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

NCT ID: NCT02372994

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-04-30

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?

Conditions

Neoplasms; Communication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Loop

Intervention Type: 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.

Control Group

Participants receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Online Clinical Collaboration System; My Team of Care (MyTOC)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amna Husain, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Temmy Latner Center for Palliative Care, Mount Sinai Hospital

Locations

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28720558 (View on PubMed)

Other Identifiers

410001734

Identifier Type: -

Identifier Source: org_study_id