Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial

Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2):e003178. doi: 10.1161/CIRCOUTCOMES.116.003178. Epub 2017 Feb 22.


Background: A Dutch online patient decision aid to support prosthetic heart valve selection was recently developed. A multicenter randomized controlled trial was conducted to assess whether use of the patient decision aid results in optimization of shared decision making in prosthetic heart valve selection.

Methods and results: In a 5-center randomized controlled trial, patients were allocated to receive either standard preoperative care (control group) or additional access to the patient decision aid (intervention group). Legally capable adult patients accepted for elective isolated or combined aortic and mitral valve replacement were included. Primary outcome was preoperative decisional conflict (Decisional Conflict Scale); secondary outcomes included patient knowledge, involvement in valve selection, anxiety and depression, (valve-specific) quality of life, and regret. Out of 306 eligible patients, 155 were randomized (78 control and 77 intervention). Preoperative decisional conflict did not differ between the groups (34% versus 33%; P=0.834). Intervention patients felt better informed (median Decisional Conflict Scale informed subscore: 8 versus 17; P=0.046) and had a better knowledge of prosthetic valves (85% versus 68%; P=0.004). Intervention patients experienced less anxiety and depression (median Hospital Anxiety and Depression Scale score: 6 versus 9; P=0.015) and better mental well-being (mean Short Form Health Survey score: 54 versus 50; P=0.032). Three months postoperatively, valve-specific quality of life and regret did not differ between the groups.

Conclusions: A patient decision aid to support shared decision making in prosthetic heart valve selection does not lower decisional conflict. It does result in more knowledgeable, better informed, and less anxious and depressed patients, with a better mental well-being.

Clinical trial registration: Unique identifier: NTR4350.

Keywords: anxiety; cardiovascular diseases; decision making; heart valves; randomized controlled trial.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anxiety / etiology
  • Anxiety / prevention & control
  • Aortic Valve / physiopathology
  • Aortic Valve / surgery*
  • Clinical Decision-Making*
  • Decision Support Techniques*
  • Depression / etiology
  • Depression / prevention & control
  • Female
  • Heart Valve Diseases / diagnosis
  • Heart Valve Diseases / physiopathology
  • Heart Valve Diseases / surgery*
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis*
  • Humans
  • Internet
  • Male
  • Mental Health
  • Middle Aged
  • Mitral Valve / physiopathology
  • Mitral Valve / surgery*
  • Netherlands
  • Patient Education as Topic
  • Patient Satisfaction
  • Patient Selection*
  • Predictive Value of Tests
  • Prospective Studies
  • Prosthesis Design*
  • Quality of Life
  • Risk Assessment
  • Risk Factors
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Young Adult

Associated data

  • NTR/NTR4350