Metz Margot J, Elfeddali Iman, Krol David G H, Veerbeek Marjolein A, de Beurs Edwin, Beekman Aartjan T F, van der Feltz-Cornelis Christina M
EMGO Institute for Health and Care Research (EMGO+), VU University, Amsterdam, The Netherlands.
GGz Breburg, Mental Health Institute, Postbus 770, 5000 AT, Tilburg, The Netherlands.
BMC Psychiatry. 2017 Mar 7;17(1):86. doi: 10.1186/s12888-017-1247-9.
Enhancing patient participation is becoming increasingly important in mental health care as patients use to have a dependent, inactive role and nonadherence to treatment is a regular problem. Research shows promising results of initiatives stimulating patient participation in partnership with their clinicians. However, few initiatives targeting both patients' and clinicians' behaviour have been evaluated in randomised trials (RCT). Therefore, in GGz Breburg, a specialized mental health institution, a digital intake approach was developed aimed at exploring treatment needs, expectations and preferences of patients intended to prepare patients for the intake consultations. Subsequently, patients and clinicians discuss this information during intake consultations and make shared decisions about options in treatment. The aim of this trial is to test the efficacy of this new digital intake approach facilitated by Routine Outcome Monitoring (ROM), peer support and training of clinicians as compared to the intake as usual. The primary outcome is decisional conflict about choices in treatment. Secondary outcomes focus on patient participation, shared decision making, working alliance, adherence to treatment and clinical outcomes.
This article presents the study protocol of a cluster-randomised controlled trial in four outpatient departments for adults with depression, anxiety and personality disorders, working in two different regions. Randomisation is done between two similar intake-teams within each department. In the four intervention teams the new intake approach is implemented. The four control teams apply the intake as usual and will implement the new approach after the completion of the study. In total 176 patients are projected to participate in the study. Data collection will be at baseline, and at two weeks and two months after the intake.
This study will potentially demonstrate the efficacy of the new digital intake approach in mental health care in terms of the primary outcome the degree of decisional conflict about choices in treatment. The findings of this study may contribute to the roll out of such eHealth initiatives fostering patient involvement in decision making about their treatment.
Trial registration: Dutch Trial Register NTR5677 . Registered 17th January 2016.
在精神卫生保健中，提高患者参与度变得越来越重要，因为患者过去常常处于依赖、消极的角色，且不坚持治疗是一个常见问题。研究表明，与临床医生合作激发患者参与的举措取得了令人鼓舞的成果。然而，很少有针对患者和临床医生行为的举措在随机试验（RCT）中得到评估。因此，在专门的精神卫生机构GGz Breburg，开发了一种数字化接诊方法，旨在探索患者的治疗需求、期望和偏好，为患者进行接诊咨询做好准备。随后，患者和临床医生在接诊咨询期间讨论这些信息，并就治疗方案共同做出决定。本试验的目的是测试这种由常规结果监测（ROM）、同伴支持和临床医生培训推动的新数字化接诊方法与常规接诊相比的疗效。主要结局是治疗选择方面的决策冲突。次要结局侧重于患者参与度、共同决策、工作联盟、治疗依从性和临床结局。
本文介绍了一项在两个不同地区的四个成人抑郁症、焦虑症和人格障碍门诊部门进行的整群随机对照试验的研究方案。在每个部门的两个相似接诊团队之间进行随机分组。四个干预团队实施新的接诊方法。四个对照组采用常规接诊，并将在研究完成后实施新方法。预计共有176名患者参与该研究。数据收集将在基线时以及接诊后两周和两个月进行。
本研究可能会在主要结局——治疗选择方面的决策冲突程度上，证明新的数字化接诊方法在精神卫生保健中的疗效。本研究的结果可能有助于推广此类促进患者参与治疗决策的电子健康举措。
试验注册：荷兰试验注册库NTR5677。2016年1月17日注册。
