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

November 24, 2022 updated by: University Health Network, Toronto

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

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. 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. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada
      • Markham, Ontario, Canada
        • Recruiting
        • Oak Valley Health Hospital
        • Contact:
          • Paul Lee
        • Principal Investigator:
          • Paul Lee, MD
      • Sudbury, Ontario, Canada
        • Not yet recruiting
        • Health Sciences North
        • Contact:
          • Robert Ohle
        • Principal Investigator:
          • Robert Ohle, MD
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Women's College Hospital
        • Contact:
          • Jennifer Price
        • Principal Investigator:
          • Jennifer Price

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. 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).
  3. 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.
  4. 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.)
  5. Able to read, write and speak English or have a caregiver who is able to do so on their behalf.
  6. Patients must have been discharged from hospital within 2 weeks during their recruitment into the study (or will be recruited prior to their discharge).

Exclusion Criteria:

1. Patients who are discharged from hospital with the intent to be admitted to a long-term care facility will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death and/or all-cause unplanned readmission
Time Frame: 30 days
The primary outcome measure for effectiveness evaluation will be a composite of death and all-cause unplanned readmission over 30 days.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death and/or all-cause unplanned readmission
Time Frame: 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.
6 months and at 1-year
All-cause mortality
Time Frame: Over 30 days, at 6 months, and at 1-year follow-up
All-cause mortality
Over 30 days, at 6 months, and at 1-year follow-up
Readmissions
Time Frame: Over 30 days, at 6 months, and at 1-year follow-up
The number of Readmissions to Hospital
Over 30 days, at 6 months, and at 1-year follow-up
Days alive and out-of-hospital
Time Frame: Over 30 days, at 6 months, and at 1-year follow-up
Days alive and out-of-hospital
Over 30 days, at 6 months, and at 1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Women's College Hospital
Markham Stouffville Hospital
William Osler Health System
Health Sciences North

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 24, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-5835
  • 510037 (Other Grant/Funding Number: CIHR)
  • SMART Study (UHN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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