Clinical trial · Interventional
Measuring and Improving the Safety of Test Result Follow-Up
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 Veteran's Health Administration (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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAFER TRACKS Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SAFER TRACKS Intervention
- description
- Each cluster starts receiving the intervention in sequence per cluster randomized control trial designs. Each cluster will participate in attending monthly coaching calls and compare their data on test results from pre-intervention to receiving the intervention.
- interventionNames
- Behavioral: SAFER TRACKS Intervention
- type
- NO_INTERVENTION
- label
- Non-intervention period
- description
- When the cluster is not in active intervention, they are in the non-intervention period. The amount of time that each site contributes to the intervention depends on which cluster they belong to.
Primary outcomes (2)
- measure
- Trigger Outcome
- timeFrame
- 32 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Medical records identified via CDW which fall under the EPRP measures (Fecal Occult Blood Test FOBT)/Fecal Immunohistochemical Test (FIT), Hepatitis C Virus (HCV), Mammogram, alpha feto protein (AFP), dual energy x-ray absorptiometry (DEXA) Scan, Pap/ human papillomavirus (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
References
Publications (28)
- BACKGROUNDWalter 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. PMID 31200676
- BACKGROUNDMurphy 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: 10.1001/jamanetworkopen.2019.12638. PMID 31584683
- BACKGROUNDGandhi 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. No abstract available. PMID 32490798
- BACKGROUNDGiardina 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 2020 Feb 21. PMID 32362355
- BACKGROUNDCifra 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: 10.1016/j.jcrc.2020.09.011. Epub 2020 Sep 18. PMID 32980235
- BACKGROUNDZimolzak 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/s11606-021-06772-y. Epub 2021 Apr 27. PMID 33907982
- BACKGROUNDMeyer 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 Jul 15.