Article Text
Abstract
Introduction This study assesses a Patient Decision Aid (PtDA) based on a Spanish Clinical Practice Guideline (CPG) for treating Generalized Anxiety Disorder (GAD) in primary care (PC).
Methods The study involved: (1) developing a web-based PtDA for GAD patients from an evidence-based CPG, and (2) assessing PtDA effectiveness in a randomized controlled trial (RCT) at PC centers in Tenerife and Gran Canaria (Spain). The RCT (NCT04364958) compared PtDA to a mental health fact sheet. Measures were collected after the intervention and at a 3-month follow-up. Primary outcome: Decisional Conflict Scale (DCS). Secondary outcomes: GAD-7 questionnaire, GAD knowledge, treatment preference, concordance, and decision quality (knowledge ≥60% and concordant decision).
Results A total of 121 participants were included, with 58 in the intervention and 63 in the control group. Sixty participants completed the 3-month questionnaires. No differences were observed between intention-to-treat (ITT) and per-protocol analyses. In the ITT analysis, no statistically significant difference was found in the DCS between the groups at post-intervention (B=3.32, 95% CI: -6.94, 13.58) or at three months (B= -6.67, 95% CI: -17.74, 4.41). However, a statistically significant difference was found in the GAD knowledge at post-intervention (B=1.65, 95% CI: 0.84, 2.46), persisting at 3-months (B=0.75; 95% CI: 0.01, 1.48). The GAD-7 showed a significant difference at 3-months post-intervention (B= -3.00, 95% CI: -5.69, -0.30).
Discussion and Conclusion The PtDA developed improves knowledge and GAD symptoms but does not impact DCS for GAD patients. Shared decision-making (SDM) extends beyond the decision-making moment, especially for GAD patients. The SDM process is shaped by the entire clinical encounter and, notably, the entire patient-provider relationship.