Intervention Protocol for Automated Point-of-Care Surveillance of Outpatient Delays in Cancer Diagnosis (PACT CREATE 3)

VA Office of Research and Development

Status: Withdrawn

Conditions: Breast Cancer; Bladder Cancer; Hepatocellular Carcinoma; Lung Cancer; Colorectal Cancer

Treatments: Behavioral: Communication of Patients Lost to Follow-up to Providers

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01710293

CRE 12-033

CIRB 15-07 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Communication of Patients Lost to Follow-up to Providers

Experimental group

Description:

This 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.

Treatment:

Behavioral: Communication of Patients Lost to Follow-up to Providers

Usual Care

No Intervention group

Description:

In the usual care group, providers will continue to use the existing notification system to receive abnormal test results in accordance with institutional norms, policies, and procedures. There are no formal patient-tracking programs currently at our study sites for all abnormal test results. The investigators will apply our computerized surveillance tools in the usual care arm only when the investigators are ready to conduct the final chart reviews on intervention patients and identify these patients in similar time periods as in the intervention arm. If persistent delays are found, the investigators will inform the patients' primary care providers.