DOES THE USE OF A DECISION AID IMPROVE DECISION MAKING IN PROSTHETIC HEART VALVE SELECTION? A MULTICENTER RANDOMIZED CLINICAL TRIAL

Purpose: Current clinical practice guidelines recommend shared decision-making (SDM) and explicit consideration of patient preferences in prosthetic heart valve selection, but no tools to support SDM are available. In the Netherlands a patient decision aid (PDA) to support prosthetic heart valve selection was recently developed. A multicenter randomized controlled trial was conducted to assess whether use of the PDA results in optimization of SDM in prosthetic heart valve selection.

Method: Patients were stratified by center and randomized in a 1:1 fashion to standard preoperative care (control group) or standard preoperative care including use of the PDA (intervention group). Patients completed two questionnaires (one preoperative after surgical workup and one 3 months postoperative). Primary endpoint was decisional conflict (DCS), secondary endpoints included patient knowledge, participation in decision-making, emotional distress (HADS), (valve-specific) quality of life (SF-36), and regret (DRS) 3 months postoperative.

Result: 155 patients (114 males/41 females; median age 66 years (range 21-84)) were randomized (78 control, 77 intervention). Outcomes of the preoperative questionnaire are presented below. Outcomes of the postoperative questionnaire will be presented during the SMDM 37^th Annual Meeting. Fifty percent of patients experienced decisional conflict (score ≥25), and 25% had scores >37.5 which are associated with decision delay or feeling unsure about implementation. There was no difference in total DCS score between intervention and control patients. With regard to DCS subscales, intervention patients felt more informed than control patients (median DCS informed subscore: 8 versus 16 respectively; p=0.046). Intervention patients had a better basic understanding of prosthetic valves than control patients (88% versus 67% respectively; p=0.004). Seventy-five percent of patients wanted to be involved in decision-making, whereas 53% agreed that they actually were involved, with no difference between intervention and control patients. Intervention patients experienced less emotional distress (median HADS score: 6 versus 9 respectively; p=0.015) and experienced better mental well-being than control patients (mean SF-36 score: 54 versus 50 respectively; p=0.032).

Conclusion: A PDA to support SDM in the setting of prosthetic heart valve selection results in more knowledgeable and less distressed patients and better patient mental well-being. Although DCS did not differ, the informed subscale shows that patients who use the PDA feel better informed. Maybe other factors such as adequate implementation are important to consider in conjunction with the tool to lower overall decisional conflict.