Comparative Effectiveness of Telemedicine in Primary Care

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04684836
Collaborator
Patient-Centered Outcomes Research Institute (Other)
216,000
4
44.6
54000
1211.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exposure to telemedicine, after the onset of the pandemic

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
216000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning From the COVID-19 Pandemic
Actual Study Start Date :
Mar 15, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Synchronous telemedicine alone

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.

Telemedicine-supplemented in-person care

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.

In-person care alone

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.

Outcome Measures

Primary Outcome Measures

  1. Number of avoidable emergency department (ED) admissions [30 days after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Avoidable emergency department (ED) admissions will be obtained from claims data

  2. Number of avoidable emergency department (ED) admissions [60 days after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Avoidable emergency department (ED) admissions will be obtained from claims data

  3. Number of avoidable emergency department (ED) admissions [6 months after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Avoidable emergency department (ED) admissions will be obtained from claims data

  4. Number of avoidable emergency department (ED) admissions [12 months after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Avoidable emergency department (ED) admissions will be obtained from claims data

  5. Number of unplanned hospital admissions from the ED [30 days after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Unplanned hospital admissions from the ED will be obtained from claims data

  6. Number of unplanned hospital admissions from the ED [60 days after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Unplanned hospital admissions from the ED will be obtained from claims data

  7. Number of unplanned hospital admissions from the ED [6 months after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Unplanned hospital admissions from the ED will be obtained from claims data

  8. Number of unplanned hospital admissions from the ED [12 months the comparator arms of clinic-level telemedicine used]

    Unplanned hospital admissions from the ED will be obtained from claims data

  9. Continuity of care as assessed by the Bice-Boxerman Continuity of Care Index [30 days after the exposure to one of the comparator arms of clinic-level telemedicine used]

    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.

  10. Continuity of care as assessed by the Bice-Boxerman Continuity of Care Index [60 days after the exposure to one of the comparator arms of clinic-level telemedicine used]

    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.

  11. Continuity of care as assessed by the Bice-Boxerman Continuity of Care Index [6 months after the exposure to one of the comparator arms of clinic-level telemedicine used]

    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. Continuity of care as assessed by the Bice-Boxerman Continuity of Care Index [12 months after the exposure to one of the comparator arms of clinic-level telemedicine used]

    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.

  13. Continuity of care as assessed by the Breslau Usual Provider of Care measure [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. 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.

  14. Continuity of care as assessed by the Breslau Usual Provider of Care measure [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. 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.

  15. Continuity of care as assessed by the Breslau Usual Provider of Care measure [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. 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.

  16. Continuity of care as assessed by the Breslau Usual Provider of Care measure [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. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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]

    Continuity of care as assessed by attendance at follow-up appointment.

Secondary Outcome Measures

  1. 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%), which is the percentage of patients 18 - 75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period

  2. 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%), which is the percentage of patients 18 - 75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period

  3. 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%), which is the percentage of patients 18 - 75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period

  4. 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 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

  5. 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]

    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. Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure [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, which is the percentage of patients 18 - 85 with hypertension diagnosis and adequate control (< 140/90 mmHg)

  7. Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure [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, which is the percentage of patients 18 - 85 with hypertension diagnosis and adequate control (< 140/90 mmHg)

  8. Evidence of controlled disease as indicated by as indicated by the National Quality Forum (NQF 0018): Controlling High Blood Pressure [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, which is the percentage of patients 18 - 85 with hypertension diagnosis and adequate control (< 140/90 mmHg)

  9. Days at home [30 days after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Days per month not in hospital or institutional setting

  10. Days at home [60 days after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Days per month not in hospital or institutional setting

  11. Days at home [6 months after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Days per month not in hospital or institutional setting

  12. Days at home [12 months after the exposure to one of the comparator arms of clinic-level telemedicine used]

    Days per month not in hospital or institutional setting

  13. Patient experiences based on the Patient Satisfaction Questionnaire (PSQ-18) [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), which is a 5-scale questionnaire including questions on patient satisfaction, communication quality with providers and accessibility/convenience of care.

  14. Ease of use and access to telemedicine based on Telehealth Usability Questionnaire (TUQ) [12 months after the exposure to one of the comparator arms of clinic-level telemedicine used]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Florida Gainesville New York United States 32610
2 Mount Sinai New York New York United States 10029
3 Weill Cornell Medicine New York New York United States 10065
4 University of North Carolina Chapel Hill North Carolina United States 27599

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jessica Ancker, MPH, PhD, Weill Medical College of Cornell University
  • Principal Investigator: Rainu Kaushal, MD, MPH, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT04684836
Other Study ID Numbers:
  • 20-12023014
First Posted:
Dec 28, 2020
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weill Medical College of Cornell University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022