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Implementation Research: Beyond the Traditional Randomized Controlled Trial

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Essentials of Clinical Research

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Abstract

Implementation research is a new scientific discipline emerging from the recognition that the public does not derive sufficient or rapid benefit from advances in the health sciences (Berwick DM, JAMA 289:1969–1975, 2003; Lenfant C, N Engl J Med 349:868–874, 2003). One often-quoted estimate claims that it takes an average of 17 years for even well-established clinical knowledge to be fully adopted into routine practice (Kiefe CI, Sales A, J Gen Intern Med 21(Suppl 2):S67–S70, 2006). In this chapter, we will discuss particular barriers to evidence implementation, present tools for implementation research, and provide a framework for designing implementation research studies, emphasizing the randomized trial. The reader is advised that this chapter only provides a basic introduction to several concepts for which new approaches are rapidly emerging. Therefore, our goal is to stimulate interest and promote additional in-depth learning for those who wish to develop new implementation research projects or better understand this exciting field.

I think when people look back at our time, they will be amazed at one thing more than any other. It is this-that we do know more about ourselves now than people did in the past, but that very little if this knowledge has been put into effect.

D Lessing http://daronlarson.blogspot.com/2006/12/prisons-we-choose-to-live-inside.html

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Acknowledgement 

We thank Winter Williams, Kierstin Leslie, and Natalie Wilson for critically reviewing a prior version of this chapter.

Author information

Authors and Affiliations

  1. Geriatric Research Education and Clinical Center (GRECC); Section of Hospital Medicine, Department of Veterans Affairs, Tennessee Valley Healthcare System, Vanderbilt University, Nashville, TN, USA

    Amanda S. Mixon M.D., M.S., MSPH

  2. Department of Quantitative Health Sciences, Graduate Research Assistant, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA, USA

    Lauren Powell BS

  3. General Internal Medicine, University of Alabama at Birmingham, Birmingham, AL, USA

    Carlos A. Estrada M.D., M.S.

  4. Veterans Affairs Quality Scholars Program, Birmingham VA Medical Center, Birmingham, AL, USA

    Carlos A. Estrada M.D., M.S.

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  1. Amanda S. Mixon M.D., M.S., MSPH
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  2. Lauren Powell BS
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  3. Carlos A. Estrada M.D., M.S.
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Corresponding author

Correspondence to Amanda S. Mixon M.D., M.S., MSPH .

Editor information

Editors and Affiliations

  1. Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA

    Stephen P. Glasser

Resources

Resources

Selected Journals That Publish Implementation Research

  • Annals of Internal Medicine

  • BMJ Quality and Safety in Health Care

  • Implementation Science

  • JAMA

  • Journal of General Internal Medicine

  • Journal of Hospital Medicine

  • Medical Care

  • Pediatrics

  • The Joint Commission Journal on Quality and Patient Safety

Selected Checklists and Reporting Guidelines

  • Standards for Quality Improvement Reporting Excellence (SQUIRE)

    • SQUIRE are guidelines for publishing quality improvement interventions.

    • The guidelines provide specific details to be addressed in each section of manuscripts that report quality improvement interventions.

    • http://squire-statement.org/

    • Davidoff F, Batalden P. Toward stronger evidence on quality improvement. Draft publication guidelines: the beginning of a consensus project. Qual Saf Health Care 2005;14:319–25.

  • Enhancing the Quality and Transparency of Health Research (EQUATOR)

    • EQUATOR is an international initiative that seeks to improve the quality of scientific reporting.

    • This initiative includes statements about reporting for a range of experimental and observational study types, including randomized trials, group randomized trials, behavioral trials, and quality interventions. It also provides education and training on the use of reporting guidelines.

    • http://www.equator-network.org

  • Consolidated Standards of Reporting Trials (CONSORT)

    • This initiative focuses on design and reporting standards for randomized controlled trials (RCTs) in health care.

    • Although originally designed for the traditional ‘parallel’ randomized clinical trial, the CONSORT criteria have been extended to include cluster RCTs and behavioral RCTs.

    • http://www.consort-statement.org/

  • Workgroup for Intervention Development and Evaluation Research (WIDER)

Selected Resources for Intervention Design

  • Agency for Healthcare Research and Quality (AHRQ) website for clinicians and providers

  • Patient-Centered Outcomes Research Institute: http://www.pcori.org/ Patient Reported Outcomes Measurement Information System (PROMIS): a National Institutes of Health (NIH) funded system of patient–reported assessment tools to health status. http://www.nihpromis.org/default

  • The National Guideline Clearinghouse is a database of evidence-based practice guidelines available to the public. http://www.guideline.gov

  • Veterans’ Administration Quality Enhancement Research Initiative (QUERI) Implementation Guides

    • The QUERI Implementation Guide is a three-part series focusing on practical issues for designing and conducing implementation research.

    • The guide includes material on conceptual models, diagnosing performance gaps, developing interventions, evaluating implementation research, lessons learned from prior QUERI projects, tools and toolkits, as well as many resources.

    • http://www.queri.research.va.gov/implementation/

  • Finding Answers

    • This program is sponsored by the Robert Wood Johnson Foundation to develop interventions for eliminating racial/ethnic disparities in health care.

    • The Finding Answers Intervention Research (FAIR) database includes 388 summaries of journal articles from 11 systematic reviews of interventions to decrease racial/ethnic disparities for many commonly encountered diseases, such as diabetes and hypertension. Interventions based on cultural leverage and performance-based reimbursement are also included.

    • http://www.solvingdisparities.org/

  • National Center for Cultural Competence

    • This center is sponsored by Georgetown University and offers several implementation tools, manuscripts, and policy statements for organizations, clinicians, and consumers.

    • The Internet site has a section describing ‘promising practices’ which may be particularly useful in designing new interventions.

    • http://nccc.georgetown.edu/

  • Clinical Microsystems

    • The Dartmouth Institute for Health Policy and Clinical Practice maintains this website that offers tools for improving clinical microsystems.

    • Most tools are generally available to the public at no cost.

    • The Clinical Microsystems Action Guide (under the materials, workbooks tab) may be particularly useful for designing new interventions.

    • http://www.clinicalmicrosystem.org/

  • Institute for Healthcare Improvement

    • This not-for-profit organization maintains an Internet site that contains several tools for improving the quality, safety, and efficiency of health care. Many tools are publically available at no cost.

    • White papers describing the ‘Breakthrough Series’ may be particularly useful for those developing new interventions.

  • http://www.ihi.org

Selected Resources for Implementing and Disseminating Quality Improvement

  • Splaine, M. E., Dolansky, M. A., Patrician, P. A., Estrada, C. A. Editors. Oakbrook: Joint Commission Resources. Practice-based Learning and Improvement: A Clinical Improvement Action Guide, 3rd Edition. 2012.

    • Authors explain proven methods for integrating the core competency of practice-based learning and improvement (PBLI) into daily clinical work. Practical tools are described for health professionals working on quality improvement.

  • Ogrinc GS, Headrick LA, Moore SM, Barton AJ, Dolansky MA, Madigosky WS. Oakbrook: Joint Commission Resources. Fundamentals of Health Care Improvement: A Guide to Improving Your Patients’ Care. 2nd Edition. 2012.

    • The book provides a single source for nursing students, medical students, and resident physicians to learn and practice the basics of QI.

  • Brownson RC, Colditz GA, Proctor EK. Dissemination and Implementation Research in Health: Translating Science to Practice. Oxford Scholarship. 2012.

    • The authors provide a comprehensive roadmap for implementation research.

Selected Training Programs

  • Veterans Affairs Quality Scholar Fellowship Program

    • A two-year inter-professional education program that offer scholars opportunities to become leaders by applying knowledge and methods of health care improvement to the care of veteran, innovate and continually improve health care, teach health professionals about health care improvement, perform research and develop new knowledge for the ongoing improvement of the quality and value of health care services.

    • http://www.vaqs.org

  • Quality and Safety Education for Nurses (QSEN) Institute

    • The Institute offers comprehensive, competency based resources to empower nurses with knowledge, skills, and attitudes to improve quality and safety across the healthcare system.

    • http://qsen.org/

  • Training in Dissemination and Implementation Research in Health (TIDIRH).

  • VA Enhancing Implementation Science in VA Cyber Seminar

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Mixon, A.S., Powell, L., Estrada, C.A. (2014). Implementation Research: Beyond the Traditional Randomized Controlled Trial. In: Glasser, S. (eds) Essentials of Clinical Research. Springer, Cham. https://doi.org/10.1007/978-3-319-05470-4_13

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