Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03244033 |
| Other study ID # |
2017-0555 |
| Secondary ID |
R01HS025374 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2018 |
| Est. completion date |
November 12, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
University of Illinois at Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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:
1. Reduces contextual error: CDS tools that inform clinicians of contextual factors and
prompt them to explore contextual red flags should result in a reduction in contextual
error.
2. Improve health care outcomes: Contextualized CDS predicts improved health care outcomes
defined as a partial or full resolution of the contextual red flag (e.g. elevated HgB
A1c) after the index visit.
3. Reduces avoidable health care costs: Contextualized CDS is associated with a reduction
in misuse and overuse of inappropriate or unnecessary medical services.
Description:
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:
1. Reduces contextual error: CDS tools that inform clinicians of contextual factors and
prompt them to explore contextual red flags should result in a reduction in contextual
error.
2. Improve health care outcomes: Contextualized CDS predicts improved health care outcomes
defined as a partial or full resolution of the contextual red flag (e.g. elevated HgB
A1c) after the index visit.
3. Reduces avoidable health care costs: Contextualized CDS is associated with a reduction
in misuse and overuse of inappropriate or unnecessary medical services.
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.
