Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT02372994
Status:
COMPLETED
Last Update Posted:
2016-08-16
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
My Team of Care: a Pilot Randomized Controlled Trial of an Online Communication Tool for Collaborative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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', 'description': 'Healthcare providers will be enrolled in the study for between 3 months and 1 year'}, {'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'}], 'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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', 'description': 'A 12 item questionnaire measuring patient-reported quality of care'}, {'measure': 'Picker Ambulatory Cancer Care Survey Continuity and Coordination subscale', 'timeFrame': '3 months', 'description': 'An 8 item questionnaire measuring patient-perceived continuity and coordination of care'}, {'measure': 'Ambulatory and Home Care Record', 'timeFrame': '3 months', 'description': 'Measure of ambulatory, home-based and acute care health services utilization, and associated public and private costs'}, {'measure': 'Edmonton Symptom Assessment Scale', 'timeFrame': '3 months', 'description': 'A 10 item questionnaire measuring symptom intensity'}, {'measure': 'Eastern Cooperative Oncology Group score', 'timeFrame': '3 months', 'description': 'A measure of performance status'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic disease', 'continuity of patient care', 'patient engagement', 'cost effectiveness analysis', 'user-centred design', 'Interdisciplinary Health Team', 'Medical Informatics', 'Patient-centred care'], 'conditions': ['Neoplasms', 'Communication']}, 'referencesModule': {'references': [{'pmid': '28720558', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with Stage IV cancer, or Patients with stage III cancer and poor prognosis as determined by a physician (\\>3 months but \\<2 years)\n2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2\n3. Each patient must have at least two healthcare providers, including an attending oncologist or palliative care physician\n4. Patient and, if applicable, family caregiver must be ≥18 years of age\n5. Literacy and language capacity and competency to provide informed consent\n6. Patient or caregiver must have access to a computer and the internet\n\nExclusion Criteria:\n\n1. 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\n2. 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\n3. A potential candidate for or currently receiving hormone therapy for breast or prostate cancer\n4. Patients with a prognosis of \\<3 months as determined by attending physician\n5. Patients with impaired mental status as previously assessed by a physician or judged by research staff using the Bedside Confusion Scale\n6. 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'}, 'identificationModule': {'nctId': 'NCT02372994', 'acronym': 'Loop', 'briefTitle': 'My Team of Care: a Pilot Randomized Controlled Trial of an Online Communication Tool for Collaborative Care', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'My Team of Care (MyTOC) Trial: a Pilot Randomized Controlled Trial of an Online Communication Tool (Loop) for Collaborative Care in Complex Patients', 'orgStudyIdInfo': {'id': '410001734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': '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.', 'interventionNames': ['Other: Loop']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants receive usual care.'}], 'interventions': [{'name': 'Loop', 'type': 'OTHER', 'otherNames': ['Online Clinical Collaboration System', 'My Team of Care (MyTOC)'], 'description': "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.", 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5T 3L9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Amna Husain, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temmy Latner Center for Palliative Care, Mount Sinai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}