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| ID | Type | Description | Link |
|---|---|---|---|
| R01HS025374 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| Loyola University | OTHER |
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Preventing contextual errors requires heightening clinician responsiveness to clues that there are contextual factors during the clinical encounter, in real time. These clues, termed contextual red flags are evident in two sources: the medical record and from patients directly. An effective intervention would prompt clinicians to determine whether there are underlying contextual factors that could be addressed in the care plan, averting contextual error. This desirable process is termed contextual probing.
While clinical decision support (CDS) has been used to provide physicians with timely biomedical information at the point of care to prevent errors and promote appropriate care, this technology also affords an opportunity to draw physician attention to both contextual red flags and contextual factors in order to avert contextual errors. This study assesses the potential of "contextualized CDS" to improve contextualization of care through a randomized controlled intervention trial, with assessment measures of both patient health care outcomes and averted costs associated with overuse and misuse of medical services. The three hypotheses are that CDS:
The term patient context refers to the myriad contextual factors in patients' lives that complicate the application of research evidence to patient care. For instance, the inability of a patient to afford a medication for a particular condition is a contextual factor. Contextual factors can be addressed when correctly identified. Substituting a low cost generic for a high cost brand name medication may enable a patient to afford a medication. Addressing contextual factors in a care plan is termed contextualizing care. Conversely, the failure to address a contextual factor when it is feasible to so is a contextual error, because it results in an inappropriate plan of care. In sum, contextual errors are medical errors caused by inattention to patient context. They are common and linked to both diminished health care outcomes and an increase in health care costs related to overuse and misuse of medical services. These findings were determined using a validated method for coding audio recorded data called Content Coding for Contextualization of Care ("4C") collected during the encounters by both real patients, and by unannounced standardized patients (USPs) employing checklists.
Preventing contextual errors requires heightening clinician responsiveness to clues that there are contextual factors during the clinical encounter, in real time. These clues, termed contextual red flags are evident in two sources: the medical record and from patients directly. An effective intervention would prompt clinicians to determine whether there are underlying contextual factors that could be addressed in the care plan, averting contextual error. This desirable process is termed contextual probing.
While clinical decision support (CDS) has been used to provide physicians with timely biomedical information at the point of care to prevent errors and promote appropriate care, this technology also affords an opportunity to draw physician attention to both contextual red flags and contextual factors in order to avert contextual errors. This study assesses the potential of "contextualized CDS" to improve contextualization of care through a randomized controlled intervention trial, with assessment measures of both patient health care outcomes and averted costs associated with overuse and misuse of medical services. The three hypotheses are that CDS:
To test the hypotheses, patients who consent to participate will be randomized to usual care or care enhanced with contextualized CDS. Participants will audio record their visits, and the data will be coded using 4C. They will be followed several months after the index visit for assessment of outcomes by blinded assessors using an established tracking method. In addition, USPs presenting with cases containing complicating contextual factors that if overlooked result in overuse and misuse of medical services, will be employed to assess the third hypothesis, and to supplement the data obtained by observing the effects of contextual alerts on the care of real patients for the first hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contextual Survey + Contextual CDS | Experimental | 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. |
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| Contextual Survey Only | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contextual clinical decision support | Other | Incorporation of contextual data into EHR clinical decision support alerts |
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| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Contextual Red Flags | Proportion of red flags noted at index visit that have resolved | 6-9 months following index visit |
| Measure | Description | Time Frame |
|---|---|---|
| Probing of Contextual Red Flags | Proportion of red flags which the examining physician probes | At index visit |
| Planning for Contextual Factors | Proportion of contextual factors identified during visit that are incorporated into care plan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saul J Weiner, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States | ||
| Loyola University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36279133 | Derived | Weiner SJ, Schwartz A, Weaver F, Galanter W, Olender S, Kochendorfer K, Binns-Calvey A, Saini R, Iqbal S, Diaz M, Michelfelder A, Varkey A. Effect of Electronic Health Record Clinical Decision Support on Contextualization of Care: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238231. doi: 10.1001/jamanetworkopen.2022.38231. |
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570 patients were assessed for eligibility to participate across the clinics at the two sites. 118 declined to participate and were not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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(As in participant flow diagram)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Resolution of Contextual Red Flags | Proportion of red flags noted at index visit that have resolved | Red flags identified in visits of participants. | Posted | Count of Units | Red flags | No | 6-9 months following index visit | Red flags | Red flags |
|
At index visit for each patient during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Saul Weiner | University of Illinois at Chicago | 312-355-1700 | sweiner@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2017 | Feb 4, 2022 | Prot_SAP_000.pdf |
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| Contextual survey | Behavioral | Patients complete a survey asking about red flags that could signal contextual factors relevant to their care |
|
| At index visit |
| Maywood |
| Illinois |
| 60153 |
| United States |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Clinic Site | Count of Participants | Participants |
|
| 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 |
|
|
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| Secondary | Probing of Contextual Red Flags | Proportion of red flags which the examining physician probes | Posted | Count of Units | Red flags | No | At index visit | Red flags | Red flags |
|
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| Secondary | Planning for Contextual Factors | Proportion of contextual factors identified during visit that are incorporated into care plan | Posted | Count of Units | Contextual factors | No | At index visit | Contextual factors | Contextual factors |
|
|
|
|
| 0 |
| 177 |
| 0 |
| 177 |
| 0 |
| 177 |
| EG001 | 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 | 0 | 275 | 0 | 275 | 0 | 275 |
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| Superiority |
| Superiority |