Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care
1 other identifier
interventional
1,256
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 23, 2011
CompletedFirst Posted
Study publicly available on registry
May 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
February 9, 2016
CompletedFebruary 9, 2016
January 1, 2016
1.5 years
February 23, 2011
August 24, 2015
January 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
15 months
Secondary Outcomes (4)
Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer
15 months
Percentage of Cases With no Documented Justification for no Follow-up
15 months
Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation
15 months
Trigger Positive Predictive Value
15 months
Study Arms (2)
Contact Intervention
EXPERIMENTALThe 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 INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- Primary care providers who do not wish to be in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- Scott and White Hospital & Cliniccollaborator
Study Sites (2)
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Related Publications (1)
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.
PMID: 26304875DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Hardeep Singh
- Organization
- Michael E. DeBakey VA Medical Center and Baylor College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Hardeep Singh, MD MPH
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 23, 2011
First Posted
May 3, 2011
Study Start
February 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
February 9, 2016
Results First Posted
February 9, 2016
Record last verified: 2016-01