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Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series
INTRODUCTION: Within the value-based healthcare framework, outcome data can be used to inform patients about (treatment) options, and empower them to make shared decisions with their health care professional. To facilitate shared decision-making (SDM) supported by outcome data, a multicomponent inte...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9345077/ https://www.ncbi.nlm.nih.gov/pubmed/35914919 http://dx.doi.org/10.1136/bmjopen-2021-055324 |
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author | Hackert, Mariska Quirina Nikita Ankersmid, Jet W Engels, Noel Prick, Janine C M Teerenstra, Steven Siesling, Sabine Drossaert, Constance H C Strobbe, Luc J A van Riet, Yvonne E A van den Dorpel, René M A Bos, Willem Jan W van der Nat, Paul B van den Berg-Vos, Renske M van Schaik, Sander M Garvelink, Mirjam M van der Wees, Philip J van Uden-Kraan, Cornelia F |
author_facet | Hackert, Mariska Quirina Nikita Ankersmid, Jet W Engels, Noel Prick, Janine C M Teerenstra, Steven Siesling, Sabine Drossaert, Constance H C Strobbe, Luc J A van Riet, Yvonne E A van den Dorpel, René M A Bos, Willem Jan W van der Nat, Paul B van den Berg-Vos, Renske M van Schaik, Sander M Garvelink, Mirjam M van der Wees, Philip J van Uden-Kraan, Cornelia F |
author_sort | Hackert, Mariska Quirina Nikita |
collection | PubMed |
description | INTRODUCTION: Within the value-based healthcare framework, outcome data can be used to inform patients about (treatment) options, and empower them to make shared decisions with their health care professional. To facilitate shared decision-making (SDM) supported by outcome data, a multicomponent intervention has been designed, including patient decision aids on the organisation of post-treatment surveillance (breast cancer); discharge location (stroke) and treatment modality (advanced kidney disease), and training on SDM for health care professionals. The SHared decision-making supported by OUTcome information (SHOUT) study will examine the effectiveness of the intervention and its implementation in clinical practice. METHODS AND ANALYSIS: Multiple interrupted time series will be used to stepwise implement the intervention. Patients diagnosed with either breast cancer (N=630), stroke (N=630) or advanced kidney disease (N=473) will be included. Measurements will be performed at baseline, three (stroke), six and twelve (breast cancer and advanced kidney disease) months. Trends on outcomes will be measured over a period of 20 months. The primary outcome will be patients’ perceived level of involvement in decision-making. Secondary outcomes regarding effectiveness will include patient-reported SDM, decisional conflict, role in decision-making, knowledge, quality of life, preferred and chosen care, satisfaction with the intervention, healthcare utilisation and health outcomes. Outcomes regarding implementation will include the implementation rate and a questionnaire on the health care professionals’ perspective on the implementation process. ETHICS AND DISSEMINATION: The Medical research Ethics Committees United in Nieuwegein, the Netherlands, has confirmed that the Medical Research Involving Human Subjects Act does not apply to this study. Bureau Onderzoek & Innovatie of Santeon, the Netherlands, approved this study. The results will contribute to insight in and knowledge on the use of outcome data for SDM, and can stimulate sustainable implementation of SDM. TRIAL REGISTRATION NUMBER: NL8374, NL8375 and NL8376. |
format | Online Article Text |
id | pubmed-9345077 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-93450772022-08-19 Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series Hackert, Mariska Quirina Nikita Ankersmid, Jet W Engels, Noel Prick, Janine C M Teerenstra, Steven Siesling, Sabine Drossaert, Constance H C Strobbe, Luc J A van Riet, Yvonne E A van den Dorpel, René M A Bos, Willem Jan W van der Nat, Paul B van den Berg-Vos, Renske M van Schaik, Sander M Garvelink, Mirjam M van der Wees, Philip J van Uden-Kraan, Cornelia F BMJ Open Health Services Research INTRODUCTION: Within the value-based healthcare framework, outcome data can be used to inform patients about (treatment) options, and empower them to make shared decisions with their health care professional. To facilitate shared decision-making (SDM) supported by outcome data, a multicomponent intervention has been designed, including patient decision aids on the organisation of post-treatment surveillance (breast cancer); discharge location (stroke) and treatment modality (advanced kidney disease), and training on SDM for health care professionals. The SHared decision-making supported by OUTcome information (SHOUT) study will examine the effectiveness of the intervention and its implementation in clinical practice. METHODS AND ANALYSIS: Multiple interrupted time series will be used to stepwise implement the intervention. Patients diagnosed with either breast cancer (N=630), stroke (N=630) or advanced kidney disease (N=473) will be included. Measurements will be performed at baseline, three (stroke), six and twelve (breast cancer and advanced kidney disease) months. Trends on outcomes will be measured over a period of 20 months. The primary outcome will be patients’ perceived level of involvement in decision-making. Secondary outcomes regarding effectiveness will include patient-reported SDM, decisional conflict, role in decision-making, knowledge, quality of life, preferred and chosen care, satisfaction with the intervention, healthcare utilisation and health outcomes. Outcomes regarding implementation will include the implementation rate and a questionnaire on the health care professionals’ perspective on the implementation process. ETHICS AND DISSEMINATION: The Medical research Ethics Committees United in Nieuwegein, the Netherlands, has confirmed that the Medical Research Involving Human Subjects Act does not apply to this study. Bureau Onderzoek & Innovatie of Santeon, the Netherlands, approved this study. The results will contribute to insight in and knowledge on the use of outcome data for SDM, and can stimulate sustainable implementation of SDM. TRIAL REGISTRATION NUMBER: NL8374, NL8375 and NL8376. BMJ Publishing Group 2022-08-01 /pmc/articles/PMC9345077/ /pubmed/35914919 http://dx.doi.org/10.1136/bmjopen-2021-055324 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/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://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Health Services Research Hackert, Mariska Quirina Nikita Ankersmid, Jet W Engels, Noel Prick, Janine C M Teerenstra, Steven Siesling, Sabine Drossaert, Constance H C Strobbe, Luc J A van Riet, Yvonne E A van den Dorpel, René M A Bos, Willem Jan W van der Nat, Paul B van den Berg-Vos, Renske M van Schaik, Sander M Garvelink, Mirjam M van der Wees, Philip J van Uden-Kraan, Cornelia F Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series |
title | Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series |
title_full | Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series |
title_fullStr | Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series |
title_full_unstemmed | Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series |
title_short | Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series |
title_sort | effectiveness and implementation of shared decision-making supported by outcome information among patients with breast cancer, stroke and advanced kidney disease: shout study protocol of multiple interrupted time series |
topic | Health Services Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9345077/ https://www.ncbi.nlm.nih.gov/pubmed/35914919 http://dx.doi.org/10.1136/bmjopen-2021-055324 |
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