Design
This quasi-experimental project is separated into two phases. The hospital prototype phase is employing a within-group, mixed-methods, descriptive pilot design in order to ascertain the feasibility of the smart technology in a hospital setting as well as testing the system as a whole. Data was collected upon discharge from the hospital apartment and at 6-month follow-up.
As the project moves from the hospital prototype phase, the community phase is adopting a more longitudinal approach in testing the project’s hypotheses. This involves a within-group, mixed-methods, repeated-measures design. Data is being collected over three assessments conducted at baseline, 6-month and 12-month follow-ups. Comparisons regarding levels of community integration, health, housing stability and service usage throughout the intervention will be observed. Ethical approval was obtained through Western University’s Research Ethics Board and Lawson Health Research Institute.
Description of the Settings
Health Care Providers (HCPs) at two inpatient psychiatric facilities and HCPs in community homes coordinated with the research staff to set up various smart technologies in the apartments for individuals with mental illness. The prototype apartments within the psychiatric facilities are available to individuals who were being discharged into the community in order to provide a transitional experience. The community homes are operated by the Canadian Mental Health Association (CMHA) and London Middlesex Community Housing (LMCH). These include group homes, family homes and individual apartments with staff members providing in-home care and support on a need-to-need basis.
The System
This project has sought to incorporate real-time integration of data in order to provide HCPs with notifications and monitoring capabilities. The system links multiple smart technology devices and funnels the data into one database. This system has been comprised of two software innovations; the Lawson Integrated Database (LIDB) and the Collaborative Health Record (CHR).
The LIDB is an information management platform that collates and manages client health information behind the St. Joseph’s Health Care hospital firewall. The LIDB keeps health data segregated in its own database schema but is capable of matching patient data across HCPs. With funds from the Canada Health Infoway, the research team was able to ensure the security of the LIDB through a third-party Privacy Impact Analysis and Threat Risk Assessment. Encrypted incremental data backups are performed on a nightly basis and full backups performed weekly with both stored securely off-site. The LIDB also utilizes virtual servers to move from one server to another to enable continuous operations with no impact to users. Weekly meetings with software engineers and monthly meetings with the hospital I.T. and Privacy departments have been held since the commencement of the project to address any data security concerns and ensure the integrity of the system. HCPs are able to log-in to the LIDB to view data from the health monitoring devices and the CHR, and also to set the reminders to be transmitted to the screen devices.
The CHR allows for both synchronous and asynchronous communication between patients and HCPs to deliver team-based, longitudinal health care. The CHR operates on the screen devices offered to the participants. The specific functions of the CHR include:
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Access to personal health information and self-assessments to enhance early identification of concerns related to symptoms.
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A comprehensive patient-record system that provides workflows for a diverse group of HCPs.
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Prompts and reminders that can support care planning for symptoms and comorbidities (e.g. medication reminders and activity prompts).
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Secure communication between HCPs and participants including videoconferencing and messaging.
This functionality aids the complex care of people with severe mental illnesses by creating an enhanced secure connection between them and their circle of care. This helps overcome barriers to care such as mobility, transportation, or lack of resources readily available, and reduces the number of in-person appointments necessary. Self-assessments (known in the software as “Qnaires©”) are also completed within the CHR by the participant which allows the HCP and care team to monitor changes and potential crises. These self-assessments can include standardised tools used such as Patient Health Questionnaire (PHQ-9) and fully customisable tools created by the HCP within the CHR. The data from these assessments are then backed up to the participant’s profile in the LIDB. In the event of a crisis (e.g. a participant indicates suicidal ideation on a Qnaire), an alert is sent to the care team so that they can act accordingly.
Equipment
Participants residing in the hospital prototype apartments can select a variety of screen devices including smartphones, tablets, and touch-screen monitors. These devices provide prompts and reminders generated by the LIDB to assist participants with cognitive deficits and facilitate self-care. The touch-screen monitors are developed in-house by the research team’s programmer. The monitor is programmed so that prompts and reminders on the screen can be “acknowledged” by the user by pushing the “Got It” button. This sends an automated message back to the HCP who set the reminder to inform them the reminder was received. Furthermore, a “Help” button was added after initial discussions with HCPs which sends a message to the participant’s care team requesting them to provide support. This exhaustive approach of ensuring all devices were able to connect to each other and allowed for ease of data exporting to the LIDB was completed after weekly meetings and thorough testing.
In addition to the screen devices, the participants are offered a choice of adjunct health monitoring devices. In the hospital prototype phase, these include weigh scales, blood pressure monitors, glucometers, and a wearable activity tracker (smartwatch). These devices account for the comorbidities that may be present and will support chronic illness management. Data from these devices is pushed to the LIDB via encrypted authentication keys and SSL connectivity. The weigh scale exports data via WiFi whereas the glucometer, weigh scale and activity tracker utilize Bluetooth connectivity.
The screen devices on offer for individuals residing in the community homes differ slightly. Participants in this phase are offered smartphones and touch-screen monitors only. This was done to further refine the intervention and allow for an additional health adjunct health monitoring device to be offered.
For participants in the community homes, their choice of health monitoring equipment also differs slightly with an automated medication dispenser being made available for selection but the blood pressure monitor and glucometer are not. The medication dispenser was not available for the hospital prototype phase due to medication protocols within the hospital. This addition of a medication dispenser represents the tailoring and refinement of the intervention for individuals living in the community. This was implemented to help participants with self-medication (if appropriate) and save time by reducing the need for participants and/or HCPs to collect medications from the pharmacy.
In both phases, participants are given the choice of devices they can use and are able to refuse any device with which they were not comfortable with. Participants recruited into the study are also allowed to refuse all devices but are still expected to complete a full semi-structured interview in order to acquire their opinions and attitudes as to why.
Recruitment
For all participants in both phases, the research team first recruited HCPs who then referred participants to the research team. For the hospital prototype phase of the project, the study is recruiting up to 20 participants and for the community phase, we are recruiting up to 13 participants. Participants are excluded from the study if they do not reside in the hospital prototype apartment for a minimum of one week.
Additional inclusion criteria for participants to participate in the community phase of the study include:
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Must be on a caseload of a participating HCP.
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Able to understand English to the degree necessary to participate.
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Living in, eligible for, and wanting, housing provided by the CMHA housing program or LMCH.
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Diagnosed with a psychotic or major mood disorder.
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Identified by the clinical team to require prompting/reminding to complete activities of daily living and self- assessments as indicated by a score between 70 and 20 on the Social and Occupational Functioning Assessment Scale [15].
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Must be between the ages of 18–85 years old and able to provide informed consent.
For both phases, this represents an opportunity sample as enrollment entirely depended on whether the participant is currently residing in the hospital or in the community. All participants have provided capable informed consent.
Procedure
The initial hospital prototype phase includes two hospital apartments located in two psychiatric inpatient facilities. Upon consenting to participate in the study, selected equipment was verified and approved by their HCP. The equipment was then delivered to the participant by the research coordinator and the research team’s programmer who then sets up the devices and provides training to the participant. Training for usage of the CHR is provided by the research coordinator with the HCP in a one-to-one session. The participant completes their first interview upon discharge from the hospital prototype apartment. The participants complete a second interview at 6 months post-discharge.
The community phase is an expansion of the hospital prototype phase but participants are not crossed over, meaning that those who are discharged from the hospital prototype apartments do not enter the community phase. Upon enrollment into the study, participants for this phase of the project complete a baseline interview consisting of questionnaires pertaining to demographic data, health, housing, community integration and service utilization. Follow-up interviews are then conducted at 6 months and 12 months.
Focus groups are being provided to HCPs for both phases at the study’s end allowing them to provide their observations and thoughts on the use of smart technology for the participants. A focus group at the study’s end for participants will only be made available for participants in the community phase.
Instruments
In both phases of the study, the participants complete semi-structured interviews that include the following assessment tools: Community Integration Questionnaire - Revised (CIQ-R), Short-Form 36, EQ5D, the Housing History survey, the Health, Social and Justice Service Utilization (HSJSU) questionnaire, and the Perception of Smart Technology Questionnaire, a researcher-developed questionnaire that inquired about participants’ attitudes and opinions of the equipment provided to them. Demographic data is also collected during these interviews.
Health data from the health monitoring devices include blood pressure, weight, blood glucose levels and heart rate. This data is backed up to the LIDB and made available to their HCPs for monitoring and tracking. Apps for these devices are preloaded onto the smartphones and tablets so that participants can also monitor their data. Participants could use the devices as and when they wished, or if directed by their HCP.
Data Analysis
Data is entered and stored on REDCap, a secure web-based database application by a research assistant. For quantitative analysis, the research team uses SPSS Statistics Software to generate descriptive statistics. It should be noted that data from the CHR’s Qnaires have not, and will not, be analysed. The primary outcome of interest is the total score from the CIQ-R. Further quantitative analyses will investigate the housing history of the participant to assess housing stability, the health status of the participant, and experience with health, social and justice services to evaluate service usage.
Individual interviews are held with all participants enrolled in the study. Focus groups, as described by Krueger [16], are held with HCPs in both phases as well as participants in the community phase. Research assistants will conduct qualitative analyses by applying a thematic grouping of responses by identifying recurrent themes and opinions expressed by the participants and HCPs. Specifically, an ethnographic method of analysis will be used to observe the broader social and cultural contexts surrounding individual experiences as well as the impact on HCPs and how the intervention influenced their practice [17].
A standardised evaluation framework facilitated systematic effectiveness, economic, ethical and policy analysis of outcomes [18].
Effectiveness analyses will utilise the mixed-methods approach of this study by analysing the quantitative data from the instruments provided during the individual interviews to assess for any changes or improvements to the participants’ health, service utilization and community integration. Common qualitative items from the focus groups will also assess the usage of the technologies and suggestions for improvement. By using a mixed methods approach, the research team is able to ascertain the participants’ experiences with the technology as well as the effects on health, housing stability, and community integration.
The economic analyses will focus on the value for money aspect of the intervention as well as the costs and benefits. Specifically, the health costs of the intervention compared to usual care as well as the costs of hospitalizations, emergency room visits, outpatient visits and home care service.
Quantitative and qualitative findings related to views of fairness, benefits and social inclusion will be compared to ethical standards derived from welfare theory and accepted ethical principles of care providers (i.e. autonomy, beneficence and respect) as part of the ethical analyses.
Finally, policy analyses will address the implications that arise from the issues identified in the interviews such as access to and utilization of services, housing history, impact of severity of illness, and need for personal resources.