Colon CancerNCT01346839
Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care
A study testing Contact Intervention in people with Colon Cancer and Lung Cancer, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Diagnostic delays in ambulatory care are often due to breakdowns of related care processes. Electronic systems can improve follow-up and reduce delays by detecting missed appointments or incomplete procedures so that patients are called back to conduct timely investigations when appropriate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colon Cancer, Lung Cancer, Prostate Cancer
- What is being tested?
- Contact Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,256 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Aug 2012
- 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
- All primary care providers at both study sites who agree to be in the study. Intervention will be performed on those whose patients are electronically identified to have suspected cancer defined as presence of any predefined clue for cancer that is not followed-up in a timely manner. Three cancers are included; colorectal, lung and prostate and their clues include • chest x-imaging suspicious for malignancy • suspected or confirmed iron deficiency anemia • positive FOBT • hematochezia • abnormal PSA Patients will be selected from the data warehouse .
Who cannot join
- Primary care providers who do not wish to be in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Scott and White Memorial Hospital
Temple, Texas, 76508
About this study
Diagnostic delays in ambulatory care are often due to breakdowns of related care processes. Electronic systems can improve follow-up and reduce delays by detecting missed appointments or incomplete procedures so that patients are called back to conduct timely investigations when appropriate. To achieve high standards of patient safety in cancer diagnosis, the investigators not only need to use information technology appropriately but also improve the processes, policies, and procedures of monitoring, communication, and coordination of care.
Given the importance of cancer-related diagnostic delays in ambulatory care, the investigators need effective methods to detect them, understand their causes, and intervene to reduce them. Manual techniques to detect these delays, such as spontaneous reporting and random chart reviews, have limited effectiveness. Our proposed study focuses on testing methods to proactively identify delays using certain "triggers" as they occur and intervene in a timely manner.
Read the detailed description
The goal of this proposal is to demonstrate and test methods by which large health care systems can efficiently identify cancer patients who are more likely to experience diagnostic delays and pre-emptively rectify these delays. This study will build upon tools developed in our recent work (Aim1, prior IRB Protocol Number: H-23801) and test their effectiveness to identify patients at risk of experiencing delays in cancer diagnosis followed by an intervention that the investigators hypothesize will reduce these delays.
This is Aim 2 (for which the investigators are seeking approval) is the final Aim of this proposal. Aim 1 was approved under Protocol Number: H-23801.
In Aim 2 the investigators will determine the effectiveness of an IT-based intervention (consisting of data mining using triggers tested in Aim 1 followed by targeted electronic communication and surveillance techniques) to facilitate cancer diagnosis as compared with usual care (no use of trigger or electronic communication and surveillance). Hypothesis 1: The time from first appearance of a diagnostic clue to follow-up action (e.g. colonoscopy performance after a positive FOBT) will be significantly less in the intervention arm than in usual care. Hypothesis 2: The percentage of patients receiving timely follow-up care will be significantly more in the intervention arm than in usual care. To improve the generalizability of our findings to multiple ambulatory care environments, the investigators will conduct our research in two settings: an urban Veterans Affairs facility in Houston, Texas and a large primary care network in central Texas. These settings include internal medicine and family medicine, academic and nonacademic practices, and significant racial, gender, ethnic, age, urban/rural, and socioeconomic diversity. Our study addresses coordination and timeliness of care, both of which are priorities to achieve high quality care.
Hypothesis 3: Overall, the trigger will achieve a positive predictive value (PPV) of at least 50% in identifying delays in care. PPV is defined as the number of charts correctly identified with a delay in diagnostic evaluation, divided by the total number of charts identified by the trigger, and was deemed to be the approximately level necessary to avoid substantial contribution to provider alert fatigue.
- Conditions
- Colon Cancer, Lung Cancer, Prostate Cancer
- Being tested
- Contact Intervention
- Keywords
- Diagnostic delay, Prevention, Diagnostic errors
- Medical subject headings
- Colonic Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact InterventionBehavioural
The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
| Study group | Role | What they receive |
|---|---|---|
| Contact Intervention | Experimental | The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites. Receives: Behavioral: Contact Intervention |
| Usual Care Control | No intervention | The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer
Differences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.
Measured: 15 months
Secondary outcomes (4)
Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer
The percentage of patients receiving timely follow-up care, as defined by action taken by provider within appropriate pre-defined time intervals for each diagnostic clue, in both intervention and control groups.
Measured: 15 months
Percentage of Cases With no Documented Justification for no Follow-up
This is a descriptive sub-analysis looking only at cases with no follow-up at the end of the follow-up period. Specifically, out of the cases that never got follow-up, this represents the percent of that subsample that had no justification in the medical record for the lack of follow-up. This is based on manual chart reviews.
Measured: 15 months
Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation
Subsequent diagnosis of nonmalignant neoplasia, cancer, or death, and treatments required as a result of new cancer diagnoses after a pre-specified interval.
Measured: 15 months
Trigger Positive Predictive Value
Positive Predictive Values of each of the triggers in identifying patients with a true delay in diagnostic evaluation. Calculated as: percentage of patients identified as trigger positive that actually had a delay.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionAug 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Scott and White Hospital & Clinic
- Responsible party
- Principal investigator, Hardeep, Baylor College of Medicine
- Investigators
- Hardeep Singh, MD MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346839
- Sponsor's protocol ID
- H-24978
- Status last verified
- Jan 2016
- First submitted
- 23 Feb 2011
- Last updated
- 9 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Murphy DR, Wu L, Thomas EJ, Forjuoh SN, Meyer AN, Singh H. Electronic Trigger-Based Intervention to Reduce Delays in Diagnostic Evaluation for Cancer: A Cluster Randomized Controlled Trial. J Clin Oncol. 2015 Nov 1;33(31):3560-7. doi: 10.1200/JCO.2015.61.1301. Epub 2015 Aug 24.
PubMed 26304875
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care
- ClinicalTrials.gov ID
- NCT01346839
- Acronym / sponsor ID
- H-24978
- Conditions
- Colon Cancer, Lung Cancer, Prostate Cancer
- Keywords
- Diagnostic delay, Prevention, Diagnostic errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,256 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Scott and White Hospital & Clinic
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Posted 9 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diagnostic delays in ambulatory care are often due to breakdowns of related care processes. Electronic systems can improve follow-up and reduce delays by detecting missed appointments or incomplete procedures so that patients are called back to conduct timely investigations when appropriate. To achieve high standards of patient safety in cancer diagnosis, the investigators not only need to use information technology appropriately but also improve the processes, policies, and procedures of monitoring, communication, and coordination of care.
Given the importance of cancer-related diagnostic delays in ambulatory care, the investigators need effective methods to detect them, understand their causes, and intervene to reduce them. Manual techniques to detect these delays, such as spontaneous reporting and random chart reviews, have limited effectiveness. Our proposed study focuses on testing methods to proactively identify delays using certain "triggers" as they occur and intervene in a timely manner.
Detailed description
The goal of this proposal is to demonstrate and test methods by which large health care systems can efficiently identify cancer patients who are more likely to experience diagnostic delays and pre-emptively rectify these delays. This study will build upon tools developed in our recent work (Aim1, prior IRB Protocol Number: H-23801) and test their effectiveness to identify patients at risk of experiencing delays in cancer diagnosis followed by an intervention that the investigators hypothesize will reduce these delays.
This is Aim 2 (for which the investigators are seeking approval) is the final Aim of this proposal. Aim 1 was approved under Protocol Number: H-23801.
In Aim 2 the investigators will determine the effectiveness of an IT-based intervention (consisting of data mining using triggers tested in Aim 1 followed by targeted electronic communication and surveillance techniques) to facilitate cancer diagnosis as compared with usual care (no use of trigger or electronic communication and surveillance). Hypothesis 1: The time from first appearance of a diagnostic clue to follow-up action (e.g. colonoscopy performance after a positive FOBT) will be significantly less in the intervention arm than in usual care. Hypothesis 2: The percentage of patients receiving timely follow-up care will be significantly more in the intervention arm than in usual care. To improve the generalizability of our findings to multiple ambulatory care environments, the investigators will conduct our research in two settings: an urban Veterans Affairs facility in Houston, Texas and a large primary care network in central Texas. These settings include internal medicine and family medicine, academic and nonacademic practices, and significant racial, gender, ethnic, age, urban/rural, and socioeconomic diversity. Our study addresses coordination and timeliness of care, both of which are priorities to achieve high quality care.
Hypothesis 3: Overall, the trigger will achieve a positive predictive value (PPV) of at least 50% in identifying delays in care. PPV is defined as the number of charts correctly identified with a delay in diagnostic evaluation, divided by the total number of charts identified by the trigger, and was deemed to be the approximately level necessary to avoid substantial contribution to provider alert fatigue.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact Intervention | Experimental | Behavioral: Contact InterventionThe intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites. |
| Usual Care Control | No intervention | –The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All primary care providers at both study sites who agree to be in the study. Intervention will be performed on those whose patients are electronically identified to have suspected cancer defined as presence of any predefined clue for cancer that is not followed-up in a timely manner. Three cancers are included; colorectal, lung and prostate and their clues include • chest x-imaging suspicious for malignancy • suspected or confirmed iron deficiency anemia • positive FOBT • hematochezia • abnormal PSA Patients will be selected from the data warehouse .
Key exclusion criteria (1 listed)
- Primary care providers who do not wish to be in the study.
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 |
|---|---|---|
| Contact InterventionThe intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites. | Behavioural | Contact Intervention |
Primary outcome
Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer
Time frame: 15 months
Differences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.
4 secondary outcomes
Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer
Time frame: 15 months
Percentage of Cases With no Documented Justification for no Follow-up
Time frame: 15 months
Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation
Time frame: 15 months
Trigger Positive Predictive Value
Time frame: 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26304875Murphy DR, Wu L, Thomas EJ, Forjuoh SN, Meyer AN, Singh H. Electronic Trigger-Based Intervention to Reduce Delays in Diagnostic Evaluation for Cancer: A Cluster Randomized Controlled Trial. J Clin Oncol. 2015 Nov 1;33(31):3560-7. doi: 10.1200/JCO.2015.61.1301. Epub 2015 Aug 24.
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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
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact Intervention in people with Colon Cancer and Lung Cancer, run by Baylor College of Medicine 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 1 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 9 Feb 2016. 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 9 Feb 2016). 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?
Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer (time frame: 15 months). 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 NCT01346839, which also lists 1 linked publication.
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 9 Feb 2016.