Measuring and Improving the Safety of Test Result Follow-Up

NCT04166240 | Completed Results

• 2 other identifiers: IIR 17-127H-45450
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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

Lung Cancer; Breast Cancer; Colon Cancer; Bladder Cancer; Hepatocellular Cancer

Keywords

Diagnostic Errors; Quality Improvement; Patient Safety; Delayed Diagnosis

Outcome Measures

Primary Outcomes (2)

• Trigger Outcome

  Percentage of missed test results determined by electronic indicators. The percentage of test results with timely follow up was calculated for each participating site, out of all abnormal tests at that site. Reporting measure type: Percentage of tests with timely follow-up across all sites.

  32 months

• External Peer Review Program (EPRP) Outcome

  Percentage of patients notified of actionable test results within seven days via EPRP

  32 months

Study Arms (2)

SAFER TRACKS Intervention

EXPERIMENTAL

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.

Behavioral: SAFER TRACKS Intervention

Non-intervention period

NO INTERVENTION

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.

Interventions

SAFER TRACKS Intervention BEHAVIORAL

SAFER Change Package delivered using a Virtual Breakthrough Series \[VBTS\] Collaborative supplemented with automated surveillance data on test results.

SAFER TRACKS Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Medical records that don't contain any tests, procedures, or appointments that need to be followed up on

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Michael E. DeBakey VA Medical Center: collaborator
• Baylor College of Medicine: collaborator
• Birmingham VA Health Care System: collaborator

Study Sites (2)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05009-0001, United States

Location

Related Publications (28)

• 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.

  PMID: 31200676 BACKGROUND

• 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: 10.1001/jamanetworkopen.2019.12638.

  PMID: 31584683 BACKGROUND

• 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. No abstract available.

  PMID: 32490798 BACKGROUND

• 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 2020 Feb 21.

  PMID: 32362355 BACKGROUND

• 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: 10.1016/j.jcrc.2020.09.011. Epub 2020 Sep 18.

  PMID: 32980235 BACKGROUND

• 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/s11606-021-06772-y. Epub 2021 Apr 27.

  PMID: 33907982 BACKGROUND

• 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 Jul 15.

  PMID: 34312032 BACKGROUND

• 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.

  PMID: 34279630 BACKGROUND

• 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):e100437. doi: 10.1136/bmjhci-2021-100437.

  PMID: 34615664 BACKGROUND

• 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.

  PMID: 35022741 BACKGROUND

• 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. No abstract available.

  PMID: 35129591 BACKGROUND

• 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. No abstract available.

  PMID: 35172968 BACKGROUND

• 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 Oct;42(10):1312-1318. doi: 10.1038/s41372-022-01359-9. Epub 2022 Mar 4.

  PMID: 35246625 BACKGROUND

• 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):1091-1100. doi: 10.1093/jamia/ocac036.

  PMID: 35348688 BACKGROUND

• 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.

  PMID: 34844874 BACKGROUND

• 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/jamanetworkopen.2021.27827.

  PMID: 34596670 BACKGROUND

• 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. No abstract available.

  PMID: 34505867 BACKGROUND

• 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(714):e19-e25. doi: 10.3399/BJGP.2021.0282. Print 2022 Jan.

  PMID: 34903517 BACKGROUND

• 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 Saf. 2022 Sep 1;18(6):521-525. doi: 10.1097/PTS.0000000000001006. Epub 2022 Apr 22.

  PMID: 35443253 BACKGROUND

• 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 2022 Aug 1.

  PMID: 35393849 BACKGROUND

• 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 Dec 1;18(8):770-778. doi: 10.1097/PTS.0000000000000999. Epub 2022 Apr 27.

  PMID: 35405723 BACKGROUND

• 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.

  PMID: 35452111 BACKGROUND

• 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 Commonly Used Quality Measure. Jt Comm J Qual Patient Saf. 2022 Apr;48(4):222-232. doi: 10.1016/j.jcjq.2022.01.003. Epub 2022 Jan 13.

  PMID: 35190249 BACKGROUND

• 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.

  PMID: 35366423 BACKGROUND

• 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 Clin Inform. 2022 Mar;13(2):495-503. doi: 10.1055/s-0042-1748147. Epub 2022 May 11.

  PMID: 35545126 BACKGROUND

• Bradford A, Shofer M, Singh H. Measure Dx: Implementing pathways to discover and learn from diagnostic errors. Int J Qual Health Care. 2022 Sep 10;34(3):mzac068. doi: 10.1093/intqhc/mzac068.

  PMID: 36047352 BACKGROUND

• Bradford A, Singh H. Building clinical pathways of the future that improve safety and reduce waste in healthcare. J Hosp Med. 2023 Feb;18(2):200-201. doi: 10.1002/jhm.13044. Epub 2023 Jan 12. No abstract available.

  PMID: 36633160 BACKGROUND

• Zubkoff L, Zimolzak AJ, Meyer AND, Sloane J, Shahid U, Giardina T, Memon SA, Scott TM, Murphy DR, Singh H. A Virtual Breakthrough Series Collaborative for Missed Test Results: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2440269. doi: 10.1001/jamanetworkopen.2024.40269.

  PMID: 39476237 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Colonic Neoplasms; Urinary Bladder Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Liver Diseases

Results Point of Contact

• Title: Hardeep Singh
• Organization: VAORD

hardeep.singh@va.gov

713 7948515

Study Officials

• Hardeep Singh, MD MPH

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: VBTS participants, providers, and outcome assessors know about the intervention and in which conditions sites are in and when.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: It's a cluster randomized control trial where 12 sites are randomized in groups of 4 in 3 clusters each.

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: October 1, 2018
• Primary Completion: April 1, 2022
• Study Completion: September 30, 2023
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)