Clinical trial NCT02372994: My Team of Care: a Pilot Randomized Controlled Trial of an Online Communication Tool for Collaborative 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Communication
Keywords: chronic disease
continuity of patient care
patient engagement
cost effectiveness analysis
user-centred design
Interdisciplinary Health Team
Medical Informatics
Patient-centred care
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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?


Eligibility 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

Primary outcomes:
measure: Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study.
timeFrame: 1 year
Secondary outcomes:
measure: Trial feasibility measured with number of healthcare providers recruited for study who have consented and participate for the duration of the study.
timeFrame: 1 year
measure: Trial feasibility measured with number of family caregivers recruited for study who have consented and participate for the duration of the study.
timeFrame: 1 year
measure: Palliative Care Outcomes Scale
timeFrame: 3 months
measure: Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale
timeFrame: 3 months
measure: Ambulatory and Home Care Record
timeFrame: 3 months
measure: Edmonton Symptom Assessment Scale
timeFrame: 3 months
measure: Eastern Cooperative Oncology Group score
timeFrame: 3 months
measure: The proportion of eligible participants who are invited to participate
timeFrame: 1 year
measure: The proportion of invited participants who consent to participate
timeFrame: 1 year
measure: The mean duration of participation of all study participants
timeFrame: 1 year
measure: Instrument completion rate for the Palliative Care Outcomes Scale
timeFrame: 1 year
measure: Item response rate for the Palliative Care Outcomes Scale
timeFrame: 1 year
measure: Instrument completion rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale
timeFrame: 1 year
measure: Item response rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale
timeFrame: 1 year
measure: Instrument completion rate for the Ambulatory and Home Care Record
timeFrame: 1 year
measure: Item response rate for the Ambulatory and Home Care Record
timeFrame: 1 year
measure: Instrument completion rate for the Edmonton Symptom Assessment Scale
timeFrame: 1 year
measure: Item response rate for the Edmonton Symptom Assessment Scale
timeFrame: 1 year
measure: Number of family physicians who participate per study group
timeFrame: 1 year
Other outcomes:
measure: Number of posts per participant on the Loop system
timeFrame: 3 months
measure: Number of times a patient logs into the Loop system
timeFrame: 3 months
measure: Number of times a caregiver logs into the Loop system
timeFrame: 3 months
measure: Number of times a healthcare provider logs into the Loop system
timeFrame: At end of study participation
measure: Time interval between a message posting by a patient/caregiver and a response by a healthcare provider on the Loop system
timeFrame: 3 months
measure: Number of occurrences of user-reported errors
timeFrame: 3 months
measure: Proportion of functions being used on the Loop system
timeFrame: 3 months
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Temmy Latner Center for Palliative Care, Mount Sinai Hospital
name: Amna Husain, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.