TY - JOUR
T1 - Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease
T2 - SHOUT study protocol of multiple interrupted time series
AU - Hackert, Mariska Quirina Nikita
AU - Ankersmid, Jet W.
AU - Engels, Noel
AU - Prick, Janine C.M.
AU - Teerenstra, Steven
AU - Siesling, Sabine
AU - Drossaert, Constance H.C.
AU - Strobbe, Luc J.A.
AU - Van Riet, Yvonne E.A.
AU - Van Den Dorpel, René M.A.
AU - Bos, Willem Jan W.
AU - Van Der Nat, Paul B.
AU - Van Den Berg-Vos, Renske M.
AU - Van Schaik, Sander M.
AU - Garvelink, Mirjam M.
AU - Van Der Wees, Philip J.
AU - Van Uden-Kraan, Cornelia F.
N1 - Funding Information:
This research project is funded by ZonMw as part of the ‘Experiment Uitkomstindicatoren Santeon’.
Funding Information:
We thank all patients, patient representatives and health care professionals for their contribution to designing the multi-component intervention and execution the SHOUT study. The SHOUT study is part of a larger program on using outcome data for SDM (‘Experiment Uitkomstindicatoren Santeon’), which is part of the Outcome-based Health care program initiated by the Dutch Ministry of Health, Welfare and Sports. We would like to thank ZonMw for funding this project.
Publisher Copyright:
© 2022 Authors.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - 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.
AB - 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.
KW - Breast surgery
KW - Chronic renal failure
KW - Medical education & training
KW - Stroke
UR - http://www.scopus.com/inward/record.url?scp=85135302263&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-055324
DO - 10.1136/bmjopen-2021-055324
M3 - Article
C2 - 35914919
AN - SCOPUS:85135302263
SN - 2044-6055
VL - 12
JO - BMJ open
JF - BMJ open
IS - 8
M1 - e055324
ER -
