Cardiovascular DiseasesNCT02376855
A Study of the Implementation of an Electronic Consultation ("eConsult") Platform
A study testing eConsult in people with Cardiovascular Diseases, run by Community Health Center, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the implementation of an electronic consultation model for specialty services (eConsults) to improve quality of care and reduce health system costs. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- eConsult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2013
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary Care Provider at Community Health Center, Inc who work at least 30 hours per week and see adult patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Health Center, Inc
Middletown, Connecticut, 06457
About this study
Official title: A Study of the Implementation of an Electronic Consultation ("eConsult") Platform to Increase Specialist Access for Patients in Underserved Populations: Impact on Provider Experience, Wait Times and Cost
The purpose of this study is to evaluate the implementation of an electronic consultation model for specialty services (eConsults) to improve quality of care and reduce health system costs. An eConsult is a non-face-to-face consultation between a primary care provider and a specialist that takes place via secure messaging.
Read the detailed description
The study is a randomized, controlled trial where the intervention is the evidence-based eConsult model in which consults are submitted by electronic, secure messaging to a specialist for review and "virtual" consultation. Primary Care Providers will be randomized to the control or intervention group. In the intervention group, ALL new, non urgent, adult cardiology referrals will be submitted to the eConsult Cardiology team for an eConsult. Consults for children (age <18) and consults for patients who already have an established relationship with another cardiologist will not be eligible for an eConsult. Urgent consults, such as those for patients with active chest pain or other acute conditions, will not be submitted for eConsult and should instead be handled by the on-site care team as per the standard protocol. For eConsults, the consult will be submitted using the eConsult pathway within the electronic health record. eConsults will be created in the same way that standard referrals are created, with attachment of a treatment summary, EKG, relevant results, and specification of the consultative question. The eConsult will be received by the intervention Cardiology team and reviewed within 2 business days. One cardiologist per day will be assigned to review and respond to eConsults.
The result will be received by the primary care provider who will be responsible for acting appropriately on the cardiologist's recommendations. Recommendations will be case specific and may include one of three broad areas of suggestion: 1) suggestions for ongoing management by the primary care provider, 2) suggestions for additional testing in advance of a cardiology face to face appointment or to better determine a next course of action, and 3) immediate cardiology referral.
For each of these options, the primary care provider will be responsible for following up and implementing the recommendations made by the Cardiologist. When referral is recommended the primary care provider will refer the patient to the cardiologist of their choice based on their location and the patient's preference. While not required, they may refer the patient to the eConsult cardiology team at University of Connecticut for face to face care if desirable, but may also refer to other Cardiologists. The intervention will last one year. Providers randomized to the control group will provide standard care which involves a traditional referral for an in-person cardiology visit.
- Conditions
- Cardiovascular Diseases
- Being tested
- eConsult
- Keywords
- Health Services Accessibility
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eConsultOther
An electronic consultation or "eConsult" is a secure message consult that allows specialists to provide advice on cases without seeing a patient face to face. They contain a reason for consult, any relevant tests, procedures or reports. The responsibility lies with the primary care provider to act, or not act on the advice as they deem fit.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Providers in the Control group followed standard care protocols. If they deemed a patient was in need of cardiology consultation, a referral was created using the standard process. The referral was processed by a referral coordinator and transmitted to an appropriate cardiologist. An appointment was then scheduled for the patient to have an in-person consultation with a cardiologist. |
| eConsult | Experimental | The intervention consisted of an eConsult pathway and standardized protocol for PCPs to obtain cardiology consults using a secure messaging "peer to peer" (P2P) module embedded within the EHR. Intervention providers were asked to send all cardiology referrals for their adult patients through the eConsult system. Providers could bypass the eConsult pathway for patients with established relationships with a cardiologist or for whom providers felt a consult was urgent (required a face-to-face visit within a week or less). eConsults contain reason for consult, relevant test results, records or reports but are sent electronically to a Cardiology Consultant for review. eConsults were responded to within two business days. Responses were case-specific and generally contained recommendations for management, additional testing, or a face-to-face cardiology visit. The PCP was responsible for considering/acting upon recommendations and determining when an eConsult was complete. Receives: Other: eConsult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first contact with a cardiologist
For eConsults, time to first contact is the time between the generation of the eConsults and when the Cardiologist replies to the eConsults. For traditional referrals, first contact is the time between the creation of the appointment and the in-person Cardiology visi.
Measured: 18 months
Secondary outcomes (6)
Completion of referrals
The percent of referrals in each group that reached completion
Measured: 18 months
Adverse events
Adverse cardiology events, including MI, following cardiology eConsult or referral
Measured: 18 months
Hospital and Emergency Department Utilization
Use of the hospital or Emergency Department for a cardiology complaint following an eConsult or referral
Measured: 18 months
Provider Satisfaction (survey)
A survey was administered to participants to measure their satisfaction with eConsults and/or the current referral process
Measured: Baseline, 6 months, 12 months
Number of in-person cardiology visits
The number of traditional, control referrals and eConsults that resulted in an in-person consultation with a cardiologist.
Measured: 18 months
Total Cost Per Patient
Clinical costs per patient in control and intervention group from claims data
Measured: 6 months pre and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Health Center, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Connecticut Health Foundation, University of Connecticut, UConn Health
- Responsible party
- Sponsor
- Investigators
- J. Nwando Olayiwola, MD, MPH, Principal investigator, Center for Excellence in Primary Care, University of California, San FranciscoDaren Anderson, MD, Principal investigator, Weitzman Institute, Community Health Center, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376855
- Sponsor's protocol ID
- 1023
- Status last verified
- Feb 2015
- First submitted
- 26 Feb 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen AH, Yee HF Jr. Improving primary care-specialty care communication: lessons from San Francisco's safety net: comment on "Referral and consultation communication between primary care and specialist physicians". Arch Intern Med. 2011 Jan 10;171(1):65-7. doi: 10.1001/archinternmed.2010.484. No abstract available.
PubMed 21220663Yee HF Jr. The patient-centered medical home neighbor: A subspecialty physician's view. Ann Intern Med. 2011 Jan 4;154(1):63-4. doi: 10.7326/0003-4819-154-1-201101040-00011.
PubMed 21200042Chen AH, Kushel MB, Grumbach K, Yee HF Jr. Practice profile. A safety-net system gains efficiencies through 'eReferrals' to specialists. Health Aff (Millwood). 2010 May;29(5):969-71. doi: 10.1377/hlthaff.2010.0027. No abstract available.
PubMed 20439891Foy R, Hempel S, Rubenstein L, Suttorp M, Seelig M, Shanman R, Shekelle PG. Meta-analysis: effect of interactive communication between collaborating primary care physicians and specialists. Ann Intern Med. 2010 Feb 16;152(4):247-58. doi: 10.7326/0003-4819-152-4-201002160-00010.
PubMed 20157139Kim Y, Chen AH, Keith E, Yee HF Jr, Kushel MB. Not perfect, but better: primary care providers' experiences with electronic referrals in a safety net health system. J Gen Intern Med. 2009 May;24(5):614-9. doi: 10.1007/s11606-009-0955-3. Epub 2009 Mar 24.
PubMed 19308334Kim-Hwang JE, Chen AH, Bell DS, Guzman D, Yee HF Jr, Kushel MB. Evaluating electronic referrals for specialty care at a public hospital. J Gen Intern Med. 2010 Oct;25(10):1123-8. doi: 10.1007/s11606-010-1402-1. Epub 2010 May 29.
PubMed 20512531Katz MH. Golden gate to health care for all? San Francisco's new universal-access program. N Engl J Med. 2008 Jan 24;358(4):327-9. doi: 10.1056/NEJMp0706590. No abstract available.
PubMed 18216352Bindman AB, Chen A, Fraser JS, Yee HF Jr, Ofman D. Healthcare reform with a safety net: lessons from San Francisco. Am J Manag Care. 2009 Oct;15(10):747-50.
PubMed 19845426Weiner M, El Hoyek G, Wang L, Dexter PR, Zerr AD, Perkins AJ, James F, Juneja R. A web-based generalist-specialist system to improve scheduling of outpatient specialty consultations in an academic center. J Gen Intern Med. 2009 Jun;24(6):710-5. doi: 10.1007/s11606-009-0971-3. Epub 2009 Apr 15.
PubMed 19367375Fischer BS, Martinez E, Driscoll M, Conway T. Practice profile. Chicago: using evidence-based rules to make smarter referrals. Health Aff (Millwood). 2010 May;29(5):972-5. doi: 10.1377/hlthaff.2010.0068. No abstract available.
PubMed 20439892
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Implementation of an Electronic Consultation ("eConsult") Platform to Increase Specialist Access for Patients in Underserved Populations: Impact on Provider Experience, Wait Times and Cost
- ClinicalTrials.gov ID
- NCT02376855
- Acronym / sponsor ID
- 1023
- Conditions
- Cardiovascular Diseases
- Keywords
- Health Services Accessibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Community Health Center, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Connecticut Health Foundation, University of Connecticut, UConn Health
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Mar 2015 (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 purpose of this study is to evaluate the implementation of an electronic consultation model for specialty services (eConsults) to improve quality of care and reduce health system costs. An eConsult is a non-face-to-face consultation between a primary care provider and a specialist that takes place via secure messaging.
Detailed description
The study is a randomized, controlled trial where the intervention is the evidence-based eConsult model in which consults are submitted by electronic, secure messaging to a specialist for review and "virtual" consultation. Primary Care Providers will be randomized to the control or intervention group. In the intervention group, ALL new, non urgent, adult cardiology referrals will be submitted to the eConsult Cardiology team for an eConsult. Consults for children (age <18) and consults for patients who already have an established relationship with another cardiologist will not be eligible for an eConsult. Urgent consults, such as those for patients with active chest pain or other acute conditions, will not be submitted for eConsult and should instead be handled by the on-site care team as per the standard protocol. For eConsults, the consult will be submitted using the eConsult pathway within the electronic health record. eConsults will be created in the same way that standard referrals are created, with attachment of a treatment summary, EKG, relevant results, and specification of the consultative question. The eConsult will be received by the intervention Cardiology team and reviewed within 2 business days. One cardiologist per day will be assigned to review and respond to eConsults.
The result will be received by the primary care provider who will be responsible for acting appropriately on the cardiologist's recommendations. Recommendations will be case specific and may include one of three broad areas of suggestion: 1) suggestions for ongoing management by the primary care provider, 2) suggestions for additional testing in advance of a cardiology face to face appointment or to better determine a next course of action, and 3) immediate cardiology referral.
For each of these options, the primary care provider will be responsible for following up and implementing the recommendations made by the Cardiologist. When referral is recommended the primary care provider will refer the patient to the cardiologist of their choice based on their location and the patient's preference. While not required, they may refer the patient to the eConsult cardiology team at University of Connecticut for face to face care if desirable, but may also refer to other Cardiologists. The intervention will last one year. Providers randomized to the control group will provide standard care which involves a traditional referral for an in-person cardiology visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Providers in the Control group followed standard care protocols. If they deemed a patient was in need of cardiology consultation, a referral was created using the standard process. The referral was processed by a referral coordinator and transmitted to an appropriate cardiologist. An appointment was then scheduled for the patient to have an in-person consultation with a cardiologist. |
| eConsult | Experimental | Other: eConsultThe intervention consisted of an eConsult pathway and standardized protocol for PCPs to obtain cardiology consults using a secure messaging "peer to peer" (P2P) module embedded within the EHR. Intervention providers were asked to send all cardiology referrals for their adult patients through the eConsult system. Providers could bypass the eConsult pathway for patients with established relationships with a cardiologist or for whom providers felt a consult was urgent (required a face-to-face visit within a week or less). eConsults contain reason for consult, relevant test results, records or reports but are sent electronically to a Cardiology Consultant for review. eConsults were responded to within two business days. Responses were case-specific and generally contained recommendations for management, additional testing, or a face-to-face cardiology visit. The PCP was responsible for considering/acting upon recommendations and determining when an eConsult was complete. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary Care Provider at Community Health Center, Inc who work at least 30 hours per week and see adult patients
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| eConsultAn electronic consultation or "eConsult" is a secure message consult that allows specialists to provide advice on cases without seeing a patient face to face. They contain a reason for consult, any relevant tests, procedures or reports. The responsibility lies with the primary care provider to act, or not act on the advice as they deem fit. | Other | eConsult |
Primary outcome
Time to first contact with a cardiologist
Time frame: 18 months
For eConsults, time to first contact is the time between the generation of the eConsults and when the Cardiologist replies to the eConsults. For traditional referrals, first contact is the time between the creation of the appointment and the in-person Cardiology visi.
6 secondary outcomes
Completion of referrals
Time frame: 18 months
Adverse events
Time frame: 18 months
Hospital and Emergency Department Utilization
Time frame: 18 months
Provider Satisfaction (survey)
Time frame: Baseline, 6 months, 12 months
Number of in-person cardiology visits
Time frame: 18 months
Total Cost Per Patient
Time frame: 6 months pre and 6 months post intervention
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 3 Mar 2015.
- Background: PubMed 21220663Chen AH, Yee HF Jr. Improving primary care-specialty care communication: lessons from San Francisco's safety net: comment on "Referral and consultation communication between primary care and specialist physicians". Arch Intern Med. 2011 Jan 10;171(1):65-7. doi: 10.1001/archinternmed.2010.484. No abstract available.
- Background: PubMed 21200042Yee HF Jr. The patient-centered medical home neighbor: A subspecialty physician's view. Ann Intern Med. 2011 Jan 4;154(1):63-4. doi: 10.7326/0003-4819-154-1-201101040-00011.
- Background: PubMed 20439891Chen AH, Kushel MB, Grumbach K, Yee HF Jr. Practice profile. A safety-net system gains efficiencies through 'eReferrals' to specialists. Health Aff (Millwood). 2010 May;29(5):969-71. doi: 10.1377/hlthaff.2010.0027. No abstract available.
- Background: PubMed 20157139Foy R, Hempel S, Rubenstein L, Suttorp M, Seelig M, Shanman R, Shekelle PG. Meta-analysis: effect of interactive communication between collaborating primary care physicians and specialists. Ann Intern Med. 2010 Feb 16;152(4):247-58. doi: 10.7326/0003-4819-152-4-201002160-00010.
- Background: PubMed 19308334Kim Y, Chen AH, Keith E, Yee HF Jr, Kushel MB. Not perfect, but better: primary care providers' experiences with electronic referrals in a safety net health system. J Gen Intern Med. 2009 May;24(5):614-9. doi: 10.1007/s11606-009-0955-3. Epub 2009 Mar 24.
- Background: PubMed 20512531Kim-Hwang JE, Chen AH, Bell DS, Guzman D, Yee HF Jr, Kushel MB. Evaluating electronic referrals for specialty care at a public hospital. J Gen Intern Med. 2010 Oct;25(10):1123-8. doi: 10.1007/s11606-010-1402-1. Epub 2010 May 29.
- Background: PubMed 18216352Katz MH. Golden gate to health care for all? San Francisco's new universal-access program. N Engl J Med. 2008 Jan 24;358(4):327-9. doi: 10.1056/NEJMp0706590. No abstract available.
- Background: PubMed 19845426Bindman AB, Chen A, Fraser JS, Yee HF Jr, Ofman D. Healthcare reform with a safety net: lessons from San Francisco. Am J Manag Care. 2009 Oct;15(10):747-50.
- Background: PubMed 19367375Weiner M, El Hoyek G, Wang L, Dexter PR, Zerr AD, Perkins AJ, James F, Juneja R. A web-based generalist-specialist system to improve scheduling of outpatient specialty consultations in an academic center. J Gen Intern Med. 2009 Jun;24(6):710-5. doi: 10.1007/s11606-009-0971-3. Epub 2009 Apr 15.
- Background: PubMed 20439892Fischer BS, Martinez E, Driscoll M, Conway T. Practice profile. Chicago: using evidence-based rules to make smarter referrals. Health Aff (Millwood). 2010 May;29(5):972-5. doi: 10.1377/hlthaff.2010.0068. No abstract available.
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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.
J. Nwando Olayiwola, MD, MPH principal investigator
Center for Excellence in Primary Care, University of California, San Francisco
Daren Anderson, MD principal investigator
Weitzman Institute, Community Health Center, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eConsult in people with Cardiovascular Diseases, run by Community Health Center, Inc. at 1 site in United States.
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 3 Mar 2015. 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 United States. 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?
Time to first contact with a cardiologist (time frame: 18 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 NCT02376855, which also lists 10 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 3 Mar 2015.