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

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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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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Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): A cluster randomized trial

Contemporary Clinical Trials ◽

10.1016/j.cct.2012.03.014 ◽

2012 ◽

Vol 33 (4) ◽

pp. 794-803 ◽

Cited By ~ 22

Author(s):

Karen L. Margolis ◽

Tessa J. Kerby ◽

Stephen E. Asche ◽

Anna R. Bergdall ◽

Michael V. Maciosek ◽

...

Keyword(s):

Blood Pressure ◽

Case Management ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Cluster Randomized

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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 P165: Improvement In Self-monitoring Frequency, Electronic Data Sharing, And Medication Changes In A Pragmatic Cluster-randomized Trial Of Home Blood Pressure Telemonitoring And Pharmacist Care (Hyperlink 3)

Hypertension ◽

10.1161/hyp.76.suppl_1.p165 ◽

2020 ◽

Vol 76 (Suppl_1) ◽

Author(s):

Karen L Margolis ◽

JoAnn M Sperl-Hillen ◽

Lauren A Crain ◽

Jeanette Y Ziegenfuss ◽

Leif I Solberg ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Baseline Survey ◽

Self Monitoring ◽

Care Intervention ◽

Cluster Randomized ◽

Medication Changes ◽

Pharmacist Care

Introduction: Telehealth and remote monitoring have become critical to patient access to care during the COVID-19 pandemic. We measured the effect of a telehealth care intervention on frequency, sharing methods, and clinical usage of home blood pressure (BP) measurements. Methods: Hyperlink 3 is an ongoing pragmatic cluster-randomized trial in 3072 patients with uncontrolled hypertension in 21 primary care clinics in an integrated health system. Clinics were randomized to Clinic-based Care (CC, 9 clinics, 1648 patients) or Telehealth Care (TC, 12 clinics, 1424 patients). TC patients were offered home BP telemonitoring with pharmacist care management. Patients were surveyed at baseline (Nov 2017 - Apr 2019) and after 6 mo of study enrollment. 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%) and 1301 (76%) of those completing the baseline survey completed the 6 mo survey (goal 75%). Baseline survey respondents' mean age was 62, 46% were men, 19% were black, and mean BP was 164/93 mm Hg. Nearly all patients (>90%) took antihypertensive medications (median 2). The odds ratio (OR) for change in measuring BP > 2 times/week vs. less often was 0.97 (95% CI 0.87 - 1.42) in CC, and 2.01 (95% CI 1.56 - 2.59) in TC. The OR for change in frequent measurement in TC vs CC was 2.08 (95% CI 1.45 - 2.97). Conclusions: A telehealth care intervention markedly increased the frequency of home BP self- monitoring, electronic data sharing, and data-driven BP medication changes, even though only a minority of TC patients received the intervention.

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A primary care pragmatic cluster randomized trial of the use of home blood pressure monitoring on blood pressure levels in hypertensive patients with above target blood pressure

Family Practice ◽

10.1093/fampra/cmp094 ◽

2009 ◽

Vol 27 (2) ◽

pp. 135-142 ◽

Cited By ~ 20

Author(s):

M. Godwin ◽

M. Lam ◽

R. Birtwhistle ◽

D. Delva ◽

R. Seguin ◽

...

Keyword(s):

Blood Pressure ◽

Primary Care ◽

Randomized Trial ◽

Blood Pressure Monitoring ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Home Blood Pressure Monitoring ◽

Pressure Monitoring ◽

Hypertensive Patients ◽

Cluster Randomized

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Sustainability of Benefits from Parenting Interventions Delivered Through Health Services: Follow-Up at Age 6 Years of a Cluster Randomized Trial

SSRN Electronic Journal ◽

10.2139/ssrn.3279187 ◽

2018 ◽

Author(s):

Joanne A Smith ◽

Susan M Chang ◽

Florencia Lopez-Boo ◽

Susan P Walker

Keyword(s):

Health Services ◽

Randomized Trial ◽

Cluster Randomized Trial ◽

Parenting Interventions ◽

Cluster Randomized

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Design and analysis of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria: Small sample considerations for cluster-randomized trials with count data

Clinical Trials ◽

10.1177/17407745211028581 ◽

2021 ◽

pp. 174077452110285

Author(s):

Conner L Jackson ◽

Kathryn Colborn ◽

Dexiang Gao ◽

Sangeeta Rao ◽

Hannah C Slater ◽

...

Keyword(s):

Randomized Trial ◽

Cluster Randomized Trial ◽

Mixed Effects ◽

Small Sample ◽

Mixed Effects Models ◽

Type I ◽

Cluster Randomized ◽

Cluster Level ◽

Generalized Estimating

Background: Cluster-randomized trials allow for the evaluation of a community-level or group-/cluster-level intervention. For studies that require a cluster-randomized trial design to evaluate cluster-level interventions aimed at controlling vector-borne diseases, it may be difficult to assess a large number of clusters while performing the additional work needed to monitor participants, vectors, and environmental factors associated with the disease. One such example of a cluster-randomized trial with few clusters was the “efficacy and risk of harms of repeated ivermectin mass drug administrations for control of malaria” trial. Although previous work has provided recommendations for analyzing trials like repeated ivermectin mass drug administrations for control of malaria, additional evaluation of the multiple approaches for analysis is needed for study designs with count outcomes. Methods: Using a simulation study, we applied three analysis frameworks to three cluster-randomized trial designs (single-year, 2-year parallel, and 2-year crossover) in the context of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria. Mixed-effects models, generalized estimating equations, and cluster-level analyses were evaluated. Additional 2-year parallel designs with different numbers of clusters and different cluster correlations were also explored. Results: Mixed-effects models with a small sample correction and unweighted cluster-level summaries yielded both high power and control of the Type I error rate. Generalized estimating equation approaches that utilized small sample corrections controlled the Type I error rate but did not confer greater power when compared to a mixed model approach with small sample correction. The crossover design generally yielded higher power relative to the parallel equivalent. Differences in power between analysis methods became less pronounced as the number of clusters increased. The strength of within-cluster correlation impacted the relative differences in power. Conclusion: Regardless of study design, cluster-level analyses as well as individual-level analyses like mixed-effects models or generalized estimating equations with small sample size corrections can both provide reliable results in small cluster settings. For 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria, we recommend a mixed-effects model with a pseudo-likelihood approximation method and Kenward–Roger correction. Similarly designed studies with small sample sizes and count outcomes should consider adjustments for small sample sizes when using a mixed-effects model or generalized estimating equation for analysis. Although the 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria is already underway as a parallel trial, applying the simulation parameters to a crossover design yielded improved power, suggesting that crossover designs may be valuable in settings where the number of available clusters is limited. Finally, the sensitivity of the analysis approach to the strength of within-cluster correlation should be carefully considered when selecting the primary analysis for a cluster-randomized trial.

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