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Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARDPCI)
  1. Tone M Norekvål1,2,3,
  2. Heather G Allore4,5,
  3. Bjørn Bendz6,7,
  4. Cathrine Bjorvatn2,8,
  5. Britt Borregaard9,
  6. Gunhild Brørs10,
  7. Christi Deaton11,
  8. Nina Fålun1,3,
  9. Heather Hadjistavropoulos12,
  10. Tina Birgitte Hansen13,14,
  11. Stig Igland15,
  12. Alf Inge Larsen2,16,
  13. Pernille Palm17,
  14. Trond Røed Pettersen1,2,
  15. Trine Bernholdt Rasmussen18,
  16. Jan Schjøtt2,19,
  17. Rikke Søgaard20,21,
  18. Irene Valaker22,
  19. Ann Dorthe Zwisler23,
  20. Svein Rotevatn1
  21. On behalf of the CONCARD Investigators
  1. 1 Department of Heart Disease, Haukeland University Hospital, Bergen, Norway
  2. 2 Department of Clinical Science, University of Bergen, Bergen, Norway
  3. 3 Faculty of Health and Social Sciences, Western Norway University of Applied Sciences, Bergen, Norway
  4. 4 Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
  5. 5 Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut, USA
  6. 6 Department of Cardiology, Oslo University Hospital, Oslo, Norway
  7. 7 Institute of Clinical Medicine, University of Oslo, Oslo, Norway
  8. 8 Centre on Learning and Mastery, Haukeland University Hospital, Bergen, Norway
  9. 9 Department of Cardiology, Odense University Hospital, Odense, Denmark
  10. 10 Clinic of Cardiology, St. Olavs University Hospital, Trondheim, Norway
  11. 11 Cambridge Institute of Public Health, University of Cambridge, Cambridge, UK
  12. 12 Department of Psychology, University of Regina, Regina, Saskatchewan, Canada
  13. 13 Department of Cardiology, Zealand University Hospital Roskilde, Roskilde, Denmark
  14. 14 Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
  15. 15 Medical Clinic, Førde Hospital Trust, Førde, Norway
  16. 16 Department of Cardiology, Stavanger University Hospital, Stavanger, Norway
  17. 17 Department of Cardiology, Copenhagen University Hospital, Copenhagen, Denmark
  18. 18 Department of Cardiology, Gentofte University Hospital, Hellerup, Denmark
  19. 19 Section of Clinical Pharmacology, Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway
  20. 20 Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
  21. 21 Department of Public Health, Aarhus University, Aarhus, Denmark
  22. 22 Faculty of Health and Social Sciences, Western Norway University of Applied Sciences, Førde, Norway
  23. 23 The Danish Knowledge Centre for Rehabilitation and Palliative Care (REHPA), Odense University Hospital, Odense, Denmark
  1. Correspondence to Professor Tone M Norekvål; tone.merete.norekval{at}helse-bergen.no

Abstract

Introduction Percutaneous coronary intervention (PCI) aims to provide instant relief of symptoms, and improve functional capacity and prognosis in patients with coronary artery disease. Although patients may experience a quick recovery, continuity of care from hospital to home can be challenging. Within a short time span, patients must adjust their lifestyle, incorporate medications and acquire new support. Thus, CONCARDPCI will identify bottlenecks in the patient journey from a patient perspective to lay the groundwork for integrated, coherent pathways with innovative modes of healthcare delivery. The main objective of the CONCARDPCI is to investigate (1) continuity of care, (2) health literacy and self-management, (3) adherence to treatment, and (4) healthcare utilisation and costs, and to determine associations with future short and long-term health outcomes in patients after PCI.

Methods and analysis This prospective multicentre cohort study organised in four thematic projects plans to include 3000 patients. All patients undergoing PCI at seven large PCI centres based in two Nordic countries are prospectively screened for eligibility and included in a cohort with a 1-year follow-up period including data collection of patient-reported outcomes (PRO) and a further 10-year follow-up for adverse events. In addition to PROs, data are collected from patient medical records and national compulsory registries.

Ethics and dissemination Approval has been granted by the Norwegian Regional Committee for Ethics in Medical Research in Western Norway (REK 2015/57), and the Data Protection Agency in the Zealand region (REG-145-2017). Findings will be disseminated widely through peer-reviewed publications and to patients through patient organisations.

Trial registration number NCT03810612.

  • continuity of care
  • adherence to treatment
  • health literacy
  • healthcare utilisation
  • percutaneous coronary intervention
  • rehabilitation
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Footnotes

  • Twitter @TNorekval, @CNRGCam, @Trond Røed Pettersen@EdTrond

  • Contributors TMN is the principal investigator of CONCARDPCI and was responsible for study conception, development of the project outline and ethical approval. HGA, GB, NF, TBH, TRP, IV and SR contributed to the development of the project outline. HGA is chairing the Scientific Advisory Board with CD, HH, RS and ADZ as contributing members. NF is the coordinator of the cohort study in CONCARDPCI with TBH as the national coordinator in Denmark, and AIL, BBe, BBo, PP, TBH and TBR are local principal investigators. CB and SI give specific input on transition of care. GB, TRP, TBH and IV are leaders of thematic projects. JS is a major contributor in design of studies on serum levels of cardiac medications and Project 3 in general. TMN wrote the first draft of the manuscript. All authors revised the manuscript critically, and read and approved the final manuscript. A more detailed description of the roles of all authors can be found in the online supplementary appendix.

  • Funding The CONCARDPCI is funded by a major grant from the Western Norway Health Authority (Grant No 912184). We also received funding from the Novo Nordisk Foundation (Grant No NNF17OC0030130), Zealand Regional Research Foundation (Grant No 15-000342), Bergen Health Trust grants 2016–2018 and the Copenhagen University Hospital, Rigshospitalet. HGA is supported in part by the NIH/NIA R01 AG047891, R33 AG057806 and P30 AG021342. TMN is supported in part by a Western Norway Health Authority research grant (Grant No 911870). TRP is supported by a Western Norway Health Authority PhD fellow grant for CONCARDPCI (Grant No 912295), and IV by a PhD fellow grant from the Western Norway University of Applied Sciences.

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  • Competing interests None declared.

  • Patient consent for publication Not required.

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

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