialysis unit was randomly designated as TAKE or HOLD units. Participants within a TAKE unit were instructed to take all BP medications as prescribed, while participants within a HOLD unit were instructed to hold medications dosed more than once daily prior to hemodialysis. The intervention lasted for 4 weeks. We hypothesized that TAKE would be non-inferior to HOLD on the primary outcome of asymptomatic IDH, defined as ≥30% of sessions with nadir systolic BP < 90 mm Hg and on the following secondary outcomes: uncontrolled hypertension (pre-dialysis systolic BP > 160 mm Hg), failure to achieve dry weight and shortened dialysis sessions. Results: We randomized 10 dialysis units in a 1:1 ratio to TAKE or HOLD, which included 65 participants in TAKE and 66 participants in HOLD. We did not show that TAKE was non-inferior to HOLD for the primary IDH outcome (mean unadjusted difference of 7.9%; CI -3.0% to 18.7%). TAKE was superior to HOLD for the outcome of uncontrolled hypertension (mean unadjusted difference of -14.6%, CI -28.0% to -1.2%). TAKE was non-inferior to HOLD for the outcomes of failure to achieve dry weight and shortened dialysis sessions. Conclusions: In this cluster randomized trial that randomized patients to either taking or holding BP medications before hemodialysis, a strategy of taking BP medications dosed more than once daily was not non-inferior to holding BP medications for the primary outcome of IDH, but did reduce the occurrence of uncontrolled hypertension. Whether any potential benefit of holding BP medications on reducing IDH is offset by any potential harms related to higher pre-dialysis BP remains to be seen.

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