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NeoplasmsLoopNCT02372994

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

A study testing Loop in people with Neoplasms and Communication, run by Mount Sinai Hospital, Canada at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Neoplasms, Communication
What is being tested?
Loop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesCanada
Study dates
Jan 2015to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
  • 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
  • A potential candidate for or currently receiving hormone therapy for breast or prostate cancer
  • Patients with a prognosis of <3 months as determined by attending physician
  • Patients with impaired mental status as previously assessed by a physician or judged by research staff using the Bedside Confusion Scale
  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5T 2M9

  • Mount Sinai Hospital

    Toronto, Ontario, M5T 3L9

Other trials in Canada

About this study

Official title: 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?

Being tested
Loop
Keywords
chronic disease, continuity of patient care, patient engagement, cost effectiveness analysis, user-centred design, Interdisciplinary Health Team, Medical Informatics, Patient-centred care
Medical subject headings
Neoplasms, Communication, Chronic Disease, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LoopOther

    Also called Online Clinical Collaboration System, My Team of Care (MyTOC)

    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.

Study groups in NCT02372994
Study groupRoleWhat they receive
Intervention GroupExperimentalThe 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.
Receives: Other: Loop
Control GroupNo interventionParticipants receive usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study.

    Measured: 1 year

Secondary outcomes (19)

  1. Trial feasibility measured with number of healthcare providers recruited for study who have consented and participate for the duration of the study.

    Measured: 1 year

  2. Trial feasibility measured with number of family caregivers recruited for study who have consented and participate for the duration of the study.

    Measured: 1 year

  3. Palliative Care Outcomes Scale

    A 12 item questionnaire measuring patient-reported quality of care

    Measured: 3 months

  4. Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale

    An 8 item questionnaire measuring patient-perceived continuity and coordination of care

    Measured: 3 months

  5. Ambulatory and Home Care Record

    Measure of ambulatory, home-based and acute care health services utilization, and associated public and private costs

    Measured: 3 months

  6. Edmonton Symptom Assessment Scale

    A 10 item questionnaire measuring symptom intensity

    Measured: 3 months

  7. Eastern Cooperative Oncology Group score

    A measure of performance status

    Measured: 3 months

  8. The proportion of eligible participants who are invited to participate

    Measured: 1 year

  9. The proportion of invited participants who consent to participate

    Measured: 1 year

  10. The mean duration of participation of all study participants

    Measured: 1 year

  11. Instrument completion rate for the Palliative Care Outcomes Scale

    Measured: 1 year

  12. Item response rate for the Palliative Care Outcomes Scale

    Measured: 1 year

  13. Instrument completion rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale

    Measured: 1 year

  14. Item response rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale

    Measured: 1 year

  15. Instrument completion rate for the Ambulatory and Home Care Record

    Measured: 1 year

  16. Item response rate for the Ambulatory and Home Care Record

    Measured: 1 year

  17. Instrument completion rate for the Edmonton Symptom Assessment Scale

    Measured: 1 year

  18. Item response rate for the Edmonton Symptom Assessment Scale

    Measured: 1 year

  19. Number of family physicians who participate per study group

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02372994
Sponsor's protocol ID
410001734
Acronym
Loop
Status last verified
Aug 2016
First submitted
26 Jan 2015
Last updated
16 Aug 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 28720558

Questions about this trial

What is this clinical trial studying?

A study testing Loop in people with Neoplasms and Communication, run by Mount Sinai Hospital, Canada at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02372994, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.

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