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

Neoplasms Clinical Trial

— Loop  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372994
• Other study ID #: 410001734
• Status: Completed
• Phase: N/A
• First received: January 26, 2015
• Last updated: August 15, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Communication
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Princess Margaret Cancer Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of posts per participant on the Loop system		3 months	No
Other	Number of times a patient logs into the Loop system		3 months	No
Other	Number of times a caregiver logs into the Loop system		3 months	No
Other	Number of times a healthcare provider logs into the Loop system	Healthcare providers will be enrolled in the study for between 3 months and 1 year	At end of study participation	No
Other	Time interval between a message posting by a patient/caregiver and a response by a healthcare provider on the Loop system		3 months	No
Other	Number of occurrences of user-reported errors		3 months	No
Other	Proportion of functions being used on the Loop system		3 months	No
Primary	Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study.		1 year	No
Secondary	Trial feasibility measured with number of healthcare providers recruited for study who have consented and participate for the duration of the study.		1 year	No
Secondary	Trial feasibility measured with number of family caregivers recruited for study who have consented and participate for the duration of the study.		1 year	No
Secondary	Palliative Care Outcomes Scale	A 12 item questionnaire measuring patient-reported quality of care	3 months	No
Secondary	Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale	An 8 item questionnaire measuring patient-perceived continuity and coordination of care	3 months	No
Secondary	Ambulatory and Home Care Record	Measure of ambulatory, home-based and acute care health services utilization, and associated public and private costs	3 months	No
Secondary	Edmonton Symptom Assessment Scale	A 10 item questionnaire measuring symptom intensity	3 months	No
Secondary	Eastern Cooperative Oncology Group score	A measure of performance status	3 months	No
Secondary	The proportion of eligible participants who are invited to participate		1 year	No
Secondary	The proportion of invited participants who consent to participate		1 year	No
Secondary	The mean duration of participation of all study participants		1 year	No
Secondary	Instrument completion rate for the Palliative Care Outcomes Scale		1 year	No
Secondary	Item response rate for the Palliative Care Outcomes Scale		1 year	No
Secondary	Instrument completion rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale		1 year	No
Secondary	Item response rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale		1 year	No
Secondary	Instrument completion rate for the Ambulatory and Home Care Record		1 year	No
Secondary	Item response rate for the Ambulatory and Home Care Record		1 year	No
Secondary	Instrument completion rate for the Edmonton Symptom Assessment Scale		1 year	No
Secondary	Item response rate for the Edmonton Symptom Assessment Scale		1 year	No
Secondary	Number of family physicians who participate per study group		1 year	No