Trial Outcomes & Findings for Comparative Effectiveness of Telemedicine in Primary Care (NCT NCT04684836)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

33100 participants

Primary outcome timeframe

Assessed per person per quarter for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	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)	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)
Overall Study STARTED	17226	15874
Overall Study COMPLETED	17226	15874
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness of Telemedicine in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Telemedicine n=17226 Participants 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)	Low Telemedicine n=15874 Participants 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)	Total n=33100 Participants Total of all reporting groups
Age, Continuous	72.64 years STANDARD_DEVIATION 10.55 • n=5 Participants	71.56 years STANDARD_DEVIATION 10.58 • n=7 Participants	72.12 years STANDARD_DEVIATION 10.58 • n=5 Participants
Sex: Female, Male Female	10448 Participants n=5 Participants	9445 Participants n=7 Participants	19893 Participants n=5 Participants
Sex: Female, Male Male	6778 Participants n=5 Participants	6429 Participants n=7 Participants	13207 Participants n=5 Participants
Race/Ethnicity, Customized White	12546 participants n=5 Participants	12489 participants n=7 Participants	25035 participants n=5 Participants
Race/Ethnicity, Customized Black	5627 participants n=5 Participants	3030 participants n=7 Participants	2597 participants n=5 Participants
Rural Urban Destination Metropolitan	16195 Participants n=5 Participants	14348 Participants n=7 Participants	30543 Participants n=5 Participants
Rural Urban Destination Non-metropolitan	1031 Participants n=5 Participants	1526 Participants n=7 Participants	2557 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed per person per quarter for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021

Population: Upon receiving the data from each study site, the investigators first examined the patterns of telehealth provision among all included practices and the extent to which practices could be categorized into one of these three study arms. Given that the data showed an insufficient number of practices would fall into the three original proposed arms, the investigators updated the analytic plan to include two study arms: high- versus low telemedicine practices.

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.

Outcome measures

Outcome measures
Measure	High Telemedicine n=17226 Participants 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)	Low Telemedicine n=15874 Participants 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)
Preventable Emergency Department (ED) Admissions	0.038 count of ED admissions per person per q Interval 0.0 to 0.0	0.048 count of ED admissions per person per q Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021

Population: Upon receiving the data from each study site, the investigators first examined the patterns of telehealth provision among all included practices and the extent to which practices could be categorized into one of these three study arms. Given that the data showed an insufficient number of practices would fall into the three original proposed arms, the investigators updated the analytic plan to include two study arms: high- versus low telemedicine practices.

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.

Outcome measures

Outcome measures
Measure	High Telemedicine n=17226 Participants 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)	Low Telemedicine n=15874 Participants 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)
Unplanned Hospital Admissions From the ED	0.015 count of admissions per person per q Interval 0.0 to 0.0	0.020 count of admissions per person per q Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021

Population: Upon receiving the data from each study site, the investigators first examined the patterns of telehealth provision among all included practices and the extent to which practices could be categorized into one of these three study arms. Given that the data showed an insufficient number of practices would fall into the three original proposed arms, the investigators updated the analytic plan to include two study arms: high- versus low telemedicine practices.

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.

Outcome measures

Outcome measures
Measure	High Telemedicine n=17226 Participants 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)	Low Telemedicine n=15874 Participants 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)
Continuity of Care as Assessed by the Breslau Usual Provider of Care Measure	0.25 average score on scale by person by q Interval 0.14 to 0.5	0.35 average score on scale by person by q Interval 0.14 to 0.5

PRIMARY outcome

Timeframe: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Assessed at the quarter level for 3 years, data collected encompasses retrospective data from Q1 2019 to Q4 2021

Population: Upon receiving the data from each study site, the investigators first examined the patterns of telehealth provision among all included practices and the extent to which practices could be categorized into one of these three study arms. Given that the data showed an insufficient number of practices would fall into the three original proposed arms, the investigators updated the analytic plan to include two study arms: high- versus low telemedicine practices.

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.

Outcome measures

Outcome measures
Measure	High Telemedicine n=17226 Participants 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)	Low Telemedicine n=15874 Participants 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)
Continuity of Care as Assessed by the Bice-Boxerman Continuity of Care Index	0.047 score on a scale per person per q Interval 0.0 to 0.167	0.047 score on a scale per person per q Interval 0.0 to 0.0153

PRIMARY outcome

Timeframe: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

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

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data was not collected for this measure.

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data was not collected for this measure.

Days per month not in hospital or institutional setting

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 days after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

Days per month not in hospital or institutional setting

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

Days per month not in hospital or institutional setting

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

Days per month not in hospital or institutional setting

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the exposure to one of the comparator arms of clinic-level telemedicine used

Population: Data was not collected for this measure.

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

Outcome measures

Outcome data not reported

Adverse Events

HIgh Telemedicine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Telemedicine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jessica Ancker, MS, PhD

Vanderrbilt University

Phone: (615) 322-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place