Impact of Decision Support Tools on Amputation Decisions in Diabetic Foot Patients: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Decisional Conflict Scale，DCS
研究概览
简要总结
To verify whether amputation decision-making aids can alleviate the decisional dilemma in diabetic foot patients.
详细描述
Through a clinical controlled study, the nurse-assisted intervention group utilized the Decision-Making Aid Tool for Amputation in Diabetic Foot Patientsto assess patients' treatment choice stages, provide disease-related knowledge, and clarify the advantages and disadvantages of different treatment options. This tool also helped patients articulate their values and preference biases. Subsequently, a questionnaire survey was conducted to evaluate decisional conflict, decisional expectations, and decisional satisfaction between the two groups, aiming to assess the tool's application efficacy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic foot ulcers with Wagner grade 4 or higher gangrene. Diabetic foot ulcers with Wagner grade 3 accompanied by severe infection or systemic symptoms; severe local infections, or chronic osteomyelitis causing functional impairment of the limb.
- •Patients with lower extremity vascular disease showing progression despite systemic treatment.
- •IWGDF stage 3 severe infections (characterized by loss of protective sensation or peripheral arterial disease, with at least one of the following: history of foot ulcer, lower limb amputation, or end-stage renal disease).
排除标准
- •History of psychiatric disorders with inability to cooperate during communication.
- •Concomitant severe complications.
研究组 & 干预措施
Experimental group
In addition to receiving routine clinical consultations and nursing care identical to the control group, the intervention group will utilize an electronic decision-making aid for diabetic foot amputation. We will design this electronic tool and deliver it to participants via a WeChat Mini Program. Patients will be instructed to spend no more than 60 minutes using the tool, with researchers supervising their sessions and providing assistance as needed. During the study period, the electronic decision-making aid will remain confidential and accessible only to the intervention group, with restricted access for physicians and non-intervention patients.
干预措施: Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot Patients (Procedure)
Control group
Patients received routine clinical consultation and nursing care before and after random assignment.
干预措施: Routine Clinical Consultation and Nursing Care (Procedure)
结局指标
主要结局
Decisional Conflict Scale，DCS
时间窗: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively
The scale consists of 16 items and has undergone standardized conversion, with a total score of 100 points. A lower score indicates a lower level of decisional conflict in patients. A score \>25 suggests the presence of decisional conflict during the decision-making process, while a score \>37.5 indicates potential delays in decision-making
次要结局
- The Satisfaction with Decision Scale，SWD(Three days post-surgery ；One month postoperatively)
- The Control Preference Scale，CPS(When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively)
- Decision Regret Scale,DRS(Three days post-surgery；One month postoperatively)
研究者
Shiwen Hong
ShiWen Hongª (MS)nursing department, sir run run shaw hospital,zhejiang university school of medicine.Hangzhou, Zhejiang Province, China
Zhejiang University