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

Not Applicable

Completed

• Conditions: Neoplasms; Communication
• Interventions: Other: Loop

• Registration Number: NCT02372994
• Lead Sponsor: 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Loop	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of family physicians who participate per study group	1 year
Instrument completion rate for the Palliative Care Outcomes Scale	1 year
Item response rate for the Edmonton Symptom Assessment Scale	1 year
Trial feasibility measured with number of healthcare providers recruited for study who have consented and participate for the duration of the study.	1 year
Trial feasibility measured with number of family caregivers recruited for study who have consented and participate for the duration of the study.	1 year
Palliative Care Outcomes Scale	3 months	A 12 item questionnaire measuring patient-reported quality of care
Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale	3 months	An 8 item questionnaire measuring patient-perceived continuity and coordination of care
Ambulatory and Home Care Record	3 months	Measure of ambulatory, home-based and acute care health services utilization, and associated public and private costs
The proportion of eligible participants who are invited to participate	1 year
Eastern Cooperative Oncology Group score	3 months	A measure of performance status
The proportion of invited participants who consent to participate	1 year
The mean duration of participation of all study participants	1 year
Instrument completion rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale	1 year
Item response rate for the Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale	1 year
Edmonton Symptom Assessment Scale	3 months	A 10 item questionnaire measuring symptom intensity
Item response rate for the Palliative Care Outcomes Scale	1 year
Instrument completion rate for the Ambulatory and Home Care Record	1 year
Item response rate for the Ambulatory and Home Care Record	1 year
Instrument completion rate for the Edmonton Symptom Assessment Scale	1 year

Trial Locations

Locations (2)

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada