Trial Outcomes & Findings for Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care (NCT NCT01346839)
NCT ID: NCT01346839
Last Updated: 2016-02-09
Results Overview
Differences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1256 participants
Primary outcome timeframe
15 months
Results posted on
2016-02-09
Participant Flow
Participant milestones
| Measure |
Contact Intervention
The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
|
Usual Care Control
The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
|
|---|---|---|
|
Overall Study
STARTED
|
683
|
573
|
|
Overall Study
COMPLETED
|
369
|
364
|
|
Overall Study
NOT COMPLETED
|
314
|
209
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care
Baseline characteristics by cohort
| Measure |
Contact Intervention
n=369 Participants
The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
|
Usual Care Control
n=364 Participants
The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
|
Total
n=733 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
60.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
331 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
629 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
334 Participants
n=5 Participants
|
331 Participants
n=7 Participants
|
665 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
141 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
213 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
369 participants
n=5 Participants
|
364 participants
n=7 Participants
|
733 participants
n=5 Participants
|
|
Number of Comorbidities
|
2.2 Comorbidities
STANDARD_DEVIATION 1.3 • n=5 Participants
|
2.1 Comorbidities
STANDARD_DEVIATION 1.4 • n=7 Participants
|
2.2 Comorbidities
STANDARD_DEVIATION 1.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 15 monthsDifferences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.
Outcome measures
| Measure |
Contact Intervention
n=369 Participants
The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
|
Usual Care Control
n=364 Participants
The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
|
|---|---|---|
|
Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer
Time to Follow-up of Colorectal Trigger
|
104 Days
Interval 91.2 to 116.8
|
200 Days
Interval 162.5 to 210.0
|
|
Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer
Time to Follow-up of Prostate Trigger
|
144 Days
Interval 131.2 to 153.1
|
192 Days
Interval 182.0 to 199.1
|
|
Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer
Time to Follow-up of Lung Trigger
|
65 Days
Interval 50.4 to 79.6
|
93 Days
Interval 70.3 to 115.7
|
SECONDARY outcome
Timeframe: 15 monthsThe percentage of patients receiving timely follow-up care, as defined by action taken by provider within appropriate pre-defined time intervals for each diagnostic clue, in both intervention and control groups.
Outcome measures
| Measure |
Contact Intervention
n=369 Participants
The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
|
Usual Care Control
n=364 Participants
The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
|
|---|---|---|
|
Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer
|
73.4 percentage of follow-up
|
52.2 percentage of follow-up
|
SECONDARY outcome
Timeframe: 15 monthsThis is a descriptive sub-analysis looking only at cases with no follow-up at the end of the follow-up period. Specifically, out of the cases that never got follow-up, this represents the percent of that subsample that had no justification in the medical record for the lack of follow-up. This is based on manual chart reviews.
Outcome measures
| Measure |
Contact Intervention
n=174 Participants
The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
|
Usual Care Control
n=98 Participants
The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
|
|---|---|---|
|
Percentage of Cases With no Documented Justification for no Follow-up
|
33.9 percentage with no documentation
|
48.0 percentage with no documentation
|
SECONDARY outcome
Timeframe: 15 monthsSubsequent diagnosis of nonmalignant neoplasia, cancer, or death, and treatments required as a result of new cancer diagnoses after a pre-specified interval.
Outcome measures
| Measure |
Contact Intervention
n=369 Participants
The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
|
Usual Care Control
n=364 Participants
The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
|
|---|---|---|
|
Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation
|
13 Number of patients diagnosed with cancer
|
10 Number of patients diagnosed with cancer
|
SECONDARY outcome
Timeframe: 15 monthsPositive Predictive Values of each of the triggers in identifying patients with a true delay in diagnostic evaluation. Calculated as: percentage of patients identified as trigger positive that actually had a delay.
Outcome measures
| Measure |
Contact Intervention
n=369 Participants
The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
|
Usual Care Control
n=364 Participants
The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
|
|---|---|---|
|
Trigger Positive Predictive Value
|
63.5 Percentage of participants
|
55.3 Percentage of participants
|
Adverse Events
Contact Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Control
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
Dr. Hardeep Singh
Michael E. DeBakey VA Medical Center and Baylor College of Medicine
Phone: 713-794-8515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place