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stepped wedge design

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https://www.readbyqxmd.com/read/29754670/knowledge-to-action-rationale-and-design-of-the-patient-centered-care-transitions-in-heart-failure-pact-hf-stepped-wedge-cluster-randomized-trial
#1
Harriette G C Van Spall, Shun Fu Lee, Feng Xie, Dennis T Ko, Lehana Thabane, Quazi Ibrahim, Peter R Mitoff, Michael Heffernan, Manish Maingi, Michael C Tjandrawidjaja, Mohammad I Zia, Mohamed Panju, Richard Perez, Kim D Simek, Liane Porepa, Ian D Graham, R Brian Haynes, Dilys Haughton, Stuart J Connolly
INTRODUCTION: Heart Failure (HF) is a common cause of hospitalization in older adults. The transition from hospital to home is high-risk, and gaps in transitional care can increase the risk of re-hospitalization and death. Combining health care services supported by meta-analyses, we designed the PACT-HF transitional care model. METHODS: Adopting an integrated Knowledge Translation (iKT) approach in which decision-makers and clinicians are partners in research, we implement and test the effectiveness of PACT-HF among patients hospitalized for HF...
May 2018: American Heart Journal
https://www.readbyqxmd.com/read/29754587/impact-of-calorie-labelling-in-worksite-cafeterias-a-stepped-wedge-randomised-controlled-pilot-trial
#2
Milica Vasiljevic, Emma Cartwright, Mark Pilling, Mei-Man Lee, Giacomo Bignardi, Rachel Pechey, Gareth J Hollands, Susan A Jebb, Theresa M Marteau
BACKGROUND: For working adults, about one-third of energy is consumed in the workplace making this an important context in which to reduce energy intake to tackle obesity. The aims of the current study were first, to identify barriers to the feasibility and acceptability of implementing calorie labelling in preparation for a larger trial, and second, to estimate the potential impact of calorie labelling on energy purchased in worksite cafeterias. METHODS: Six worksite cafeterias were randomised to the intervention starting at one of six fortnightly periods, using a stepped wedge design...
May 14, 2018: International Journal of Behavioral Nutrition and Physical Activity
https://www.readbyqxmd.com/read/29743326/reducing-urinary-catheter-use-a-protocol-for-a-mixed-methods-evaluation-of-an-electronic-reminder-system-in-hospitalised-patients-in-australia
#3
Oyebola Fasugba, Allen C Cheng, Philip L Russo, Maria Northcote, Hannah Rosebrock, Brett G Mitchell
INTRODUCTION: Despite advances in infection prevention and control, catheter-associated urinary tract infections (CAUTIs) are common and remain problematic. Prolonged urinary catheterisation is the main risk factor for development of CAUTIs; hence, interventions that target early catheter removal warrant investigation. The study's objectives are to examine the efficacy of an electronic reminder system, the CATH TAG, in reducing urinary catheter use (device utilisation ratio) and to determine the effect of the CATH TAG on nurses' ability to deliver patient care...
May 9, 2018: BMJ Open
https://www.readbyqxmd.com/read/29703254/evaluation-of-a-novel-vital-sign-device-to-reduce-maternal-mortality-and-morbidity-in-low-resource-settings-a-mixed-method-feasibility-study-for-the-cradle-3-trial
#4
Nicola Vousden, Elodie Lawley, Hannah L Nathan, Paul T Seed, Adrian Brown, Tafadzwa Muchengwa, Umesh Charantimath, Mrutyunjaya Bellad, Muchabayiwa Francis Gidiri, Shivaprasad Goudar, Lucy C Chappell, Jane Sandall, Andrew H Shennan
BACKGROUND: The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined...
April 27, 2018: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/29700844/process-evaluation-of-implementing-protected-mealtimes-under-clinical-trial-conditions
#5
Judi Porter, Ella Ottrey
AIM: To evaluate the implementation of Protected Mealtimes and contrast the findings with implementation fidelity. BACKGROUND: Protected Mealtimes is a systems approach developed to address the issue of malnutrition in hospitalised patients. Previous studies have used a pre-post study design, with no high-quality trials previously undertaken to measure the effect of the intervention. DESIGN: A prospective, stepped-wedge cluster randomised controlled trial was undertaken October - November 2015...
April 27, 2018: Journal of Advanced Nursing
https://www.readbyqxmd.com/read/29696191/the-reporting-quality-of-abstracts-of-stepped-wedge-randomized-trials-is-suboptimal-a-systematic-survey-of-the-literature
#6
REVIEW
Mei Wang, Yanling Jin, Zheng Jing Hu, Alex Thabane, Brittany Dennis, Olga Gajic-Veljanoski, James Paul, Lehana Thabane
Background: The stepped wedge trial (SWT) design is a type of the randomized clinical trial (RCT) design in which clusters or individuals are randomly and sequentially crossed over from control to intervention over a number of time periods. Trials using SWT design have become increasingly popular in medical, behavioral and social sciences research. Therefore, complete and transparent reporting of these studies is crucial. In particular, the quality of the abstracts of their reports is important because these may be the only accessible sources for their results...
December 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29678459/impact-of-elementary-school-located-influenza-vaccinations-a-stepped-wedge-trial-across-a-community
#7
Peter G Szilagyi, Stanley Schaffer, Cynthia M Rand, Nicolas P N Goldstein, A Dirk Hightower, Mary Younge, Ashley Eagan, Aaron Blumkin, Christina S Albertin, Kristine DiBitetto, Cathleen Concannon, Phyllis Vincelli, Byung-Kwang Yoo, Sharon G Humiston
BACKGROUND: Influenza vaccination rates among children are low and novel strategies are needed to raise coverage. We measured the impact of school-located influenza vaccination (SLIV) on coverage, examined whether SLIV substitutes for practice-based influenza vaccination ("substitution"), and estimated whether a second year of experience with SLIV increases its impact. METHODS: We implemented a stepped wedge study design with schools as clusters. In Year 1, we randomly allocated schools to SLIV or control...
May 11, 2018: Vaccine
https://www.readbyqxmd.com/read/29678155/a-stepped-wedge-implementation-and-evaluation-of-the-healthy-active-peaceful-playgrounds-for-youth-happy-intervention
#8
Dean Dudley, Wayne Cotton, Louisa Peralta, Matthew Winslade
BACKGROUND: Increasing physical activity in children is a health priority. The Healthy Active Peaceful Playgrounds for Youth (HAPPY) study aimed to examine a multi-component playground intervention designed to increase the proportion of physical activity during recess and lunch of primary school students. METHODS: The 2016 Australian focused HAPPY Study was a 12-month, metropolitan primary school based intervention, which was evaluated using a stepped wedge design...
April 20, 2018: BMC Public Health
https://www.readbyqxmd.com/read/29678137/supporting-teams-to-optimize-function-and-independence-in-veterans-a-multi-study-program-and-mixed-methods-protocol
#9
Virginia Wang, Kelli Allen, Courtney H Van Houtven, Cynthia Coffman, Nina Sperber, Elizabeth P Mahanna, Cathleen Colón-Emeric, Helen Hoenig, George L Jackson, Teresa M Damush, Erika Price, Susan N Hastings
BACKGROUND: Successful implementation of new clinical programs depends on effectively establishing, reorganizing, or enhancing team structures and processes to coordinate the work of individuals who are interdependent in their tasks, manage relationships, and share responsibility for outcomes. However, a one-size-fits-all approach is rarely effective. In partnership with VA national clinical leaders and local clinical champions, the Optimizing Function and Independence VA Quality Enhancement Research Initiative program (Function QUERI) will evaluate efforts to implement team-based clinical programs for Veterans at risk for functional decline and disability...
April 20, 2018: Implementation Science: IS
https://www.readbyqxmd.com/read/29673337/communities-in-charge-of-alcohol-cica-a-protocol-for-a-stepped-wedge-randomised-control-trial-of-an-alcohol-health-champions-programme
#10
Penny A Cook, Suzy C Hargreaves, Elizabeth J Burns, Frank de Vocht, Steve Parrott, Margaret Coffey, Suzanne Audrey, Cathy Ure, Paul Duffy, David Ottiwell, Kiran Kenth, Susan Hare, Kate Ardern
BACKGROUND: Communities In Charge of Alcohol (CICA) takes an Asset Based Community Development (ABCD) approach to reducing alcohol harm. Through a cascade training model, supported by a designated local co-ordinator, local volunteers are trained to become accredited 'Alcohol Health Champions' to provide brief opportunistic advice at an individual level and mobilise action on alcohol availability at a community level. The CICA programme is the first time that a devolved UK region has attempted to coordinate an approach to building health champion capacity, presenting an opportunity to investigate its implementation and impact at scale...
April 19, 2018: BMC Public Health
https://www.readbyqxmd.com/read/29615134/improving-outcomes-after-pediatric-cardiac-arrest-the-icu-resuscitation-project-study-protocol-for-a-randomized-controlled-trial
#11
Ron W Reeder, Alan Girling, Heather Wolfe, Richard Holubkov, Robert A Berg, Maryam Y Naim, Kathleen L Meert, Bradley Tilford, Joseph A Carcillo, Melinda Hamilton, Matthew Bochkoris, Mark Hall, Tensing Maa, Andrew R Yates, Anil Sapru, Robert Kelly, Myke Federman, J Michael Dean, Patrick S McQuillen, Deborah Franzon, Murray M Pollack, Ashley Siems, John Diddle, David L Wessel, Peter M Mourani, Carleen Zebuhr, Robert Bishop, Stuart Friess, Candice Burns, Shirley Viteri, David A Hehir, R Whitney Coleman, Tammara L Jenkins, Daniel A Notterman, Robert F Tamburro, Robert M Sutton
BACKGROUND: Quality of cardiopulmonary resuscitation (CPR) is associated with survival, but recommended guidelines are often not met, and less than half the children with an in-hospital arrest will survive to discharge. A single-center before-and-after study demonstrated that outcomes may be improved with a novel training program in which all pediatric intensive care unit staff are encouraged to participate in frequent CPR refresher training and regular, structured resuscitation debriefings focused on patient-centric physiology...
April 3, 2018: Trials
https://www.readbyqxmd.com/read/29580249/evaluation-of-a-program-for-routine-implementation-of-shared-decision-making-in-cancer-care-study-protocol-of-a-stepped-wedge-cluster-randomized-trial
#12
Isabelle Scholl, Pola Hahlweg, Anja Lindig, Carsten Bokemeyer, Anja Coym, Henning Hanken, Volkmar Müller, Ralf Smeets, Isabell Witzel, Levente Kriston, Martin Härter
BACKGROUND: Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR)...
March 27, 2018: Implementation Science: IS
https://www.readbyqxmd.com/read/29532329/long-term-costs-and-health-consequences-of-issuing-shorter-duration-prescriptions-for-patients-with-chronic-health-conditions-in-the-english-nhs
#13
Adam Martin, Rupert Payne, Edward Cf Wilson
BACKGROUND: The National Health Service (NHS) in England spends over £9 billion on prescription medicines dispensed in primary care, of which over two-thirds is accounted for by repeat prescriptions. Recently, GPs in England have been urged to limit the duration of repeat prescriptions, where clinically appropriate, to 28 days to reduce wastage and hence contain costs. However, shorter prescriptions will increase transaction costs and thus may not be cost saving. Furthermore, there is evidence to suggest that shorter prescriptions are associated with lower adherence, which would be expected to lead to lower clinical benefit...
June 2018: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/29528918/statewide-quality-improvement-initiative-to-reduce-early-elective-deliveries-and-improve-birth-registry-accuracy
#14
Heather C Kaplan, Eileen King, Beth E White, Susan E Ford, Sandra Fuller, Michael A Krew, Michael P Marcotte, Jay D Iams, Jennifer L Bailit, Jo M Bouchard, Kelly Friar, Carole M Lannon
OBJECTIVE: To evaluate the success of a quality improvement initiative to reduce early elective deliveries at less than 39 weeks of gestation and improve birth registry data accuracy rapidly and at scale in Ohio. METHODS: Between February 2013 and March 2014, participating hospitals were involved in a quality improvement initiative to reduce early elective deliveries at less than 39 weeks of gestation and improve birth registry data. This initiative was designed as a learning collaborative model (group webinars and a single face-to-face meeting) and included individual quality improvement coaching...
April 2018: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/29515989/variation-in-research-designs-used-to-test-the-effectiveness-of-dissemination-and-implementation-strategies-a-review
#15
REVIEW
Stephanie Mazzucca, Rachel G Tabak, Meagan Pilar, Alex T Ramsey, Ana A Baumann, Emily Kryzer, Ericka M Lewis, Margaret Padek, Byron J Powell, Ross C Brownson
Background: The need for optimal study designs in dissemination and implementation (D&I) research is increasingly recognized. Despite the wide range of study designs available for D&I research, we lack understanding of the types of designs and methodologies that are routinely used in the field. This review assesses the designs and methodologies in recently proposed D&I studies and provides resources to guide design decisions. Methods: We reviewed 404 study protocols published in the journal Implementation Science from 2/2006 to 9/2017...
2018: Frontiers in Public Health
https://www.readbyqxmd.com/read/29471849/implementing-alcohol-misuse-sbirt-in-a-national-cohort-of-pediatric-trauma-centers-a-type-iii-hybrid-effectiveness-implementation-trial
#16
Michael J Mello, Sara J Becker, Julie Bromberg, Janette Baird, Mark R Zonfrillo, Anthony Spirito
BACKGROUND: The American College of Surgeons mandates universal screening for alcohol misuse and delivery of an intervention for those screening positive as a requirement for certification as a level 1 trauma center. Though this requirement has been mandated for over a decade, its implementation has been challenging. Our research team completed an implementation study supporting seven pediatric trauma centers' compliance with the requirement by developing and implementing an institutional alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) policy for adolescent trauma patients...
February 22, 2018: Implementation Science: IS
https://www.readbyqxmd.com/read/29465679/a-cluster-randomized-evaluation-of-a-health-department-data-to-care-intervention-designed-to-increase-engagement-in-hiv-care-and-antiretroviral-use
#17
Julia C Dombrowski, James P Hughes, Susan E Buskin, Amy Bennett, David Katz, Mark Fleming, Angela Nunez, Matthew R Golden
BACKGROUND: Many U.S. health departments have implemented Data to Care interventions, which use HIV surveillance data to identify persons who are inadequately engaged in HIV medical care and assist them with care re-engagment, but the effectiveness of this strategy is uncertain. METHODS: We conducted a stepped wedge cluster randomized evaluation of a Data to Care intervention in King County, Washington 2011-2014. Persons diagnosed with HIV for ≥6 months were eligible based on one of two criteria: 1) VL >500 copies/mL and CD4 <350 cells/μL at last report in the past 12 months or 2) no CD4 or viral load (VL) reported to the health department for ≥12 months...
November 16, 2017: Sexually Transmitted Diseases
https://www.readbyqxmd.com/read/29409469/neoadjuvant-chemoradiotherapy-plus-surgery-versus-active-surveillance-for-oesophageal-cancer-a-stepped-wedge-cluster-randomised-trial
#18
Bo Jan Noordman, Bas P L Wijnhoven, Sjoerd M Lagarde, Jurjen J Boonstra, Peter Paul L O Coene, Jan Willem T Dekker, Michael Doukas, Ate van der Gaast, Joos Heisterkamp, Ewout A Kouwenhoven, Grard A P Nieuwenhuijzen, Jean-Pierre E N Pierie, Camiel Rosman, Johanna W van Sandick, Maurice J C van der Sangen, Meindert N Sosef, Manon C W Spaander, Roelf Valkema, Edwin S van der Zaag, Ewout W Steyerberg, J Jan B van Lanschot
BACKGROUND: Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer. METHODS: This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial...
February 6, 2018: BMC Cancer
https://www.readbyqxmd.com/read/29402313/the-improve-gap-trial-aiming-to-improve-evidence-based-management-of-community-acquired-pneumonia-study-protocol-for-a-stepped-wedge-randomised-controlled-trial
#19
Elizabeth H Skinner, Melanie Lloyd, Edward Janus, May Lea Ong, Amalia Karahalios, Terry P Haines, Anne-Maree Kelly, Melina Shackell, Harin Karunajeewa
BACKGROUND: Community-acquired pneumonia is a leading worldwide cause of hospital admissions and healthcare resource consumption. The largest proportion of hospitalisations now occurs in older patients, with high rates of multimorbidity and complex care needs. In Australia, this population is usually managed by hospital inpatient general internal medicine units. Adherence to consensus best-practice guidelines is poor. Ensuring evidence-based care and reducing length of stay may improve patient outcomes and reduce organisational costs...
February 5, 2018: Trials
https://www.readbyqxmd.com/read/29402303/stepped-wedge-randomised-trial-of-laparoscopic-ventral-mesh-rectopexy-in-adults-with-chronic-constipation-study-protocol-for-a-randomized-controlled-trial
#20
Ugo Grossi, Natasha Stevens, Eleanor McAlees, Jon Lacy-Colson, Steven Brown, Anthony Dixon, Gian Luca Di Tanna, S Mark Scott, Christine Norton, Nadine Marlin, James Mason, Charles H Knowles
BACKGROUND: Laparoscopic ventral mesh rectopexy (LVMR) is an established treatment for external full-thickness rectal prolapse. However, its clinical efficacy in patients with internal prolapse is uncertain due to the lack of high-quality evidence. METHODS: An individual level, stepped-wedge randomised trial has been designed to allow observer-blinded data comparisons between patients awaiting LVMR with those who have undergone surgery. Adults with symptomatic internal rectal prolapse, unresponsive to prior conservative management, will be eligible to participate...
February 5, 2018: Trials
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