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BMJ open
08 01, 2022;12 (8): e055324.

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.

Mariska Quirina Nikita Hackert, Jet W Ankersmid, Noel Engels, Janine C M Prick, Steven Teerenstra, Sabine Siesling, Constance H C Drossaert, Luc J A Strobbe, Yvonne E A van Riet, René M A van den Dorpel, Willem Jan W Bos, Paul B van der Nat, Renske M van den Berg-Vos, Sander M van Schaik, Mirjam M Garvelink, Philip J van der Wees, Cornelia F van Uden-Kraan, Santeon VBHC breast cancer, stroke and chronic kidney disease group
Author Information
  1. Mariska Quirina Nikita Hackert: Santeon Hospital Group, Utrecht, The Netherlands m.hackert@santeon.nl. ORCID
  2. Jet W Ankersmid: Santeon Hospital Group, Utrecht, The Netherlands.
  3. Noel Engels: Santeon Hospital Group, Utrecht, The Netherlands. ORCID
  4. Janine C M Prick: Santeon Hospital Group, Utrecht, The Netherlands. ORCID
  5. Steven Teerenstra: Radboud Institute for Health Sciences, Health Evidence, section Biostatistics, Radboud University Medical Centre, Nijmegen, The Netherlands.
  6. Sabine Siesling: Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, The Netherlands.
  7. Constance H C Drossaert: Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.
  8. Luc J A Strobbe: Surgical Oncology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
  9. Yvonne E A van Riet: Surgical Oncology, Catharina Hospital, Eindhoven, The Netherlands.
  10. René M A van den Dorpel: Internal Medicine, Maasstad Hospital, Rotterdam, The Netherlands.
  11. Willem Jan W Bos: Internal Medicine, St. Antonius Hospital, Nieuwegein, The Netherlands.
  12. Paul B van der Nat: Value-Based Health Care, St. Antonius Hospital, Nieuwegein, The Netherlands.
  13. Renske M van den Berg-Vos: Neurology, OLVG, Amsterdam, The Netherlands.
  14. Sander M van Schaik: Neurology, OLVG, Amsterdam, The Netherlands.
  15. Mirjam M Garvelink: Value-Based Health Care, St. Antonius Hospital, Nieuwegein, The Netherlands.
  16. Philip J van der Wees: Radboud Institute for Health Sciences, Scientific Centre for Quality of Healthcare (IQ Healthcare), Radboud University Medical Centre, Nijmegen, The Netherlands.
  17. Cornelia F van Uden-Kraan: Santeon Hospital Group, Utrecht, The Netherlands.
PMID: 35914919 DOI: 10.1136/bmjopen-2021-055324

Abstract

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.

Keywords

Breast surgery Chronic renal failure MEDICAL EDUCATION & TRAINING Stroke

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MeSH Term

Breast Neoplasms
Decision Making
Decision Support Techniques
Female
Humans
Interrupted Time Series Analysis
Kidney Diseases
Patient Participation
Quality of Life
Stroke
Journal Article Research Support, Non-U.S. Gov't
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