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The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.

Publication ,  Journal Article
O'Brien, EC; Sugarman, J; Weinfurt, KP; Larson, EB; Heagerty, PJ; Hernandez, AF; Curtis, LH
Published in: Trials
May 21, 2022

BACKGROUND: The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare delivery systems, they may be at high risk of disruption due to the dual impacts on the conduct of both care and research. METHODS: We collected qualitative data using multiple methods to characterize the impact of COVID-19 on the research activities of 14 active pragmatic clinical trials in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. A COVID-19 impact questionnaire was administered electronically to principal investigators in June 2020. Text responses were analyzed thematically, and qualitative summaries were subsequently reviewed by five independent reviewers, who made iterative revisions. Additional COVID-19-related impacts were identified during virtual meetings with trial teams during April-July 2020 and combined with questionnaire responses for analysis. RESULTS: Impacts of the pandemic were broadly classified into two main types: healthcare operations and social distancing. In some instances, trial delays created statistical challenges, particularly with trials using stepped-wedge designs, and necessitated changing data collection strategies or modifying interventions. The majority of projects used existing stakeholder-driven approaches to adapt interventions. Several benefits of these adaptions were identified, including expanded outreach capabilities and ability to study virtual intervention delivery. All trial teams were able to adapt to pandemic-related modifications. CONCLUSION: In a group of 14 ongoing pragmatic clinical trials, there was significant impact of COVID-19 on trial activities. Engaging appropriate stakeholders was critical to designing and implementing trial modifications and making continued safe progress toward meeting research objectives.

Duke Scholars

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Published In

Trials

DOI

EISSN

1745-6215

Publication Date

May 21, 2022

Volume

23

Issue

1

Start / End Page

424

Location

England

Related Subject Headings

  • United States
  • Pragmatic Clinical Trials as Topic
  • Pandemics
  • National Institutes of Health (U.S.)
  • Humans
  • General & Internal Medicine
  • Delivery of Health Care
  • Cardiovascular System & Hematology
  • COVID-19
  • 4203 Health services and systems
 

Citation

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O’Brien, E. C., Sugarman, J., Weinfurt, K. P., Larson, E. B., Heagerty, P. J., Hernandez, A. F., & Curtis, L. H. (2022). The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory. Trials, 23(1), 424. https://doi.org/10.1186/s13063-022-06385-8
O’Brien, Emily C., Jeremy Sugarman, Kevin P. Weinfurt, Eric B. Larson, Patrick J. Heagerty, Adrian F. Hernandez, and Lesley H. Curtis. “The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.Trials 23, no. 1 (May 21, 2022): 424. https://doi.org/10.1186/s13063-022-06385-8.
O’Brien EC, Sugarman J, Weinfurt KP, Larson EB, Heagerty PJ, Hernandez AF, et al. The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory. Trials. 2022 May 21;23(1):424.
O’Brien, Emily C., et al. “The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.Trials, vol. 23, no. 1, May 2022, p. 424. Pubmed, doi:10.1186/s13063-022-06385-8.
O’Brien EC, Sugarman J, Weinfurt KP, Larson EB, Heagerty PJ, Hernandez AF, Curtis LH. The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory. Trials. 2022 May 21;23(1):424.
Journal cover image

Published In

Trials

DOI

EISSN

1745-6215

Publication Date

May 21, 2022

Volume

23

Issue

1

Start / End Page

424

Location

England

Related Subject Headings

  • United States
  • Pragmatic Clinical Trials as Topic
  • Pandemics
  • National Institutes of Health (U.S.)
  • Humans
  • General & Internal Medicine
  • Delivery of Health Care
  • Cardiovascular System & Hematology
  • COVID-19
  • 4203 Health services and systems