RESUMO
BACKGROUND: The completion rate of Advance Directives (ADs) has been low. This study aims to examine the effectiveness of two interventions 1) active counseling sessions coupled with passive patient education pamphlets, and 2) patient education pamphlets alone, compared with 3) control group (usual care), in increasing the completion rates of ADs in the primary care setting. METHODS: Multicenter randomised controlled trial in four public primary care clinics in Singapore under Singapore Health Services. Randomization was performed via block randomization with Sequential Numbered Opaque Sealed Envelopes. Participants were randomized into 1) active intervention group (both counseling by primary care physicians and patient education pamphlets) or 2) passive intervention group (only patient education pamphlets), and 3) control group (usual care) with follow-up at 6 weeks. The main outcome measure is the proportion of participants who completed / planned to complete) ADs six weeks post-intervention. RESULTS: Four hundred five participants were eligible to participate in the study. One hundred eighty-eight participants were recruited into the study (response rate = 46.4%), of which 158 completed the study. There was no significant difference between the control group, passive intervention group, and active intervention group, in terms of completion rates of ADs (29.4, 36.4, and 30.8% respectively). CONCLUSIONS: This randomized controlled trial did not support the use of patient education pamphlets with or without active counseling sessions in increasing the completion of ADs in a primary care setting in Singapore. The optimal intervention strategy depends on each health system's context and resources, taking into consideration patients' profiles, which deserves further studies. TRIAL REGISTRATION: Registered on April 17, 2018 clinicaltrials.gov ( NCT03499847 ).
