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Randomised clinical trial of an early palliative care intervention (SUPPORT) for patients with idiopathic pulmonary fibrosis (IPF) and their caregivers: protocol and key design considerations
  1. Kathleen Oare Lindell1,
  2. Mehdi Nouraie2,
  3. Melinda J Klesen1,
  4. Sara Klein3,
  5. Kevin F Gibson1,
  6. Daniel J Kass1 and
  7. Margaret Quinn Rosenzweig3
  1. 1Department of Medicine, PACCM, Dorothy P. and Richard P. Simmons, Center for Interstitial Lung Disease, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  2. 2Department of Medicine/PACCM, University of Pittsburgh, Pitttsburgh, Pennsylvania, USA
  3. 3School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  1. Correspondence to Dr Kathleen Oare Lindell; lindellko{at}upmc.edu

Footnotes

  • Contributors KOL: conception of idea and design for this clinical trial, manuscript generation; MQR: contributed crucial intellectual content for design of this clinical trial, manuscript review and project oversight; MN: statistical guidance, manuscript review and contributed crucial intellectual content; KFG, DJK: contributed crucial intellectual content and manuscript review; MJK (research coordinator) and SK (nurse interventionist): both provided topic insight. All authors contributed to and approved the final version.

  • Funding US Department of Health and Human Services, National Institutes of Health, National Institute of Nursing Research 1K23NR016276-01A1, Three Lakes Partners, LLC, and The University of Pittsburgh Dorothy P. & Richard P. Simmons Center for Interstitial Lung Disease at UPMC.

  • Competing interests None declared.

  • Patient consent None.

  • Ethics approval The research protocol was approved by the University of Pittsburgh Institutional Review Board PRO16070539 and the trial is registered as NCT02929017 on clinicaltrials.gov.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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Footnotes

  • Contributors KOL: conception of idea and design for this clinical trial, manuscript generation; MQR: contributed crucial intellectual content for design of this clinical trial, manuscript review and project oversight; MN: statistical guidance, manuscript review and contributed crucial intellectual content; KFG, DJK: contributed crucial intellectual content and manuscript review; MJK (research coordinator) and SK (nurse interventionist): both provided topic insight. All authors contributed to and approved the final version.

  • Funding US Department of Health and Human Services, National Institutes of Health, National Institute of Nursing Research 1K23NR016276-01A1, Three Lakes Partners, LLC, and The University of Pittsburgh Dorothy P. & Richard P. Simmons Center for Interstitial Lung Disease at UPMC.

  • Competing interests None declared.

  • Patient consent None.

  • Ethics approval The research protocol was approved by the University of Pittsburgh Institutional Review Board PRO16070539 and the trial is registered as NCT02929017 on clinicaltrials.gov.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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