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/41644166/Actively Recruiting
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
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 interventions acceptability and feasibility. The study also monitors how well the diagnostic process steps are followed, the interventions 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
A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency
E
Eric Thomas, MD,MPH
E
Eric Thomas, MD, MPH
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The University of Texas Health Science Center, Houston
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Enhanced diagnostic team (trial intervention) | Usual care (trial comparator) |
|---|---|---|
| What this approach is | Primary care clinics use a team‑based intervention that combines automated abnormal result tracking, clinical pathologist input, and nurse navigator coordination | Primary care clinics continue standard practice where providers order tests and referrals for patients with anemia and low GFR |
| Role in the trial | This is the experimental condition being evaluated | This condition serves as the control comparator in the crossover design |
| Primary purpose | To increase the proportion of patients correctly diagnosed with cause of anemia and decreased GFR within 6 months | To represent the existing standard diagnostic process against which the intervention is evaluated |
| How the approach is implemented | Clinics receive automated lab abnormality alerts; pathologists consult with providers; nurse navigators help coordinate follow‑up | Providers manage diagnostic follow‑up and referrals in routine fashion |
| Evidence status | Effectiveness is under study; results pending when trial completes | Represents current diagnostic process in participating clinics |
| Potential risks | Unknown; the protocol does not anticipate specific safety risks from team‑based process changes | No new risks beyond those of routine diagnosis |
| Important limitations | Results are pending and limited to primary care clinics within a single health system | Diagnosis under usual care may vary between clinics and may change over time |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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Zhanna Novikov, Nikhilesh Mehra, Xiao Li...
https://pubmed.ncbi.nlm.nih.gov/41644166/The University of Texas Health Science Center, Houston
Lead Sponsor