Applying King's Theory of Goal Attainment combined with FMEA-PDCA quality management tool in Gestational Diabetes Mellitus health education: A randomized controlled trial

Abstract

Background Gestational Diabetes Mellitus (GDM) is a prevalent obstetric complication that impacts both maternal and neonatal health by increasing the risk of adverse outcomes such as preterm birth and macrosomia. Traditional health education methods for GDM lack in clinical efficacy due to the absence of timely evaluation and personalized feedback, a gap attributed to the insufficient integration of nursing theories and quality management tools. This study aims to explore a novel approach for clinical health education in GDM patients by evaluating the efficacy of combining King’s Theory of Goal Attainment and the Failure Modes and Effects Analysis with the Plan-Do-Check-Act (FMEA-PDCA) quality management tool. Methods The study was conducted among pregnant women attending tertiary hospitals in Fujian Province from March 1, 2022, to May 31, 2023. Eligible participants were randomly divided into two groups (59 per group), via a computer-generated randomization method, to receive either an innovative health education integrating King’s Theory and FMEA-PDCA or conventional education, respectively. We measured and evaluated the changes in blood glucose, glycated hemoglobin (HbA1c), anxiety levels, quality of life, and pregnancy outcomes pre- and post-intervention. Results Following the intervention, the experimental group showed significantly lower fasting blood glucose, improved anxiety levels and quality of life (P<0.001), and a reduced rate of cesarean sections compared to the control group (P = 0.037). No significant differences were found in HbA1c levels (P = 0.671) and several pregnancy-related complications across both groups (P>0.05). Conclusion The integration of King’s Theory with the FMEA-PDCA tool in health education significantly enhances the educational quality and clinical outcomes for GDM patients, suggesting a promising strategy for clinical practice. Clinical trial registration: http://www.chictr.org.cn (ChiCTR2400083435).