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Gastroenterology and hepatology
Protocol
Nurse-led clinic for patients with liver cirrhosis—effects on health-related quality of life: study protocol of a pragmatic multicentre randomised controlled trial
  1. Maria Hjorth1,2,
  2. Daniel Sjöberg1,
  3. Anncarin Svanberg2,3,4,
  4. Elenor Kaminsky3,
  5. Sophie Langenskiöld3,
  6. Fredrik Rorsman2
  1. 1 Center of Clinical Reaerch in Dalarna, Falun, Sweden
  2. 2 Department of Medical Sciences, Uppsala Universitet Medicinska fakulteten, Uppsala, Sweden
  3. 3 Department of Public Health and Caring Sciences, Uppsala University, Falun, Sweden
  4. 4 Dalarna University, Falun, Sweden
  1. Correspondence to Mrs Maria Hjorth; maria.hjorth{at}medsci.uu.se

Abstract

Introduction Liver cirrhosis affects health-related quality of life (HRQoL) even in its early stages. Morbidity is especially high when the disease decompensates and self-care actions become essential. Nurse involvement in secondary prevention in other chronic diseases has contributed to better symptom control, less need of inpatient care and improved HRQoL. In order to evaluate the impact of nurse involvement in the follow-up of patients with liver cirrhosis, we decided to compare structured nurse-led clinics, inspired by Dorothea Orem’s nursing theory and motivational strategies, with a group of patients receiving standard care. The primary outcome is HRQoL and the secondary outcomes are quality of care, visits to outpatient clinics or hospitals, disease progress and health literacy.

Methods and analysis This is a pragmatic, multicentre randomised controlled study conducted at six Swedish hepatology departments. Eligible patients are adults with diagnosed cirrhosis of the liver (n=500). Participants are randomised into either an intervention with nurse-led follow-up group or into a standard of care group. Recruitment started in November 2016 and is expected to proceed until 2020. Primary outcomes are physical and mental HRQoL measured by RAND-36 at enrolment, after 1 and 2 years.

Ethics and dissemination The study is ethically approved by the Regional Ethical Review Board in Uppsala. The results shall be disseminated in international conferences and peer-reviewed articles.

Trial registration number NCT02957253; Pre-results.

  • liver cirrhosis
  • nurse-led clinic
  • health-related quality Of life
  • qualituy of care
  • economics
  • nursing

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-023064

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    Footnotes

    • Contributors MH has contributed to the design, implementation of the study and responsible for drafting the manuscript. DS has taken part in the design of the study and supervised MH in drafting the Manuscript, and has approved the final manuscript. AS has taken part in the design of the study and supervised MH in drafting the manuscript, and has approved the final manuscript. EK has taken part in the design of the study and supervised MH in drafting the Manuscript, and has approved the final manuscript. SL has taken part in the design of the study and supervised MH in drafting the manuscript, and has approved the final manuscript. FR has taken part in the design of the study and supervised MH in drafting the manuscript, and has approved the final manuscript.

    • Funding This work was supported by Ester Åsberg Lindberg foundation and Centre for Clinical Research in Dalarna. The CRT equipment was funded by Norgine.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The study has been approved by the Regional Ethical Review Board in Uppsala (Dnr: 2016/146) and is performed according to the Declaration of Helsinki and to the Swedish Ethical Review Act.

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