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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShiwen Hong

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

History of psychiatric disorders with inability to cooperate during communication.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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 Care

    Procedure/Surgery

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Experimental groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Shiwen Hong

Lead sponsor

Zhejiang University

Sponsor institution

Sir Run Run Shaw Hospital

Collaborator

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