AsthmaNCT04684836
Comparative Effectiveness of Telemedicine in Primary Care
An observational study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure
- What is being tested?
- Exposure to telemedicine, after the onset of the pandemic
- How many people
- 33,100 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Mar 2021to 1 Apr 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- Adult, Older adult
Study population: The study population encompasses patients that are attributed to primary care clinics in one of the four health systems defined above. Patients are included in the study if they are ages 19 or older and received two or more outpatient visits at a participating practice during a one-year period before the COVID-19 pandemic, and 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. For the claims analyses, it will be required that patients are continuously enrolled over the entire study time period.
Who may be able to join
- 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
Who cannot join
- Patients who tested COVID-positive
- Patients from hospice and palliative care practices
- Patients from osteopathic medicine practices
- Patients from pediatric practices
- Patients that did not reside in states where the four health systems were located: the New York-Tri State Area (Connecticut, New York, and New Jersey), Florida, and North Carolina.
- Patients that moved out of state (or out of the New York-Tri State Area) or who died during the study period were also excluded.
- Patients who were not continuously enrolled over the entire study period (2019-2021).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Florida
Gainesville, New York, 32610
Mount Sinai
New York, New York, 10029
Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning From the COVID-19 Pandemic
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.
Read the 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 October 1, 2023.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure, Diabetes, Hypertension
- Being tested
- Exposure to telemedicine, after the onset of the pandemic
- Keywords
- telemedicine, primary care
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Heart Failure, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to telemedicine, after the onset of the pandemicOther
The exposure of interest was the switch to primary care telemedicine prompted by the COVID-19 epidemic
| Study group | Role | What they receive |
|---|---|---|
| High Telemedicine | Patients in practices that had high telemedicine use, based on the percent of visits the practice delivered via telemedicine from April 2020 to December 2021 (the study post-period) Receives: Other: Exposure to telemedicine, after the onset of the pandemic | |
| Low Telemedicine | Patients in practices that had some telemedicine use, based on the percent of visits the practice delivered via telemedicine from April 2020 to December 2021 (the study post-period) Receives: Other: Exposure to telemedicine, after the onset of the pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventable Emergency Department (ED) Admissions
Avoidable emergency department (ED) admissions will be obtained from claims data. The Effect of telemedicine on preventable emergency department admissions will be calculated using difference-in-differences methodology. The estimate coefficient of the difference-in-difference model will be reported.
Measured: Assessed per person per quarter for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
Unplanned Hospital Admissions From the ED
Unplanned hospital admissions from the ED will be obtained from claims data. The effect of telemedicine on unplanned hospital admissions will be calculated using difference-in-difference methodology. The estimate coefficient will be reported.
Measured: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
Continuity of Care as Assessed by the Breslau Usual Provider of Care Measure
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. The effect of telemedicine on continuity of care using the Breslau Usual Provider of Care measure will be calculated using difference-in-difference methodology. The estimate coefficient will be reported.
Measured: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
Number of Unplanned Hospital Admissions From the ED
Unplanned hospital admissions from the ED will be obtained from claims data
Measured: 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
Continuity of Care as Assessed by the Bice-Boxerman Continuity of Care Index. The Bice-Boxerman Continuity of Care Index is also an indicator of continuity of care, ranging from 0 to 1, where 1 represents continuity of care. The effect of telemedicine on continuity of care using the Bice-Boxerman Continuity of care index will be calculated using difference-in-difference methodology. The estimate coefficient will be reported.
Measured: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
Number of Unplanned Hospital Admissions From the ED
Unplanned hospital admissions from the ED will be obtained from claims data
Measured: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
Number of Unplanned Hospital Admissions From the ED
Unplanned hospital admissions from the ED will be obtained from claims data
Measured: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
Number of Avoidable Emergency Department (ED) Admissions
Avoidable emergency department (ED) admissions will be obtained from claims data
Measured: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
Number of Avoidable Emergency Department (ED) Admissions
Avoidable emergency department (ED) admissions will be obtained from claims data
Measured: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
Number of Avoidable Emergency Department (ED) Admissions
Avoidable emergency department (ED) admissions will be obtained from claims data
Measured: 12 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Continuity of care as assessed by attendance at follow-up appointment.
Measured: 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
Continuity of care as assessed by attendance at follow-up appointment.
Measured: 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
Continuity of care as assessed by attendance at follow-up appointment.
Measured: 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
Continuity of care as assessed by attendance at follow-up appointment.
Measured: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
Secondary outcomes (14)
Evidence of Controlled Disease as Indicated by as Indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)
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
Measured: 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%)
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
Measured: 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%)
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
Measured: 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%)
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
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
Days at Home
Days per month not in hospital or institutional setting
Measured: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
Days at Home
Days per month not in hospital or institutional setting
Measured: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
Days at Home
Days per month not in hospital or institutional setting
Measured: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
Days at Home
Days per month not in hospital or institutional setting
Measured: 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)
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.
Measured: 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)
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
Measured: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start15 Mar 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Jessica Ancker, MPH, PhD, Principal investigator, Vanderbilt University Medical CenterRainu Kaushal, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684836
- Sponsor's protocol ID
- 20-12023014
- Status last verified
- Apr 2024
- First submitted
- 21 Dec 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning From the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04684836
- Acronym / sponsor ID
- 20-12023014
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure, Diabetes, Hypertension
- Keywords
- telemedicine, primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33,100 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 October 1, 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Telemedicine | – | Other: Exposure to telemedicine, after the onset of the pandemicPatients in practices that had high telemedicine use, based on the percent of visits the practice delivered via telemedicine from April 2020 to December 2021 (the study post-period) |
| Low Telemedicine | – | Other: Exposure to telemedicine, after the onset of the pandemicPatients in practices that had some telemedicine use, based on the percent of visits the practice delivered via telemedicine from April 2020 to December 2021 (the study post-period) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population encompasses patients that are attributed to primary care clinics in one of the four health systems defined above. Patients are included in the study if they are ages 19 or older and received two or more outpatient visits at a participating practice during a one-year period before the COVID-19 pandemic, and 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. For the claims analyses, it will be required that patients are continuously enrolled over the entire study time period.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Patients who tested COVID-positive
- Patients from hospice and palliative care practices
- Patients from osteopathic medicine practices
- Patients from pediatric practices
- Patients that did not reside in states where the four health systems were located: the New York-Tri State Area (Connecticut, New York, and New Jersey), Florida, and North Carolina.
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 |
|---|---|---|
| Exposure to telemedicine, after the onset of the pandemicThe exposure of interest was the switch to primary care telemedicine prompted by the COVID-19 epidemic | Other | High Telemedicine, Low Telemedicine |
Primary outcome
Preventable Emergency Department (ED) Admissions
Time frame: Assessed per person per quarter for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
Avoidable emergency department (ED) admissions will be obtained from claims data. The Effect of telemedicine on preventable emergency department admissions will be calculated using difference-in-differences methodology. The estimate coefficient of the difference-in-difference model will be reported.
Unplanned Hospital Admissions From the ED
Time frame: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
Unplanned hospital admissions from the ED will be obtained from claims data. The effect of telemedicine on unplanned hospital admissions will be calculated using difference-in-difference methodology. The estimate coefficient will be reported.
Continuity of Care as Assessed by the Breslau Usual Provider of Care Measure
Time frame: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
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. The effect of telemedicine on continuity of care using the Breslau Usual Provider of Care measure will be calculated using difference-in-difference methodology. The estimate coefficient will be reported.
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
Continuity of Care as Assessed by the Bice-Boxerman Continuity of Care Index
Time frame: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
Continuity of Care as Assessed by the Bice-Boxerman Continuity of Care Index. The Bice-Boxerman Continuity of Care Index is also an indicator of continuity of care, ranging from 0 to 1, where 1 represents continuity of care. The effect of telemedicine on continuity of care using the Bice-Boxerman Continuity of care index will be calculated using difference-in-difference methodology. The estimate coefficient will be reported.
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
Number of Unplanned Hospital Admissions From the ED
Time frame: 12 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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
14 secondary outcomes
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%)
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%)
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%)
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
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
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
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
Time frame: 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 at Home
Time frame: 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 at Home
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)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jessica Ancker, MPH, PhD principal investigator
Vanderbilt University Medical Center
Rainu Kaushal, MD, MPH principal investigator
Weill Medical College of Cornell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 4 sites 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 3 inclusion and 7 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Preventable Emergency Department (ED) Admissions (time frame: Assessed per person per quarter for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.