Randomized Trial of eOncoNote

NCT ID: NCT03333785

Last Updated: 2021-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2021-02-17

Brief Summary

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Improving Cancer Care Together through eOncoNote is a pragmatic randomized trial involving a secure online eConsultation system (referred to as eOncoNote) that will allow primary care providers and cancer specialist providers to communicate about their patients.

Detailed Description

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The overall objectives of this randomized trial are to test an intervention designed to improve coordination/continuity of care between primary care providers (PCPs) and cancer specialist providers (CSPs), and to improve patient experience with regards to patients' perceived continuity of care. Participants will be patients at The Ottawa Hospital Cancer Centre in any one of three phases of the cancer continuum: diagnosis (colorectal, prostate, or lung cancer), active treatment (breast or prostate cancer) or survivorship (breast or colorectal cancer). The intervention involves a secure online eConsultation system that will allow PCPs and CSPs to communicate about their patient. Patients will be randomly allocated to one of two groups: 1) intervention group whereby their PCP and CSP will use a cancer-specific modification of the eConsultation system (eOncoNote) in addition to usual methods of communication or 2) control group receiving usual care (i.e. usual methods of communication such as telephone, fax, mailed consultation letters and progress notes). Randomization and outcomes will be at the level of the individual patient. The primary outcome is patients' perception of team/cross-boundary continuity. Secondary outcomes include measures of patients' anxiety and depression, and patients' experience of the care process. Qualitative methods including interviews with patients, PCPs, CSPs, and cancer system managers will also be conducted.

Conditions

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Communication Research Breast Cancer Prostate Cancer Colorectal Cancer Lung Cancer Program, Communication Remote Consultation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Improving Cancer Care Together through eOncoNote is a concurrent mixed-methods hybrid type I effectiveness-implementation study design. Effectiveness of eOncoNote will be assessed by a pragmatic randomized controlled trial with individual patient randomization and outcomes measured at the patient level. Implementation will be assessed using a mixed methods process evaluation involving key stakeholders to assess barriers and facilitators to implementation of the intervention.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention group

Primary care providers whose patients have been randomized to the intervention group will receive an invitation from their patient's cancer specialist provider to communicate using eOncoNote. Primary care providers and cancer specialist providers will use eOncoNote in addition to usual methods of communication.

Group Type EXPERIMENTAL

eOncoNote

Intervention Type BEHAVIORAL

* Diagnosis phase: The patient's nurse navigator will initiate an eOncoNote to the patient's PCP, inviting them to send any questions related to the patient's diagnostic process. The nurse navigator will initiate case closure after the diagnostic process has been completed (case will be open up to 4 months).
* Treatment phase: The patient's medical or radiation oncologist will initiate an eOncoNote to the patient's PCP inviting them to ask questions related to the patient's cancer treatment and/or request information related to the patient's co-morbidities. The oncologist will initiate case closure after the treatment has been completed.
* Survivorship phase: The patient's registered nurse within the Wellness Beyond Cancer Program will send an eOncoNote invitation to the patient's PCP inviting them to ask any questions as the patient transitions back to their care. The nurse will initiate case closure after one year.

Control group

Primary care providers whose patients have been randomized to the control group will receive usual care (i.e. their primary care providers will not access eOncoNote to communicate with the cancer specialist providers and vice versa) and will be able to contact each other via telephone, fax, and mail consultation letters and progress notes, as per usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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eOncoNote

* Diagnosis phase: The patient's nurse navigator will initiate an eOncoNote to the patient's PCP, inviting them to send any questions related to the patient's diagnostic process. The nurse navigator will initiate case closure after the diagnostic process has been completed (case will be open up to 4 months).
* Treatment phase: The patient's medical or radiation oncologist will initiate an eOncoNote to the patient's PCP inviting them to ask questions related to the patient's cancer treatment and/or request information related to the patient's co-morbidities. The oncologist will initiate case closure after the treatment has been completed.
* Survivorship phase: The patient's registered nurse within the Wellness Beyond Cancer Program will send an eOncoNote invitation to the patient's PCP inviting them to ask any questions as the patient transitions back to their care. The nurse will initiate case closure after one year.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age,
* being in one of the following three cancer continuum specific phases:

1. Diagnosis phase: patients referred to the Cancer Assessment Clinic with suspected colorectal, prostate, or lung cancer;
2. Treatment phase: patients receiving adjuvant chemotherapy for early stage breast cancer, or radical or adjuvant radiation therapy for localized prostate cancer;
3. Survivorship phase: patients referred to the Wellness Beyond Cancer Program post completion of their adjuvant therapy for either breast or colorectal cancer with the intent of being discharged for survivorship care to their own family physician;
* no prior history of cancer in the past 5 years (those with non-melanoma skin cancer can participate).

Exclusion Criteria

* Currently participating in another study requiring ongoing completion of patient reported outcome measures (such as quality of life measures) in order to minimize respondent burden,
* Does not have a primary care provider,
* Patients will be excluded if their primary care provider has another patient enrolled in the trial in order to control for contamination between randomization groups,
* Inability to read and write in English,
* Inability to provide informed consent, and
* In the survivorship phase, patients who are discharged to the Wellness Beyond Cancer Program nurse practitioner (rather than their primary care providers) will be excluded.

Primary care providers eligibility criteria:

* Licensed family physician or nurse practitioner,
* Their patient has consented to be enrolled in the study, and they do not have any other patients enrolled in the study (to avoid contamination between intervention and control groups),
* They are already registered on the Champlain BASE(TM) eConsult system prior to their patient being enrolled in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role collaborator

Ottawa Regional Cancer Centre

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Eva Grunfeld

Director, Knowledge Translation Research (OICR); Giblon Professor and Vice-Chair Research (Department of Family & Community Medicine, University of Toronto)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Grunfeld, MD, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Sharon McGee, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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Petrovic B, Julian JA, Liddy C, Afkham A, McGee SF, Morgan SC, Segal R, Sussman J, Pond GR, O'Brien MA, Bender JL, Grunfeld E. Web-Based Asynchronous Tool to Facilitate Communication Between Primary Care Providers and Cancer Specialists: Pragmatic Randomized Controlled Trial. J Med Internet Res. 2023 Jan 18;25:e40725. doi: 10.2196/40725.

Reference Type DERIVED
PMID: 36652284 (View on PubMed)

Related Links

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http://www.champlainbaseeconsult.com/

Champlain BASE eConsult Website

Other Identifiers

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128272

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OHSN-REB#20170381-01H

Identifier Type: -

Identifier Source: org_study_id

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