Trial Outcomes & Findings for Integrating Contextual Factors Into Clinical Decision Support (NCT NCT03244033)
NCT ID: NCT03244033
Last Updated: 2023-01-10
Results Overview
Proportion of red flags noted at index visit that have resolved
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
452 participants
Primary outcome timeframe
6-9 months following index visit
Results posted on
2023-01-10
Participant Flow
570 patients were assessed for eligibility to participate across the clinics at the two sites. 118 declined to participate and were not randomized.
Participant milestones
| Measure |
Contextual Survey + Contextual CDS
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will produce a variety of Contextual Clinical Decision Support, both passive and interruptive alerts.
Contextual clinical decision support: Incorporation of contextual data into EHR clinical decision support alerts
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
Contextual Survey Only
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will not be used for CDS or to produce alerts.
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
275
|
|
Overall Study
COMPLETED
|
177
|
275
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Contextual Survey + Contextual CDS
n=177 Participants
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will produce a variety of Contextual Clinical Decision Support, both passive and interruptive alerts.
Contextual clinical decision support: Incorporation of contextual data into EHR clinical decision support alerts
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
Contextual Survey Only
n=275 Participants
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will not be used for CDS or to produce alerts.
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Adult (18 and older)
|
177 Participants
n=177 Participants
|
275 Participants
n=275 Participants
|
452 Participants
n=452 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=177 Participants
|
182 Participants
n=275 Participants
|
293 Participants
n=452 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=177 Participants
|
93 Participants
n=275 Participants
|
159 Participants
n=452 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
177 participants
n=177 Participants
|
275 participants
n=275 Participants
|
452 participants
n=452 Participants
|
|
Clinic Site
Site 1
|
118 Participants
n=177 Participants
|
160 Participants
n=275 Participants
|
278 Participants
n=452 Participants
|
|
Clinic Site
Site 2
|
59 Participants
n=177 Participants
|
115 Participants
n=275 Participants
|
174 Participants
n=452 Participants
|
PRIMARY outcome
Timeframe: 6-9 months following index visitPopulation: Red flags identified in visits of participants.
Proportion of red flags noted at index visit that have resolved
Outcome measures
| Measure |
Contextual Survey + Contextual CDS
n=362 Red flags
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will produce a variety of Contextual Clinical Decision Support, both passive and interruptive alerts.
Contextual clinical decision support: Incorporation of contextual data into EHR clinical decision support alerts
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
Contextual Survey Only
n=540 Red flags
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will not be used for CDS or to produce alerts.
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
|---|---|---|
|
Resolution of Contextual Red Flags
Red flag improved/resolved
|
116 Red flags
|
240 Red flags
|
|
Resolution of Contextual Red Flags
Red flag worsened
|
83 Red flags
|
99 Red flags
|
|
Resolution of Contextual Red Flags
Red flag unchanged or mixed
|
163 Red flags
|
201 Red flags
|
SECONDARY outcome
Timeframe: At index visitProportion of red flags which the examining physician probes
Outcome measures
| Measure |
Contextual Survey + Contextual CDS
n=362 Red flags
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will produce a variety of Contextual Clinical Decision Support, both passive and interruptive alerts.
Contextual clinical decision support: Incorporation of contextual data into EHR clinical decision support alerts
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
Contextual Survey Only
n=540 Red flags
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will not be used for CDS or to produce alerts.
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
|---|---|---|
|
Probing of Contextual Red Flags
Not probed
|
147 Red flags
|
269 Red flags
|
|
Probing of Contextual Red Flags
Probed
|
215 Red flags
|
271 Red flags
|
SECONDARY outcome
Timeframe: At index visitProportion of contextual factors identified during visit that are incorporated into care plan
Outcome measures
| Measure |
Contextual Survey + Contextual CDS
n=383 Contextual factors
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will produce a variety of Contextual Clinical Decision Support, both passive and interruptive alerts.
Contextual clinical decision support: Incorporation of contextual data into EHR clinical decision support alerts
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
Contextual Survey Only
n=509 Contextual factors
Contextual factors obtained from patients in the Contextual Survey along with contextual red flags already stored in the EHR will not be used for CDS or to produce alerts.
Contextual survey: Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
|
|---|---|---|
|
Planning for Contextual Factors
Plan contextualized for factor
|
221 Contextual factors
|
255 Contextual factors
|
|
Planning for Contextual Factors
Plan not contextualized for factor
|
162 Contextual factors
|
254 Contextual factors
|
Adverse Events
Contextual Survey + Contextual CDS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Contextual Survey Only
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place