Development and Evaluation of an Online Shared Decision-Making Educational Program for Nurses and Patients With Chronic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Change in nurses' shared decision-making competence
研究概览
简要总结
This study aims to develop and evaluate an online shared decision-making (SDM) educational program for nurses and patients with chronic diseases. Shared decision-making is a process in which healthcare professionals and patients make health-related decisions together based on the best available evidence and the patient's values and preferences. The study includes an evaluation phase. In the evaluation phase, the program will be tested among nurses working in general hospitals and adults with chronic diseases living in the community. Outcomes related to shared decision-making will be assessed at baseline, immediately after the 4-week program, and 1 month later. The study is expected to improve shared decision-making competence, experience, and preparedness among both nurses and patients.
详细描述
Shared decision-making is a key component of patient-centered care and is particularly important in chronic disease management, where patients often face repeated decisions about treatment options, symptom management, lifestyle modification, and long-term care. Effective shared decision-making requires healthcare professionals and patients to exchange information, consider available options, and make decisions that reflect both clinical evidence and patient values and preferences. Nurses play an important role in chronic disease care by providing education, coordinating communication, and supporting patient participation in health-related decision-making. Patients with chronic diseases also need support to understand their options, clarify their values, and participate actively in decisions about their care. However, structured educational opportunities to strengthen shared decision-making competence are limited for both nurses and patients. This study will develop an online shared decision-making educational program for nurses and patients with chronic diseases and will evaluate its effectiveness in two parallel sub-studies. For nurses, the study will be conducted as a cluster-randomized pretest-posttest controlled trial in general hospitals in Daejeon and Chungcheong-do, Republic of Korea. Hospitals will serve as clusters, and one hospital will be assigned to the intervention group and the other to the control group by coin toss conducted by a third researcher who is not involved in study implementation or data analysis. For patients with chronic diseases, the study will be conducted as a cluster-randomized pretest-posttest controlled trial in community health and welfare institutions. Institutions will serve as clusters and will be assigned in a 1:1 ratio to intervention or control conditions using a computer-generated random allocation sequence prepared by a third researcher not involved in study implementation or data analysis. The intervention will consist of a 4-week online SDM educational program delivered through a web-based platform. Nurses in the intervention group will receive an online program consisting of 12 educational videos. Patients in the intervention group will receive an online program consisting of 5 educational videos. Control participants will receive comparison materials according to the study protocol. Outcome measures will be collected at baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment. The study will evaluate whether the program improves shared decision-making-related competence, experience, knowledge, decisional preparedness, and related outcomes in the two target populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered nurses currently providing direct patient care in participating general hospitals
- •Able to understand the purpose and procedures of the study and provide informed consent
- •Able to use a computer, tablet, or smartphone to access the online program
排除标准
- •Not currently engaged in direct patient care
- •Unable to clearly express willingness to participate
- •Unable to complete the educational program or questionnaires because of technical or language limitations
- •Inclusion Criteria for Patients:
- •Adults aged 19 years or older living in the community
- •Diagnosed with one or more chronic diseases requiring ongoing management, including but not limited to hypertension, diabetes mellitus, dyslipidemia, arthritis, chronic respiratory disease, or cardiovascular disease, with at least 3 months elapsed since diagnosis
- •Able to understand the purpose and procedures of the study and provide informed consent
- •Able to read and respond to survey questions
- •Able to use a computer, tablet, or smartphone to access the online program
- •Exclusion Criteria for Patients:
- •Cognitive impairment or communication problems that make participation difficult
- •Unable to complete the educational program or questionnaires because of technical or language limitations
研究组 & 干预措施
Control Group
Participants will be provided access to publicly available comparison materials during the 4-week study period.
干预措施: General Communication Education for Nurses (Behavioral)
Control Group
Participants will be provided access to publicly available comparison materials during the 4-week study period.
干预措施: General Health Information for Patients With Chronic Diseases (Behavioral)
Online SDM Educational Program Group
Participants will receive access to a web-based shared decision-making educational program tailored for nurses or patients with chronic diseases for 4 weeks.
干预措施: Online Shared Decision-Making Educational Program for Nurses (Behavioral)
Online SDM Educational Program Group
Participants will receive access to a web-based shared decision-making educational program tailored for nurses or patients with chronic diseases for 4 weeks.
干预措施: Online Shared Decision-Making Educational Program for Patients With Chronic Diseases (Behavioral)
结局指标
主要结局
Change in nurses' shared decision-making competence
时间窗: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
Nurses' shared decision-making competence will be assessed using a shared decision-making competence scale for nurses. The scale consists of 26 items with total scores ranging from 26 to 130. Higher scores indicate greater shared decision-making competence. Changes in scores from baseline to each follow-up assessment will be compared between the intervention and control groups.
Change in patients' shared decision-making experience
时间窗: Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment
Patients' shared decision-making experience will be assessed using the Shared Decision-Making Questionnaire-9 items(SDM-Q-9). The SDM-Q-9 consists of 9 items, with total raw scores ranging from 0 to 45. Higher scores indicate a greater level of patient-perceived shared decision-making. Changes in scores from baseline to each follow-up assessment will be compared between the intervention and control groups.
次要结局
- Change in nurses' shared decision-making experience(Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment)
- Change in patients' decisional conflict(Baseline, immediately after the 4-week intervention, and 1 month after the first post-intervention assessment)
- Change in shared decision-making knowledge(Baseline and immediately after the 4-week intervention)
- Preparation for decision making after the intervention(Immediately after the 4-week intervention and 1 month after the first post-intervention assessment)
研究者
Myonghwa Park
Dean, College of Nursing, Chungnam National University
Chungnam National University