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

February 22, 2018 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center, Chicago, IL
      • Hines, Illinois, United States, 60141-5000
        • Edward Hines Jr. VA Hospital, Hines, IL
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System, Minneapolis, MN
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center, Houston, TX
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • William S. Middleton Memorial Veterans Hospital, Madison, WI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Communication of Patients Lost to Follow-up to Providers
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.
Behavioral: Communication of Patients Lost to Follow-up to Providers
The investigators will query the VA's database weekly to identify possible lost to follow-up events for a random sample of about half of the providers at our study sites. The queries will use the trigger criteria developed in our previous work for colorectal cancer, lung cancer, hepatocellular carcinoma, breast cancer, and bladder cancer. The list of trigger positive patients will be transmitted to a facility-level recipient who will either disseminate the information to existing facility individual cancer care coordinators/trackers or will review the charts of the "triggered" patients in order to determine whether these patients have been truly lost to follow-up or not. If patients are found to be lost to follow-up, the Facility Recipient or cancer care coordinator/tracker will communicate the need for follow-up to the PACT or primary care provider, using secure emails, phone calls, or in person, depending on which method of communication they deem most appropriate and effective.
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hardeep Singh, MD MPH BS, Michael E. DeBakey VA Medical Center, Houston, TX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRE 12-033
  • CIRB 15-07 (Other Identifier: VA Central IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

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Dietary Supplements

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Locations

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