The implementation of decision support tools (DCTs) will improve the level of shared decision making in patients with perihilar cholangiocarcinoma and hepatocellular adenoma
ID
Bron
Verkorte titel
Aandoening
Perhilar cholangiocarcinoma en hepatocellular adenoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The change in the level of patient involvement during PHC and HCA consultations in which a treatment decision is to be made, with the DSTs, scored objectively by independent observers with the use of the OPTION-5 instrument.
Achtergrond van het onderzoek
Summary
Rationale: Shared decision-making (SDM) is a process in which the best available evidence on possible benefits and harms of the different treatment options and patients’ preferences are integrated. SDM requires bidirectional communication between doctors and patients to involve the patient's preference in the eventual treatment decision, thereby respecting the patient's autonomy. The application of SDM is clinical practice might lead to improved affective-cognitive outcomes as well as improved health outcomes and reduced costs. SDM may already be present to some extent, but can often be improved substantially.
Objective: The proposed study aims to improve the participation of patients with hepatocellular adenoma (HCA) and perihilar cholangiocarcinoma in decisions regarding their own treatment with the help of decision support tools (DSTs).
Study design: A multicentre prospective study, consisting of three phases:
1. Baseline measurement of the level of SDM
2. Development of DSTs
3. Introduction of DSTs and post-introduction measurements of the level of SDM.
Study population: All adult patients with a perihilar cholangiocarcinoma of hepatocellular adenoma, visiting the outpatient clinic of a participating surgery and/or gastroenterology department will be asked to participate.
Intervention: In order to improve the level of SDM, various DST. DSTs need to be developed and applied. The use of various DSTs will be compared to patients who receive the standard information from their treating physician (often a surgeon or gastroenterologist) without the use of DSTs. Examples of DSTs are: decision aids, consultation aids and offering shared decision-making training for physicians.
Main study parameters/endpoints: The level of patient involvement during PHC and HCA consultations in which a treatment decision is to be made, with the DSTs, scored objectively by independent observers with the use of the OPTION-5 instrument.
Doel van het onderzoek
The implementation of decision support tools (DCTs) will improve the level of shared decision making in patients with perihilar cholangiocarcinoma and hepatocellular adenoma
Onderzoeksopzet
Follow-up moments: at inclusion, during consultation, immediately after consultation, shortly before intervention
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria
- Age > 18 years
- Newly diagnosed patients with PHC or HCA
- Capable of providing written and oral informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Insufficient understanding of the Dutch language or cognitively unable to complete Dutch questionnaires.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8399 |
| Ander register | METC AMC : W20_079 #20.107 |