Evaluation of the Clinical Nursing Effects of a Traditional Chinese Medicine Nursing Program Based on Care Pathways for Patients With Type 2 Diabetes: Protocol for a Randomized Controlled Clinical Trial.

Abstract

Background: To improve the performance of health care institutions, reduce overmedication, and minimize the waste of medical resources, China is committed to implementing a clinical pathway management model. This study aims to standardize nursing practices, foster clinical thinking in nurses, and promote patient recovery.

Objective: The purpose of this study is to evaluate the clinical effects of a traditional Chinese medicine (TCM) nursing program based on nursing pathways for patients with type 2 diabetes mellitus (T2DM).

Methods: This study uses a prospective, randomized, single-blind, parallel-controlled design. Based on sample size calculations, the study will include 594 patients with diabetes, with 2 groups of 297 patients: an observation group will receive a TCM nursing program based on clinical pathways, while a control group will receive routine care. Both groups will be evaluated before and after the intervention using assessment indicators. The primary outcome is the quality of life score, measured by a diabetes-specific quality of life questionnaire. Secondary outcomes include hospital stay duration, medical expenses, health knowledge, blood glucose control, symptom scores, and patient satisfaction.

Results: This study was funded in August 2021 and has received approval from the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (2022-022-KY-01). The trial is ongoing, with the first patient enrolled in September 2022. The study is expected to conclude in April 2025. To date, 380 patients have been recruited, with 202 randomized into the study, though no statistical analysis of the data has yet been conducted. A single-blind method is used; nurses are aware of group assignments and intervention plans, while patients remain blinded. Final results are planned for release in the first quarter of 2025.

Conclusions: This study seeks to integrate existing national standardized nursing protocols with clinical pathways to implement more efficient and higher-quality nursing practices. The goal is to standardize nursing procedures, enhance patients' quality of life, and improve self-care and medication adherence after discharge.

Trial registration: International Traditional Medicine Clinical Trial Registry ITMCTR2022000048; https://tinyurl.com/y4jd68h4.

International registered report identifier (irrid): DERR1-10.2196/58951.