Integrating Contextual Factors Into Clinical Decision Support

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Suspended
CT.gov ID
NCT03244033
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed), Loyola University (Other)
500
2
2
45.9
250
5.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Contextual clinical decision support
  • Behavioral: Contextual survey
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Integrating Contextual Factors Into Clinical Decision Support to Reduce Contextual Error and Improve Outcomes in Ambulatory Care
Actual Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Contextual clinical decision support
Incorporation of contextual data into EHR clinical decision support alerts

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

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Resolution of contextual red flags [6-9 months following index visit]

    Proportion of red flags noted at index visit that have resolved

Secondary Outcome Measures

  1. Probing of contextual red flags [up to 25 months]

    Proportion of red flags which the examining physician probes

  2. Planning for contextual factors [up to 25 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.
Exclusion Criteria:
  • • Patients with emergent or unscheduled visits or who do not speak English.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois at Chicago Chicago Illinois United States 60612
2 Loyola University Medical Center Maywood Illinois United States 60153

Sponsors and Collaborators

  • University of Illinois at Chicago
  • Agency for Healthcare Research and Quality (AHRQ)
  • Loyola University

Investigators

  • Principal Investigator: Saul J Weiner, MD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alan Schwartz, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT03244033
Other Study ID Numbers:
  • 2017-0555
  • R01HS025374
First Posted:
Aug 9, 2017
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alan Schwartz, Professor, University of Illinois at Chicago

Study Results

No Results Posted as of Apr 27, 2021