Development and Application of a Decision-Making Aid Tool for Amputation Surgery in Diabetic Foot Patients Based on the Ottawa Decision Support Framework

N/ANot Yet RecruitingNCT07252089

Shiwen Hong80 enrolled

Overview

To verify whether amputation decision-making aids can alleviate the decisional dilemma in diabetic foot patients.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Diabetic Foot Disease

Interventions

Applications of Decision-Support Tools in Amputation Decision-Making for Diabetic Foot PatientsPROCEDURE

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.

Routine Clinical Consultation and Nursing CarePROCEDURE

Patients received routine clinical consultation and nursing care before and after random assignment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). Exclusion Criteria: * History of psychiatric disorders with inability to cooperate during communication. Concomitant severe complications.

Outcomes

Primary Outcomes

Decisional Conflict Scale，DCS

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

Time frame: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively

Secondary Outcomes

The Control Preference Scale，CPS

The scale consists of five options, categorized into three decision-making types: Proactive, Cooperative, and Passive. Decision-makers select the option that best aligns with their expectations based on their self-assessment.

Time frame: When the patient was admitted to the hospital；Three days post-surgery；One month postoperatively

The Satisfaction with Decision Scale，SWD

The scale consists of 6 items, allowing decision-makers to select the hospital description that best aligns with their individual circumstances.

Time frame: Three days post-surgery ；One month postoperatively

Decision Regret Scale,DRS

The scale consists of 5 items rated using a Likert 5-point rating scale, with responses ranging from "Strongly Agree" to "Strongly Disagree" assigned scores of 1 to 5 respectively. Items 2 and 4 are reverse-coded. The total score is calculated by converting the mean score of all items using the formula: Total Score = (Mean Score - 1) × 5 This results in a total score range of 0-20 points, where higher scores indicate greater decision regret

Time frame: Three days post-surgery；One month postoperatively

Data from ClinicalTrials.gov

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