- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02527915
Mental Health eConsults
The Effects of Mental Health eConsults: A Clinic-level Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study assesses the effects of electronic consultations (eConsults) between primary care providers and psychiatrists as a way to support the delivery of mental health services in primary care settings. The setting for the study are the primary care clinics of Allina Health.
The study uses a randomized rollout design. Across 45 primary care clinics, half of the clinics will be randomly assigned to receive access to eConsults at the start of the study. The other half of the clinics will provide care-as-usual for nine months, at which point they will also gain access to eConsults. Stratified randomization will be used, with stratification on whether primary care clinics have co-located specialty mental health services.
For primary care clinics that are given access to eConsults, the primary care providers in those clinics will have the option of ordering an eConsult on behalf of their patients, which will include specific questions about a particular patient's care. The request is routed to the service region's psychiatry pool, and the psychiatrists have the option of responding. If they choose to respond, the psychiatrist responds with their recommendations within one business day, and the PCP proceeds with care accordingly. The psychiatrist receives 0.75 work relative value units (wRVUs) for providing this service. All communications for the eConsult are routed through Allina's Epic system. Although patients will not be billed for eConsults over the course of the proposed research, some insurance plans do cover it and evidence of eConsult effectiveness may impel other insurers to cover the service.
The study will have two components. First, the investigators will collect web survey data from the primary care providers to assess how access to eConsults affects providers' perceptions of their support and skill for delivering mental health services to their patients. Second, the investigators will assess the effects of receiving eConsults at the patient level, by using data from the Electronic Medical Record system.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Allina Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- For the provider surveys, we will recruit all of the primary care providers who work in Allina's primary care clinics to participate in the surveys
- For the patient-level analysis, we will examine data from all patients seen in Allina's primary care clinics during the study period. We will include children and adults.
Exclusion Criteria:
- We will exclude patients from the patient-level analysis who have opted that their secondary data not be used by Allina for research purposes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mental Health eConsults
Primary care clinics that will receive the eConsults intervention at the start of the study.
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Providers in primary care clinics who receive the intervention will be able to use electronic consultations (eConsults) with psychiatrists.
If a primary care provider wishes to use eConsults, he/she will enter a specific question about a patient in the electronic medical record system and submit as an eConsult.
A psychiatrist will review the question and the patient's record, and send a response back to the primary care provider within one business day.
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Active Comparator: Usual care
Primary care clinics that will deliver care as usual for nine months, and will receive the eConsults intervention nine months subsequent to the eConsults "intervention" clinics.
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Providers in primary care clinics will deliver care as usual to their patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of eConsults
Time Frame: Within one day of a primary care clinic visit
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Whether an eConsult was actually ordered in a primary care visit for a mental health issue.
Data will be extracted from the electronic medical record system.
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Within one day of a primary care clinic visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of specialist consultation
Time Frame: Baseline and 6 months
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Primary care providers report how often in the past 6 months they consult with a mental health specialist for help with a patient's mental health issues at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and 6 months
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How easy to consult with specialist
Time Frame: Baseline and 6 months
|
Primary care providers report how easy it is in the past 6 months to consult with a mental health specialist for help with a patient's mental health issues at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and 6 months
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Patient contact with a specialist, 1 month
Time Frame: 1-month
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Whether patients see a mental health specialist within a month after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Patient contact with a specialist, 3 months
Time Frame: 3-month
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Whether patients see a mental health specialist within 3 months after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Patient contact with a specialist, 6 months
Time Frame: 6-month
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Whether patients see a mental health specialist within 6 months after a primary care visit.
Data will be extracted from the electronic medical record system.
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6-month
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Change in depression symptoms
Time Frame: Baseline office visit to followup within 6 months
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Depressive symptoms, as measured by the PHQ-9 at the office visit and again at a routine PHQ9 measurement within six months.
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Baseline office visit to followup within 6 months
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Total cost of care, 1 month
Time Frame: 1-month
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Total health care spending one month after a primary care visit (including the primary care visit).
Data will be extracted from the electronic medical record system.
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1-month
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Total cost of care, 3 month
Time Frame: 3-month
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Total health care spending three months after a primary care visit (including the primary care visit).
Data will be extracted from the electronic medical record system.
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3-month
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Total cost of care, 6 month
Time Frame: 6-month
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Total health care spending six months after a primary care visit (including the primary care visit).
Data will be extracted from the electronic medical record system.
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6-month
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Providers get needed support for mental health care
Time Frame: Baseline and 6 months
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Providers indicate agreement with whether they have adequate support for delivering five aspects of mental health care at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and 6 months
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Any mental health service use, 2 week
Time Frame: 2-week
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Whether any mental health services (medication, counseling) were used after a primary care visit.
Data will be extracted from the electronic medical record system.
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2-week
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Any mental health service use, 1 month
Time Frame: 1-month
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Whether any mental health services (medication, counseling) were used after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Any mental health service use, 3-month
Time Frame: 3-month
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Whether any mental health services (medication, counseling) were used after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Any mental health service use, 6 month
Time Frame: 6-months
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Whether any mental health services (medication, counseling) were used after a primary care visit.
Data will be extracted from the electronic medical record system.
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6-months
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Provider-perceived patient access
Time Frame: Baseline and six months
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Providers' perceptions of how quickly their patients are able to access needed specialty mental health services at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and six months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency department use, 1 month
Time Frame: 1-month
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Whether there was any emergency department use in the months after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Emergency department use, 3 months
Time Frame: 3-month
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Whether there was any emergency department use in the three months after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Psychotropic medication use, 1 month
Time Frame: 1-month
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Whether there was any psychotropic drug prescription and use in the month after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Psychotropic medication use, 3 month
Time Frame: 3-month
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Whether there was any psychotropic drug prescription and use in the three months after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Inpatient use, 1 month
Time Frame: 1-month
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Whether there was any emergency department use in the month after a primary care visit.
Data will be extracted from the electronic medical record system.
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1-month
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Inpatient use, 3 month
Time Frame: 3-month
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Whether there was any emergency department use in the three months after a primary care visit.
Data will be extracted from the electronic medical record system.
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3-month
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Confidence in depression treatment
Time Frame: Baseline and six months
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Providers are asked about their levels of confidence in five aspects of depression treatment at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and six months
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Skill in depression treatment
Time Frame: Baseline and six months
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Providers are asked to assess their skill in four aspects of depression treatment at the baseline web survey questionnaire and the 6-month followup survey.
Survey data will be collected from up to 400 primary care providers.
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Baseline and six months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ezra Golberstein, Ph.D., University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1507S76668
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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