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

NCT02372994 | Completed

• 1 other identifier: 410001734
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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

Keywords

chronic disease; continuity of patient care; patient engagement; cost effectiveness analysis; user-centred design; Interdisciplinary Health Team; Medical Informatics; Patient-centred care

Outcome Measures

Primary Outcomes (1)

• Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study.

  1 year

Secondary Outcomes (19)

• 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

• Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale

  3 months

• Ambulatory and Home Care Record

  3 months

Other Outcomes (7)

• Number of posts per participant on the Loop system

  3 months

• Number of times a patient logs into the Loop system

  3 months

• Number of times a caregiver logs into the Loop system

  3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants receive usual care.

Interventions

Loop 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.

Also known as: Online Clinical Collaboration System, My Team of Care (MyTOC)

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Stage IV cancer, or Patients with stage III cancer and poor prognosis as determined by a physician (\>3 months but \<2 years)
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
• Each patient must have at least two healthcare providers, including an attending oncologist or palliative care physician
• Patient and, if applicable, family caregiver must be ≥18 years of age
• Literacy and language capacity and competency to provide informed consent
• Patient or caregiver must have access to a computer and the internet

You may not qualify if:

• 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
• 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
• A potential candidate for or currently receiving hormone therapy for breast or prostate cancer
• Patients with a prognosis of \<3 months as determined by attending physician
• Patients with impaired mental status as previously assessed by a physician or judged by research staff using the Bedside Confusion Scale
• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (2)

Princess Margaret Cancer Center

Toronto, Ontario, M5T 2M9, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (1)

• 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.

  PMID: 28720558 DERIVED

MeSH Terms

Conditions

Neoplasms; Communication; Chronic Disease; Patient Participation

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Amna Husain, MD MPH

  Temmy Latner Center for Palliative Care, Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 26, 2015
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

CA (2)