Comparative Effectiveness of Telemedicine in Primary Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning From the COVID-19 Pandemic

Conditions
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Asthma, Chronic Obstructive Pulmonary Disease (COPD, Congestive Heart Failure, Diabetes, Hypertension

Intervention / Treatment
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* Other: Exposure to telemedicine, after the onset of the pandemic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Synchronous telemedicine alone<br> | Other: Exposure to telemedicine, after the onset of the pandemic<br>* Telemedicine exposure will be defined based on the proportion of all visits at a given clinic that are delivered via telemedicine in each month.<br>|
| Telemedicine-supplemented in-person care<br> | Other: Exposure to telemedicine, after the onset of the pandemic<br>* Telemedicine exposure will be defined based on the proportion of all visits at a given clinic that are delivered via telemedicine in each month.<br>|
| In-person care alone<br> | Other: Exposure to telemedicine, after the onset of the pandemic<br>* Telemedicine exposure will be defined based on the proportion of all visits at a given clinic that are delivered via telemedicine in each month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of avoidable emergency department (ED) admissions | 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 | 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 | 
| Number of unplanned hospital admissions from the ED | 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 | 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 | 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 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. | 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 | 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. | 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 | 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 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%) | 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%) | 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%) | 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%) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, primary care