Evidence-based team intervention to reduce diagnostic errors in anaemia and CKD diagnoses in primary care: protocol for a stepped-wedge cluster RCT.
Zhanna Novikov, Nikhilesh Mehra, Xiao Li...
https://pubmed.ncbi.nlm.nih.gov/41644166Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05735314
A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency: a Stepped Wedge Cluster Randomized Control Trial
Led by The University of Texas Health Science Center, Houston · Updated on 2025-12-30
450
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new combination of evidence-based interventions (EBIs) aimed at improving diagnostic safety and efficiency in primary care for patients with anemia and decreased glomerular filtration rate. The study is designed as a stepped wedge cluster randomized control trial to measure how these interventions affect patient safety and healthcare efficiency, while also assessing factors influencing their implementation such as acceptability, cost, and sustainability. The study compares an enhanced diagnostic team approach to usual care. The enhanced approach includes automated detection and tracking of abnormal test results, expanding the primary care team to include clinical pharmacists to guide anemia evaluation, and engaging patients through nurse navigators to increase their activation in the diagnostic process. The study involves several clinic groups that receive the intervention at different times, ranging from 12 to 24 months, with some initial control periods. Participants will have their diagnostic accuracy for causes of low hemoglobin and decreased glomerular filtration rate assessed within six months. Researchers will track time to diagnosis, appropriate test usage, treatment costs, and primary care physicians' views on the intervention's acceptability and feasibility. The study also monitors how well the diagnostic process steps are followed, the intervention's reach among patients, and sustainability in clinics over 2.5 years. Patient activation and clinic-level facilitators and barriers are evaluated through surveys and measures during the study period.
CONDITIONS
Brief Title
A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Primary care providers including physicians, physician assistants, and advanced practice registered nurses who care for patients at participating clinics and agree to participate
- Patients with hemoglobin below 10.8 for females or below 12.5 for males, with normal white cell and platelet counts and a prior normal hemoglobin within two years
- Patients with estimated glomerular filtration rate (eGFR) below 60, with prior normal eGFR and matching normal creatinine within two years
- Not pregnant
- Speak English or Spanish
You will not qualify if you...
- Pregnant patients
- Patients who do not speak English or Spanish
- Patients without the specified abnormal hemoglobin or eGFR test results
- Primary care providers who do not agree to participate or do not care for patients at the clinic when enrollment begins
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Intervention
Duration - Up to 24 months depending on clinic assignment
Participants receive an enhanced diagnostic team process including automated abnormal test result detection, expanded primary care team support, and patient engagement to improve diagnosis of anemia and decreased kidney function.
Visits occur as part of routine primary care with additional assessments depending on clinic schedule
Monitoring
Duration - Up to 6 months from baseline
Participants are monitored for diagnostic outcomes and patient activation over time following the intervention.
Assessments occur periodically within 6 months after baseline
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Loading map...
Research Team
E
Eric Thomas, MD,MPH
E
Eric Thomas, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here