Breast Cancer Clinical Trial
— PACT CREATE 3Official title:
Automated Point-of-Care Surveillance of Outpatient Delays in Cancer Diagnosis
Verified date | February 2018 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 27, 2017 |
Est. primary completion date | January 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois |
United States | Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois |
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin |
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
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. — View 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. — View 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. Epub 2016 Feb 19. — View 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. — View 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. — View 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. — View 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. — View 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. 2017 Feb 28. doi: 10.1097/PTS.0000000000000317. [Epub ahead of print] — View Citation
Singh H, Graber ML, Hofer TP. Measures to Improve Diagnostic Safety in Clinical Practice. J Patient Saf. 2016 Oct 20. [Epub ahead of print] — View 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. — View 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. — View 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year |
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