My Team of Care: a Pilot Randomized Controlled Trial of an Online Communication Tool for Collaborative Care (Loop)

My Team of Care (MyTOC) Trial: a Pilot Randomized Controlled Trial of an Online Communication Tool (Loop) for Collaborative Care in Complex Patients

This project will pilot and test a new online communication tool, Loop, developed within a research framework with participatory and user-centred design. This pilot trial focuses on advanced cancer as an example of complex care. Cancer care involves many healthcare providers, spanning hospital to home. There is no organized way for them to communicate. Loop is a practical tool for ongoing collaboration in the patient's actual team of care that engages patients. The study will answer the questions: does Loop improve communication efficiency, engage patients and family physicians, and show early benefits in quality and health care costs?

Study Overview

• Status: Completed
• Conditions: Neoplasms; Communication
• Intervention / Treatment: Other: Loop

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 3L9
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M5T 2M9
      • Princess Margaret Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with Stage IV cancer, or Patients with stage III cancer and poor prognosis as determined by a physician (>3 months but <2 years)
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
3. Each patient must have at least two healthcare providers, including an attending oncologist or palliative care physician
4. Patient and, if applicable, family caregiver must be ≥18 years of age
5. Literacy and language capacity and competency to provide informed consent
6. Patient or caregiver must have access to a computer and the internet

Exclusion Criteria:

1. Patients without the capacity to participate in use of the online tool, and do not have a caregiver who can engage in use of the tool on their behalf
2. Participants without the capacity to participate in evaluation of outcome measures, including, but not limited to, online and paper-based multiple-choice questions, checklists, and visual analogue scales, and do not have a family caregiver who can complete outcome measures
3. A potential candidate for or currently receiving hormone therapy for breast or prostate cancer
4. Patients with a prognosis of <3 months as determined by attending physician
5. Patients with impaired mental status as previously assessed by a physician or judged by research staff using the Bedside Confusion Scale
6. It has been determined that the patient is participating in another study precluding them from taking part in this study, as determined by an agreed-upon algorithm, tracked and managed by study coordinators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The randomization is at the level of attending healthcare professional who identifies patients for recruitment. For each participant in the intervention arm, a secure space (called a Patient Loop) is created in the online clinical communication system. A Patient Loop can be accessed by the patient, their caregiver, and the healthcare providers who have permission to do so through an algorithm of invitation, authentication and careful partitioning. In each Patient Loop, team members can post messages that can be read and responded to by the entire team. Each Patient Loop consists of a patient, their caregiver and at least two healthcare professionals.	Other: Loop; Loop is a secure online communication system centered on the patient that assembles the patient's actual healthcare team for ongoing collaborative care. The patient and caregiver are integral members of the team. Loop is cross-organizational, cross-setting and interprofessional. It is for ongoing, interactive, contextual, team-based communication. Loop is explicitly for asynchronous communication, not instant messaging. The stream of messages is stored and can be sorted for ease of viewing. The tool was developed with user-centred design and requires no prior training.; Other Names: Online Clinical Collaboration System; My Team of Care (MyTOC)
No Intervention: Control Group; Participants receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial feasibility measured with number of healthcare providers recruited for study who have consented and participate for the duration of the study.		1 year
Trial feasibility measured with number of family caregivers recruited for study who have consented and participate for the duration of the study.		1 year
Palliative Care Outcomes Scale	A 12 item questionnaire measuring patient-reported quality of care	3 months
Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale	An 8 item questionnaire measuring patient-perceived continuity and coordination of care	3 months
Ambulatory and Home Care Record	Measure of ambulatory, home-based and acute care health services utilization, and associated public and private costs	3 months
Edmonton Symptom Assessment Scale	A 10 item questionnaire measuring symptom intensity	3 months
Eastern Cooperative Oncology Group score	A measure of performance status	3 months
The proportion of eligible participants who are invited to participate		1 year
The proportion of invited participants who consent to participate		1 year
The mean duration of participation of all study participants		1 year
Instrument completion rate for the Palliative Care Outcomes Scale		1 year
Item response rate for the Palliative Care Outcomes Scale		1 year
Instrument completion rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale		1 year
Item response rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale		1 year
Instrument completion rate for the Ambulatory and Home Care Record		1 year
Item response rate for the Ambulatory and Home Care Record		1 year
Instrument completion rate for the Edmonton Symptom Assessment Scale		1 year
Item response rate for the Edmonton Symptom Assessment Scale		1 year
Number of family physicians who participate per study group		1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of posts per participant on the Loop system		3 months
Number of times a patient logs into the Loop system		3 months
Number of times a caregiver logs into the Loop system		3 months
Number of times a healthcare provider logs into the Loop system	Healthcare providers will be enrolled in the study for between 3 months and 1 year	At end of study participation
Time interval between a message posting by a patient/caregiver and a response by a healthcare provider on the Loop system		3 months
Number of occurrences of user-reported errors		3 months
Proportion of functions being used on the Loop system		3 months

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Investigators: Principal Investigator: Amna Husain, MD MPH, Temmy Latner Center for Palliative Care, Mount Sinai Hospital

Publications and helpful links

General Publications

• Voruganti T, Grunfeld E, Jamieson T, Kurahashi AM, Lokuge B, Krzyzanowska MK, Mamdani M, Moineddin R, Husain A. My Team of Care Study: A Pilot Randomized Controlled Trial of a Web-Based Communication Tool for Collaborative Care in Patients With Advanced Cancer. J Med Internet Res. 2017 Jul 18;19(7):e219. doi: 10.2196/jmir.7421.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Medical Informatics; chronic disease; Interdisciplinary Health Team; Patient-centred care; patient engagement; cost effectiveness analysis; continuity of patient care; user-centred design
• Other Study ID Numbers: 410001734