Development and Pilot Implementation of a Shared Decision-Making Intervention for Type 2 Diabetes Using the Ottawa Framework

Construction and Preliminary Application of a Shared Decision-Making Intervention Program for Patients With Type 2 Diabetes Based on the Ottawa Decision Support Framework

The goal of this clinical trial is to evaluate the effectiveness of a shared decision-making (SDM) intervention program based on the Ottawa Decision Support Framework in adult patients with type 2 diabetes (aged ≥18 years, without severe complications). The main questions it aims to answer are:

• Does the intervention improve patients' decisional self-efficacy compared to usual care?
• Does the intervention enhance patients' actual participation in treatment decision-making?
• Does the intervention reduce diabetes-related distress?
• Does the intervention improve diabetes self-management behaviors? Researchers will compare the intervention group (receiving the SDM intervention plus usual care) with the control group (receiving usual care only) to see if the intervention leads to significantly better outcomes in decision self-efficacy, decision participation, diabetes distress, and self-management.

Participants will:

• Receive a Question Prompt List (QPL) handbook and be guided by a nurse to mark their most concerning questions.
• Attend face-to-face educational sessions covering disease basics, medication comparisons, lifestyle adjustments, and complication prevention.
• Engage in shared decision-making discussions with physicians, nurses, and family members to co-develop a personalized treatment plan.
• Complete follow-up assessments at 4 weeks and 6 weeks after discharge via telephone or outpatient visit, including questionnaires on decision participation, self-efficacy, satisfaction, diabetes distress, and self-management behaviors.

Inclusion criteria:

1. Diagnosed with type 2 diabetes mellitus according to the diagnostic criteria established by the Chinese Diabetes Society.
2. Aged 18 years or older.
3. Conscious, able to communicate normally, and capable of reading and completing questionnaires independently or with assistance.
4. Informed consent obtained and voluntary participation.

Exclusion criteria:

1. Complicated with severe acute or chronic complications of diabetes (e.g., diabetic ketoacidosis, severe diabetic nephropathy, proliferative retinopathy, etc.).
2. Complicated with severe heart, liver, kidney, or other organ dysfunction, or malignant tumors.
3. With cognitive impairment, mental disorders, or communication disorders.
4. Currently participating in other interventional clinical studies.