Dataset Information

A stepped-wedge cluster randomized trial designed to improve completion of HPV vaccine series and reduce missed opportunities to vaccinate in rural primary care practices.

ABSTRACT: OBJECTIVES:To test the effectiveness of a comprehensive team-based intervention to improve human papillomavirus (HPV) vaccination completion rates and reduce missed opportunities to vaccinate in rural Oregon. DESIGN:Stepped-wedge cluster randomized trial. PARTICIPANTS:Forty family physicians and pediatricians who are members of the Oregon Rural Practice-based Research Network. INTERVENTION:Tailored to individual practice needs, components will include (1) practice facilitation with clinicians, nurses, front office staff, and others who have patient contact to redesign patient care and communication strategies to optimize HPV vaccine series completion; (2) workflow mapping adapted to practice context to support HPV vaccine delivery; (3) a practice improvement model designed to firmly establish reminder and recall systems and then standing orders; (4) education for patients and parents that underscores HPV vaccination is safe, effective, and an important approach for reducing cancer risk; and (5) partnering with community organizations to plan and implement a social marketing campaign on HPV vaccination. MAIN OUTCOME MEASURES:Initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate derived from Oregon Immunization Program data. TRIAL REGISTRATION:ClinicalTrials.govPRS, NCT03604393 : .Trial was registered on July 11, 2018. The first participant was enrolled on September 11, 2018.

SUBMITTER: Carney PA

PROVIDER: S-EPMC6417191 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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A stepped-wedge cluster randomized trial designed to improve completion of HPV vaccine series and reduce missed opportunities to vaccinate in rural primary care practices.

Carney Patricia A PA Hatch Brigit B Stock Isabel I Dickinson Caitlin C Davis Melinda M Larsen Rex R Valenzuela Steele S Marino Miguel M Darden Paul M PM Gunn Rose R Ferrara Laura L Fagnan Lyle J LJ

Implementation science : IS 20190314 1

<h4>Objectives</h4>To test the effectiveness of a comprehensive team-based intervention to improve human papillomavirus (HPV) vaccination completion rates and reduce missed opportunities to vaccinate in rural Oregon.<h4>Design</h4>Stepped-wedge cluster randomized trial.<h4>Participants</h4>Forty family physicians and pediatricians who are members of the Oregon Rural Practice-based Research Network.<h4>Intervention</h4>Tailored to individual practice needs, components will include (1) practice fa ...[more]

PMID: 30866981

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Project description:BACKGROUND:Adult immunization rates are below Healthy People 2020 targets. Our objective was to evaluate the effectiveness of a multicomponent intervention to improve adult immunization rates. METHODS:This prospective interventional before-and-after non-randomized study was conducted through the American Academy of Family Physicians National Research Network with 43 primary care physicians from a large multi-specialty healthcare organization (multicomponent intervention group n?=?23; comparator group n?=?20) in the United States. The multicomponent intervention included provider reminders, quarterly provider-level performance reports, provider education, patient visual aid materials, and standing orders on adult pneumococcal, influenza, and zoster immunizations. We assessed individual and comparative provider-level vaccination rates and missed opportunities detailing concordance with targets established by Healthy People 2020 for pneumococcal, influenza, and zoster immunizations. RESULTS:Vaccination rates increased after 12?months in intervention and comparator groups respectively for: a). influenza from 44.4?±?16.7 to 51.3%?±?12.9% (by 6.9 percentage points, p?=?0.001) and from 35.1?±?19.1 to 41.3%?±?14.2%, (by 6.2 percentage points, p?=?0.01); b). pneumococcal vaccinations in older adults from 62.8?±?17.6 to 81.4%?±?16.6% (by 18.6 percentage points, for p?<?0.0001) and from 55.9?±?20.0 to 72.7%?±?18.4% (by 16.7 percentage points, p?<?0.0001); and c). zoster from 37.1?±?13.4 to 41.9%?±?13.1% (by 4.8 percentage points, p?<?0.0001) and from 35.0?±?18.7 to 42.3%?±?20.9% (7.3 percentage points, p?=?0.001). Pneumococcal vaccinations in adults at risk did not change from baseline in intervention group (35.7?±?19.6 to 34.5%?±?19.0%, p?=?0.3) and improved slightly in comparator group (24.3?±?20.1 to 28.2%?±?20.0%, p?=?0.003). Missed opportunities reduced after 12?months, most noticeably, for: a). for influenza from 57.7 to 48.6% (by 9.1 percentage points, p?<?0.0001) and from 69.7 to 59.6% (by 10.1 percentage points, p?<?0.0001); b). pneumococcal vaccinations in older adults from 18.1 to 11.5% (by 6.6 percentage points p?<?0.0001) and from 24.6 to 20.4% (by 4.3 percentage points, p?<?0.0001) in intervention and comparator groups respectively. CONCLUSIONS:Multicomponent interventions show promise in improving vaccination rates and reducing missed opportunities in older adults for pneumococcal and zoster vaccines and vaccination against influenza. Provider reminders remain the most effective strategy when delivered either as a component of these interventions or alone.

Project description:BACKGROUND:Controlled implementation trials often randomize the intervention at the site level, enrolling relatively few sites (e.g., 6-20) compared to trials that randomize by subject. Trials with few sites carry a substantial risk of an imbalance between intervened (cases) and non-intervened (control) sites in important site characteristics, thereby threatening the internal validity of the primary comparison. A stepped wedge design (SWD) staggers the intervention at sites over a sequence of times or time waves until all sites eventually receive the intervention. We propose a new randomization method, sequential balance, to control time trend in site allocation by minimizing sequential imbalance across multiple characteristics. We illustrate the new method by applying it to a SWD implementation trial. METHODS:The trial investigated the impact of blended internal-external facilitation on the establishment of evidence-based teams in general mental health clinics in nine US Department of Veterans Affairs medical centers. Prior to randomization to start time, an expert panel of implementation researchers and health system program leaders identified by consensus a series of eight facility-level characteristics judged relevant to the success of implementation. We characterized each of the nine sites according to these consensus features. Using a weighted sum of these characteristics, we calculated imbalance scores for each of 1680 possible site assignments to identify the most sequentially balanced assignment schemes. RESULTS:From 1680 possible site assignments, we identified 34 assignments with minimal imbalance scores, and then randomly selected one assignment by which to randomize start time. Initially, the mean imbalance score was 3.10, but restricted to the 34 assignments, it declined to 0.99. CONCLUSIONS:Sequential balancing of site characteristics across groups of sites in the time waves of a SWD strengthens the internal validity of study conclusions by minimizing potential confounding. TRIAL REGISTRATION:Registered at ClinicalTrials.gov as clinical trials # NCT02543840 ; entered 9/4/2015.

Project description:ImportanceImplementation of new cancer treatment strategies as recommended by evidence-based guidelines is often slow and suboptimal.ObjectiveTo improve the implementation of guideline-based best practices in the Netherlands in pancreatic cancer care and assess the impact on survival.Design, setting, and participantsThis multicenter, stepped-wedge cluster randomized trial compared enhanced implementation of best practices with usual care in consecutive patients with all stages of pancreatic cancer. It took place from May 22, 2018 through July 9, 2020. Data were analyzed from April 1, 2022, through February 1, 2023. It included all patients in the Netherlands with pathologically or clinically diagnosed pancreatic ductal adenocarcinoma. This study reports 1-year follow-up (or shorter in case of deceased patients).InterventionThe 5 best practices included optimal use of perioperative chemotherapy, palliative chemotherapy, pancreatic enzyme replacement therapy (PERT), referral to a dietician, and use of metal stents in patients with biliary obstruction. A 6-week implementation period was completed, in a randomized order, in all 17 Dutch networks for pancreatic cancer care.Main outcomes and measuresThe primary outcome was 1-year survival. Secondary outcomes included adherence to best practices and quality of life (European Organisation for Research and Treatment of Cancer [EORTC] global health score).ResultsOverall, 5887 patients with pancreatic cancer (median age, 72.0 [IQR, 64.0-79.0] years; 50% female) were enrolled, 2641 before and 2939 after implementation of best practices (307 during wash-in period). One-year survival was 24% vs 23% (hazard ratio, 0.98, 95% CI, 0.88-1.08). There was no difference in the use of neoadjuvant chemotherapy (11% vs 11%), adjuvant chemotherapy (48% vs 51%), and referral to a dietician (59% vs 63%), while the use of palliative chemotherapy (24% vs 30%; odds ratio [OR], 1.38; 95% CI, 1.10-1.74), PERT (34% vs 45%; OR, 1.64; 95% CI, 1.28-2.11), and metal biliary stents increased (74% vs 83%; OR, 1.78; 95% CI, 1.13-2.80). The EORTC global health score did not improve (area under the curve, 43.9 vs 42.8; median difference, -1.09, 95% CI, -3.05 to 0.94).Conclusions and relevanceIn this randomized clinical trial, implementation of 5 best practices in pancreatic cancer care did not improve 1-year survival and quality of life. The finding that most patients received no tumor-directed treatment paired with the poor survival highlights the need for more personalized treatment options.Trial registrationClinicalTrials.gov Identifier: NCT03513705.

Project description:BackgroundClinical guidelines recommend anticoagulation for patients with atrial fibrillation (AF) at high risk of stroke; however, studies report 40% of this population is not anticoagulated.ObjectiveTo evaluate a population health intervention to increase anticoagulation use in high-risk patients with AF.MethodsWe used machine learning algorithms to identify patients with AF from electronic health records at high risk of stroke (CHA2DS2-VASc risk score ≥2), and no anticoagulant prescriptions within 12 months. A clinical pharmacist in the anticoagulation service reviewed charts for algorithm-identified patients to assess appropriateness of initiating an anticoagulant. The pharmacist then contacted primary care providers of potentially undertreated patients and offered assistance with anticoagulation management. We used a stepped-wedge design, evaluating the proportion of potentially undertreated patients with AF started on anticoagulant therapy within 28 days for clinics randomised to intervention versus usual care.ResultsOf 1727 algorithm-identified high-risk patients with AF in clinics at the time of randomisation to intervention, 432 (25%) lacked evidence of anticoagulant prescriptions in the prior year. After pharmacist review, only 17% (75 of 432) of algorithm-identified patients were considered potentially undertreated at the time their clinic was randomised to intervention. Over a third (155 of 432) were excluded because they had a single prior AF episode (transient or provoked by serious illness); 36 (8%) had documented refusal of anticoagulation, the remainder had other reasons for exclusion. The intervention did not increase new anticoagulant prescriptions (intervention: 4.1% vs usual care: 4.0%, p=0.86).ConclusionsAlgorithms to identify underuse of anticoagulation among patients with AF in healthcare databases may not capture clinical subtleties or patient preferences and may overestimate the extent of undertreatment. Changing clinician behaviour remains challenging.

Dataset Information

A stepped-wedge cluster randomized trial designed to improve completion of HPV vaccine series and reduce missed opportunities to vaccinate in rural primary care practices.

Publications

A stepped-wedge cluster randomized trial designed to improve completion of HPV vaccine series and reduce missed opportunities to vaccinate in rural primary care practices.

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