Comparative Effectiveness of Telemedicine in Primary Care

NCT04684836 | Completed Results

• 1 other identifier: 20-12023014
• Study Type: observational
• Target: 33,100
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

telemedicine; primary care

Outcome Measures

Primary Outcomes (20)

• 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.

  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.

  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.

  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

  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.

  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

  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

  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

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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%)

  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%)

  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%)

  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%)

  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

  30 days after the exposure to one of the comparator arms of clinic-level telemedicine used

Study Arms (2)

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)

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)

Other: Exposure to telemedicine, after the onset of the pandemic

Interventions

Exposure to telemedicine, after the onset of the pandemic OTHER

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

High Telemedicine; Low Telemedicine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (4)

University of Florida

Gainesville, New York, 32610, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Heart Failure; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases

Results Point of Contact

• Title: Jessica Ancker, MS, PhD
• Organization: Vanderrbilt University

jessica.s.ancker@vumc.org

(615) 322-5000

Study Officials

• Jessica Ancker, MPH, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Rainu Kaushal, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 28, 2020
• Study Start: March 15, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)