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

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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Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽

10.1161/hyp.70.suppl_1.p494 ◽

2017 ◽

Vol 70 (suppl_1) ◽

Author(s):

Karen L Margolis ◽

Stephen E Asche ◽

Anna R Bergdall ◽

Steven P Dehmer ◽

Beverly B Green ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Clinical Care ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Uncontrolled Hypertension ◽

Routine Clinical Care ◽

Differential Reduction ◽

Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

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School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2018.06.048 ◽

2019 ◽

Vol 143 (2) ◽

pp. 755-764 ◽

Cited By ~ 5

Author(s):

Joe K. Gerald ◽

Julia M. Fisher ◽

Mark A. Brown ◽

Conrad J. Clemens ◽

Melissa A. Moore ◽

...

Keyword(s):

Randomized Trial ◽

Cluster Randomized Trial ◽

Inhaled Corticosteroid ◽

Once Daily ◽

Cluster Randomized

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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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Culturally Adapted Hypertension Education (CAHE) to Improve Blood Pressure Control and Treatment Adherence in Patients of African Origin with Uncontrolled Hypertension: Cluster-Randomized Trial

PLoS ONE ◽

10.1371/journal.pone.0090103 ◽

2014 ◽

Vol 9 (3) ◽

pp. e90103 ◽

Cited By ~ 25

Author(s):

Erik J. A. J. Beune ◽

Eric P. Moll van Charante ◽

Leo Beem ◽

Jacob Mohrs ◽

Charles O. Agyemang ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Treatment Adherence ◽

Cluster Randomized Trial ◽

Pressure Control ◽

Uncontrolled Hypertension ◽

African Origin ◽

Improve Blood Pressure Control ◽

Culturally Adapted ◽

Cluster Randomized

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Abstract 15008: Improvement in Patient Ratings of Hypertension Care in a Pragmatic Cluster-randomized Trial of Home Blood Pressure Telemonitoring and Pharmacist Care (Hyperlink 3)

Circulation ◽

10.1161/circ.142.suppl_3.15008 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Karen L Margolis ◽

Leif I Solberg ◽

A Lauren Crain ◽

Jeanette Y Ziegenfuss ◽

Anna R Bergdall ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Care Management ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Uncontrolled Hypertension ◽

Baseline Survey ◽

Cluster Randomized ◽

Pharmacist Care ◽

Over Time

Introduction: Patient ratings of their experience of care are part of the “Triple Aim”. Improvements are highly valued by health care organizations, but are hard to achieve. Hypothesis: We tested the effect of a telehealth intervention on satisfaction with hypertension care. Methods: Hyperlink 3 is an ongoing pragmatic cluster-randomized trial in 3072 patients with uncontrolled hypertension in 21 primary care clinics in HealthPartners, an integrated health system in Minnesota and Wisconsin. Clinics were randomized to Clinic-based Care (CC, 9 clinics, 1648 patients) or Telehealth Care (TC, 12 clinics, 1424 patients). CC patients received guideline-based hypertension care in face-to-face visits. TC patients were additionally offered home blood pressure (BP) telemonitoring with pharmacist care management. Patients were surveyed at baseline and after 6 months of study enrollment and asked to rate their hypertension care in the previous 6 months on a scale of 0-10. We compared change in the proportion of patients rating their care at the highest level (9 or 10). Results: In the TC group, about 37% of patients attended an intake pharmacist visit and 434 (30%) participated in home BP telemonitoring. Baseline surveys were completed by 1719 (56%) of patients at baseline (goal 50% completion) and 1301 (76%) of those completing the baseline survey completed the 6 month survey (goal 75% completion). Baseline survey respondents’ mean age was 62 y (non-respondents 58 y), 46% were men (non-respondents 48%), 19% were black (non-respondents 20%), and mean BP was 164/93 mm Hg (non-respondents 164/95 mm Hg.) Nearly all patients (over 90%) took antihypertensive medications (median 2). Hypertension care ratings of 9 or 10 were 27.9% at baseline and 30.2% at 6 months in CC, compared with 29.0% at baseline and 39.5% at 6 months in TC. The odds ratio (OR) for change over time in 9 or 10 ratings was 1.11 (95% CI 0.87 - 1.42) in CC, and 1.61 (95% CI 1.26 - 2.07) in TC. The OR for change in 9 or 10 ratings over time in TC vs CC was 1.45 (95% CI 1.03 - 2.06). Conclusions: Home BP telemonitoring with pharmacist care management increased the proportion of patients who highly rated their experience of hypertension care, even though only a minority of the TC patients received the intervention.

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

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfz246 ◽

2019 ◽

Author(s):

Mark E Thomas ◽

Tarek S Abdelaziz ◽

Gavin D Perkins ◽

Alice J Sitch ◽

Jyoti Baharani ◽

...

Keyword(s):

Pilot Study ◽

Randomized Trial ◽

Primary Outcome ◽

Cluster Randomized Trial ◽

Teaching Hospitals ◽

Specialist Care ◽

Outreach Service ◽

Intervention Hospital ◽

Catchment Areas ◽

Cluster Randomized

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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School–Supervised Use of a Once-Daily Inhaled Corticosteroid Regimen: A Cluster Randomized Trial

PEDIATRICS ◽

10.1542/peds.2019-2461dddd ◽

2019 ◽

Vol 144 (Supplement 1) ◽

pp. S54-S55 ◽

Cited By ~ 1

Author(s):

Christopher Ng ◽

Pooja Varshney

Keyword(s):

Randomized Trial ◽

Cluster Randomized Trial ◽

Inhaled Corticosteroid ◽

Once Daily ◽

Cluster Randomized

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A Cluster-Randomized Trial of Hydroxychloroquine as Prevention of Covid-19 Transmission and Disease

10.1101/2020.07.20.20157651 ◽

2020 ◽

Cited By ~ 9

Author(s):

Oriol Mitja ◽

Maria Ubals ◽

Marc Corbacho ◽

Andrea Alemany ◽

Clara Suner ◽

...

Keyword(s):

Usual Care ◽

Randomized Trial ◽

Primary Outcome ◽

Cluster Randomized Trial ◽

Secondary Outcome ◽

Open Label ◽

Definitive Evidence ◽

Beneficial Effects ◽

Significant Difference ◽

Cluster Randomized

Background Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are limited to non-pharmacological interventions. Hydroxychloroquine (HCQ) has been proposed as a postexposure therapy to prevent Coronavirus disease 2019 (Covid-19) but definitive evidence is lacking. Methods We conducted an open-label, cluster-randomized trial including asymptomatic contacts exposed to a PCR-positive Covid-19 case in Catalonia, Spain. Clusters were randomized to receive no specific therapy (control arm) or HCQ 800mg once, followed by 400mg daily for 6 days (intervention arm). The primary outcome was PCR-confirmed symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, either symptomatically compatible or a PCR-positive result regardless of symptoms. Adverse events (AEs) were assessed up to 28 days. Results The analysis included 2,314 healthy contacts of 672 Covid-19 index cases identified between Mar 17 and Apr 28, 2020. A total of 1,198 were randomly allocated to usual care and 1,116 to HCQ therapy. There was no significant difference in the primary outcome of PCR-confirmed, symptomatic Covid-19 disease (6.2% usual care vs. 5.7% HCQ; risk ratio 0.89 [95% confidence interval 0.54-1.46]), nor evidence of beneficial effects on prevention of SARS-CoV-2 transmission (17.8% usual care vs. 18.7% HCQ). The incidence of AEs was higher in the intervention arm than in the control arm (5.9% usual care vs 51.6% HCQ), but no treatment-related serious AEs were reported. Conclusions Postexposure therapy with HCQ did not prevent SARS-CoV-2 disease and infection in healthy individuals exposed to a PCR-positive case. Our findings do not support HCQ as postexposure prophylaxis for Covid-19.

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