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Clinical Trials/NCT01710293
NCT01710293
Withdrawn
Not Applicable

Automated Point-of-Care Surveillance of Outpatient Delays in Cancer Diagnosis

VA Office of Research and Development5 sites in 1 countryJanuary 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
VA Office of Research and Development
Locations
5
Primary Endpoint
Median Time from Initial Follow-up Delay to Follow-up Action
Status
Withdrawn
Last Updated
8 years ago

Overview

Brief Summary

Many missed and delayed cancer diagnoses result from breakdowns in communication and coordination of abnormal findings suspicious for cancer, which often first emerge in the primary care setting. Delays in the follow-up of abnormal test results persist despite the reliable delivery of test results through the electronic health record.

This intervention is the final study in a three-phase project that will develop and test an innovative automated surveillance intervention to improve timely diagnosis and follow-up of five common cancers in primary care practice.

The investigators hypothesize that the median time in days from diagnostic clue to follow-up action (e.g. time to colonoscopy examination after am abnormal colon-related test) will be significantly less in the intervention arm than in usual care. The investigators also hypothesize that the proportion of patients receiving appropriate and timely follow-up care will be significantly higher in the intervention arm than in usual care.

Detailed Description

The CREATE Project encompasses three phases, the first and second of which do not contain interventions. The first phase of the project determines the effectiveness of computerized queries the investigators develop to accurately identify which patients are at risk for delays in cancer diagnosis. Patients the investigators identify will have abnormal test results or symptoms that have not been followed up by their providers. In Phase 2 of the study, the research team will use interviewing and other participatory techniques to determine the best way to convey information about such at-risk patients to providers in an automated fashion. In Phase 3 of the project, the investigators will evaluate the effects of an automated surveillance intervention on the timeliness of the diagnostic process of five cancers. This project will improve communication and coordination of cancer-related diagnostic information to improve quality and safety.

Registry
clinicaltrials.gov
Start Date
January 27, 2017
End Date
January 27, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient charts: Medical charts of Veteran patients who receive care from participating VA facility (Madison VAH, Jesse Brown VAMC, Hines VAH, Michael E. DeBakey VAMC, and Minneapolis VAMC) providers during the one year study period (tentatively October 2016-October 2017) and who have potential delays in diagnostic evaluation for lung, colorectal, liver, bladder, or breast cancer will be reviewed as part of the study.
  • Providers: Providers who have seen primary care outpatients in any of the participating facilities or their outpatient clinics within the year-long study period.

Exclusion Criteria

  • Patient Charts: Medical charts of patients who are not receiving care from participating facility providers or charts of patients who do not have potential follow-up delays for lung, colorectal, liver, bladder, or breast cancer in the time period of interest.
  • Providers: Providers who have not seen primary care outpatients in any of the participating facilities or their outpatient clinics within the time period of interest.

Outcomes

Primary Outcomes

Median Time from Initial Follow-up Delay to Follow-up Action

Time Frame: 1 year

The investigators will conduct chart reviews of patients shown by our automated surveillance system to have not received appropriate follow-up care in both intervention and control groups at least 6 months after the first documentation of a diagnostic clue (e.g., initial abnormal chest X-ray). Chart review will be used to quantify time in days from documentation of the clinical clue to the time when follow-up action on that clue was initiated.

Study Sites (5)

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