Integrating Contextual Factors Into Clinical Decision Support

NCT03244033 | Completed Results DMC

• 2 other identifiers: 2017-0555R01HS025374
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 2

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. 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. 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. 3.Reduces avoidable health care costs: Contextualized CDS is associated with a reduction in misuse and overuse of inappropriate or unnecessary medical services.

Conditions

Medical Errors; Decision Support Systems, Clinical; Diagnostic Errors

Keywords

context; contextual error; contextual care; electronic medical record; clinical decision support

Outcome Measures

Primary Outcomes (1)

• Resolution of Contextual Red Flags

  Proportion of red flags noted at index visit that have resolved

  6-9 months following index visit

Secondary Outcomes (2)

• Probing of Contextual Red Flags

  At index visit

• Planning for Contextual Factors

  At index visit

Study Arms (2)

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.

Other: Contextual clinical decision support; Behavioral: Contextual survey

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.

Behavioral: Contextual survey

Interventions

Contextual clinical decision support OTHER

Incorporation of contextual data into EHR clinical decision support alerts

Contextual Survey + Contextual CDS

Contextual survey BEHAVIORAL

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

Contextual Survey + Contextual CDS; Contextual Survey Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (1)

• 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.

  PMID: 36279133 DERIVED

Results Point of Contact

• Title: Dr. Saul Weiner
• Organization: University of Illinois at Chicago

sweiner@uic.edu

312-355-1700

Study Officials

• Saul J Weiner, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 9, 2017
• Study Start: September 1, 2018
• Primary Completion: November 12, 2021
• Study Completion: November 12, 2021
• Last Updated: January 10, 2023
• Results First Posted: January 10, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)