ObjectivesTo investigate the effects on patients’ outcome of the consultations when provided with: a Digital Audio Recording (DAR) of the consultation and a Question Prompt List (QPL).MethodsThis is a three-armed randomised controlled cluster trial. One group of patients received standard care, while the other two groups received either the QPL in combination with a recording of their consultation or only the recording. Patients from four outpatient clinics participated: Paediatric, Orthopaedic, Internal Medicine, and Urology. The effects were evaluated by patient-administered questionnaires.ResultsA total of 4349 patients participated in the study. DAR significantly increased the probability of fulfilling the participants’ self-perceived information needs by 4.1% to 6.3%, particularly with regard to test results (OR = 1.41, 95%CI: 1.14-1.74, p = 0.001) and treatment options (OR = 1.39, 95%CI: 1.13-1.71, p = 0.002). Additionally, the interventions positively influenced the participants’ satisfaction with the treatment, their relationship with the health professional, and their experience of being involved in the decision-making.ConclusionProviding outpatients with a QPL and DAR of their consultation positively influences the patients’ perception of having adequate information after the consultation.Practice implicationsThe implementation of a QPL and audio recording of consultations should be considered in routine practice.