Lung CancerNCT04166240
Measuring and Improving the Safety of Test Result Follow-Up
A study testing SAFER TRACKS Intervention in people with Lung Cancer and Breast Cancer, run by VA Office of Research and Development at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Cancer, Breast Cancer, Colon Cancer
- What is being tested?
- SAFER TRACKS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2018to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Medical records that don't contain any tests, procedures, or appointments that need to be followed up on
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05009-0001
About this study
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.
Read the detailed description
The goal of this study is to develop and evaluate a new program for surveillance and improvement of test results-related diagnostic safety. The investigators will use a multifaceted measurement approach, the Virtual Breakthrough Series (VBTS) model, to account for processes of care and work systems issues as well as outcomes and implement change.
This is for Aim 2 of the study which was approved under Institutional Review Board (IRB) Protocol Number: H-45450. This study will implement the Change Package which was developed in the research team's recent work (Aim1, prior IRB Protocol Number: H-43661 from October 2018 - September 2019) via Virtual Breakthrough Series using a stepped-wedge cluster-randomized control trial. The study design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. A Change Package is a catalogue of evidence-based practices, change concepts, and action steps/strategies that help guide improvement efforts. VBTS involves monthly learning sessions where participants are provided with education/review of a specific component of a Change Package along with reviewing de-identified data, and having a facilitated discussion about successes, challenges, and implementation progress related to needed changes. The intervention will consist of coached implementation of the SAFER Change Package using a VBTS Collaborative, plus automated near real-time surveillance data on potentially missed test results through monthly data extraction within the Corporate Data Warehouse (CDW) platform.
The study's outcome measures will be the rate of missed test results, determined through random manual medical record review conducted nationally as part of the VHA performance-measurement system, known as the External Peer Review Program (EPRP) which has been collecting facility-level data on timeliness of communication of test results to patients within the time periods specified by VHA Directive 1088, as well as automated indicators (Triggers) of missed test results. Electronic surveillance will be made possible through the use of the research team's trigger algorithms which will determine the number of patients potentially lost to follow-up for the specified condition based on a previously validated timeframe. The triggers use the national EHR data warehouse (VINCI/CDW) to identify patients at risk for delays or patients who may have fallen through the cracks. For data surveillance, the investigators will apply five triggers to the medical record data contained within the CDW for the participating facilities during the Intervention Phase along with evaluating EPRP data. The research team hypothesizes there will be fewer missed test results in participating sites during the SAFER TRACKS Intervention as compared to during the pre-intervention period.
- Conditions
- Lung Cancer, Breast Cancer, Colon Cancer, Bladder Cancer, Hepatocellular Cancer
- Being tested
- SAFER TRACKS Intervention
- Keywords
- Diagnostic Errors, Quality Improvement, Patient Safety, Delayed Diagnosis
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Colonic Neoplasms, Urinary Bladder Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFER TRACKS InterventionBehavioural
SAFER Change Package delivered using a Virtual Breakthrough Series [VBTS] Collaborative supplemented with automated surveillance data on test results.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 32 months
External Peer Review Program (EPRP) Outcome
Percentage of patients notified of actionable test results within seven days via EPRP
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Oct 2018
- Primary completion1 Apr 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's a cluster randomized control trial where 12 sites are randomized in groups of 4 in 3 clusters each.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Michael E. DeBakey VA Medical Center, Baylor College of Medicine, Birmingham VA Health Care System
- Responsible party
- Sponsor
- Investigators
- Hardeep Singh, MD MPH, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166240
- Sponsor's protocol ID
- IIR 17-127
- Other IDs
- H-45450
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2019
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share individual site data.
Publications
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.
PubMed 31200676Murphy 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.
PubMed 31584683Gandhi 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.
PubMed 32490798Giardina 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.
PubMed 32362355Cifra 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.
PubMed 32980235Zimolzak 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.
PubMed 33907982Meyer 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.
PubMed 34312032Vaghani 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.
PubMed 34279630Murphy 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.
PubMed 34615664Sittig 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.
PubMed 35022741Sittig 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.
PubMed 35129591Singh 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.
PubMed 35172968Shafer 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.
PubMed 35246625Giardina 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.
PubMed 35348688Shen 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.
PubMed 34844874
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring and Improving the Safety of Test Result Follow-Up
- ClinicalTrials.gov ID
- NCT04166240
- Acronym / sponsor ID
- IIR 17-127
- Conditions
- Lung Cancer, Breast Cancer, Colon Cancer, Bladder Cancer, Hepatocellular Cancer
- Keywords
- Diagnostic Errors, Quality Improvement, Patient Safety, Delayed Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Michael E. DeBakey VA Medical Center, Baylor College of Medicine, Birmingham VA Health Care System
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study is to develop and evaluate a new program for surveillance and improvement of test results-related diagnostic safety. The investigators will use a multifaceted measurement approach, the Virtual Breakthrough Series (VBTS) model, to account for processes of care and work systems issues as well as outcomes and implement change.
This is for Aim 2 of the study which was approved under Institutional Review Board (IRB) Protocol Number: H-45450. This study will implement the Change Package which was developed in the research team's recent work (Aim1, prior IRB Protocol Number: H-43661 from October 2018 - September 2019) via Virtual Breakthrough Series using a stepped-wedge cluster-randomized control trial. The study design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. A Change Package is a catalogue of evidence-based practices, change concepts, and action steps/strategies that help guide improvement efforts. VBTS involves monthly learning sessions where participants are provided with education/review of a specific component of a Change Package along with reviewing de-identified data, and having a facilitated discussion about successes, challenges, and implementation progress related to needed changes. The intervention will consist of coached implementation of the SAFER Change Package using a VBTS Collaborative, plus automated near real-time surveillance data on potentially missed test results through monthly data extraction within the Corporate Data Warehouse (CDW) platform.
The study's outcome measures will be the rate of missed test results, determined through random manual medical record review conducted nationally as part of the VHA performance-measurement system, known as the External Peer Review Program (EPRP) which has been collecting facility-level data on timeliness of communication of test results to patients within the time periods specified by VHA Directive 1088, as well as automated indicators (Triggers) of missed test results. Electronic surveillance will be made possible through the use of the research team's trigger algorithms which will determine the number of patients potentially lost to follow-up for the specified condition based on a previously validated timeframe. The triggers use the national EHR data warehouse (VINCI/CDW) to identify patients at risk for delays or patients who may have fallen through the cracks. For data surveillance, the investigators will apply five triggers to the medical record data contained within the CDW for the participating facilities during the Intervention Phase along with evaluating EPRP data. The research team hypothesizes there will be fewer missed test results in participating sites during the SAFER TRACKS Intervention as compared to during the pre-intervention period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It's a cluster randomized control trial where 12 sites are randomized in groups of 4 in 3 clusters each.
| Arm | Type | Receives |
|---|---|---|
| SAFER TRACKS Intervention | Experimental | Behavioral: SAFER TRACKS InterventionEach 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Medical records that don't contain any tests, procedures, or appointments that need to be followed up on
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAFER TRACKS InterventionSAFER Change Package delivered using a Virtual Breakthrough Series [VBTS] Collaborative supplemented with automated surveillance data on test results. | Behavioural | SAFER TRACKS Intervention |
Primary outcome
Trigger Outcome
Time frame: 32 months
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.
External Peer Review Program (EPRP) Outcome
Time frame: 32 months
Percentage of patients notified of actionable test results within seven days via EPRP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31200676Walter 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.
- Background: PubMed 31584683Murphy 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.
- Background: PubMed 32490798Gandhi 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.
- Background: PubMed 32362355Giardina 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.
- Background: PubMed 32980235Cifra 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.
- Background: PubMed 33907982Zimolzak 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.
- Background: PubMed 34312032Meyer 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.
- Background: PubMed 34279630Vaghani 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.
- Background: PubMed 34615664Murphy 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.
- Background: PubMed 35022741Sittig 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.
- Background: PubMed 35129591Sittig 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.
- Background: PubMed 35172968Singh 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.
- Individual participant dataSharing planned: No. No plans to share individual site data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hardeep Singh, MD MPH principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAFER TRACKS Intervention in people with Lung Cancer and Breast Cancer, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trigger Outcome (time frame: 32 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04166240, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.