scholarly journals Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial

2018 ◽  
Vol 13 (1) ◽  
Author(s):  
Lila J. Finney Rutten ◽  
Carmen Radecki Breitkopf ◽  
Jennifer L. St. Sauver ◽  
Ivana T. Croghan ◽  
Debra J. Jacobson ◽  
...  
Keyword(s):  
Primary Care Patient ◽  
Implementation Strategies ◽  
Cluster Randomized Trial ◽  
Care Patient ◽  
Evidence Based ◽  
Stepped Wedge ◽  
Human Papillomavirus Vaccination ◽  
Vaccination Rates ◽  
Cluster Randomized ◽  
The Impact

scholarly journals Study protocol: A stepped-wedge, cluster-randomized trial of the effectiveness of a deliberative loop in identifying implementation strategies for the adoption of a dental sealant guideline in dental clinics

2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Deborah E. Polk ◽  
Erick G. Guerrero ◽  
Inga Gruß ◽  
Nilesh H. Shah ◽  
Nadia M. Yosuf ◽  
...  
Keyword(s):  
Implementation Strategies ◽  
Cluster Randomized Trial ◽  
Background Information ◽  
Evidence Based ◽  
Stepped Wedge ◽  
Link Type ◽  
Dental Clinics ◽  
Occlusal Surfaces ◽  
Cluster Randomized ◽  
General Dentists

Abstract Background The American Dental Association (ADA) recommends dental providers apply dental sealants to the occlusal surfaces of permanent molars for the prevention or treatment of non-cavitated dental caries. Despite the evidence-based support for this guideline, adherence among general dentists is low, ranging from less than 5 to 38.5%. Thus, an evidence-to-practice gap exists, and it is unclear which implementation strategies would best support providers in adopting and implementing the evidence-based practice. One potential approach to selecting and tailoring implementation strategies is a deliberative loop process, a stakeholder-engaged approach to decision-making. This trial aims to test the acceptability, feasibility, and effectiveness of using a deliberative loop intervention with stakeholders (i.e., providers and staff) to enable managers to select implementation strategies that facilitate the adoption of an evidence-based dental practice. Methods Sixteen dental clinics within Kaiser Permanente Northwest Dental will be cluster randomized to determine the timing of receiving the intervention in this stepped-wedge trial. In the three-part deliberative loop intervention, clinic stakeholders engage in the following activities: (1) receive background information, (2) participate in facilitated small-group discussions designed to promote learning from each other’s lived experiences and develop informed opinions about effective clinic-level implementation strategies, and (3) share their informed opinions with clinic leaders, who may then choose to select and deploy implementation strategies based on the stakeholders’ informed opinions. The primary outcome of Reach will be defined as patient-level receipt of guideline-concordant care. Secondary outcomes will include the cost-effectiveness, acceptability, and feasibility of the deliberative loop process. Implementation strategies deployed will be catalogued over time. Discussion These results will establish the extent to which the deliberative loop process can help leaders select and tailor implementation strategies with the goal of improving guideline-concordant dental care. Trial registration This project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 12/18/2020. https://clinicaltrials.gov/ct2/show/NCT04682730

scholarly journals Reopening schools safely in the face of COVID-19: Can cluster randomized trials help?

2021 ◽  
pp. 174077452098486
Author(s):  
Charles Weijer ◽  
Karla Hemming ◽  
Spencer Phillips Hey ◽  
Holly Fernandez Lynch
Keyword(s):  
Randomized Trials ◽  
Cluster Randomized Trial ◽  
Evidence Based ◽  
School Closures ◽  
School Aged Children ◽  
The Face ◽  
Community Transmission ◽  
Cluster Randomized ◽  
The Impact ◽  
Health Policymaking

The COVID-19 pandemic has highlighted the challenges of evidence-based health policymaking, as critical precautionary decisions, such as school closures, had to be made urgently on the basis of little evidence. As primary and secondary schools once again close in the face of surging infections, there is an opportunity to rigorously study their reopening. School-aged children appear to be less affected by COVID-19 than adults, yet schools may drive community transmission of the virus. Given the impact of school closures on both education and the economy, schools cannot remain closed indefinitely. But when and how can they be reopened safely? We argue that a cluster randomized trial is a rigorous and ethical way to resolve these uncertainties. We discuss key scientific, ethical, and resource considerations both to inform trial design of school reopenings and to prompt discussion of the merits and feasibility of conducting such a trial.

scholarly journals Effect of Real-Time Feedback Devices on Primary Care Patient Experience Scores: A Cluster-Randomized Trial

2021 ◽  
Vol 8 ◽  
pp. 237437352199695
Author(s):  
Kaitlyn Philips ◽  
Nina Dadlez ◽  
Melissa Fazzari ◽  
Shawn Samuel ◽  
William Southern ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Trial ◽  
Real Time ◽  
Patient Experience ◽  
Primary Care Patient ◽  
Cluster Randomized Trial ◽  
Care Patient ◽  
Critical Measure ◽  
Cluster Randomized ◽  
Domain Scores

Patient experience is a critical measure for ambulatory primary care, although it is unclear how to best improve patient experience scores. This study aimed to determine whether use of a real-time feedback (RTF) device improved patient experience scores in a cluster-randomized trial. The primary outcomes were change from baseline in 9 Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) question and domain scores most closely related to the RTF questions asked in a linear mixed effects model. There were no observed statistically significant intervention-related differences in CG-CAHPS scores in any of the 9 CG-CAHPS questions or domains ( P = .12-.99). In intervention clinics, there were no statistically significant correlation between CG-CAHPS top box scores and RTF device scores ( P = .23-.98). Clinics in an urban primary care network randomized to receive RTF devices did not significantly improve related CG-CAHPS question or domain scores nor were those scores correlated with RTF device scores. More research is needed to identify effective interventions to improve ambulatory primary care patient experience.

scholarly journals PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Krithika Suresh ◽  
Jodi Summers Holtrop ◽  
L. Miriam Dickinson ◽  
Emileigh Willems ◽  
Peter C. Smith ◽  
...  
Keyword(s):  
Primary Care ◽  
Weight Loss ◽  
Randomized Trial ◽  
Weight Management ◽  
Implementation Strategies ◽  
Cluster Randomized Trial ◽  
Weight Loss Maintenance ◽  
Stepped Wedge ◽  
Patient Weight ◽  
Cluster Randomized

Abstract Background Despite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care. Implementation strategies are employed to facilitate adoption and use of the PATHWEIGH tools and processes. The current study will compare the effectiveness of PATHWEIGH versus standard of care (SOC) on patient weight loss in primary care and explore factors for its successful implementation. Methods A stepped wedge cluster randomized trial design will be used within an effectiveness-implementation hybrid study. Adult patient weight loss and weight loss maintenance will be compared in PATHWEIGH versus SOC in 57 family and internal medicine clinics in a large health system in Colorado, USA. Effectiveness will be evaluated using generalized linear mixed models to determine statistical differences in weight loss and weight loss maintenance at 6, 12, and 18 months. Patient-, provider-, and clinic-level predictors will be identified using mediator and moderator analyses. Conceptually guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), a mixed methods approach including quantitative (practice surveys, use tracking) and qualitative (interviews, observations) data collection will be used to determine factors impeding and facilitating adoption, implementation, and maintenance of PATHWEIGH and evaluate specified implementation strategies. A cost analysis of the practice and system costs and resources required by PATHWEIGH relative to the reimbursement collected will be performed. Discussion The effectiveness and implementation of PATHWEIGH, and their interrelatedness, for patient weight loss are collectively the focus of the current trial. Findings from this study are expected to serve as a blueprint for available and effective weight management in primary care medical practice. Trial registration ClinicalTrials.govNCT04678752. Registered on December 21, 2020.

scholarly journals The impact of basic vs. enhanced Go NAPSACC on child care centers’ healthy eating and physical activity practices: protocol for a type 3 hybrid effectiveness-implementation cluster-randomized trial

2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Amber E. Vaughn ◽  
Christina R. Studts ◽  
Byron J. Powell ◽  
Alice S. Ammerman ◽  
Justin G. Trogdon ◽  
...  
Keyword(s):  
Physical Activity ◽  
Child Care ◽  
Implementation Strategies ◽  
Cluster Randomized Trial ◽  
Evidence Based ◽  
Child Care Centers ◽  
Post Intervention ◽  
Implementation Approach ◽  
Cluster Randomized ◽  
Type 3

Abstract Background To prevent childhood obesity and promote healthy development, health authorities recommend that child care programs use the evidence-based practices that foster healthy eating and physical habits in children. Go NAPSACC is an intervention shown to improve use of these recommended practices, but it is known to encounter barriers that limit its impact and widespread use. Methods This study will use a type 3 hybrid effectiveness-implementation cluster-randomized trial to compare effectiveness and implementation outcomes achieved from Go NAPSACC delivered with a basic or enhanced implementation approach. Participants will include approximately 25 coaches from Child Care Aware of Kentucky (serving four geographic regions), 97 child care centers with a director and teacher from each and two cross-sectional samples of 485 3–4-year-old children (one recruitment at baseline, another at follow-up). Coaches will be randomly assigned to deliver Go NAPSACC using either the basic or enhanced implementation approach. “Basic Go NAPSACC” represents the traditional way of delivering Go NAPSACC. “Enhanced Go NAPSACC” incorporates preparatory and support activities before and during their Go NAPSACC work, which are guided by the Quality Implementation Framework and the Consolidated Framework for Implementation Research. Data will be collected primarily at baseline and post-intervention, with select measures continuing through 6, 12, and 24 months post-intervention. Guided largely by RE-AIM, outcomes will assess change in centers’ use of evidence-based nutrition and physical activity practices (primary, measured via observation); centers’ adoption, implementation, and maintenance of the Go NAPSACC program (assessed via website use); center directors’, teachers’, and coaches’ perceptions of contextual factors (assessed via self-report surveys); children’s eating and physical activity behaviors at child care (measured via observation and accelerometers); and cost-effectiveness (assessed via logs and expense tracking). The hypotheses anticipate that “Enhanced Go NAPSACC” will have greater effects than “Basic Go NAPSACC.” Discussion This study incorporates many lessons gleaned from the growing implementation science field, but also offers opportunities to address the field’s research priorities, including applying a systematic method to tailor implementation strategies, examining the processes and mechanisms through which implementation strategies produce their effects, and conducting an economic evaluation of implementation strategies. Trial Registration ClinicalTrials.gov, NCT03938103, Registered April 8, 2019

Adjuvanted influenza vaccine and influenza outbreaks in U.S. nursing homes: Results from a pragmatic cluster-randomized clinical trial

2021 ◽  
Author(s):  
Stefan Gravenstein ◽  
Kevin W McConeghy ◽  
Elie Saade ◽  
H Edward Davidson ◽  
David H Canaday ◽  
...  
Keyword(s):  
Nursing Homes ◽  
Influenza Vaccine ◽  
Cluster Randomized Trial ◽  
Exploratory Analysis ◽  
Vaccination Rates ◽  
Trivalent Influenza Vaccine ◽  
Facility Level ◽  
Cluster Randomized ◽  
Influenza Outbreaks ◽  
The Impact

Abstract Background Influenza outbreaks in nursing homes pose a threat to frail residents and occur even in vaccinated populations. We conducted a pragmatic cluster-randomized trial comparing adjuvanted trivalent influenza vaccine (aTIV) versus trivalent influenza vaccine (TIV). Here, we report an exploratory analysis to compare the effect of aTIV versus TIV on facility-reported influenza outbreaks. Methods Nursing homes were randomized to offer older residents either aTIV or TIV for the 2016-17 influenza season. The impact of the intent-to-treat vaccine assignment was evaluated for the total number of outbreaks reported from November-March. We collected data according to standard CDC definitions for both suspected outbreaks and those with a laboratory-confirmed case in nursing homes, and adjusted for facility-level vaccination rates and resident characteristics. Results Of 823 randomized nursing homes, 777 (aTIV, n=387; TIV, n=390) reported information on influenza outbreaks. The treatment groups had similar characteristics at baseline except for race/ethnicity: homes assigned to TIV had a higher percentage of African-American residents (18.0% versus 13.7%). There were 133 versus 162 facility-reported suspected influenza outbreaks in aTIV versus TIV facilities respectively, of these 115 versus 140 were laboratory confirmed. The aTIV group experienced a 17% reduction in suspected (rate ratio, RR, 0.83, 95% confidence interval, CI: 0.65, 1.05) and laboratory-confirmed influenza outbreaks (RR 0.83, 95%CI: 0.63, 1.06). Covariate adjustment increased the estimated reduction for suspected outbreaks to 21% (RR 0.79, 95%CI: 0.61, 0.99) and 22% for laboratory confirmed (RR 0.78, 95%CI: 0.60, 1.02). Conclusions In an exploratory analysis of a cluster-RCT we observed 17-21% fewer outbreaks with aTIV than TIV. ClinicalTrials.gov number, NCT02882100.

scholarly journals Using a participatory method to test a strategy supporting the implementation of a state policy on screening children for adverse childhood experiences (ACEs) in a Federally Qualified Health Center system: a stepped-wedge cluster randomized trial

2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Monica Perez Jolles ◽  
Wendy J. Mack ◽  
Christina Reaves ◽  
Lisa Saldana ◽  
Nicole A. Stadnick ◽  
...  
Keyword(s):  
Mental Health ◽  
Adverse Childhood Experiences ◽  
Implementation Strategy ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Childhood Experiences ◽  
Federally Qualified Health Center ◽  
Adverse Childhood ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Adverse childhood experiences (ACEs) are potentially traumatic events occurring before age 18, such as maltreatment or exposure to violence. ACE screening is increasingly recommended to prevent and address physical and mental health conditions associated with ACEs. To promote ACE screening uptake, the state of California issued the “ACEs Aware” policy that provides Medicaid reimbursement for ACE screening annually for child primary care visits. However, policy directives alone often do not translate into effective screening efforts and greater access to care. Few rigorous studies have developed and tested implementation strategies for ACE pediatric screening policies. This study will fill this gap by testing a multifaceted implementation strategy in partnership with a Federally Qualified Health Center (FQHC) system serving low-income families in Southern California to support the ACE Aware policy. Methods We will use Implementation Mapping, with study process and consideration of determinants and mechanisms guided by the EPIS framework, to co-create and refine an implementation strategy. The proposed strategy is comprised of online training videos, a customized algorithm and use of technology to improve workflow efficiency, implementation training to internal FQHC personnel, clinic support and coaching, and written implementation protocols. A hybrid type 2, stepped-wedge cluster randomized trial design with five primary care clinics will test whether a multifaceted implementation strategy improves (a) fidelity to the ACE screening protocol, (b) reach defined as the proportion of eligible children screened for ACEs, and (c) the impact of the ACE policy on child-level mental health referrals and symptom outcomes. The study will use mixed methods with data to include electronic health records, surveys, and interviews with clinic personnel and caregivers. Discussion This study is designed to increase the capacity of FQHCs’ inner context to successfully implement an outer context-initiated ACE policy designed to benefit pediatric patients. It capitalizes on a rare opportunity to use a co-creation approach to develop, adapt, refine, and pilot test an implementation strategy to maximize the impact of a new state-wide policy intended to improve ACE assessment and subsequent care to improve child health, particularly those from underserved communities. Trial registration Trial # NCT04916587 registered at ClinicalTrials.gov on June 4, 2021.

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