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
,
Philip J van der Wees,
Paul B van der Nat,
Noel Engels,
Steven Teerenstra,
Sabine Siesling,
R Saxena,
Cornelia F van Uden-Kraan,
Willem Jan W Bos,
Sander M van Schaik,
Renske M van den Berg-Vos,
Mariska Quirina Nikita Hackert,
Jet W Ankersmid,
Janine C M Prick,
Constance H C Drossaert,
Luc J A Strobbe,
Yvonne E A van Riet,
René M A van den Dorpel,
Mirjam M Garvelink,
YEA van Riet,
LJA Strobbe,
AE Dassen,
AFT Olieman,
HHG Witjes,
R Koelemij,
A Doeksen,
CME Contant,
PJAM Brouwers,
GW van Dijk,
RAR Gons,
PHE Hilkens,
SM van Schaik,
ES Schut,
WJW Bos,
MA van den Dorpel,
CEH Siegert,
CJAM Konings,
CG ter Meulen,
WMT Janssen,
JN Brinkman
Affiliations
Philip J van der Wees
2 Radboud Institute for Health Sciences, Scientific Center for Quality of Healthcare (IQ Healthcare), Radboud University Medical Center, Nijmegen, The Netherlands
Paul B van der Nat
1 Department of Value-Based Healthcare, St. Antonius Hospital, Nieuwegein, The Netherlands
Noel Engels
1 Shared decision making, Santeon, Utrecht, Utrecht, The Netherlands
Steven Teerenstra
Department of Epidemiology, Biostatistics and Health Technology Assessment, Radboudumc, Nijmegen, The Netherlands
Sabine Siesling
professor
R Saxena
Dr R P Centre for Ophthalmic Sciences, AIIMS, New Delhi, India
Cornelia F van Uden-Kraan
2Department of Clinical Psychology, VU University, Amsterdam, The Netherlands
Willem Jan W Bos
2Department of Internal Medicine, St Antonius Hospital, Nieuwegein, The Netherlands
Sander M van Schaik
Neurology, OLVG, Amsterdam, The Netherlands
Renske M van den Berg-Vos
Neurology, OLVG, Amsterdam, The Netherlands
Mariska Quirina Nikita Hackert
Santeon Hospital Group, Utrecht, The Netherlands
Jet W Ankersmid
Santeon Hospital Group, Utrecht, The Netherlands
Janine C M Prick
Santeon Hospital Group, Utrecht, The Netherlands
Constance H C Drossaert
Psychology, Health and Technology, University of Twente, Enschede, The Netherlands
Luc J A Strobbe
Surgical Oncology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands
Yvonne E A van Riet
Surgical Oncology, Catharina Hospital, Eindhoven, The Netherlands
René M A van den Dorpel
Internal Medicine, Maasstad Hospital, Rotterdam, The Netherlands
Mirjam M Garvelink
Value-Based Health Care, St. Antonius Hospital, Nieuwegein, The Netherlands
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.
