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Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder

BACKGROUND: To evaluate the impact of a nurse navigation program on treatment adherence and resolution of hepatitis C infection in patients with severe mental disorder. METHODS: An open, randomized, controlled trial with blinded outcome assessment. The intervention group will engage in a nurse navig...

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Autores principales: Quemada-González, Casta, Morales-Asencio, José Miguel, Hurtado, María M., Martí-García, Celia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9020053/
https://www.ncbi.nlm.nih.gov/pubmed/35443727
http://dx.doi.org/10.1186/s12912-022-00870-w
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author Quemada-González, Casta
Morales-Asencio, José Miguel
Hurtado, María M.
Martí-García, Celia
author_facet Quemada-González, Casta
Morales-Asencio, José Miguel
Hurtado, María M.
Martí-García, Celia
author_sort Quemada-González, Casta
collection PubMed
description BACKGROUND: To evaluate the impact of a nurse navigation program on treatment adherence and resolution of hepatitis C infection in patients with severe mental disorder. METHODS: An open, randomized, controlled trial with blinded outcome assessment. The intervention group will engage in a nurse navigation program designed by mental health nurses. The program involves active screening for patients with severe mental disorder. The patients and caregivers included in the program will receive information, training, support and guidance throughout the treatment and recovery process, which involves different healthcare professionals and units. The control group will receive the standard of care, which includes follow-up by a family physician, referral to the hepatologist, serological testing, new referral to the hepatologist, onset of treatment, and follow-up. Multidisciplinary care will be provided along a coordinated and seamless clinical pathway led by a nurse navigator. The primary endpoints are total recovery (hepatitis C cure) and treatment adherence. Occurrence of symptoms of schizophrenia and health-related quality of life will be also recorded. Follow-up of patients will be performed three and six months after the administration of antiviral treatment. The study was authorised by the Ethics Committee of Malaga in December 2021. Funding was approved in March 2021. DISCUSSION: If this intervention is proven to be effective in improving treatment access and adherence, it will represent a step forward in addressing a chronic health issue that is 16 times more prevalent in the population with severe mental disease. Finally, this intervention may lead to the detection of undertreated HCV infection in this population of patients. TRIAL REGISTRATION: This protocol has been registered in ClinicalTrials.gov with identifier code NCT04891445 on May 18, 2021.
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spelling pubmed-90200532022-04-21 Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder Quemada-González, Casta Morales-Asencio, José Miguel Hurtado, María M. Martí-García, Celia BMC Nurs Study Protocol BACKGROUND: To evaluate the impact of a nurse navigation program on treatment adherence and resolution of hepatitis C infection in patients with severe mental disorder. METHODS: An open, randomized, controlled trial with blinded outcome assessment. The intervention group will engage in a nurse navigation program designed by mental health nurses. The program involves active screening for patients with severe mental disorder. The patients and caregivers included in the program will receive information, training, support and guidance throughout the treatment and recovery process, which involves different healthcare professionals and units. The control group will receive the standard of care, which includes follow-up by a family physician, referral to the hepatologist, serological testing, new referral to the hepatologist, onset of treatment, and follow-up. Multidisciplinary care will be provided along a coordinated and seamless clinical pathway led by a nurse navigator. The primary endpoints are total recovery (hepatitis C cure) and treatment adherence. Occurrence of symptoms of schizophrenia and health-related quality of life will be also recorded. Follow-up of patients will be performed three and six months after the administration of antiviral treatment. The study was authorised by the Ethics Committee of Malaga in December 2021. Funding was approved in March 2021. DISCUSSION: If this intervention is proven to be effective in improving treatment access and adherence, it will represent a step forward in addressing a chronic health issue that is 16 times more prevalent in the population with severe mental disease. Finally, this intervention may lead to the detection of undertreated HCV infection in this population of patients. TRIAL REGISTRATION: This protocol has been registered in ClinicalTrials.gov with identifier code NCT04891445 on May 18, 2021. BioMed Central 2022-04-20 /pmc/articles/PMC9020053/ /pubmed/35443727 http://dx.doi.org/10.1186/s12912-022-00870-w Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Quemada-González, Casta
Morales-Asencio, José Miguel
Hurtado, María M.
Martí-García, Celia
Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder
title Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder
title_full Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder
title_fullStr Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder
title_full_unstemmed Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder
title_short Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder
title_sort study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis c virus in patients with severe mental disorder
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9020053/
https://www.ncbi.nlm.nih.gov/pubmed/35443727
http://dx.doi.org/10.1186/s12912-022-00870-w
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