Breast Cancer Clinical Trial
Official title:
Measuring and Improving the Safety of Test Result Follow-Up
Verified date | September 2022 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Improving communication is foundational to improving patient safety. Electronic health records (EHRs) can improve communication, but also introduce unique vulnerabilities. Failure to follow-up abnormal test results (missed results) is a key preventable factor in diagnosis and treatment delays in the VHA and often involves EHR-based communication breakdowns. Effective methods are needed to detect diagnostic delays and intervene appropriately. Manual techniques to detect care delays, such as spontaneous reporting and random chart reviews, have limited effectiveness, due in part to bias and lack of provider awareness of delays. They are also inefficient and cost-prohibitive when applied to large numbers of patients. Diagnostic errors are considered harder to tackle, in part because they are difficult to measure. Rigorous measurement of diagnostic safety is essential and should be prioritized given the increasing amount of electronically available data. To create an effective measurement and learning program researchers must (1) ensure teams know how to take actionable steps on data and have assistance in doing so and (2) prioritize diagnostic safety at the organizational level by securing commitment from local VA leadership and clinical operations personnel. This will ensure that safety measurement will translate into action. The proposed study focuses on creating a novel program to develop and evaluate multifaceted socio-technical tools and strategies to help prevent, detect, mitigate, and ameliorate breakdowns in EHR-based communication that often lead to "missed" test results in the VHA.
Status | Active, not recruiting |
Enrollment | 11 |
Est. completion date | September 1, 2023 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Medical records identified via CDW which fall under the EPRP measures (FOBT/FIT, HCV, Mammogram, AFP, DEXA Scan, Pap/HPV, Chest X-ray, and Chest CT) - Medical records containing clinical findings suspicious for breast cancer, lung cancer, bladder cancer, hepatocellular carcinoma, and colorectal cancer (CRC) Exclusion Criteria: - Medical records that don't contain any tests, procedures, or appointments that need to be followed up on |
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | White River Junction VA Medical Center, White River Junction, VT | White River Junction | Vermont |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Baylor College of Medicine, Birmingham Veterans Affairs Health Care System, Michael E. DeBakey VA Medical Center |
United States,
Bradford A, Shahid U, Schiff GD, Graber ML, Marinez A, DiStabile P, Timashenka A, Jalal H, Brady PJ, Singh H. Development and Usability Testing of the Agency for Healthcare Research and Quality Common Formats to Capture Diagnostic Safety Events. J Patient — View Citation
Cifra CL, Dukes KC, Ayres BS, Calomino KA, Herwaldt LA, Singh H, Reisinger HS. Referral communication for pediatric intensive care unit admission and the diagnosis of critically ill children: A pilot ethnography. J Crit Care. 2021 Jun;63:246-249. doi: 10. — View Citation
Cifra CL, Tigges CR, Miller SL, Curl N, Monson CD, Dukes KC, Reisinger HS, Pennathur PR, Sittig DF, Singh H. Reporting Outcomes of Pediatric Intensive Care Unit Patients to Referring Physicians via an Electronic Health Record-Based Feedback System. Appl C — View Citation
Fischer H, Hahn EE, Li BH, Munoz-Plaza CE, Luong TQ, Harrison TN, Slezak JM, Sim JJ, Mittman BS, Lee EA, Singh H, Kanter MH, Reynolds K, Danforth KN. Potentially Harmful Medication Dispenses After a Fall or Hip Fracture: A Mixed Methods Study of a Commonl — View Citation
Gandhi TK, Singh H. Reducing the Risk of Diagnostic Error in the COVID-19 Era. J Hosp Med. 2020 Jun;15(6):363-366. doi: 10.12788/jhm.3461. Review. — View Citation
Giardina TD, Choi DT, Upadhyay DK, Korukonda S, Scott TM, Spitzmueller C, Schuerch C, Torretti D, Singh H. Inviting patients to identify diagnostic concerns through structured evaluation of their online visit notes. J Am Med Inform Assoc. 2022 May 11;29(6 — View Citation
Giardina TD, Hunte H, Hill MA, Heimlich SL, Singh H, Smith KM. Defining Diagnostic Error: A Scoping Review to Assess the Impact of the National Academies' Report Improving Diagnosis in Health Care. J Patient Saf. 2022 Apr 27. doi: 10.1097/PTS.000000000000 — View Citation
Giardina TD, Royse KE, Khanna A, Haskell H, Hallisy J, Southwick F, Singh H. Health Care Provider Factors Associated with Patient-Reported Adverse Events and Harm. Jt Comm J Qual Patient Saf. 2020 May;46(5):282-290. doi: 10.1016/j.jcjq.2020.02.004. Epub 2 — View Citation
Makris KI, Clark DL, Buffie AW, Steen EH, Ramsey DJ, Singh H. Missed Opportunities to Promptly Diagnose and Treat Adrenal Tumors. J Surg Res. 2022 Aug;276:174-181. doi: 10.1016/j.jss.2022.02.049. Epub 2022 Mar 30. — View Citation
Meyer AND, Giardina TD, Khawaja L, Singh H. Patient and clinician experiences of uncertainty in the diagnostic process: Current understanding and future directions. Patient Educ Couns. 2021 Nov;104(11):2606-2615. doi: 10.1016/j.pec.2021.07.028. Epub 2021 — View Citation
Meyer AND, Scott TMT, Singh H. Adherence to National Guidelines for Timeliness of Test Results Communication to Patients in the Veterans Affairs Health Care System. JAMA Netw Open. 2022 Apr 1;5(4):e228568. doi: 10.1001/jamanetworkopen.2022.8568. — View Citation
Murphy DR, Giardina TD, Satterly T, Sittig DF, Singh H. An Exploration of Barriers, Facilitators, and Suggestions for Improving Electronic Health Record Inbox-Related Usability: A Qualitative Analysis. JAMA Netw Open. 2019 Oct 2;2(10):e1912638. doi: 10.10 — View Citation
Murphy DR, Savoy A, Satterly T, Sittig DF, Singh H. Dashboards for visual display of patient safety data: a systematic review. BMJ Health Care Inform. 2021 Oct;28(1). pii: e100437. doi: 10.1136/bmjhci-2021-100437. — View Citation
Ramesh S, Ayres B, Eyck PT, Dawson JD, Reisinger HS, Singh H, Herwaldt LA, Cifra CL. Impact of subspecialty consultations on diagnosis in the pediatric intensive care unit. Diagnosis (Berl). 2022 Apr 11;9(3):379-384. doi: 10.1515/dx-2021-0137. eCollection — View Citation
Read AJ, Waljee AK, Sussman JB, Singh H, Chen GY, Vijan S, Saini SD. Testing Practices, Interpretation, and Diagnostic Evaluation of Iron Deficiency Anemia by US Primary Care Physicians. JAMA Netw Open. 2021 Oct 1;4(10):e2127827. doi: 10.1001/jamanetworko — View Citation
Shafer GJ, Singh H, Thomas EJ, Thammasitboon S, Gautham KS. Frequency of diagnostic errors in the neonatal intensive care unit: a retrospective cohort study. J Perinatol. 2022 Mar 4. doi: 10.1038/s41372-022-01359-9. [Epub ahead of print] — View Citation
Shen L, Levie A, Singh H, Murray K, Desai S. Harnessing Event Report Data to Identify Diagnostic Error During the COVID-19 Pandemic. Jt Comm J Qual Patient Saf. 2022 Feb;48(2):71-80. doi: 10.1016/j.jcjq.2021.10.002. Epub 2021 Oct 29. — View Citation
Singh H, Connor DM, Dhaliwal G. Five strategies for clinicians to advance diagnostic excellence. BMJ. 2022 Feb 16;376:e068044. doi: 10.1136/bmj-2021-068044. — View Citation
Sittig DF, Lakhani P, Singh H. Applying requisite imagination to safeguard electronic health record transitions. J Am Med Inform Assoc. 2022 Apr 13;29(5):1014-1018. doi: 10.1093/jamia/ocab291. — View Citation
Sittig DF, Sengstack P, Singh H. Guidelines for US Hospitals and Clinicians on Assessment of Electronic Health Record Safety Using SAFER Guides. JAMA. 2022 Feb 22;327(8):719-720. doi: 10.1001/jama.2022.0085. — View Citation
Sittig DF, Singh H. Policies to Promote Shared Responsibility for Safer Electronic Health Records. JAMA. 2021 Oct 19;326(15):1477-1478. doi: 10.1001/jama.2021.13945. — View Citation
Vaghani V, Wei L, Mushtaq U, Sittig DF, Bradford A, Singh H. Validation of an electronic trigger to measure missed diagnosis of stroke in emergency departments. J Am Med Inform Assoc. 2021 Sep 18;28(10):2202-2211. doi: 10.1093/jamia/ocab121. — View Citation
Walter FM, Thompson MJ, Wellwood I, Abel GA, Hamilton W, Johnson M, Lyratzopoulos G, Messenger MP, Neal RD, Rubin G, Singh H, Spencer A, Sutton S, Vedsted P, Emery JD. Evaluating diagnostic strategies for early detection of cancer: the CanTest framework. BMC Cancer. 2019 Jun 14;19(1):586. doi: 10.1186/s12885-019-5746-6. — View Citation
Zhou Y, Walter FM, Mounce L, Abel GA, Singh H, Hamilton W, Stewart GD, Lyratzopoulos G. Identifying opportunities for timely diagnosis of bladder and renal cancer via abnormal blood tests: a longitudinal linked data study. Br J Gen Pract. 2021 Dec 31;72(7 — View Citation
Zimolzak AJ, Shahid U, Giardina TD, Memon SA, Mushtaq U, Zubkoff L, Murphy DR, Bradford A, Singh H. Why Test Results Are Still Getting "Lost" to Follow-up: a Qualitative Study of Implementation Gaps. J Gen Intern Med. 2022 Jan;37(1):137-144. doi: 10.1007/ — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trigger Outcome | Number of missed test results determined by electronic indicators | 6 months | |
Primary | EPRP Outcome | Percentage of patients notified of actionable test results within seven days via EPRP | 6 months |
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