Evaluation of a Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study

Sponsor

University Health Network, Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05543720

Collaborator

Markham Stouffville Hospital (Other), William Osler Health System (Other), Health Sciences North (Other), Women's College Hospital (Other)

350

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In Canada, 3 out of 4 Canadians aged 65 and older have at least one chronic condition, while 1 in 4 seniors reported having three or more.1 Caring for complex patients who usually have multiple chronic conditions (MCC) is one of the biggest challenges facing our healthcare system. For patients, the lack of coordination and continuity of care as they transfer between healthcare settings and healthcare providers (HCPs) often results in a higher risk of readmission, suboptimal and fragmented care plans, delays in required medical intervention, inadequate self-care, and confusion on whom they should contact when they have questions. For the patient's care team, they often have no indication how patients are doing between clinic visits unless the patient can provide a log of their home measurements (e.g., blood pressure). Therefore, they are unable to detect and intervene if their patient's health is worsening between visits.

In order to address this increasing need to bridge the current gap in clinical management and self-care of complex patients during their transition from healthcare settings to home care, our team aims to design, implement and evaluate the SMaRT (Safe, Managed, and Responsive Transitions) Clinic, a nurse-led integrated care model facilitated by telemonitoring (TM). Specifically, the SMaRT Clinics aim to meaningfully introduce a nurse (or nurse practitioner) role to improve clinical coordination across patient care teams and reinforce proper self-care education through the use of telemonitoring. This project will be conducted in two phases across four years; Phase I: Design and Development, and Phase II: Implementation and Effectiveness Evaluation. The Phase II research activities include enrolling 350 patients with complex chronic conditions in the SMaRT clinics across four study sites. The implementation and effectiveness of the SMaRT clinics will be evaluated through a mix of semi-structured interviews, ethnographic observation, patient questionnaires, and analyses of health utilization outcomes using propensity-matched controls from the ICES provincial database.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure，Congestive Mental Health (Depression) Diabetes Mellitus Chronic Obstructive Pulmonary Disease Hypertension	Device: Medly	N/A

Detailed Description

The overall objective of this study is to design, implement, and evaluate SMaRT Clinics at four hospitals across Ontario serving complex patients transitioning home from the hospital in urban, suburban and rural settings. Instead of developing new technology for the nurse-led SMaRT Clinic, an existing validated TM system that is able to monitor patients with multiple chronic conditions, named Medly, was chosen. Medly was developed at eHealth Innovation (now called the Centre for Digital Therapeutics), UHN and was designed to monitor a medley of chronic conditions, and has been evaluated in trials for single chronic conditions and multiple chronic conditions. For the purposes of this trial, Medly will enable the TM of heart failure, COPD, diabetes, hypertension, and depression.

The patient-facing technology includes the Medly smartphone application (app). The app enables patients to complete symptom surveys and record physiological measures using peripheral devices relevant to their chronic condition (e.g., weight scale, blood pressure monitor, and/or blood glucose monitoring). Designed as a modular app, features and parameters to be monitored can be added and removed, and target values for each parameter (e.g. blood pressure) can be individualized according to the needs of each patient. The inputted measures are processed by an embedded rules-based algorithm (customized to the patient by the setting of target thresholds) which triggers appropriate self-care messages being displayed to the patient within the app (e.g., instructing patients to take their prescribed medication, informing patients to contact their care team, etc.). Other features of the Medly app include the ability to view a historical record of their inputted readings, view graphical trends of blood glucose and blood pressure values, and to assist with adherence, an automated phone call to remind patients if they have not yet taken their readings by the appropriate time for their condition.

The clinician-facing technology includes the Medly dashboard. To support clinical decision-making, clinicians are alerted to clinically significant changes to patient health status and are able to assess alerts generated by the embedded algorithm and review patient data, including which parameters triggered the alert, prescribed medications, graphical trends of lab results and relevant measures, and contact information. Clinicians may also be informed of triggered alerts through email notifications. Information presented on the Medly dashboard may be leveraged to inform clinical decision-making throughout the patient's follow-up care journey.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Propensity-score matched controlsPropensity-score matched controls

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The Safe, Managed, and Responsive Transitions (SMaRT) Study

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Control groups will be compared to 350 patients who received standard of care via propensity-matched controls from the ICES provincial database.
Experimental: Telemonitoring (Medly MCC) Medly is a smartphone application allows patients with heart failure, diabetes, depression, hypertension, and/or COPD to measure and record their daily self-reported symptoms. This monitoring information is then transmitted wirelessly to a data server where an algorithm is used to generate an alert to a healthcare provider as necessary. The patient also receives an automated self-care message based on their measurements and reported symptoms.	Device: Medly Medly will enable patients with HF, COPD, Hypertension, Mental Health, or Diabetes to input measurements with wireless home medical devices and to answer symptom questions on the smartphone. The measurements will be automatically and wirelessly transmitted to the mobile phone and then to a data server. Automated self-care instructions/messages will be sent to the patient based on the readings and reported symptoms. If there are signs of their status deteriorating, an alert will be sent to a clinician that is responsible for the particular chronic condition of concern. The clinicians will have all the relevant patient data sent to them and will be able to access (through a secure web portal) to view historical and trending data for their patients.

Arm

Intervention/Treatment

No Intervention: Control

Control groups will be compared to 350 patients who received standard of care via propensity-matched controls from the ICES provincial database.

Experimental: Telemonitoring (Medly MCC)

Medly is a smartphone application allows patients with heart failure, diabetes, depression, hypertension, and/or COPD to measure and record their daily self-reported symptoms. This monitoring information is then transmitted wirelessly to a data server where an algorithm is used to generate an alert to a healthcare provider as necessary. The patient also receives an automated self-care message based on their measurements and reported symptoms.

Device: Medly

Medly will enable patients with HF, COPD, Hypertension, Mental Health, or Diabetes to input measurements with wireless home medical devices and to answer symptom questions on the smartphone. The measurements will be automatically and wirelessly transmitted to the mobile phone and then to a data server. Automated self-care instructions/messages will be sent to the patient based on the readings and reported symptoms. If there are signs of their status deteriorating, an alert will be sent to a clinician that is responsible for the particular chronic condition of concern. The clinicians will have all the relevant patient data sent to them and will be able to access (through a secure web portal) to view historical and trending data for their patients.

Outcome Measures

Primary Outcome Measures

Death and/or all-cause unplanned readmission [30 days]
The primary outcome measure for effectiveness evaluation will be a composite of death and all-cause unplanned readmission over 30 days.

Secondary Outcome Measures

Death and/or all-cause unplanned readmission [6 months and at 1-year]
The secondary outcome measure for effectiveness evaluation will be a composite of death and all-cause unplanned readmission over 6 months and 1 year.
All-cause mortality [Over 30 days, at 6 months, and at 1-year follow-up]
All-cause mortality
Readmissions [Over 30 days, at 6 months, and at 1-year follow-up]
The number of Readmissions to Hospital
Days alive and out-of-hospital [Over 30 days, at 6 months, and at 1-year follow-up]
Days alive and out-of-hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older
Discharged from hospital or seen within 48 hours of discharge at Health Sciences North (HSN), William Osler Health Systems (WOHS), Women's College Hospital (WCH), and Markham Stouffville Hospital (MSH).
Have at least one complex chronic condition (i.e., heart failure, complex obstructive pulmonary disease (COPD), hypertension, diabetes, and/or depression) that would benefit if monitored through telemonitoring.
Able to comply with use of the telemonitoring application and applicable peripheral devices (e.g., able to stand on the weight scale, able to answer symptom questions, etc.)
Able to read, write and speak English or have a caregiver who is able to do so on their behalf.
Patients must have been discharged from hospital within 2 weeks during their recruitment into the study (or will be recruited prior to their discharge).