Comparative Effectiveness of Telemedicine in Primary Care

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684836
• Other study ID #: 20-12023014
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 care.

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 July 30, 2023.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216000
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD
• Congestive Heart Failure
• Diabetes
• Heart Failure
• Hypertension
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Exposure to telemedicine, after the onset of the pandemic
Telemedicine exposure will be defined based on the proportion of all visits at a given clinic that are delivered via telemedicine in each month.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Florida	Gainesville	New York
United States	Mount Sinai	New York	New York
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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