scholarly journals The Diabetes Telephone Study: Design and Challenges of a Pragmatic Cluster Randomized Trial to Improve Diabetic Peripheral Neuropathy Treatment

2015 ◽  
Vol 18 (7) ◽  
pp. A723-A724
Author(s):  
AS Adams ◽  
E Bayliss ◽  
JA Schmittdiel ◽  
A Altschuler ◽  
W Dyer ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Randomized Trial ◽  
Study Design ◽  
Diabetic Peripheral Neuropathy ◽  
Cluster Randomized Trial ◽  
Cluster Randomized

scholarly journals The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment

2016 ◽  
Vol 13 (3) ◽  
pp. 286-293 ◽  
Author(s):  
Alyce S Adams ◽  
Elizabeth A Bayliss ◽  
Julie A Schmittdiel ◽  
Andrea Altschuler ◽  
Wendy Dyer ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Randomized Trial ◽  
Study Design ◽  
Diabetic Peripheral Neuropathy ◽  
Cluster Randomized Trial ◽  
Cluster Randomized

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.

scholarly journals Reflection on modern methods: when is a stepped-wedge cluster randomized trial a good study design choice?

2020 ◽  
Vol 49 (3) ◽  
pp. 1043-1052 ◽  
Author(s):  
Karla Hemming ◽  
Monica Taljaard
Keyword(s):  
Randomized Trial ◽  
Study Design ◽  
Statistical Power ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Randomized Evaluation ◽  
Design Choice ◽  
Cluster Randomized ◽  
Study Designs ◽  
Roll Out

Abstract The stepped-wedge cluster randomized trial (SW-CRT) involves the sequential transition of clusters (such as hospitals, public health units or communities) from control to intervention conditions in a randomized order. The use of the SW-CRT is growing rapidly. Yet the SW-CRT is at greater risks of bias compared with the conventional parallel cluster randomized trial (parallel-CRT). For this reason, the CONSORT extension for SW-CRTs requires that investigators provide a clear justification for the choice of study design. In this paper, we argue that all other things being equal, the SW-CRT is at greater risk of bias due to misspecification of the secular trends at the analysis stage. This is particularly problematic for studies randomizing a small number of heterogeneous clusters. We outline the potential conditions under which an SW-CRT might be an appropriate choice. Potentially appropriate and often overlapping justifications for conducting an SW-CRT include: (i) the SW-CRT provides a means to conduct a randomized evaluation which otherwise would not be possible; (ii) the SW-CRT facilitates cluster recruitment as it enhances the acceptability of a randomized evaluation either to cluster gatekeepers or other stakeholders; (iii) the SW-CRT is the only feasible design due to pragmatic and logistical constraints (for example the roll-out of a scare resource); and (iv) the SW-CRT has increased statistical power over other study designs (which will include situations with a limited number of clusters). As the number of arguments in favour of an SW-CRT increases, the likelihood that the benefits of using the SW-CRT, as opposed to a parallel-CRT, outweigh its risks also increases. We argue that the mere popularity and novelty of the SW-CRT should not be a factor in its adoption. In situations when a conventional parallel-CRT is feasible, it is likely to be the preferred design.

scholarly journals The Fit Study: Design and rationale for a cluster randomized trial of school-based BMI screening and reporting

2017 ◽  
Vol 58 ◽  
pp. 40-46 ◽  
Author(s):  
Kristine A. Madsen ◽  
Jennifer Linchey ◽  
Lorrene Ritchie ◽  
Hannah R. Thompson
Keyword(s):  
Randomized Trial ◽  
Study Design ◽  
Cluster Randomized Trial ◽  
School Based ◽  
Cluster Randomized

scholarly journals Reducing office workers’ sitting time: rationale and study design for the Stand Up Victoria cluster randomized trial

2013 ◽  
Vol 13 (1) ◽  
Author(s):  
David W Dunstan ◽  
Glen Wiesner ◽  
Elizabeth G Eakin ◽  
Maike Neuhaus ◽  
Neville Owen ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Study Design ◽  
Cluster Randomized Trial ◽  
Office Workers ◽  
Sitting Time ◽  
Cluster Randomized

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

2021 ◽  
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 three months of baseline data on rates of deprescribing. Thereafter, every three 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 https://clinicaltrials.gov/show/NCT04762303

scholarly journals Study design and rationale for a cluster randomized trial of a safe child feces management intervention in rural Odisha, India

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Gloria D. Sclar ◽  
Valerie Bauza ◽  
Hans-Joachim Mosler ◽  
Alokananda Bisoyi ◽  
Howard H. Chang ◽  
...  
Keyword(s):  
Behavior Change ◽  
Randomized Trial ◽  
Study Design ◽  
Low Income ◽  
Fecal Contamination ◽  
Cluster Randomized Trial ◽  
Change Strategies ◽  
Safe Disposal ◽  
Safe Management ◽  
Cluster Randomized

Abstract Background Poor child feces management (CFM) is believed to be an important source of exposure to enteric pathogens that contribute to a large disease burden in low-income settings. While access to sanitation facilities is improving, national surveys indicate that even households with latrines often do not safely dispose of their child’s feces. Working with caregivers in rural Odisha, India, we co-developed an intervention aimed at improving safe disposal of child feces and encouraging child latrine use at an earlier age. We describe the rationale for the intervention and summarize the protocol for a cluster randomized trial (CRT) to evaluate its effectiveness at changing CFM practices. Methods The intervention consists of six behavior change strategies together with hardware provision: wash basin and bucket with lid to aid safe management of soiled nappies and a novel latrine training mat to aid safe disposal and latrine training. The intervention will be offered at the village level to interested caregivers of children < 5 years of age by a community-based organization. Following a baseline survey, 74 villages were randomly allocated to either intervention or control arm. The primary outcome is caregiver reported safe disposal of child feces after last defecation, either by the caregiver disposing of the child’s feces into the latrine or the child using the latrine, measured approximately four to six months following intervention delivery. Secondary outcomes include fecal contamination of household drinking water and the childs’ hands. A process evaluation will also be conducted to assess intervention fidelity and reach, and explore implementer and participant feedback. Discussion This study addresses a crucial knowledge gap in sanitation by developing a scalable intervention to improve safe management of child feces. The behavior change strategies were designed following the Risks, Attitudes, Norms, Abilities and Self-Regulation (RANAS) approach, which has shown to be effective for other environmental behavior change interventions in low-income settings. The latrine training mat hardware is a novel design developed cooperatively and manufactured locally. The evaluation follows a rigorous CRT study design assessing the impact of the intervention on CFM behavior change, as well as fecal contamination of two sources of potential exposure. Trial registration This trial is registered at ISRCTN: ISRCTN15831099.

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