Structured Goal Planning and Supportive Telephone Follow‐up in Rheumatology Care: Results From a Pragmatic, Stepped‐Wedge, Cluster‐Randomized Trial

2018 ◽  
Vol 70 (11) ◽  
pp. 1576-1586 ◽  
Author(s):  
Gunnhild Berdal ◽  
Ingvild Bø ◽  
Turid N. Dager ◽  
Anne Dingsør ◽  
Siv G. Eppeland ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Cluster Randomized ◽  
Goal Planning

Digital Adherence Technology for Tuberculosis Treatment Supervision: A Stepped-Wedge Cluster Randomized Trial

2020 ◽  
Author(s):  
Adithya Cattamanchi ◽  
Rebecca R. Crowder ◽  
Alex Kityamuwesi ◽  
Noah Kiwanuka ◽  
Maureen Lamunu ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Tuberculosis Treatment ◽  
Stepped Wedge ◽  
Cluster Randomized

scholarly journals 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

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.

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

Hypertension ◽  
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.

scholarly journals Spread and scale of an electronic deprescribing software to improve health outcomes of older adults living in nursing homes: study protocol for a stepped wedge cluster randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marc-Eric Nadeau ◽  
Justine L. Henry ◽  
Todd C. Lee ◽  
Émilie Bortolussi-Courval ◽  
Carole Goodine ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Trial ◽  
Study Design ◽  
Long Term Care ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Term Care ◽  
Medication Reviews ◽  
Cluster Randomized

Abstract Background Medication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications (PIMs), and residents in long-term care (LTC) are frequently prescribed 10 or more medications at once. One strategy to address this problem is for the physician and/or pharmacist to perform regular medication reviews; however, this process can be complicated and time-consuming. With a prescription review, medications may be decreased, changed, or stopped altogether. MedReviewRx is a software that runs an analysis using deprescribing rules to produce a report to guide medication reviews addressing medication overload for residents in LTC. Methods This study will employ a mixed methods effectiveness-implementation hybrid type 2 study design. To measure effectiveness, a stepped wedge cluster randomized trial design is planned, which allows us to approximate a randomized clinical trial. Approximately 1000 residents living in LTC will be recruited from five facilities in New Brunswick. The study will begin with 3 months of baseline data on rates of deprescribing. Thereafter, every 3 months a new cluster will enter the intervention mode. The intervention consists of medication reviews augmented with the MedReviewRx software, which will be used by staff and clinicians in the facilities. The estimated study duration is 18 months and the main outcome will be the proportion of patients with one or more PIMs deprescribed (reduced/stopped or changed to a safer alternative) in the 90 days following a prescription review. The goal is to study the impact of MedReviewRx on medication overload among older adults living in LTC. In typical fashion of a stepped wedge cluster randomized trial, each cluster acts as an internal control (before and after) as well as a control for the other clusters (external control). Qualitative data collected will include resident/caregiver attitudes towards deprescribing and semi-structured interviews with staff working in the long-term care homes. Discussion This study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. This study will provide valuable information on PIM use, cost savings, and facilitators and challenges associated with medication reviews and deprescribing. This study represents an important step towards understanding and promoting tools to guide safe and rational reduction of PIM use among older adults. Trial registration NCT04762303, Registered February 21, 2021.

Variance formulae for multiphase stepped wedge cluster randomized trial

2020 ◽  
Vol 39 (28) ◽  
pp. 4147-4168 ◽  
Author(s):  
Pengyue Zhang ◽  
Abigail Shoben ◽  
Rebecca Jackson ◽  
Soledad Fernandez
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Cluster Randomized
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