Shared Decision Making in mental health care using Routine Outcome Monitoring as a source of information: a cluster randomised controlled trial

Abstract

BackgroundShared Decision Making (SDM) is a way to empower patients when decisions are made about treatment. In order to be effective agents in this process, patients need access to information of good quality. Routine Outcome Monitoring (ROM) may provide such information and therefore may be a key element in SDM. This trial tests the effectiveness of SDM using ROM, primarily aiming to diminish decisional conflict of the patient while making decisions about treatment. The degree of decisional conflict, the primary outcome of this study, encompasses personal certainty about choosing an appropriate treatment, information about options, clarification of patient values, support from others and patients experience of an effective decision making process. Secondary outcomes of the study focus on the working alliance between patient and clinician, adherence to treatment, and clinical outcome and quality of life.Methods/DesignThis article presents the study protocol of a multi-centre two-arm cluster randomised controlled trial (RCT). The research is conducted in Dutch specialised mental health care teams participating in the ROM Quality Improvement Collaborative (QIC), which aims to implement ROM in daily clinical practice. In the intervention teams, ROM is used as a source of information during the SDM process between the patient and clinician. Control teams receive no specific SDM or ROM instructions and apply decision making as usual. Randomisation is conducted at the level of the participating teams within the mental health organisations. A total of 12 teams from 4 organisations and 364 patients participate in the study. Prior to data collection, the intervention teams are trained to use ROM during the SDM process. Data collection will be at baseline, and at 3 and 6 months after inclusion of the patient. Control teams will implement the SDM and ROM model after completion of the study.DiscussionThis study will provide useful information about the effectiveness of ROM within a SDM framework. Furthermore, with practical guidelines this study may contribute to the implementation of SDM using ROM in mental health care. Reporting of the results is expected from December 2016 onwards.Trial registrationDutch trial register: TC5262Trial registration date: 24th of June 2015

Shared decision‐making in outpatients with mental disorders: Patients´ preferences and associated factors

“…Whilst research in SDM topic is well developed, its focus to date has been mainly on primary care . In the field of psychiatry, decision‐making process has been less well evaluated . Some recent studies have highlighted the need for more research into decision‐making process especially in psychiatric care …”

Measurement issues of shared decision making in mental health: challenges and opportunities

“…In this sense, the quality and quantity of SDM may be routinely assessed. Both SDM and routine outcome monitoring are able to empower the patient during the treatment process and to provide good quality information in order to be a more effective agent in the decision-making process (Metz et al, 2015). The active participation of the patients in these decisions and an effective communication with the health care provider will increase the likelihood of achieving an optimal adjustment of pharmacological treatment.…”

“…However, there is little or no consensus about the core set of measures and constructs for SDM in mental health, and the evidence available on the performance of published instruments is variable (Scholl et al 2011;Metz et al 2015;Bouniols et al 2016). In this sense, theory development on a set of core constructs to be measured is paramount.…”

“…The active participation of 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 Finally, from an organizational perspective, although there is no universally agreed measure of SDM, there are some proposed solutions at different levels (micro, meso or macro level) to overcome key challenges to measure SDM (Barr, Scholl, et al 2016). In particular, it would be useful for organizations: to involve patients and healthcare professionals in designing, developing and testing measures; to build strategies to include patient-reported outcomes in organizational registries (e.g., electronic medical records); to set up automated analysis methods to provide rapid feedback and methods of monitoring SDM in clinical encounters (to service users, mental health professionals, multidisciplinary teams care, organizations and health care systems); to set aside staff time to measure and monitor key outcomes; and finally, to promote tools as a component of a continuous monitoring set of routines, and build the tools into balanced scorecard when the value of measuring may not be recognized (Barr et al, 2015;Metz et al, 2015).…”

“…In particular, it would be useful for organizations: to involve patients and healthcare professionals in designing, developing and testing measures; to build strategies to include patient-reported outcomes in organizational registries (e.g., electronic medical records); to set up automated analysis methods to provide rapid feedback and methods of monitoring SDM in clinical encounters (to service users, mental health professionals, multidisciplinary teams care, organizations and health care systems ); to set aside staff time to measure and monitor key outcomes; and finally, to promote tools as a component of a continuous monitoring set of routines, and build the tools into balanced scorecard when the value of measuring may not be recognized (Barr et al 2015;Metz et al 2015).…”