Clinical trial NCT04684836: Comparative Effectiveness of Telemedicine in Primary Care
Official title: Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning From the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Congestive Heart Failure
Diabetes
Hypertension
Keywords: telemedicine
primary care
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-12-28
Enrollment: 33100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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
* 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).

Primary outcomes:
measure: Preventable Emergency Department (ED) Admissions
timeFrame: Assessed per person per quarter for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
measure: Unplanned Hospital Admissions From the ED
timeFrame: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
measure: Continuity of Care as Assessed by the Breslau Usual Provider of Care Measure
timeFrame: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
measure: Number of Unplanned Hospital Admissions From the ED
timeFrame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by the Bice-Boxerman Continuity of Care Index
timeFrame: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021
measure: Number of Unplanned Hospital Admissions From the ED
timeFrame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Number of Unplanned Hospital Admissions From the ED
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Number of Avoidable Emergency Department (ED) Admissions
timeFrame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Number of Avoidable Emergency Department (ED) Admissions
timeFrame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Number of Avoidable Emergency Department (ED) Admissions
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by the Bice-Boxerman Continuity of Care Index
timeFrame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by the Bice-Boxerman Continuity of Care Index
timeFrame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by the Bice-Boxerman Continuity of Care Index
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by the Breslau Usual Provider of Care Measure
timeFrame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by the Breslau Usual Provider of Care Measure
timeFrame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by the Breslau Usual Provider of Care Measure
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by Attendance at Follow-up Appointment
timeFrame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by Attendance at Follow-up Appointment
timeFrame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by Attendance at Follow-up Appointment
timeFrame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Continuity of Care as Assessed by Attendance at Follow-up Appointment
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
Secondary outcomes:
measure: Evidence of Controlled Disease as Indicated by as Indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)
timeFrame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Evidence of Controlled Disease as Indicated by as Indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)
timeFrame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Evidence of Controlled Disease as Indicated by as Indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)
timeFrame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Evidence of Controlled Disease as Indicated by as Indicated by the National Quality Forum (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Evidence of Controlled Disease as Indicated by as Indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure
timeFrame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Evidence of Controlled Disease as Indicated by as Indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure
timeFrame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Evidence of Controlled Disease as Indicated by as Indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure
timeFrame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Evidence of Controlled Disease as Indicated by as Indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Days at Home
timeFrame: 30 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Days at Home
timeFrame: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Days at Home
timeFrame: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Days at Home
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Patient Experiences Based on the Patient Satisfaction Questionnaire (PSQ-18)
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
measure: Ease of Use and Access to Telemedicine Based on Telehealth Usability Questionnaire (TUQ)
timeFrame: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jessica Ancker, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Rainu Kaushal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: