Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 452
Est. completion date November 12, 2021
Est. primary completion date November 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Illinois at Chicago Chicago Illinois
United States Loyola University Medical Center Maywood Illinois

Sponsors (3)

Lead Sponsor Collaborator
University of Illinois at Chicago Agency for Healthcare Research and Quality (AHRQ), Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resolution of Contextual Red Flags Proportion of red flags noted at index visit that have resolved 6-9 months following index visit
Secondary Probing of Contextual Red Flags Proportion of red flags which the examining physician probes At index visit
Secondary Planning for Contextual Factors Proportion of contextual factors identified during visit that are incorporated into care plan At index visit
See also
  Status Clinical Trial Phase
Completed NCT01190488 - Feasibility Of An Advanced Care Decision Aid Among Patients And Physicians_Matlock N/A
Completed NCT04602676 - The Acceptability and Impact of Diarrheal Etiology Prediction (DEP) Algorithm N/A
Recruiting NCT04802941 - Neoadjuvant Chemotherapy in Breast Cancer N/A
Completed NCT04028557 - An Implementation Model for Clinical Decision Support for Heart Failure Prescribing N/A
Not yet recruiting NCT06293794 - Decision Support for Heart Failure Prescribing N/A
Completed NCT00915304 - Evidence-Based Medicine Electronic Decision Support Study Phase 1/Phase 2
Completed NCT00348751 - CholGate - The Effect of Alerting Versus on Demand Computer Based Decision Support on Treatment of Dyslipidaemia by General Practitioners N/A
Recruiting NCT05777187 - Mitigation of Postoperative Delirium in High-Risk Patients N/A
Completed NCT04910750 - Tools for the Integrated Management of Childhood Illness (TIMCI): Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care N/A
Not yet recruiting NCT05967273 - CirrhosisRx CDS System N/A
Completed NCT03397160 - Pioneering Advances in Care and Education (PACE) N/A
Not yet recruiting NCT05196802 - Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients N/A
Not yet recruiting NCT04145609 - Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease N/A
Completed NCT05065320 - Tools for the Integrated Management of Childhood Illness: Cross-country Quasi-experimental Pre-post Study in Kenya and Senegal
Completed NCT05303025 - Qualitative Research Among Physicians and Junior Doctors Into the Preconditions for Implementing a CDSS Based on AI in the ICU