Effect of Handing a Written Document to Share Concerns and Values to Physicians When Making Decisions About Starting Drug Treatment Among Patients: A Pre-post Quasi-experimental Study with Propensity Score Matching.

Abstract Background Little evidence surrounds the effectiveness of decision aids to encourage physicians’ understanding of patients’ subjective perceptions. This study aimed to evaluate the impact of using a patient-filled standard template to express patients’ views, preferences, or concerns to their physicians in a clinical decision-making setting, on patients’ perceived decisional conflict and post-decision regrets. Methods A pre-post quasi-experimental study with a six-month control period followed by a 12-month intervention period. Participants came from six teaching hospitals and two clinics in Japan. The target population included 150 patients affected by diabetes mellitus, hypertension, and/or dyslipidemia, whose physicians had recently suggested to start drug treatment as a medical option. In the control period, a booklet on general informed consent was distributed, while in the intervention period, a “template for shared decision-making” was also provided. Patients were asked to fill out the template, which was then attached to the electronic medical records. Results Two months after enrollment, the decision conflict and decision regret scales were mailed to the patients. Three months after enrollment, the decision status about starting drug treatment and the concordance between the patients’ decision status and initial medical recommendation were observed. Seventy-nine and seventy-one participants assigned to the control and intervention groups were enrolled. Fifty-five patient pairs generated by propensity score matching were analyzed. No significant difference was observed between both groups in the decision conflict scale’s subscale scores and decision regret scale scores. The relative risk of the patients with a decision status of “still considering” regarding starting drug treatment was 2.2 (95% CI, 1.02–4.9) in the intervention group. The concordance rate between the physicians’ recommendation for starting drug treatment at enrollment and the patients’ actual decision made was 78.2% and 90.9% in the control and intervention groups, respectively (relative risk = 1.5; 95% CI, 1.05–2.2). Conclusions Using a template document to express patients’ personal values and feelings to their physicians is associated with longer deliberation times in making decisions about starting drug treatment; this may lead to decisions that are closer to medical recommendations.