This study is a multicenter cluster-randomized controlled trial conducted in Korea. A parallel, two-group cluster-randomized design will be used to test whether the Shared decision-making Group (SDM; intervention) is different from the Standard Care Group (SC; control).
The primary objective of this clinical trial is to evaluate whether the group provided with a decision support tool for treatment planning (Intervention; SDM group) demonstrates improved satisfaction with the decision-making process compared to the group receiving standard care (Control; SC group) among patients diagnosed with low-risk thyroid cancer who need to determine their treatment plan. The data are collected from patients who are diagnosed with low-risk PTC and Twenty doctors with various experience of AS will participate in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
310
Card news and Videos related to general knowledge and treatment of low-risk thyroid cancer
Decision Conflict Scale: DCS
which assesses an individual's perception and understanding of decision-making by 16 items. The scale is 5-point Likert scale from 0 (Strongly Agree) to 4 (Strongly Disagree), and scores are calculated through a) summed, b) divided by 16, and c) multiplied by 25, and range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Time frame: at enrollment
Decision Regret Scale: DRS
measures distress and remorse after making a healthcare decision. Scale ranges from 1 (Strongly agree) to 5(Strongly Disagree). The final score, the items are summed and averaged. ranging from 0 (no regret) to 100 (high regret).
Time frame: at 6month, 12month after enrollment
Shared Decision Making Questionnaire (SDM-Q-9)
a nine-item questionnaire assessing the quality of SDM from both patient and clinician perspectives. Scale ranges from 1(completely disagree) to 6(completely agree). Higher scores are indicative of more SDM.
Time frame: at enrollment, and 6month, 12month after enrollment
Patients' Perceived involvement of Care Scale (PICS)
a 13-item questionnaire evaluating patient engagement in primary care \[12\]. It measures Clinician's information provision, patient's proactive information-seeking, and patient participation in treatment decisions (5-point Likert scale; 1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate lower clinician control and greater patient involvement in decision-making.
Time frame: at enrollment, and 6month, 12month after enrollment
multifocal approach to sharing in shared decision making(Mappin'SDM)
that incorporates physician, patient, and observer perspectives during medical consultations. a 15-item tool adapted from the 12-item OPTION scale to evaluate observed patient involvement in decision-making \[13\]. Each item consists of behavioral and outcome components (a total of 30 items), rated by patients, clinicians, and observers (through real-time or via video review). Scale ranges from 0(not at all) to 5(absolutely true). High scores indicate high quality of decision-making communication across patient engagement.
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Time frame: at enrollment, and 6month, 12month after enrollment
Comparison of Quality of Life between the shared decision group and standard care group
The Quality of Life - Thyroid (QOL-Thyroid) questionnaire was 30 items. These are assigned to four scales, each reflecting an aspect of QoL. Physical well-being is measured with two items and 13 questions, psychological well-being with 13 items and 22 questions, social concerns with eight items and 14 questions, and spiritual well-being with seven items and questions. Response options range from '0 = worst outcome' to '10 = best outcome' on an ordinal 11-point scale.
Time frame: at enrollment, and 6month, 12month after enrollment
Hospital Anxiety and Depression
a 14-item tool (7 for anxiety, 7 for depression), developed to measure hospital patients' levels of anxiety and depression. Each item is rated on a 0-3 scale, with total scores ranging from 0 to 21 per subscale. A cutoff score of 8 or higher indicates clinically significant symptoms, based on Korean validation studies.
Time frame: at enrollment, and 6month, 12month after enrollment