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

August 15, 2016 updated by: Mount Sinai Hospital, Canada

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 1 year
1 year
Trial feasibility measured with number of family caregivers recruited for study who have consented and participate for the duration of the study.
Time Frame: 1 year
1 year
Palliative Care Outcomes Scale
Time Frame: 3 months
A 12 item questionnaire measuring patient-reported quality of care
3 months
Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale
Time Frame: 3 months
An 8 item questionnaire measuring patient-perceived continuity and coordination of care
3 months
Ambulatory and Home Care Record
Time Frame: 3 months
Measure of ambulatory, home-based and acute care health services utilization, and associated public and private costs
3 months
Edmonton Symptom Assessment Scale
Time Frame: 3 months
A 10 item questionnaire measuring symptom intensity
3 months
Eastern Cooperative Oncology Group score
Time Frame: 3 months
A measure of performance status
3 months
The proportion of eligible participants who are invited to participate
Time Frame: 1 year
1 year
The proportion of invited participants who consent to participate
Time Frame: 1 year
1 year
The mean duration of participation of all study participants
Time Frame: 1 year
1 year
Instrument completion rate for the Palliative Care Outcomes Scale
Time Frame: 1 year
1 year
Item response rate for the Palliative Care Outcomes Scale
Time Frame: 1 year
1 year
Instrument completion rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale
Time Frame: 1 year
1 year
Item response rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale
Time Frame: 1 year
1 year
Instrument completion rate for the Ambulatory and Home Care Record
Time Frame: 1 year
1 year
Item response rate for the Ambulatory and Home Care Record
Time Frame: 1 year
1 year
Instrument completion rate for the Edmonton Symptom Assessment Scale
Time Frame: 1 year
1 year
Item response rate for the Edmonton Symptom Assessment Scale
Time Frame: 1 year
1 year
Number of family physicians who participate per study group
Time Frame: 1 year
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of posts per participant on the Loop system
Time Frame: 3 months
3 months
Number of times a patient logs into the Loop system
Time Frame: 3 months
3 months
Number of times a caregiver logs into the Loop system
Time Frame: 3 months
3 months
Number of times a healthcare provider logs into the Loop system
Time Frame: At end of study participation
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
Time Frame: 3 months
3 months
Number of occurrences of user-reported errors
Time Frame: 3 months
3 months
Proportion of functions being used on the Loop system
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mount Sinai Hospital, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amna Husain, MD MPH, Temmy Latner Center for Palliative Care, Mount Sinai Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 410001734

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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