A breakthrough series collaborative to increase patient participation with hemodialysis tasks: A stepped wedge cluster randomised controlled trial

Background Compared to in-centre, home hemodialysis is associated with superior outcomes. The impact on patient experience and clinical outcomes of consistently providing the choice and training to undertake hemodialysis-related treatment tasks in the in-centre setting is unknown. Methods A stepped-wedge cluster randomised trial in 12 UK renal centres recruited prevalent in-centre hemodialysis patients with sites randomised into early and late participation in a 12-month breakthrough series collaborative that included data collection, learning events, Plan-Study-Do-Act cycles, and teleconferences repeated every 6 weeks, underpinned by a faculty, co-production, materials and a nursing course. The primary outcome was the proportion of patients undertaking five or more hemodialysis-related tasks or home hemodialysis. Secondary outcomes included independent hemodialysis, quality of life, symptoms, patient activation and hospitalisation. ISRCTN Registration Number 93999549. Results 586 hemodialysis patients were recruited. The proportion performing 5 or more tasks or home hemodialysis increased from 45.6% to 52.3% (205 to 244/449, difference 6.2%, 95% CI 1.4 to 11%), however after analysis by step the adjusted odds ratio for the intervention was 1.63 (95% CI 0.94 to 2.81, P = 0.08). 28.3% of patients doing less than 5 tasks at baseline performed 5 or more at the end of the study (69/244, 95% CI 22.2–34.3%, adjusted odds ratio 3.71, 95% CI 1.66–8.31). Independent or home hemodialysis increased from 7.5% to 11.6% (32 to 49/423, difference 4.0%, 95% CI 1.0–7.0), but the remaining secondary endpoints were unaffected. Conclusions Our intervention did not increase dialysis related tasks being performed by a prevalent population of centre based patients, but there was an increase in home hemodialysis as well as an increase in tasks among patients who were doing fewer than 5 at baseline. Further studies are required that examine interventions to engage people who dialyse at centres in their own care.

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Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial

BMC Medicine ◽

10.1186/s12916-020-01728-1 ◽

2020 ◽

Vol 18 (1) ◽

Author(s):

Samantha Keogh ◽

Caroline Shelverton ◽

Julie Flynn ◽

Gabor Mihala ◽

Saira Mathew ◽

...

Keyword(s):

Patient Outcomes ◽

Control Period ◽

Randomised Trial ◽

Intervention Group ◽

Trial Registration ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Intention To Treat ◽

Cluster Randomised ◽

The Impact

Abstract Background Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. Methods This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. Results Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference − 8%, 95% CI − 14 to − 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. Conclusions This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. Trial registration Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415.

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The Impact of Improved Water Supply on Cholera and Diarrhoeal Diseases in Uvira, Democratic Republic of the Congo: A Protocol for a Pragmatic Stepped-Wedge Cluster Randomised Trial and Economic Evaluation

10.21203/rs.3.rs-61607/v1 ◽

2021 ◽

Author(s):

Karin Gallandat ◽

Aurélie Jeandron ◽

Ian Ross ◽

Jaime Mufitini Saidi ◽

Baron Bashige Rumedeka ◽

...

Keyword(s):

Water Supply ◽

Large Scale ◽

Democratic Republic ◽

Randomised Trial ◽

Diarrhoeal Disease ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Cluster Randomised ◽

Republic Of The Congo ◽

The Impact

Abstract Introduction. Diarrhoeal disease remains a leading cause of mortality and morbidity worldwide. Cholera alone is estimated to cause 95,000 deaths per year, most of which occur in endemic settings with inadequate water access. Whilst a global strategy to eliminate cholera by 2030 calls for investment in improved drinking water services, there is limited rigorous evidence for the impact of improved water supply on endemic cholera transmission in low-income urban settings. Our protocol is designed to deliver a pragmatic health impact evaluation of a large-scale water supply intervention in Uvira (Democratic Republic of the Congo), a cholera transmission hotspot. Methods/Design.A stepped-wedge cluster randomised trial (SW-CRT) was designed to evaluate the impact of a large-scale drinking water supply intervention on cholera incidence among the 280,000 inhabitants of Uvira. The city was divided into 16 clusters, where new community and household taps will be installed following a randomised sequence over a transition period of up to 8 weeks in each cluster. The primary trial outcomes are the monthly incidence of “confirmed” cholera cases (patients testing positive by rapid detection kit) and of “suspected” cholera cases (patients admitted to the cholera treatment centre). Concurrent process and economic evaluations will provide further information on the context, costs and efficiency of the intervention. Discussion.In this protocol, we describe a pragmatic approach to conducting rigorous research to assess the impacts of a complex water supply intervention on severe diarrhoeal disease and cholera in an unstable, low-resource setting representative of cholera-affected areas. In particular, we discuss a series of pre-identified risks and linked mitigation strategies as well as the value of combining different data collection methods and preparation of multiple analysis scenarios to account for possible deviations from the protocol. The study described here has the potential to provide robust evidence to support more effective cholera control in challenging, high-burden settings. Trial registration. This trial is registered on clinicaltrials.gov (NCT02928341, 10th October 2016, https://clinicaltrials.gov/ct2/show/NCT02928341) and has received ethics approval from the London School of Hygiene and Tropical Medicine (8913, 10603) and from the Ethics Committee from the School of Public Health, University of Kinshasa, Democratic Republic of the Congo (ESP/CE/088/2015).

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The impact of the HEART risk score in the early assessment of patients with acute chest pain: design of a stepped wedge, cluster randomised trial

BMC Cardiovascular Disorders ◽

10.1186/1471-2261-13-77 ◽

2013 ◽

Vol 13 (1) ◽

Cited By ~ 35

Author(s):

Judith M Poldervaart ◽

Johannes B Reitsma ◽

Hendrik Koffijberg ◽

Barbra E Backus ◽

A Jacob Six ◽

...

Keyword(s):

Chest Pain ◽

Risk Score ◽

Randomised Trial ◽

Acute Chest Pain ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Early Assessment ◽

Cluster Randomised ◽

The Impact

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The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation

Trials ◽

10.1186/s13063-021-05249-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Karin Gallandat ◽

Aurélie Jeandron ◽

Ian Ross ◽

Jaime Mufitini Saidi ◽

Baron Bashige Rumedeka ◽

...

Keyword(s):

Water Supply ◽

Large Scale ◽

Democratic Republic ◽

Randomised Trial ◽

Diarrhoeal Disease ◽

Cluster Randomised Trial ◽

Stepped Wedge ◽

Cluster Randomised ◽

Republic Of The Congo ◽

The Impact

Abstract Introduction Diarrhoeal disease remains a leading cause of mortality and morbidity worldwide. Cholera alone is estimated to cause 95,000 deaths per year, most of which occur in endemic settings with inadequate water access. Whilst a global strategy to eliminate cholera by 2030 calls for investment in improved drinking water services, there is limited rigorous evidence for the impact of improved water supply on endemic cholera transmission in low-income urban settings. Our protocol is designed to deliver a pragmatic health impact evaluation of a large-scale water supply intervention in Uvira (Democratic Republic of the Congo), a cholera transmission hotspot. Methods/design A stepped-wedge cluster randomised trial (SW-CRT) was designed to evaluate the impact of a large-scale drinking water supply intervention on cholera incidence among the 280,000 inhabitants of Uvira. The city was divided into 16 clusters, where new community and household taps will be installed following a randomised sequence over a transition period of up to 8 weeks in each cluster. The primary trial outcomes are the monthly incidence of “confirmed” cholera cases (patients testing positive by rapid detection kit) and of “suspected” cholera cases (patients admitted to the cholera treatment centre). Concurrent process and economic evaluations will provide further information on the context, costs, and efficiency of the intervention. Discussion In this protocol, we describe a pragmatic approach to conducting rigorous research to assess the impacts of a complex water supply intervention on severe diarrhoeal disease and cholera in an unstable, low-resource setting representative of cholera-affected areas. In particular, we discuss a series of pre-identified risks and linked mitigation strategies as well as the value of combining different data collection methods and preparation of multiple analysis scenarios to account for possible deviations from the protocol. The study described here has the potential to provide robust evidence to support more effective cholera control in challenging, high-burden settings. Trial registration This trial is registered on clinicaltrials.gov (NCT02928341, 10th October 2016) and has received ethics approval from the London School of Hygiene and Tropical Medicine (8913, 10603) and from the Ethics Committee from the School of Public Health, University of Kinshasa, Democratic Republic of the Congo (ESP/CE/088/2015).

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Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application

BMJ Open ◽

10.1136/bmjopen-2019-033640 ◽

2020 ◽

Vol 10 (6) ◽

pp. e033640 ◽

Cited By ~ 1

Author(s):

R I Helou ◽

Gaud Catho ◽

Annabel Peyravi Latif ◽

Johan Mouton ◽

M Hulscher ◽

...

Keyword(s):

Antimicrobial Stewardship ◽

Professional Training ◽

Primary Outcome ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Great Promise ◽

Antimicrobial Use ◽

Stepped Wedge ◽

Cluster Randomised ◽

The Impact

IntroductionWith the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing.Methods and analysisUse of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later.Ethics and disseminationThis protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.Trial registration numberClinicalTrials.gov registry (NCT03793946). Stage; pre-results.

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VA Teledermstudy: protocol for a stepped-wedge cluster randomised trial to compare access to care for a mobile app versus a workstation-based store-and-forward teledermatology process

BMJ Open ◽

10.1136/bmjopen-2018-022218 ◽

2018 ◽

Vol 8 (12) ◽

pp. e022218 ◽

Cited By ~ 4

Author(s):

Nicolae Done ◽

Dennis H Oh ◽

Martin A Weinstock ◽

John D Whited ◽

George L Jackson ◽

...

Keyword(s):

Completion Time ◽

Randomised Trial ◽

Mobile App ◽

Cluster Randomised Trial ◽

Health Administration ◽

Stepped Wedge ◽

Cluster Randomised ◽

Us Veterans ◽

Store And Forward ◽

The Impact

IntroductionTeledermatology has emerged as an important strategy to enhance access to high-quality skin care.VA Teledermis a provider-facing, web-based mobile app designed to integrate into the existing teledermatology workflow in the US Veterans Health Administration (VHA). In this study, we will conduct a systematic evaluation ofVA Teledermon access outcomes in VHA facilities using a pragmatic trial guided by clinical and operational leaders.Methods and analysisThe study is a prospective, stepped-wedge cluster randomised trial with cross-sectional exposure and outcome measurement via retrospective database analysis of administrative records. Each cluster is a VHA facility deemed eligible for the trial. We assign the intervention using a cluster-level balanced randomisation scheme based on facility size, baseline teledermatology uptake and geographic location. The trial will test whether patients receiving dermatological care at participating facilities will have better access compared with patients receiving care through the current standard process. The primary outcomes proxy for patient-level access to dermatology services, including (1) consult completion time for teledermatology consults; (2) appointment completion time for new dermatology consults; and (3) travel distance for dermatology services. As secondary outcomes, we will assess facility-level adoption outcomes, that is, the number of dermatology encounters and the proportion of teledermatology consults out of all dermatology encounters. To account for secular trends in outcomes and for correlation across individuals within clusters, we will assess the impact of the intervention using generalised linear mixed regression models.DiscussionStreamlining the current practice for store-and-forward teledermatology in the VHA can improve access to expert dermatological care for US veterans. The lessons learnt in this trial could validate the use of mobile technology for consultative store-and-forward dermatology in a large healthcare organisation. The results may also be of interest to other medical specialties assessing the merits of implementing mobile telehealth.Protocol versionVersion 3; 7 November 2018.Trial registration numberNCT03241589; Pre-results.

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The RATIONS (Reducing Activation of Tuberculosis by Improvement of Nutritional Status) study: a cluster randomised trial of nutritional support (food rations) to reduce TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosis in communities with a high prevalence of undernutrition, Jharkhand, India

BMJ Open ◽

10.1136/bmjopen-2020-047210 ◽

2021 ◽

Vol 11 (5) ◽

pp. e047210

Author(s):

Anurag Bhargava ◽

Madhavi Bhargava ◽

Banurekha Velayutham ◽

Kannan Thiruvengadam ◽

Basilea Watson ◽

...

Keyword(s):

Risk Factor ◽

Nutritional Status ◽

G Proteins ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Household Contacts ◽

Cluster Randomised ◽

High Prevalence ◽

Secondary Outcomes ◽

The Impact

IntroductionIndia has the largest burden of cases and deaths related to tuberculosis (TB). Undernutrition is the leading risk factor accounting for TB incidence, while severe undernutrition is a common risk factor for mortality in patients with TB in India. The impact of nutritional supplementation on TB incidence is unknown, while few underpowered studies have assessed its impact on TB mortality. We designed an open-label, field-based cluster randomised trial to assess the impact of nutritional supplementation (with food rations) on TB incidence in a group at higher risk of TB infection and disease, viz household contacts (HHC) of patients with microbiologically confirmed pulmonary TB (PTB) in Jharkhand, a state with a high prevalence of undernutrition.Methods and analysisWe shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 eligible contacts. The sample size has 80% power to detect the primary outcome of 50% reduction in incidence of active TB in HHC over 2 years of follow-up. Patients and HHC in both the arms will undergo nutritional assessment and counselling. Patients will receive monthly food rations (supplying 1200 kcal and 52 g proteins/day) and multivitamins along with antitubercular treatment. The HHC in the intervention arm will receive food rations (supplying 750 kcal and 23 g proteins/day) and multivitamins while HHC in control arm will be on usual diet. The secondary outcomes in HHC will include effects on nutritional status, non-TB infections. Secondary outcomes in patients are effects on TB mortality, adherence, adverse effects, nutritional and performance status. Substudies will examine micronutrient status and effects on dietary intake, body composition, muscle strength and immune function.Ethics and disseminationThe institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations.Trial registration numberClinical Trial Registry of India: CTRI/2019/08/020490.

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