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209 Effectiveness of a web-based decision aid for patients with generalized anxiety disorder in Spain: a randomized controlled trial
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  1. Vanesa Ramos-García1,2,3,4,
  2. Wenceslao Peñate-Castro2,
  3. Amado Rivero-Santana1,3,4,
  4. Yolanda Álvarez Pérez1,3,4,
  5. Alezandra Torres-Castaño1,3,4,
  6. Andrea Duarte-Díaz1,3,4,
  7. María del Mar Trujillo-Martín1,3,4,
  8. Ana Isabel González-González4,5,
  9. Anthea Santos-Álvarez1,
  10. Himar González-Pacheco1,3,4,
  11. Lilisbeth Perestelo-Pérez3,4,6
  1. 1Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain
  2. 2University of La Laguna (ULL), Tenerife, Spain
  3. 3The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS), Tenerife, Spain
  4. 4Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
  5. 5Innovation and International Projects Unit. Vice-Directorate for Health Research and Documentation. Directorate General for Research, Education and Innovation. Madrid Health Ministry, Spain
  6. 6Evaluation Unit (SESCS), Canary Islands Health Service (SCS), Tenerife, Spain

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.

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