Back to results

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

Primary Purpose

Lung Cancer, Bladder Cancer, Colorectal Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Communication of Patients Lost to Follow-up to Providers

About this trial

This is an interventional health services research trial for Lung Cancer focused on measuring Electronic Health Records, Diagnostic Delay, Triggers

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Jesse Brown VA Medical Center, Chicago, IL
Edward Hines Jr. VA Hospital, Hines, IL
Minneapolis VA Health Care System, Minneapolis, MN
Michael E. DeBakey VA Medical Center, Houston, TX
William S. Middleton Memorial Veterans Hospital, Madison, WI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Communication of Patients Lost to Follow-up to Providers

Usual Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT01710293

First Posted

October 16, 2012

Last Updated

February 22, 2018

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01710293

Brief Title

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

Acronym

PACT CREATE 3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to obtain data needed to run the RCT; project never began recruitment

Study Start Date

January 27, 2017 (Actual)

Primary Completion Date

January 27, 2017 (Actual)

Study Completion Date

January 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Bladder Cancer, Colorectal Cancer, Hepatocellular Carcinoma, Breast Cancer

Keywords

Electronic Health Records, Diagnostic Delay, Triggers

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Communication of Patients Lost to Follow-up to Providers

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Communication of Patients Lost to Follow-up to Providers

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hardeep Singh, MD MPH BS

Organizational Affiliation

Michael E. DeBakey VA Medical Center, Houston, TX

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jesse Brown VA Medical Center, Chicago, IL

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Edward Hines Jr. VA Hospital, Hines, IL

City

Hines

State/Province

Illinois

ZIP/Postal Code

60141-5000

Country

United States

Facility Name

Minneapolis VA Health Care System, Minneapolis, MN

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55417

Country

United States

Facility Name

Michael E. DeBakey VA Medical Center, Houston, TX

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

William S. Middleton Memorial Veterans Hospital, Madison, WI

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26974737

Citation

Murphy DR, Meyer AN, Russo E, Sittig DF, Wei L, Singh H. The Burden of Inbox Notifications in Commercial Electronic Health Records. JAMA Intern Med. 2016 Apr;176(4):559-60. doi: 10.1001/jamainternmed.2016.0209. No abstract available.

Results Reference

background

PubMed Identifier

28366427

Citation

Bhise V, Meyer AND, Singh H, Wei L, Russo E, Al-Mutairi A, Murphy DR. Errors in Diagnosis of Spinal Epidural Abscesses in the Era of Electronic Health Records. Am J Med. 2017 Aug;130(8):975-981. doi: 10.1016/j.amjmed.2017.03.009. Epub 2017 Mar 31.

Results Reference

result

PubMed Identifier

28326433

Citation

Murphy DR, Meyer AN, Vaghani V, Russo E, Sittig DF, Richards KA, Wei L, Wu L, Singh H. Application of Electronic Algorithms to Improve Diagnostic Evaluation for Bladder Cancer. Appl Clin Inform. 2017 Mar 22;8(1):279-290. doi: 10.4338/ACI-2016-10-RA-0176.

Results Reference

result

PubMed Identifier

28138875

Citation

Meyer AND, Murphy DR, Al-Mutairi A, Sittig DF, Wei L, Russo E, Singh H. Electronic Detection of Delayed Test Result Follow-Up in Patients with Hypothyroidism. J Gen Intern Med. 2017 Jul;32(7):753-759. doi: 10.1007/s11606-017-3988-z. Epub 2017 Jan 30.

Results Reference

result

PubMed Identifier

28031286

Citation

Menon S, Singh H, Giardina TD, Rayburn WL, Davis BP, Russo EM, Sittig DF. Safety huddles to proactively identify and address electronic health record safety. J Am Med Inform Assoc. 2017 Mar 1;24(2):261-267. doi: 10.1093/jamia/ocw153.

Results Reference

result

PubMed Identifier

27720139

Citation

Baldwin JL, Singh H, Sittig DF, Giardina TD. Patient portals and health apps: Pitfalls, promises, and what one might learn from the other. Healthc (Amst). 2017 Sep;5(3):81-85. doi: 10.1016/j.hjdsi.2016.08.004. Epub 2016 Oct 3.

Results Reference

result

PubMed Identifier

27768655

Citation

Singh H, Graber ML, Hofer TP. Measures to Improve Diagnostic Safety in Clinical Practice. J Patient Saf. 2019 Dec;15(4):311-316. doi: 10.1097/PTS.0000000000000338.

Results Reference

result

PubMed Identifier

28334582

Citation

Singh H. Improving Diagnostic Safety in Primary Care by Unlocking Digital Data. Jt Comm J Qual Patient Saf. 2017 Jan;43(1):29-31. doi: 10.1016/j.jcjq.2016.10.007. Epub 2016 Oct 14. No abstract available.

Results Reference

result

PubMed Identifier

27347474

Citation

Giardina TD, Sarkar U, Gourley G, Modi V, Meyer AN, Singh H. Online public reactions to frequency of diagnostic errors in US outpatient care. Diagnosis (Berl). 2016 Mar;3(1):17-22. doi: 10.1515/dx-2015-0022. Epub 2016 Feb 19.

Results Reference

result

PubMed Identifier

27530239

Citation

Singh H, Schiff GD, Graber ML, Onakpoya I, Thompson MJ. The global burden of diagnostic errors in primary care. BMJ Qual Saf. 2017 Jun;26(6):484-494. doi: 10.1136/bmjqs-2016-005401. Epub 2016 Aug 16.

Results Reference

result

PubMed Identifier

27830226

Citation

Sittig DF, Wright A, Ash J, Singh H. New Unintended Adverse Consequences of Electronic Health Records. Yearb Med Inform. 2016 Nov 10;(1):7-12. doi: 10.15265/IY-2016-023.

Results Reference

result

PubMed Identifier

28248748

Citation

Pfoh ER, Engineer L, Singh H, Hall LL, Fried ED, Berger Z, Wu AW. Informing the Design of a New Pragmatic Registry to Stimulate Near Miss Reporting in Ambulatory Care. J Patient Saf. 2021 Apr 1;17(3):e121-e127. doi: 10.1097/PTS.0000000000000317.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs