Developing a Hypothetical Implementation Framework of Expectations for Monitoring Early Signs of Psychosis Relapse Using a Mobile App: Qualitative Study

Abstract

BackgroundRelapse is a common experience for people diagnosed with psychosis, which is associated with increased service costs and profound personal and familial distress. EMPOWER (Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery) is a peer worker–supported digital intervention that aims to enable service users to self-monitor their mental health with the aim of encouraging self-management and the shared use of personal data to promote relapse prevention. Digital interventions have not been widely used in relapse prevention and, therefore, little is currently known about their likely implementation—both within trials and beyond.ObjectiveSeeking the perspectives of all relevant stakeholder groups is recommended in developing theories about implementation because this can reveal important group differences in understandings and assumptions about whether and for whom the intervention is expected to work. However, the majority of intervention implementation research has been retrospective. This study aimed to discover and theoretically frame implementation expectations in advance of testing and synthesize these data into a framework.MethodsTo develop a hypothetical implementation framework, 149 mental health professionals, carers, and people diagnosed with psychosis participated in 25 focus groups in both Australia and the United Kingdom. An interview schedule informed by the normalization process theory was used to explore stakeholders’ expectations about the implementation of the EMPOWER intervention. Data were analyzed using thematic analysis and then theoretically framed using the Medical Research Council guidelines for understanding the implementation of complex interventions.ResultsAll groups expected that EMPOWER could be successfully implemented if the intervention generated data that were meaningful to mental health staff, carers, and service users within their unique roles. However, there were key differences between staff, carers, and service users about what facilitators and barriers that stakeholders believe exist for intervention implementation in both the cluster randomized controlled trial stage and beyond. For example, service user expectations mostly clustered around subjective user experiences, whereas staff and carers spoke more about the impact upon staff interactions with service users.ConclusionsA hypothetical implementation framework synthesized from stakeholder implementation expectations provides an opportunity to compare actual implementation data gathered during an ongoing clinical trial, giving valuable insights into the accuracy of these stakeholders’ previous expectations. This is among the first studies to assess and record implementation expectations for a newly developed digital intervention for psychosis in advance of testing in a clinical trial.Trial RegistrationISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262

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“…Indeed, some studies found a negative correlation between the time spent using eHealth apps and the engagement of patients [ 20 , 21 ]. In addition, many clinicians expressed their concern that if these systems integrate seamlessly with clinical workflow, they will result in an increase in the clinicians’ workload [ 22 , 23 ], which might affect their engagement with the app.…”

Virtual Reality Cognitive Therapy in Inpatient Psychiatric Wards: Protocol for a Qualitative Investigation of Staff and Patient Views Across Multiple National Health Service Sites

“…The study methodology also has several strengths. First, multiple stakeholder involvement is considered important for implementation research [ 45 , 47 ]. Thus, conducting focus groups with staff of varying professional groups and patients is a particular strength of the study; a wide selection of viewpoints is likely to be gained.…”

“…Therefore, it is likely to fit well with the goals of both staff and patients on wards. Finally, the majority of implementation research is retrospective [ 47 ]. This study benefits from prospectively assessing feasibility of implementation in this setting.…”

Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation

“…Analysis of key implementation themes constructed from formative qualitative work conducted before the trial involving 25 focus groups held with mental health staff, carers, and service users across international sites in both the United Kingdom and Australia [47].…”

“…Following mapping out key EMPOWER components as described in the protocol (step 1), our formative qualitative work conducted in advance of the trial [47] was key to developing the process evaluation framework (step 2 of our process) and will be described briefly. The person-based approach to intervention evaluation [48] provided a useful guide for structuring the qualitative data as the process evaluation team developed the framework.…”