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Completed

NCT Number: NCT02372994

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

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?

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Key information

Conditions

Neoplasms Behavior Chronic Disease Communication Disease Attributes Health Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Loop

Other

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Palliative Care Outcomes Scale

    Time frame: 3 months

    A 12 item questionnaire measuring patient-reported quality of care

  4. 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

  5. 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

  6. Edmonton Symptom Assessment Scale

    Time frame: 3 months

    A 10 item questionnaire measuring symptom intensity

  7. Eastern Cooperative Oncology Group score

    Time frame: 3 months

    A measure of performance status

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

    Time frame: 1 year

  9. The proportion of invited participants who consent to participate

    Time frame: 1 year

  10. The mean duration of participation of all study participants

    Time frame: 1 year

  11. Instrument completion rate for the Palliative Care Outcomes Scale

    Time frame: 1 year

  12. Item response rate for the Palliative Care Outcomes Scale

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 1 year

  17. Instrument completion rate for the Edmonton Symptom Assessment Scale

    Time frame: 1 year

  18. Item response rate for the Edmonton Symptom Assessment Scale

    Time frame: 1 year

  19. Number of family physicians who participate per study group

    Time frame: 1 year

Other outcomes

  1. Number of posts per participant on the Loop system

    Time frame: 3 months

  2. Number of times a patient logs into the Loop system

    Time frame: 3 months

  3. Number of times a caregiver logs into the Loop system

    Time frame: 3 months

  4. 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

  5. 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

  6. Number of occurrences of user-reported errors

    Time frame: 3 months

  7. Proportion of functions being used on the Loop system

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Official study title

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

Acronym: Loop

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2015
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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