Successful implementation of a patient decision aid regarding breast cancer follow-up care facilitates shared decision-making and results in quality improvement in breast cancer follow-up care.
ID
Bron
Verkorte titel
Aandoening
Breast cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Patients' perceived level of involvement in the decision-making process (using the SDM-Q-9).
Achtergrond van het onderzoek
The primary objectives are to assess the effectiveness of shared decision-making supported by outcome data; alongside its implementation in daily clinical practice. The secondary objectives are to assess the extent to which shared decision-making supported by outcome data leads to changes in the utilisation and outcomes of healthcare.
Doel van het onderzoek
Successful implementation of a patient decision aid regarding breast cancer follow-up care facilitates shared decision-making and results in quality improvement in breast cancer follow-up care.
Onderzoeksopzet
In total, seven hospitals will participate in this trial for 20 months. In the first 6 months we will assess daily clinical practice in hospitals with the aim to measure the current level of shared decision-making. Each month from May 2020 onwards, one hospital will make the transition, that will take approximately 1 month, to using shared decision-making supported by outcome data (see the description of the intervention), until all seven hospitals have implemented this in their daily clinical practice. Subsequently, for at least 6 months, we will assess the effectiveness and the extent to which shared decision-making supported by outcome data is implemented. Due to the stepwise design, some hospitals will be monitored longer before the transition, while others will be monitored longer after the transition, allowing us to make between-hospital comparisons. In each hospital 5 patients will be included per month. Patients included before and after the transition will receive a questionnaire and two follow-up questionnaires (after 6 and 12 months) to monitor patients’ experiences in consultation, their daily functioning and other subjects related to the care they received. Also, in each hospital, 15 patients, both before and after the transition, will be asked permission to audio-tape consultations. These will be used to monitor the length of consultation and for two trained observers to assess shared decision-making supported by outcome data during consultation. Healthcare professionals will receive a questionnaire 3 months after the transition phase, to evaluate the effectiveness and extent to which shared decision-making supported by outcome data is implemented.
Onderzoeksproduct en/of interventie
Healthcare professionals, guiding patients facing the decision for follow-up care, will be introduced to a patient decision aid including (personalised) care outcomes, to support the process of shared decision-making. In addition, they will receive a training on shared decision-making: they will be informed on the guiding principles, motivated to use shared decision-making in clinical practice, and taught how to apply it.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1) Patients must be facing the decision for the organisation of follow-up care after receiving curative treatment for invasive breast cancer (in the first follow-up consultation about 1 year after surgery); 2) Being treated in a Santeon hospital; 3) ≥ 18 years of age; 4) Understand the Dutch language in speech and writing, and; 5) Able to provide informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1) Patients diagnosed with non-invasive breast cancer (e.g. Ductal Carcinoma In Situ (DCIS)); 2) Patients who receive palliative treatment; 3) Patients who received neoadjuvant therapy; 4) Male breast cancer patients; 5) Patients with dementia; 6) Patients who received treatment for a recurrence or second primary tumor; 7) Patients with a breast cancer-related gene alteration (e.g. BRCA).
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8374 |
Ander register | MEC-U; Bureau Onderzoek en Innovatie, Santeon : W19.154 (MEC-U Nieuwegein); 2019-077 (Adviescommissie nWMO Martini Ziekenhuis Groningen) |