Creating the evidence base for quality improvement collaboratives

Intensive efforts are under way to improve health care quality and safety throughout the United States and abroad. Many of these efforts use the quality improvement collaborative method, an approach emphasizing collaborative learning and exchange of insights and support among a set of health care organizations. Unfortunately, the widespread acceptance and reliance on this approach are based not on solid evidence but on shared beliefs and anecdotal affirmations that may overstate the actual effectiveness of the method. More effective use of the collaborative method will require a commitment by users, researchers, and other stakeholders to rigorous, objective evaluation and the creation of a valid, useful knowledge and evidence base. Development of this evidence base will require improved conceptions of the nature of quality problems, quality improvement processes, and the types of research needed to elucidate these processes. Researchers, journal editors, and funding agencies must also cooperate to ensure that published evaluations are relevant, comprehensive, and cumulative. Ann Intern Med. 2004;140:897-901. www.annals.org For author affiliation, see end of text. See related article on pp 887-896

Requirements for ethics committee review for studies submitted to Implementation Science

The requirement for ethics review of studies submitted to Implementation Science has been unclear. Therefore, in this editorial, we set out our requirements for ethics committee review of experimental and non-experimental studies. For any study that meets the criteria of human subject research (which includes research on healthcare providers), irrespective of study design, we will require proof of either satisfactory ethics committee review or of the granting of an official exemption or waiver

Welcome to Implementation Science

Implementation research is the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services and care. This relatively new field includes the study of influences on healthcare professional and organisational behaviour. Implementation Science will encompass all aspects of research in this field, in clinical, community and policy contexts. This online journal will provide a unique platform for this type of research and will publish a broad range of articles – study protocols, debate, theoretical and conceptual articles, rigorous evaluations of the process of change, and articles on methodology and rigorously developed tools – that will enhance the development and refinement of implementation research. No one discipline, research design, or paradigm will be favoured. Implementation Science looks forward to receiving manuscripts that facilitate the continued development of the field, and contribute to healthcare policy and practice

The implementation research institute: Training mental health implementation researchers in the United States

Abstract Background The Implementation Research Institute (IRI) provides two years of training in mental health implementation science for 10 new fellows each year. The IRI is supported by a National Institute of Mental Health (NIMH) R25 grant and the Department of Veterans Affairs (VA). Fellows attend two annual week-long trainings at Washington University in St. Louis. Training is provided through a rigorous curriculum, local and national mentoring, a ‘learning site visit’ to a federally funded implementation research project, pilot research, and grant writing. Methods This paper describes the rationale, components, outcomes to date, and participant experiences with IRI. Results IRI outcomes include 31 newly trained implementation researchers, their new grant proposals, contributions to other national dissemination and implementation research training, and publications in implementation science authored by the Core Faculty and fellows. Former fellows have obtained independent research funding in implementation science and are beginning to serve as mentors for more junior investigators. Conclusions Based on the number of implementation research grant proposals and papers produced by fellows to date, the IRI is proving successful in preparing new researchers who can inform the process of making evidence-based mental healthcare more available through real-world settings of care and who are advancing the field of implementation science

Project ACHIEVE – Using Implementation Research to Guide the Evaluation of Transitional Care Effectiveness

Background: Poorly managed hospital discharges and care transitions between health care facilities can cause poor outcomes for both patients and their caregivers. Unfortunately, the usual approach to health care delivery does not support continuity and coordination across the settings of hospital, doctors’ offices, home or nursing homes. Though complex efforts with multiple components can improve patient outcomes and reduce 30-day readmissions, research has not identified which components are necessary. Also we do not know how delivery of core components may need to be adjusted based on patient, caregiver, setting or characteristics of the community, or how system redesign can be accelerated. Methods/design: Project ACHIEVE focuses on diverse Medicare populations such as individuals with multiple chronic diseases, patients with low health literacy/numeracy and limited English proficiency, racial and ethnic minority groups, low-income groups, residents of rural areas, and individuals with disabilities. During the first phase, we will use focus groups to identify the transitional care outcomes and components that matter most to patients and caregivers to inform development and validation of assessment instruments. During the second phase, we will evaluate the comparative effectiveness of multi-component care transitions programs occurring across the U.S. Using a mixed-methods approach for this evaluation, we will study historical (retrospective) and current and future (prospective) groups of patients, caregivers and providers using site visits, surveys, and clinical and claims data. In this natural experiment observational study, we use a fractional factorial study design to specify comparators and estimate the individual and combined effects of key transitional care components. Discussion: Our study will determine which evidence-based transitional care components and/or clusters most effectively produce patient and caregiver desired outcomes overall and among diverse patient and caregiver populations in different healthcare settings. Using the results, we will develop concrete, actionable recommendations regarding how best to implement these strategies. Finally, this work will provide tools for hospitals, community-based organizations, patients, caregivers, clinicians and other stakeholders to help them make informed decisions about which strategies are most effective and how best to implement them in their communities. Trial registration: Registered as NCT02354482 on clinicaltrials.gov on 1/29/201

Developing Implementation Research Capacity: Longitudinal Evaluation of the King’s College London Implementation Science Masterclass, 2014-2019

Background: Despite an increasing number of training opportunities in implementation science becoming available, the demand for training amongst researchers and practitioners is unmet. To address this training shortfall, we developed the King\u27s College London \u27Implementation Science Masterclass\u27 (ISM), an innovative 2-day programme (and currently the largest of its kind in Europe), developed and delivered by an international faculty of implementation experts. Methods: This paper describes the ISM and provides delegates\u27 quantitative and qualitative evaluations (gathered through a survey at the end of the ISM) and faculty reflections over the period it has been running (2014-2019). Results: Across the 6-year evaluation, a total of 501 delegates have attended the ISM, with numbers increasing yearly from 40 (in 2014) to 147 (in 2019). Delegates represent a diversity of backgrounds and 29 countries from across the world. The overall response rate for the delegate survey was 64.5% (323/501). Annually, the ISM has been rated \u27highly\u27 in terms of delegates\u27 overall impression (92%), clear and relevant learning objectives (90% and 94%, respectively), the course duration (85%), pace (86%) and academic level 87%), and the support provided on the day (92%). Seventy-one percent of delegates reported the ISM would have an impact on how they approached their future work. Qualitative feedback revealed key strengths include the opportunities to meet with an international and diverse pool of experts and individuals working in the field, the interactive nature of the workshops and training sessions, and the breadth of topics and contexts covered. Conclusions: Yearly, the UK ISM has grown, both in size and in its international reach. Rated consistently favourably by delegates, the ISM helps to tackle current training demands from all those interested in learning and building their skills in implementation science. Evaluation of the ISM will continue to be an annual iterative process, reflective of changes in the evidence base and delegates changing needs as the field evolves

Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED).

BackgroundRecurrent strokes are preventable through awareness and control of risk factors such as hypertension, and through lifestyle changes such as healthier diets, greater physical activity, and smoking cessation. However, vascular risk factor control is frequently poor among stroke survivors, particularly among socio-economically disadvantaged blacks, Latinos and other people of color. The Chronic Care Model (CCM) is an effective framework for multi-component interventions aimed at improving care processes and outcomes for individuals with chronic disease. In addition, community health workers (CHWs) have played an integral role in reducing health disparities; however, their effectiveness in reducing vascular risk among stroke survivors remains unknown. Our objectives are to develop, test, and assess the economic value of a CCM-based intervention using an Advanced Practice Clinician (APC)-CHW team to improve risk factor control after stroke in an under-resourced, racially/ethnically diverse population.Methods/designIn this single-blind randomized controlled trial, 516 adults (≥40 years) with an ischemic stroke, transient ischemic attack or intracerebral hemorrhage within the prior 90 days are being enrolled at five sites within the Los Angeles County safety-net setting and randomized 1:1 to intervention vs usual care. Participants are excluded if they do not speak English, Spanish, Cantonese, Mandarin, or Korean or if they are unable to consent. The intervention includes a minimum of three clinic visits in the healthcare setting, three home visits, and Chronic Disease Self-Management Program group workshops in community venues. The primary outcome is blood pressure (BP) control (systolic BP <130 mmHg) at 1 year. Secondary outcomes include: (1) mean change in systolic BP; (2) control of other vascular risk factors including lipids and hemoglobin A1c, (3) inflammation (C reactive protein [CRP]), (4) medication adherence, (5) lifestyle factors (smoking, diet, and physical activity), (6) estimated relative reduction in risk for recurrent stroke or myocardial infarction (MI), and (7) cost-effectiveness of the intervention versus usual care.DiscussionIf this multi-component interdisciplinary intervention is shown to be effective in improving risk factor control after stroke, it may serve as a model that can be used internationally to reduce race/ethnic and socioeconomic disparities in stroke in resource-constrained settings.Trial registrationClinicalTrials.gov Identifier NCT01763203