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Intervention Protocol for Automated Point-of-Care Surveillance of Outpatient Delays in Cancer Diagnosis

Not Applicable
Withdrawn
Conditions
Bladder Cancer
Colorectal Cancer
Breast Cancer
Lung Cancer
Hepatocellular Carcinoma
Interventions
Behavioral: Communication of Patients Lost to Follow-up to Providers
Registration Number
NCT01710293
Lead Sponsor
VA Office of Research and Development
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Communication of Patients Lost to Follow-up to ProvidersCommunication of Patients Lost to Follow-up to ProvidersThis intervention will consist of two related, continuous steps over at least a 12-month period. In the first step, the investigators will query the VA's Corporate Data Warehouse (CDW, a repository of near real-time patient data from all VA medical centers) weekly to identify possible lost to follow-up events in a pre-specified time period and for a random sample of about half of the providers at the investigators' study sites. These identified patient charts will be reviewed by Facility Recipients/Cancer Trackers at each site who will then communicate patients truly found to be lost to follow-up to the appropriate provider/care team.
Primary Outcome Measures
NameTimeMethod
Median Time from Initial Follow-up Delay to Follow-up Action1 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (5)

Edward Hines Jr. VA Hospital, Hines, IL

🇺🇸

Hines, Illinois, United States

Jesse Brown VA Medical Center, Chicago, IL

🇺🇸

Chicago, Illinois, United States

William S. Middleton Memorial Veterans Hospital, Madison, WI

🇺🇸

Madison, Wisconsin, United States

Minneapolis VA Health Care System, Minneapolis, MN

🇺🇸

Minneapolis, Minnesota, United States

Michael E. DeBakey VA Medical Center, Houston, TX

🇺🇸

Houston, Texas, United States

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