- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684836
Comparative Effectiveness of Telemedicine in Primary Care
Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning From the COVID-19 Pandemic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During the COVID-19 pandemic, telemedicine has quickly emerged as the primary method of providing outpatient care in many regions with shelter-in-place and social distancing policies. It is critical to understand the impact of this rapid and widespread transition from in-person to remote visits on disparities in access to primary care, especially in chronic disease where ongoing communication between providers and patients is essential. Also, these newly developed or expanded telemedicine programs vary widely, raising important questions about the effect of these differences on uptake of telemedicine among different patient populations and on patient-centered outcomes. Leveraging a natural experiment approach, the investigators will examine rapidly changing telemedicine and in-person models of care during and after the COVID-19 crisis to determine whether certain patients could safely choose to continue telemedicine or telemedicine-supplemented care, rather than return to in-person care. The overarching goals of this study are to describe the features of telemedicine programs in primary care during the COVID-19 pandemic and to use natural experiment methods to provide rigorous evidence on the effects of these programs.
PCORI has granted an extension for the final research report to July 30, 2023.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Jessica Ancker, MPH, PhD
- Phone Number: 646-248-9281
- Email: jessica.s.ancker@vumc.org
Study Contact Backup
- Name: Samuel Carter, MPH
- Email: sac7036@med.cornell.edu
Study Locations
-
-
New York
-
Gainesville, New York, United States, 32610
- University of Florida
-
New York, New York, United States, 10065
- Weill Cornell Medicine
-
New York, New York, United States, 10029
- Mount Sinai
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients that are attributed to primary care clinics across four health systems in the INSIGHT (Mount Sinai Health System and Weill Cornell Medicine), OneFlorida (University of Florida Health), and STAR (University of North Carolina Health) CRNs.
- Patients received two or more outpatient visits at a participating practice during a one-year period before the COVID-19 pandemic,
- Patients had one or more of five chronic illnesses (asthma, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), diabetes, hypertension) as defined by the Medicare Chronic Conditions Warehouse algorithm
Exclusion Criteria:
- Patients who tested COVID-positive
- Patients from hospice and palliative care practices
- Patients from osteopathic medicine practices
- Patients from pediatric practices
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Synchronous telemedicine alone
|
Telemedicine exposure will be defined based on the proportion of all visits at a given clinic that are delivered via telemedicine in each month.
|
Telemedicine-supplemented in-person care
|
Telemedicine exposure will be defined based on the proportion of all visits at a given clinic that are delivered via telemedicine in each month.
|
In-person care alone
|
Telemedicine exposure will be defined based on the proportion of all visits at a given clinic that are delivered via telemedicine in each month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of avoidable emergency department (ED) admissions
Time Frame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Avoidable emergency department (ED) admissions will be obtained from claims data
|
30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Number of avoidable emergency department (ED) admissions
Time Frame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Avoidable emergency department (ED) admissions will be obtained from claims data
|
60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Number of avoidable emergency department (ED) admissions
Time Frame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Avoidable emergency department (ED) admissions will be obtained from claims data
|
6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Number of avoidable emergency department (ED) admissions
Time Frame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Avoidable emergency department (ED) admissions will be obtained from claims data
|
12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Number of unplanned hospital admissions from the ED
Time Frame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Unplanned hospital admissions from the ED will be obtained from claims data
|
30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Number of unplanned hospital admissions from the ED
Time Frame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Unplanned hospital admissions from the ED will be obtained from claims data
|
60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Number of unplanned hospital admissions from the ED
Time Frame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Unplanned hospital admissions from the ED will be obtained from claims data
|
6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Number of unplanned hospital admissions from the ED
Time Frame: 12 months the comparator arms of clinic-level telemedicine used
|
Unplanned hospital admissions from the ED will be obtained from claims data
|
12 months the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Bice-Boxerman Continuity of Care Index
Time Frame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care will be measured using the Bice-Boxerman Continuity of Care Index.
The Bice-Boxerman continuity of care (COC) index reflects the relative share of all of a patient's visits during the year that are billed by distinct providers and/or practices.
The index ranges from 0 to 1, where 0 indicates that each visit involved a different provider than all other visits, and 1 that all visits were billed by a single provider, representing continuity of care.
|
30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Bice-Boxerman Continuity of Care Index
Time Frame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care will be measured using the Bice-Boxerman Continuity of Care Index.
The Bice-Boxerman continuity of care (COC) index reflects the relative share of all of a patient's visits during the year that are billed by distinct providers and/or practices.
The index ranges from 0 to 1, where 0 indicates that each visit involved a different provider than all other visits, and 1 that all visits were billed by a single provider, representing continuity of care.
|
60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Bice-Boxerman Continuity of Care Index
Time Frame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care will be measured using the Bice-Boxerman Continuity of Care Index.
The Bice-Boxerman continuity of care (COC) index reflects the relative share of all of a patient's visits during the year that are billed by distinct providers and/or practices.
The index ranges from 0 to 1, where 0 indicates that each visit involved a different provider than all other visits, and 1 that all visits were billed by a single provider, representing continuity of care.
|
6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Bice-Boxerman Continuity of Care Index
Time Frame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care will be measured using the Bice-Boxerman Continuity of Care Index.
The Bice-Boxerman continuity of care (COC) index reflects the relative share of all of a patient's visits during the year that are billed by distinct providers and/or practices.
The index ranges from 0 to 1, where 0 indicates that each visit involved a different provider than all other visits, and 1 that all visits were billed by a single provider, representing continuity of care.
|
12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Breslau Usual Provider of Care measure
Time Frame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Breslau Usual Provider of Care measure.
The Breslau Usual Provider of Care index is also an indicator of continuity of care, ranging from 0 to 1, where 1 represents continuity of care.
|
30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Breslau Usual Provider of Care measure
Time Frame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Breslau Usual Provider of Care measure.
The Breslau Usual Provider of Care index is also an indicator of continuity of care, ranging from 0 to 1, where 1 represents continuity of care.
|
60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Breslau Usual Provider of Care measure
Time Frame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Breslau Usual Provider of Care measure.
The Breslau Usual Provider of Care index is also an indicator of continuity of care, ranging from 0 to 1, where 1 represents continuity of care.
|
6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Breslau Usual Provider of Care measure
Time Frame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by the Breslau Usual Provider of Care measure.
The Breslau Usual Provider of Care index is also an indicator of continuity of care, ranging from 0 to 1, where 1 represents continuity of care.
|
12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by attendance at follow-up appointment
Time Frame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by attendance at follow-up appointment.
|
30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by attendance at follow-up appointment
Time Frame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by attendance at follow-up appointment.
|
60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by attendance at follow-up appointment
Time Frame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by attendance at follow-up appointment.
|
6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by attendance at follow-up appointment
Time Frame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Continuity of care as assessed by attendance at follow-up appointment.
|
12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)
Time Frame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%), which is the percentage of patients 18 - 75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period
|
30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)
Time Frame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%), which is the percentage of patients 18 - 75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period
|
60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)
Time Frame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%), which is the percentage of patients 18 - 75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period
|
6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)
Time Frame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%), which is the percentage of patients 18 - 75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period
|
12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure
Time Frame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure, which is the percentage of patients 18 - 85 with hypertension diagnosis and adequate control (< 140/90 mmHg)
|
30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure
Time Frame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure, which is the percentage of patients 18 - 85 with hypertension diagnosis and adequate control (< 140/90 mmHg)
|
60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure
Time Frame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure, which is the percentage of patients 18 - 85 with hypertension diagnosis and adequate control (< 140/90 mmHg)
|
6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure
Time Frame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure, which is the percentage of patients 18 - 85 with hypertension diagnosis and adequate control (< 140/90 mmHg)
|
12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Days at home
Time Frame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Days per month not in hospital or institutional setting
|
30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Days at home
Time Frame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Days per month not in hospital or institutional setting
|
60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Days at home
Time Frame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Days per month not in hospital or institutional setting
|
6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Days at home
Time Frame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Days per month not in hospital or institutional setting
|
12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Patient experiences based on the Patient Satisfaction Questionnaire (PSQ-18)
Time Frame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Patient experiences based on the Patient Satisfaction Questionnaire (PSQ-18), which is a 5-scale questionnaire including questions on patient satisfaction, communication quality with providers and accessibility/convenience of care.
|
12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Ease of use and access to telemedicine based on Telehealth Usability Questionnaire (TUQ)
Time Frame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
For individuals who accessed a telemedicine visit, we will ask questions based on the validated Telehealth Usability Questionnaire (TUQ), including the ease of use and access to the telemedicine service, quality of the interaction with the provider, and satisfaction
|
12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jessica Ancker, MPH, PhD, Vanderbilt University Medical Center
- Principal Investigator: Rainu Kaushal, MD, MPH, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-12023014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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