Health Services ResearcheConsultNCT02053467
Building Capacity for Specialized Services Through eConsultation
A study testing Champlain BASE eConsult Service in people with Health Services Research, run by Bruyère Health Research Institute. at 1 site in Canada.
Trial summary
The consultation-referral process is complex, involving several steps including 1) the PCP recognizing the need for specialist advice/intervention, 2) patient agreement on seeing the specialist, 3) referral letter and information sent to specialist, 4) appointment booked and communicated, 5) patient visit(s) with the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Services Research
- What is being tested?
- Champlain BASE eConsult Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2014to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any practicing primary care provider (PCP) in Ontario who is not currently registered to use the Champlain BASE eConsult service may be recruited to participate in the research study, beginning with the Champlain and South East Local Health Integration Networks.
Who cannot join
- Those not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Bruyere Research Institute, C. T. Lamont Primary Health Care Research Centre
Ottawa, Ontario
About this study
The consultation-referral process is complex, involving several steps including 1) the PCP recognizing the need for specialist advice/intervention, 2) patient agreement on seeing the specialist, 3) referral letter and information sent to specialist, 4) appointment booked and communicated, 5) patient visit(s) with the specialist and 6) communication back to the PCP.
There are many factors during this process which limit the effectiveness and efficiency of patient care. These include inequitable access for patients and providers, long wait times before specialist advice received/implemented, delayed communication and mismatched consult expectations. These gaps result in significant breakdowns in transitions of care, inappropriate treatment, patient dissatisfaction and potential harm. Moreover, not all individuals are willing or able to travel to see specialists in a large academic medical centre even when recommended by the PCP.
Electronic consultation (eConsult) service is a form of asynchronous communication whereby primary care providers (PCP) and specialists can communicate directly about a patient through a secure web-based application. eConsult has the potential for improving transitions in care through improved communication ensuring that patients are seen by the right specialist, when necessary, with the right information and in a timely manner. The goal of this project is to evaluate the impact of eConsult on specialist referral rates using health administrative data.
Read the detailed description
Research Question: What is the impact of an electronic consultation (eConsult) service on referral rates from primary care doctors to specialists?
The objective of this study is to assess the impact of eConsult service on referral rates using a randomized controlled trial (RCT) of eConsult versus usual referral practices. We hypothesized that access to eConsult would lead to a decrease in referral requests for face-to-face specialist visits from primary care providers in the intervention group.
Trial Design: This study is a parallel arm RCT that recruited family physicians in Ontario to use the Champlain BASE™ eConsult service. Physicians will be randomized 1:1 to either the intervention or control arm between January 31, 2014 and September 26, 2014. Although originally intended as a stepped wedge RCT, the design was changed to a parallel arm before and after RCT due to the fact that randomization could not be performed at a discrete time point for all participants.
Intervention: In 2009 our team began developing, implementing, and evaluating an innovative eHealth solution called the Champlain BASE™ (Building Access to Specialists through eConsultation) eConsult service. eConsult is a form of asynchronous communication whereby primary care providers (PCP) and specialists can communicate directly about a patient through a secure web-based application. Specifically, PCPs can submit a patient question (usually for a patient who would otherwise have been referred) to a specialty service via a web-based portal. They can attach any additional information (e.g. photos, test results, Electronic Medical Record-generated letter). The case is assigned to a specialist, who receives an email notification prompting them to access the case via the secure site. Specialists are expected to provide an answer within one week. They can reply to the question, request additional information, or recommend a referral, and advise the PCP on other matters such as medication changes, additional tests, or other critical actions to be completed before the face-to-face specialty care appointment. PCPs ultimately decide how to apply the specialist's suggestion and when the case can be closed. Specialists are compensated on a pro-rated hourly basis. The communication between PCPs and specialists is iterative and the discussion can occur back and forth until, ultimately, the PCP closes the case. After undergoing registration, which included orientation and brief training on the use of the service, physicians randomized to the intervention group will receive access to eConsult right away (pending completion of an orientation session), while those randomized to the control group will use standard referral practices for one year after randomization and then will receive an option to use eConsult in the second year. The intervention period for the treatment group therefore will last one year following the enrollment/randomization period.The pre-randomization period will be 12 months in duration for both groups.
Sample size: With 50 physicians in each arm, assuming an average of 800 patients per physician for a total of 80,000 patients seen, the investigators will achieve 80% power to detect an absolute reduction in referrals of 6 per 100 patients from a control arm referral rate of 31 per 100 patients, estimated from a previous study, using a two-sided significance level of 5% and assuming a between-provider coefficient of variation of 0.38.
Data sources: The following databases from the Institute for Clinical Evaluative Sciences (ICES, ices.on.ca) will be used to obtain physician and patient characteristics: Registered Persons Database, containing demographic data for all residents eligible for provincial health care; Ontario Health Insurance Program (OHIP) billing claims system capturing approximately 95% of physician services in Ontario; the Client Agency Program Enrolment Registry and Corporate Provider Database, for patient enrolment with individual primary care physicians; and the ICES Physician Database, containing physician demographic information, training, and practice setting. 2006 Statistics Canada Census data will be used to assign income quintile to patients based on their postal code. These datasets will be linked using unique encoded identifiers and analyzed at ICES. In addition, the Champlain BASE™ eConsult utilization data, which is routinely collected by the service, will be used to identify the physicians in each group (treatment and control) as well as the date of randomization which was used to identify the relevant 12 month long pre- and post-intervention periods for referral rates assessment.
Data Analysis: All analyses will estimate Intent to Treat (ITT) effects. Descriptive statistics will be generated to describe patient and physician characteristics at the time of randomization for the two groups: eConsult and control. The primary outcome, referral rate per 100 patients seen to all medical specialties available via eConsult service, will be analyzed using a repeated measures multivariable random effects negative binomial regression model. The unit of analysis will be the provider.To account for underlying secular/time trends in the rate of referrals over the study period, the effect of the intervention will be expressed as the between-arm difference in the change in referral rates from the pre- to post-intervention periods (both 12 months in duration).
- Conditions
- Health Services Research
- Being tested
- Champlain BASE eConsult Service
- Keywords
- eConsultation, Specialist care, Primary health care, Reducing wait times for specialist care, Reducing referral rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Champlain BASE eConsult ServiceOther
Also called A secure Microsoft SharePoint network
After undergoing registration, which includes orientation and brief training on the use of the service, physicians randomized to intervention arm will be able to submit patient-specific clinical questions to specialists through a secure, web-based application. Specialists are asked to respond within 7 days and, for each eConsult, are able to: (1) provide a recommendation, (2) request more information, or (3) recommend a face-to-face referral. The communication between PCPs and specialists is iterative and the discussion can occur back and forth until, ultimately, the PCP closes the case.
| Study group | Role | What they receive |
|---|---|---|
| eConsult | Experimental | Physicians randomized to the intervention will have access to the Champlain BASE eConsult service right away (pending completion of an orientation session) Receives: Other: Champlain BASE eConsult Service |
| Control | No intervention | Physicians randomized to the control group will use their standard referral practices for one year after randomization and only then will be given the option to use eConsult. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specialist referral rate per 100 patients seen (to medical specialties available through eConsult)
Specialist referral rate defined as the total number of referrals to all medical specialties available through eConsult service during the study period per 100 unique patients (not encounters) seen. The denominator "patients seen" included patients who were seen at least once during the assessment period (baseline or post-intervention).
Measured: 24 months
Secondary outcomes (1)
Specialist referral rates per 100 patients seen (to all medical specialties)
Specialist referral rate defined as the total number of referrals to all medical specialties per 100 unique patients (not encounters) seen. The denominator "patients seen" included patients who were seen at least once during the assessment period (baseline or post-intervention).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health Services ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, The Ottawa Hospital, Ontario Medical Association, Champlain Local Health Integration Network
- Responsible party
- Sponsor
- Investigators
- Clare Liddy, MD, Principal investigator, Bruyere Research Institute, C. T. Lamont Primary Health Care Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053467
- Sponsor's protocol ID
- 20130674-01H
- Acronym
- eConsult
- Status last verified
- Feb 2017
- First submitted
- 30 Jan 2014
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liddy C, Maranger J, Afkham A, Keely E. Ten steps to establishing an e-consultation service to improve access to specialist care. Telemed J E Health. 2013 Dec;19(12):982-90. doi: 10.1089/tmj.2013.0056. Epub 2013 Sep 27.
PubMed 24073898Keely E, Liddy C, Afkham A. Utilization, benefits, and impact of an e-consultation service across diverse specialties and primary care providers. Telemed J E Health. 2013 Oct;19(10):733-8. doi: 10.1089/tmj.2013.0007. Epub 2013 Aug 27.
PubMed 23980939Liddy C, Rowan MS, Afkham A, Maranger J, Keely E. Building access to specialist care through e-consultation. Open Med. 2013 Jan 8;7(1):e1-8. Print 2013.
PubMed 23687533Liddy C, Moroz I, Keely E, Taljaard M, Deri Armstrong C, Afkham A, Kendall CE. Understanding the impact of a multispecialty electronic consultation service on family physician referral rates to specialists: a randomized controlled trial using health administrative data. Trials. 2019 Jun 10;20(1):348. doi: 10.1186/s13063-019-3393-5.
PubMed 31182123
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity for Specialized Services Through eConsultation
- ClinicalTrials.gov ID
- NCT02053467
- Acronym / sponsor ID
- eConsult / 20130674-01H
- Conditions
- Health Services Research
- Keywords
- eConsultation, Specialist care, Primary health care, Reducing wait times for specialist care, Reducing referral rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, The Ottawa Hospital, Ontario Medical Association, Champlain Local Health Integration Network
- Study start
- 1 Jan 2014
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The consultation-referral process is complex, involving several steps including 1) the PCP recognizing the need for specialist advice/intervention, 2) patient agreement on seeing the specialist, 3) referral letter and information sent to specialist, 4) appointment booked and communicated, 5) patient visit(s) with the specialist and 6) communication back to the PCP.
There are many factors during this process which limit the effectiveness and efficiency of patient care. These include inequitable access for patients and providers, long wait times before specialist advice received/implemented, delayed communication and mismatched consult expectations. These gaps result in significant breakdowns in transitions of care, inappropriate treatment, patient dissatisfaction and potential harm. Moreover, not all individuals are willing or able to travel to see specialists in a large academic medical centre even when recommended by the PCP.
Electronic consultation (eConsult) service is a form of asynchronous communication whereby primary care providers (PCP) and specialists can communicate directly about a patient through a secure web-based application. eConsult has the potential for improving transitions in care through improved communication ensuring that patients are seen by the right specialist, when necessary, with the right information and in a timely manner. The goal of this project is to evaluate the impact of eConsult on specialist referral rates using health administrative data.
Detailed description
Research Question: What is the impact of an electronic consultation (eConsult) service on referral rates from primary care doctors to specialists?
The objective of this study is to assess the impact of eConsult service on referral rates using a randomized controlled trial (RCT) of eConsult versus usual referral practices. We hypothesized that access to eConsult would lead to a decrease in referral requests for face-to-face specialist visits from primary care providers in the intervention group.
Trial Design: This study is a parallel arm RCT that recruited family physicians in Ontario to use the Champlain BASE™ eConsult service. Physicians will be randomized 1:1 to either the intervention or control arm between January 31, 2014 and September 26, 2014. Although originally intended as a stepped wedge RCT, the design was changed to a parallel arm before and after RCT due to the fact that randomization could not be performed at a discrete time point for all participants.
Intervention: In 2009 our team began developing, implementing, and evaluating an innovative eHealth solution called the Champlain BASE™ (Building Access to Specialists through eConsultation) eConsult service. eConsult is a form of asynchronous communication whereby primary care providers (PCP) and specialists can communicate directly about a patient through a secure web-based application. Specifically, PCPs can submit a patient question (usually for a patient who would otherwise have been referred) to a specialty service via a web-based portal. They can attach any additional information (e.g. photos, test results, Electronic Medical Record-generated letter). The case is assigned to a specialist, who receives an email notification prompting them to access the case via the secure site. Specialists are expected to provide an answer within one week. They can reply to the question, request additional information, or recommend a referral, and advise the PCP on other matters such as medication changes, additional tests, or other critical actions to be completed before the face-to-face specialty care appointment. PCPs ultimately decide how to apply the specialist's suggestion and when the case can be closed. Specialists are compensated on a pro-rated hourly basis. The communication between PCPs and specialists is iterative and the discussion can occur back and forth until, ultimately, the PCP closes the case. After undergoing registration, which included orientation and brief training on the use of the service, physicians randomized to the intervention group will receive access to eConsult right away (pending completion of an orientation session), while those randomized to the control group will use standard referral practices for one year after randomization and then will receive an option to use eConsult in the second year. The intervention period for the treatment group therefore will last one year following the enrollment/randomization period.The pre-randomization period will be 12 months in duration for both groups.
Sample size: With 50 physicians in each arm, assuming an average of 800 patients per physician for a total of 80,000 patients seen, the investigators will achieve 80% power to detect an absolute reduction in referrals of 6 per 100 patients from a control arm referral rate of 31 per 100 patients, estimated from a previous study, using a two-sided significance level of 5% and assuming a between-provider coefficient of variation of 0.38.
Data sources: The following databases from the Institute for Clinical Evaluative Sciences (ICES, ices.on.ca) will be used to obtain physician and patient characteristics: Registered Persons Database, containing demographic data for all residents eligible for provincial health care; Ontario Health Insurance Program (OHIP) billing claims system capturing approximately 95% of physician services in Ontario; the Client Agency Program Enrolment Registry and Corporate Provider Database, for patient enrolment with individual primary care physicians; and the ICES Physician Database, containing physician demographic information, training, and practice setting. 2006 Statistics Canada Census data will be used to assign income quintile to patients based on their postal code. These datasets will be linked using unique encoded identifiers and analyzed at ICES. In addition, the Champlain BASE™ eConsult utilization data, which is routinely collected by the service, will be used to identify the physicians in each group (treatment and control) as well as the date of randomization which was used to identify the relevant 12 month long pre- and post-intervention periods for referral rates assessment.
Data Analysis: All analyses will estimate Intent to Treat (ITT) effects. Descriptive statistics will be generated to describe patient and physician characteristics at the time of randomization for the two groups: eConsult and control. The primary outcome, referral rate per 100 patients seen to all medical specialties available via eConsult service, will be analyzed using a repeated measures multivariable random effects negative binomial regression model. The unit of analysis will be the provider.To account for underlying secular/time trends in the rate of referrals over the study period, the effect of the intervention will be expressed as the between-arm difference in the change in referral rates from the pre- to post-intervention periods (both 12 months in duration).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eConsult | Experimental | Other: Champlain BASE eConsult ServicePhysicians randomized to the intervention will have access to the Champlain BASE eConsult service right away (pending completion of an orientation session) |
| Control | No intervention | –Physicians randomized to the control group will use their standard referral practices for one year after randomization and only then will be given the option to use eConsult. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any practicing primary care provider (PCP) in Ontario who is not currently registered to use the Champlain BASE eConsult service may be recruited to participate in the research study, beginning with the Champlain and South East Local Health Integration Networks.
Key exclusion criteria (1 listed)
- Those not meeting the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Champlain BASE eConsult ServiceAlso: A secure Microsoft SharePoint networkAfter undergoing registration, which includes orientation and brief training on the use of the service, physicians randomized to intervention arm will be able to submit patient-specific clinical questions to specialists through a secure, web-based application. Specialists are asked to respond within 7 days and, for each eConsult, are able to: (1) provide a recommendation, (2) request more information, or (3) recommend a face-to-face referral. The communication between PCPs and specialists is iterative and the discussion can occur back and forth until, ultimately, the PCP closes the case. | Other | eConsult |
Primary outcome
Specialist referral rate per 100 patients seen (to medical specialties available through eConsult)
Time frame: 24 months
Specialist referral rate defined as the total number of referrals to all medical specialties available through eConsult service during the study period per 100 unique patients (not encounters) seen. The denominator "patients seen" included patients who were seen at least once during the assessment period (baseline or post-intervention).
1 secondary outcome
Specialist referral rates per 100 patients seen (to all medical specialties)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Background: PubMed 24073898Liddy C, Maranger J, Afkham A, Keely E. Ten steps to establishing an e-consultation service to improve access to specialist care. Telemed J E Health. 2013 Dec;19(12):982-90. doi: 10.1089/tmj.2013.0056. Epub 2013 Sep 27.
- Background: PubMed 23980939Keely E, Liddy C, Afkham A. Utilization, benefits, and impact of an e-consultation service across diverse specialties and primary care providers. Telemed J E Health. 2013 Oct;19(10):733-8. doi: 10.1089/tmj.2013.0007. Epub 2013 Aug 27.
- Background: PubMed 23687533Liddy C, Rowan MS, Afkham A, Maranger J, Keely E. Building access to specialist care through e-consultation. Open Med. 2013 Jan 8;7(1):e1-8. Print 2013.
- Derived from this study: PubMed 31182123Liddy C, Moroz I, Keely E, Taljaard M, Deri Armstrong C, Afkham A, Kendall CE. Understanding the impact of a multispecialty electronic consultation service on family physician referral rates to specialists: a randomized controlled trial using health administrative data. Trials. 2019 Jun 10;20(1):348. doi: 10.1186/s13063-019-3393-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Liddy, MD principal investigator
Bruyere Research Institute, C. T. Lamont Primary Health Care Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Champlain BASE eConsult Service in people with Health Services Research, run by Bruyère Health Research Institute. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specialist referral rate per 100 patients seen (to medical specialties available through eConsult) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053467, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.