Continue, adjust, or stop antipsychotic medication: developing and user testing an encounter decision aid for people with first-episode and long-term psychosis

People with serious mental illness, such as schizophrenia, face decisions to continue, reduce or discontinue antipsychotic medications daily. Many fail to formally consult their psychiatrists as part of this decision process. Few prescribers explicitly address this issue with patients during the clinical encounter [1‐3]. This situation illuminates two important points to consider in clinical practice. First, it raises concerns about the effectiveness of antipsychotic medications as a primary approach for preventing relapse in psychosis [4]. Second, people with serious mental illness make treatment decisions about their use of medications independently, often without enough information gained in consultation with psychiatrists and other mental health providers about the likely risks and benefits [5‐7].

Many studies have addressed the benefits and risks of continuing antipsychotics [8‐13] as well as the effects of nonadherence to antipsychotic medications and its antecedents, factors, and outcomes [3, 14, 15]. However, few have focused on the decision-making process in psychiatric consultation or on how to present and discuss the relevant options [16‐21]. Existing studies suggest that the use of a shared decision making (SDM) process in psychiatric medication consultations is preferred for making mental health care decisions characterized by uncertainty and when more than one reasonable option is available [22]. Indeed, a recent review by the Australian National Mental Health Consumer Carer Forum on the topic of psychiatric medications concluded, among other things, that a SDM approach encourages the empowered use of psychiatric medications as part of the recovery process and positions patients as active agents in their own recovery process [23].

SDM is a health communication model that helps patients and clinicians make treatment decisions jointly. It gives both parties a framework and legitimacy for the discussion [24], focuses on the patient–clinician interaction, and encourages open dialogue in which both parties have expertise, which should lead to the choice of a consensus plan [25‐27]. From an ethical perspective, SDM embraces patients’ experiences, autonomy, and empowerment, which are aligned with personal recovery values and self-determination [28, 29].

One promising approach to operationalizing SDM in the medical consultation is the use of an encounter decision aid (EDA) to help patients and clinicians discuss relevant treatment options, support patients in exploring what is clinically available, and incorporate patient preferences [30, 31]. EDAs are evidence-based tools used before, during, or after a medical encounter to supplement the clinical consultation and to help patients make an informed, deliberate choice among treatment options [32, 33]. EDAs differ from health education materials because they make explicit a specific decision [34], and simplify the information about the patient’s condition and his or her options for treatment, screening, or diagnostic procedures. Previous research on the effects of EDA on various patient populations generally supports the potential positive effects of EDAs on patients’ medical decision-making: improving their knowledge regarding their treatment options and risk perceptions, reducing their level of decisional conflict, and decreasing the proportion of people who remain undecided [31]. However, this review included only two studies of EDAs in mental health [16, 35], both showing the effects of the EDA on uptake of psychoeducation [16] or completion of psychotherapy [35], not on antipsychotic medications adherence, which is strongly different from participation in psychotherapy or psychoeducation. Therefore, although Stacey et al. [31] found strong evidence when the patient choice is about whether to undergo surgery or treatment for heart failure or diabetes, their conclusions cannot be easily extended to patients with mental disorders.

Indeed, previous reviews focusing specifically on SDM in mental health have recommended using decision aids when discussing treatment options [17, 36], but similar biases and methodological limitations in the included articles, as with the findings by Stacey et al. [31], still exist. A recent review of SDM interventions in mental health by Zisman-Ilani et al. [37] included, in addition to randomized control trials (RCT), non-RCT studies and conceptual articles. The authors included 31 articles, of which 12 have described decision aids (or EDAs); only seven (of these 12 articles) were research articles and described an evaluation of a decision aid. Results were mixed; in three studies that used a decision aid, without supplemental elements before or after introducing it (such as goal setting), there was at least one significant outcome related to improved health behaviors (i.e. adherence, service utilization) [19, 38], mental health symptoms [39], and SDM-related outcomes (i.e. involvement, knowledge, self-efficacy). One study [40] reported no significant effect of the decision aid on patient outcomes. Four additional studies, that used a decision aid with supplemental elements, were found to have at least one positive significant effect on SDM-related outcomes (i.e. involvement, knowledge, self-efficacy) [16, 18, 41], and one study showed improved engagement in preferred treatment (psychotherapy, not medications) [35].

To help address the concerns from the limited studies available from these reviews, our purpose in this study was to develop a tool to help patients with psychosis who have stabilized, their carers, and clinicians explicitly address the daily dilemma of continuing, adjusting, or discontinuing antipsychotics during the mental health consultation. Specifically, our aims were: (1) to develop an EDA for antipsychotic medications decision-making that formally addresses the three options (continue, adjust, or stop); and, (2) to revise the tool based on a qualitative user-testing study with potential users that was designed to evaluate the clarity, usability, and potential barriers to and facilitators of future implementation of the new EDA in psychiatric consultations.

The EDA was developed according to the recommendations of the International Patient Decision Aid Standards (IPDAS) collaboration [42], the IPDAS instrument (IPDASi) [43], and the previous experience of developing 50 Option Grids™ decision aids. We used a community-based participatory research approach both in developing the EDA and during the evaluation of the proposed EDA by clinicians, carers and consumers [44]. The study had two phases: (1) EDA development, and (2) user testing.

The newly developed EDA was positively evaluated by the different stakeholders who participated in user-testing. The EDA was perceived as usable, context-appropriate, and potentially feasible in psychiatric consultations. Some respondents, particularly patients and family members, were concerned that the early version of the EDA strongly advocated against antipsychotic medications, which led to revisions to the final version. Interviewees encouraged us to present the information neutrally. This recommendation is aligned with previous work on the role of persuasive approaches in medical decision-making and the need to determine whether medical decisions are the result of a doctor–patient partnership or of persuasive tactics based. on power and hierarchical relationships [54]. Persuasive theories are one subset of health communication theories; they can be applied at many levels including intrapersonal, interpersonal, organizational, and mass communication [55]. Accordingly, persuasion can play a critical role in doctor–patient communication, as it is often the intent of a practitioner to shape, reinforce, or change a patient’s behavior [56], especially when discussing medication and treatment adherence [55], and even more in psychiatric settings, where patients are often questioned about their ability and capability to make treatment decisions [17, 57].

Our respondents raised the issue of patients’ ability to make decisions. This is particularly relevant to patients with schizophrenia spectrum disorders and serious mental illness, who may lack awareness of their illness [58‐60]. However, findings from the last decade about SDM in mental health provide evidence that people with mental conditions, including schizophrenia [16], can effectively participate in SDM with their health provider [37] and will make medication decisions independently without clinical guidance [23]. Therefore, because people with long-term illness provided most of the revisions to the EDA’s wording and content, this may demonstrate their ability and capacity to engage in these ideas as well as anyone else, challenging perhaps the assumption that they lack capacity.

Family members were guarded in their initial reactions to the EDA, perhaps fearing that discussion of stopping medication might suggest an alternative that would harm their family member. Another explanation might be related to a sense of family burden in caring for a loved one with a mental illness [61‐63], and a fear of a sudden increase in this burden may explain family members’ concerns about the EDA. Because family members play a major role in a triadic decision-making in mental health care [64, 65], their concerns are valid and should be addressed to facilitate and support the discussion on medication management. The present EDA and future SDM tools should include family members as targeted end-users, along with patients and clinicians, to support implementation and increase buy-in.

Our study has several strengths: First, we presented a heterogeneous overall sample representing unique access to the different stakeholder groups that created an important diversity of participant groups in the final sample. Second, we have described the development of a tool using a participatory approach that considered participants “active consultants” rather than “research subjects.” This research approach allows people with severe mental illness / psychotic illness, who may be largely excluded from decisions about their treatment, to become actively involved in the research and provide important feedback. Therefore, not only may SDM and tools such as decision aids help shift the power balance in medical encounters to help address coercive treatment, but also the participatory approach may help patients feel valued for their input, which, in turn, may further empower them. These strengths allowed us to explore and compare the different perceptions and perspectives of people with lived experiences of antipsychotic medication management. Yet, several limitations should be noted: First, the relatively small sample in each group may affect the generalizability of the results. Second, the intention of this article is not to venture into making suggestions about clinical impact, as this was a small, qualitative user-testing. Future field-testing research in various settings, such as clinics, hospitals, and community programs, is needed. In addition, future potential research would require a further study with much larger samples to test the effectiveness of the EDA and should include clinical and more psychosocial impact measurements.

Our participants, people who are involved in antipsychotic medication management, found the EDA to be valuable and acceptable. Our aim in this research and article was not to provide answers or to solve the dilemma of whether to continue, adjust, or stop antipsychotic medications. We believe it is a very personal decision that has no “one-size-fits-all” answer. Our aim in this project was to give voice and room for such a question/dilemma to be openly addressed as part of the psychiatric encounter and to help patients and other people involved in their care to “lay their cards on the table” and to openly raise concerns and questions about antipsychotics. As one of our interviewees shared with us: “I think a lot of people wouldn’t have even considered these options [unless their provider shows them the EDA].” We hope that this EDA will help patients and carers openly raise the dilemma, without fearing the response to and stigma associated with people with serious mental illness who wish to stop or adjust their medications [4, 66]. We anticipate that giving this dilemma room and space to be addressed as part of a psychiatric consultation may have a personal-rehabilitative benefit for the person with the illness as well as for others involved in his/her care. We hope that use of this EDA in psychiatric consultations will contribute to making personalized-better choices, ones that patients understand, agree to, and are more likely to follow, and that use of the EDA will encourage an open discussion between patients and their care team, improving engagement in psychiatric care.