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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372994
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

Brief 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. 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?

Condition or disease Intervention/treatment Phase
Neoplasms Communication Other: Loop Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372994


Locations
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Canada, Ontario
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5T 2M9
Mount Sinai Hospital
Toronto, Ontario, Canada, M5T 3L9
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Amna Husain, MD MPH Temmy Latner Center for Palliative Care, Mount Sinai Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02372994    
Other Study ID Numbers: 410001734
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Keywords provided by Mount Sinai Hospital, Canada:
chronic disease
continuity of patient care
patient engagement
cost effectiveness analysis
user-centred design
Interdisciplinary Health Team
Medical Informatics
Patient-centred care