Comparative Effectiveness of Telemedicine in Primary Care

NCT ID: NCT04684836

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2022-04-01

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.

Conditions

Asthma; Chronic Obstructive Pulmonary Disease (COPD); Congestive Heart Failure; Diabetes; Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

Exposure to telemedicine, after the onset of the pandemic

Intervention Type: OTHER

The exposure of interest was the switch to primary care telemedicine prompted by the COVID-19 epidemic

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)

Exposure to telemedicine, after the onset of the pandemic

Intervention Type: OTHER

The exposure of interest was the switch to primary care telemedicine prompted by the COVID-19 epidemic

Interventions

Exposure to telemedicine, after the onset of the pandemic

The exposure of interest was the switch to primary care telemedicine prompted by the COVID-19 epidemic

Intervention Type: OTHER

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).

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Ancker, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Rainu Kaushal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

University of Florida

Gainesville, New York, United States

Mount Sinai

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-12023014

Identifier Type: -

Identifier Source: org_study_id