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

NCT05543720 | Unknown

• 3 other identifiers: 21-5835510037SMaRT Study
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 4

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. 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.

Conditions

Heart Failure，Congestive; Mental Health (Depression); Diabetes Mellitus; Chronic Obstructive Pulmonary Disease; Hypertension

Keywords

Telemonitoring; Smartphone application; Chronic disease management; Remote monitoring; Multiple chronic conditions; mHealth; Nurse-led; Holistic care

Outcome Measures

Primary Outcomes (1)

• Death and/or all-cause unplanned readmission

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

  30 days

Secondary Outcomes (4)

• Death and/or all-cause unplanned readmission

  6 months and at 1-year

• All-cause mortality

  Over 30 days, at 6 months, and at 1-year follow-up

• Readmissions

  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

Study Arms (2)

Control

NO INTERVENTION

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

Telemonitoring (Medly MCC)

EXPERIMENTAL

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

Interventions

Medly DEVICE

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.

Telemonitoring (Medly MCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Markham Stouffville Hospital: collaborator
• William Osler Health System: collaborator
• Health Sciences North: collaborator
• Women's College Hospital: collaborator

Study Sites (4)

William Osler Health System

Brampton, Ontario, Canada

RECRUITING

Health Sciences North

Greater Sudbury, Ontario, Canada

RECRUITING

Oak Valley Health Hospital

Markham, Ontario, Canada

RECRUITING

Women's College Hospital

Toronto, Ontario, Canada

RECRUITING

Related Publications (10)

• Van Spall HGC, Rahman T, Mytton O, Ramasundarahettige C, Ibrahim Q, Kabali C, Coppens M, Brian Haynes R, Connolly S. Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta-analysis. Eur J Heart Fail. 2017 Nov;19(11):1427-1443. doi: 10.1002/ejhf.765. Epub 2017 Feb 24.

  PMID: 28233442 BACKGROUND

• Haggerty JL, Reid RJ, Freeman GK, Starfield BH, Adair CE, McKendry R. Continuity of care: a multidisciplinary review. BMJ. 2003 Nov 22;327(7425):1219-21. doi: 10.1136/bmj.327.7425.1219.

  PMID: 14630762 BACKGROUND

• Seto E, Leonard KJ, Cafazzo JA, Masino C, Barnsley J, Ross HJ. Self-care and quality of life of heart failure patients at a multidisciplinary heart function clinic. J Cardiovasc Nurs. 2011 Sep-Oct;26(5):377-85. doi: 10.1097/JCN.0b013e31820612b8.

  PMID: 21263339 BACKGROUND

• Liddy C, Blazkho V, Mill K. Challenges of self-management when living with multiple chronic conditions: systematic review of the qualitative literature. Can Fam Physician. 2014 Dec;60(12):1123-33.

  PMID: 25642490 BACKGROUND

• Gordon K, Gray CS, Dainty KN, deLacy J, Seto E. Nurse-Led Models of Care for Patients with Complex Chronic Conditions: A Scoping Review. Nurs Leadersh (Tor Ont). 2019 Sep;32(3):57-76. doi: 10.12927/cjnl.2019.25972.

  PMID: 31714207 BACKGROUND

• Gordon K, Dainty KN, Steele Gray C, DeLacy J, Shah A, Seto E. Normalizing Telemonitoring in Nurse-Led Care Models for Complex Chronic Patient Populations: Case Study. JMIR Nurs. 2022 Apr 28;5(1):e36346. doi: 10.2196/36346.

  PMID: 35482375 BACKGROUND

• Gordon K, Dainty KN, Steele Gray C, DeLacy J, Shah A, Resnick M, Seto E. Experiences of Complex Patients With Telemonitoring in a Nurse-Led Model of Care: Multimethod Feasibility Study. JMIR Nurs. 2020 Sep 29;3(1):e22118. doi: 10.2196/22118.

  PMID: 34406972 BACKGROUND

• Gordon K, Steele Gray C, Dainty KN, DeLacy J, Ware P, Seto E. Exploring an Innovative Care Model and Telemonitoring for the Management of Patients With Complex Chronic Needs: Qualitative Description Study. JMIR Nurs. 2020 Mar 6;3(1):e15691. doi: 10.2196/15691. eCollection 2020 Jan-Dec.

  PMID: 34345777 BACKGROUND

• Ware P, Shah A, Ross HJ, Logan AG, Segal P, Cafazzo JA, Szacun-Shimizu K, Resnick M, Vattaparambil T, Seto E. Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study. J Med Internet Res. 2022 Jan 26;24(1):e31754. doi: 10.2196/31754.

  PMID: 35080502 BACKGROUND

• Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909.

  PMID: 22356799 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Psychological Well-Being; Depression; Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive; Hypertension; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Personal Satisfaction; Behavior; Behavioral Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Emily Seto, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Seto, PhD

CONTACT

416-669-9295; emily.seto@utoronto.ca

Denise Ng, MHI

CONTACT

denise.ng@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Propensity-score matched controls

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: October 17, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 28, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)