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Medical ErrorsNCT03244033

Integrating Contextual Factors Into Clinical Decision Support

A study testing Contextual clinical decision support and Contextual survey in people with Medical Errors and Decision Support Systems, Clinical, run by University of Illinois at Chicago at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Contextual clinical decision support and Contextual survey
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
2 sitesUnited States
Study dates
1 Sep 2018to 12 Nov 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English-speaking adult patients presenting to outpatient primary care clinics for scheduled appointments who can be contacted in advance of their appointment and the clinicians (physicians or nurse practitioners) seeing those patients at those visits.

Who cannot join

  • • Patients with emergent or unscheduled visits or who do not speak English.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Loyola University Medical Center

    Maywood, Illinois, 60153

Other trials in United States

About this study

Official title: Integrating Contextual Factors Into Clinical Decision Support to Reduce Contextual Error and Improve Outcomes in Ambulatory Care

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.
Read the detailed 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.

Being tested
Contextual clinical decision support, Contextual survey
Keywords
context, contextual error, contextual care, electronic medical record, clinical decision support

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contextual clinical decision supportOther

    Incorporation of contextual data into EHR clinical decision support alerts

  • Contextual surveyBehavioural

    Patients complete a survey asking about red flags that could signal contextual factors relevant to their care

Study groups in NCT03244033
Study groupRoleWhat they receive
Contextual Survey + Contextual CDSExperimentalContextual 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.
Receives: Other: Contextual clinical decision support; Behavioral: Contextual survey
Contextual Survey OnlyActive comparatorContextual 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.
Receives: Behavioral: Contextual survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution of Contextual Red Flags

    Proportion of red flags noted at index visit that have resolved

    Measured: 6-9 months following index visit

Secondary outcomes (2)
  1. Probing of Contextual Red Flags

    Proportion of red flags which the examining physician probes

    Measured: At index visit

  2. Planning for Contextual Factors

    Proportion of contextual factors identified during visit that are incorporated into care plan

    Measured: At index visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start1 Sep 2018
  3. Primary completion12 Nov 2021
  4. Study completion12 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03244033
Sponsor's protocol ID
2017-0555
Other IDs
R01HS025374
Status last verified
Apr 2022
First submitted
31 Jul 2017
Last updated
10 Jan 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36279133

Questions about this trial

What is this clinical trial studying?

A study testing Contextual clinical decision support and Contextual survey in people with Medical Errors and Decision Support Systems, Clinical, run by University of Illinois at Chicago at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of Contextual Red Flags (time frame: 6-9 months following index visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03244033, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023; AzTrials last refreshed its copy on 28 Oct 2026.

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