. 2017 Sep 18;17(1):144.

doi: 10.1186/s12874-017-0420-7.

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

Kevin P Weinfurt^{1

2

3}, Adrian F Hernandez^{4

5}, Gloria D Coronado⁶, Lynn L DeBar⁶, Laura M Dember⁷, Beverly B Green⁸, Patrick J Heagerty⁹, Susan S Huang¹⁰, Kathryn T James⁹, Jeffrey G Jarvik⁹, Eric B Larson¹¹, Vincent Mor¹², Richard Platt¹³, Gary E Rosenthal¹⁴, Edward J Septimus¹⁵, Gregory E Simon⁸, Karen L Staman¹⁶, Jeremy Sugarman¹⁷, Miguel Vazquez¹⁸, Douglas Zatzick¹⁹, Lesley H Curtis^{4

5}

Affiliations

¹ Department of Population Health Sciences, Duke University School of Medicine, 220 W Main St., Suite 720A, Durham, NC, 27705, USA. kevin.weinfurt@duke.edu.
² Duke Clinical Research Institute, 2400 Pratt St., Durham, NC, 27710, USA. kevin.weinfurt@duke.edu.
³ Department of Psychology and Neuroscience, Duke Clinical Research Institute, Durham, NC, 27710, USA. kevin.weinfurt@duke.edu.
⁴ Duke Clinical Research Institute, 2400 Pratt St., Durham, NC, 27710, USA.
⁵ Duke University School of Medicine, 3115 N. Duke Street, Durham, NC, 27704, USA.
⁶ Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227-1098, USA.
⁷ Perelman School of MedicineBlockley Hall, Office 920, 423 Guardian Drive, Philadelphia, PA, 19104, USA.
⁸ Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101-1466, USA.
⁹ University of Washington, 325 Ninth Ave, Box 359728, Seattle, WA, 98104-2499, USA.
¹⁰ University of California Irvine School of Medicine, 101 The City Drive South, City Tower, Suite 400, Mail Code: 4081, Orange, CA, 92868, USA.
¹¹ Group Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101-1466, USA.
¹² Department of Community Health, Brown University, Box G-S121-2, Providence, RI, 02912, USA.
¹³ Department of Population Medicine, Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA, 02215, USA.
¹⁴ Department of Internal Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
¹⁵ Hospital Corporation of America Nashville TN, AND Texas A&M College of Medicine, One Park Plaza, Nashville, TN, 37203, USA.
¹⁶ CHB Wordsmith, Inc., 22 Bagwell Ave, Raleigh, NC, 27607, USA.
¹⁷ Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Ave., Room 203, Baltimore, MD, 21205, USA.
¹⁸ University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX, 75390-8856, USA.
¹⁹ University of Washington School of Medicine, 325 9th Ave, Seattle, WA, 98104, USA.

PMID: 28923013
PMCID: PMC5604499
DOI: 10.1186/s12874-017-0420-7

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

Kevin P Weinfurt et al. BMC Med Res Methodol. 2017.

. 2017 Sep 18;17(1):144.

doi: 10.1186/s12874-017-0420-7.

Authors

Affiliations

¹ Department of Population Health Sciences, Duke University School of Medicine, 220 W Main St., Suite 720A, Durham, NC, 27705, USA. kevin.weinfurt@duke.edu.
² Duke Clinical Research Institute, 2400 Pratt St., Durham, NC, 27710, USA. kevin.weinfurt@duke.edu.
³ Department of Psychology and Neuroscience, Duke Clinical Research Institute, Durham, NC, 27710, USA. kevin.weinfurt@duke.edu.
⁴ Duke Clinical Research Institute, 2400 Pratt St., Durham, NC, 27710, USA.
⁵ Duke University School of Medicine, 3115 N. Duke Street, Durham, NC, 27704, USA.
⁶ Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227-1098, USA.
⁷ Perelman School of MedicineBlockley Hall, Office 920, 423 Guardian Drive, Philadelphia, PA, 19104, USA.
⁸ Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101-1466, USA.
⁹ University of Washington, 325 Ninth Ave, Box 359728, Seattle, WA, 98104-2499, USA.
¹⁰ University of California Irvine School of Medicine, 101 The City Drive South, City Tower, Suite 400, Mail Code: 4081, Orange, CA, 92868, USA.
¹¹ Group Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101-1466, USA.
¹² Department of Community Health, Brown University, Box G-S121-2, Providence, RI, 02912, USA.
¹³ Department of Population Medicine, Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA, 02215, USA.
¹⁴ Department of Internal Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
¹⁵ Hospital Corporation of America Nashville TN, AND Texas A&M College of Medicine, One Park Plaza, Nashville, TN, 37203, USA.
¹⁶ CHB Wordsmith, Inc., 22 Bagwell Ave, Raleigh, NC, 27607, USA.
¹⁷ Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Ave., Room 203, Baltimore, MD, 21205, USA.
¹⁸ University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX, 75390-8856, USA.
¹⁹ University of Washington School of Medicine, 325 9th Ave, Seattle, WA, 98104, USA.

PMID: 28923013
PMCID: PMC5604499
DOI: 10.1186/s12874-017-0420-7

Abstract

Background: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.

Methods: To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.

Results: In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.

Conclusion: A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

Keywords: Cluster randomized trials; Embedded clinical trials; Pragmatic clinical research; Pragmatic research; Stakeholder engagement.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

Not applicable. We are not reporting patient data.

Consent for publication

Not applicable.

Competing interests

Dr. Coronado served as a co-Investigator on a study, Adherence to Minimally Invasive CRC Screening in Patients Who Have Not Completed CRC Screening (ADMIT) 11/14–08/15, funded by Epigenomics.

Dr. Jarvik was a consultant for HealthHelp, a radiology benefits management company. He currently is a section editor for UpToDate.

Dr. Mor holds stock of unknown value in PointRight, Inc. an information services company providing advice and consultation to the long-term care and post-acute care industry; he chairs the Independent Quality Committee for HRC Manor Care, Inc., a nursing home chain and chairs the Scientific Advisory Committee for NaviHealth, a post-acute care service organization.

Dr. Huang conducted clinical trials and studies in which participating hospitals and nursing homes received contributed antiseptic products from Sage Products, Molnlycke, 3 M, Clorox, and Xttrium. The ABATE Infection Trial hospitals received antiseptic products from Sage Products and Molnlycke. All companies that contributed product had no role in the design, conduct, analysis, or publication of these studies.

Dr. Platt has research support from Clorox Corporation.

Dr. Septimus for the ABATE Infection Trial hospitals received antiseptic products from Sage Products and Molnlycke. All companies that contributed product had no role in the design, conduct, analysis, or publication of these studies.

Authors not named here have disclosed no conflicts of interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

Affiliations

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory

Authors

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

References

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical