Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 8, 2021
Date Accepted: Feb 28, 2022
Effectiveness of individual feedback and coaching on shared decision-making consultations in oncology care: Study protocol for a randomized clinical trial
ABSTRACT
Background:
Shared decision-making (SDM) is particularly important in oncology since many treatments involve serious side effects, and treatment decisions involve a trade-off of benefits and risks. However, implementation of SDM in oncology care is challenging and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM, but is considered time-consuming.
Objective:
This study addresses the effectiveness of an individual SDM training program, using the concept of deliberate practice.
Methods:
This multicentre single-blinded randomized clinical trial will be performed in 12 Dutch hospitals. Clinicians involved in decisions with oncology patients are invited to participate in the study and are allocated to the control group or intervention group. All clinicians will record 3 decision-making processes, with 3 different oncology patients. Clinicians in the intervention group receive the SDM-intervention: completing E-learnings, reflecting on feedback reports, doing a self-assessment and defining 1-3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group do not receive the SDM-intervention until the end of the study. The primary outcome will be the extent in which clinicians involve their patients in the decision-making process, as scored using the OPTION-5 instrument. As secondary outcome patients will rate their perceived involvement in the decision-making and the duration of the consultations will be registered.
Results:
We hypothesize that clinicians exposed to this intervention are more likely to adopt SDM behaviours than clinicians who do not. A secondary aim is to evaluate whether patients perceive more involvement in the decision-making process.
Conclusions:
This theory-based and blended approach will increase our knowledge about effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target knowledge, attitude and skills of clinicians. Patients are involved in the design and implementation of the study. Clinical Trial: This trial is retrospectively registered (Netherlands Trial Registry number NL9647; August 03, 2021, https://www.trialregister.nl/trial/9647). All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand. Approval for the study was obtained from the Ethical Review Board (medical research ethics committee Delft and Leiden, the Netherlands (N20.170)).
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